soil investigation report -...
TRANSCRIPT
Soil Investigation Report
For
Construction work of API Production unit at Plot no Plot no
825-826 Sector III Industrial area Pithampur Distt Dhar (MP)
Submitted to
Ms Enaltech Labs Pvt Ltd
Plot no 825-826 Sector III Industrial area
Pithampur Distt Dhar (MP)
Submitted By
Apron Test Labs amp Consultants Pvt Ltd
108-110 Girnar Tower 25 New Palasia Indore (MP)
Ph no 0731-2534488 Mob No 92294 11760 97555 80888
Apron Test Labs amp Consult
for reposing confidence and award work
Production unit at Plot no
Distt Dhar (MP)
ACKNOWLEDGEMENT
Apron Test Labs amp Consultants Pvt Ltd is grateful to Ms Enaltech Lab Pvt Ltd
reposing confidence and award work of Soil Investigation for Construction
no Plot no 825-826 Sector III Industrial area
Hitesh S Jaiswal (Sr Manager)
Page 1 of 20
Enaltech Lab Pvt Ltd
Construction of API
ial area Pithampur
Hitesh S Jaiswal (Sr Manager)
Page 2 of 20
Chapter 1Chapter 1Chapter 1Chapter 1
INTRODUCTION
Ms Enaltech Labs Pvt Ltd has proposed the construction of API Production
unit at Plot no Plot no 825-826 Sector III Industrial area Pithampur Distt Dhar
(MP) assigned to ATLCPL to conduct the soil investigation work
The report presents the complied data of test results of geotechnical
investigation The observed data of field investigations and laboratory tests are
presented and used to access the nature of subsoil strata and to evaluate the soil
parameters required for the detailed design of proposed API Production unit
Ms Apron Test Labs amp Consultants Pvt Ltd (ATLCPL) Indore under took
aforesaid Geotechnical Investigation Job Ms ATLCPLrsquos Geotechnical Engineers
conducted the test at the proposed site and has collected the primary information
about proposed site
Page 3 of 20
Chapter 2Chapter 2Chapter 2Chapter 2
SITE TOPOGRAPHY
The site is located at Plot no Plot no 825-826 Sector III Industrial area
Pithampur Distt Dhar (MP) The investigations are required for construction of API
Production unit Pithampur is an industrial city and has close proximity to Indore
Once called Detroit of India Pithampur houses major industries and companies of
Madhya Pradesh The city of Indore covers an area of 214 square kilometers and is
It is situated at Lat 22deg37rsquo15rdquo north and long 75deg34rsquo 22rdquo The site is perched at an
average height of 545 meters above the sea level The site lies in seismic zone ndash III
The maximum Temperature during summer season reaches 45degC and the minimum
temperature during winter falls to 10ordm C The humidity ranges between 85 to 20
GEOLOGICAL CROSS-SECTION IN THE AREA
The surface observations and geophysical studies reveal the following
general x-section in the study area
Depth from GL Type of Strata
BH ndash 1 BH - 2
0 to 200 m Filled up material Black Soil
200 to 270 m Black Soil Black Soil
270 to 650 Light Yellow Soil Light Yellow Soil
650 to 1300 m Silty Yellow Soil Silty Yellow Soil
Page 4 of 20
AIMS OF INVESTIGATION
The subject of Safe bearing capacity of soils is of great importance to
Engineers who have to design foundations for buildings and structures which are
heavy large and tall Such structures are required to be put to meet the varying
requirements which have come about in the work of substantial More important the
structure is greater need to give attention to design and construction of its
foundation
The design and construction of foundation of heavy structure is not an easy
task It calls for ability and experience The most important factor which influences
design of foundations is the load bearing capacity of soils met with Therefore in
arriving at the safe load bearing capacity of soils the properties and characteristics
of the soil at site is required to be determined
It has many times been experienced that not only the design of foundation is
difficult task the pre- requisite for which are the proper site investigation field test
and laboratory testing but the actual construction of foundation also poses difficult
Problems It is therefore necessary to conduct the detail investigations at site are
essential before a design can be finalized The object of subsurface and related site
investigations is to provide the engineer Architect with as much information as
possible about the existing conditions for example the exposed overburden the
course of a stream nearby a rock outcrop or a hillock vegetation and other
geological features of the area It is equally important to know the sub soil conditions
below a proposed structure
Page 5 of 20
The methods of sub surface investigation enable vertical sections of the strata
to be drawn and samples to be tested on the site or in a laboratory for determining
Shear strength parameters bearing capacity of the soils water table type
classification and other geophysical information in the field This information together
With the normal topographical survey provides the Engineer with complete details of
the site and enables him to know the complexity of natural deposits No one method
of exploration is best for all situations Site reconnaissance would help in deriving
program of field investigations that is to assess the need for preliminary or detailed
investigations
Page 6 of 20
Chapter 3Chapter 3Chapter 3Chapter 3
SCOPE OF WORK
bull The present scope of work is related to Geotechnical Investigation and Ms
Enaltech Labs Pvt Ltd placed order to Ms ATLCPL Indore to carryout
Investigation within very short span of time conducting of SPT at every 150
mtr Interval in Soil and collection of disturbed amp undisturbed soil samples for
laboratory tests
bull The laboratory test includes grain size analysis Liquid amp plastic limits
classification shear parameters one in each borehole with recommendation
and report submission As Mentioned within the framework of this job
contract the field investigations comprised of the following-
a) Boring of two borehole of 150mm diameter up to the 130 mtr
bull b) Collection of representative disturbed amp undisturbed soil samples
c) Carrying out standard penetration tests as per IS2131 - 1981 in each bore
hole and Subsequently preparation of penetration charts depth-wise for each
bore hole The SPT has been performed at 15m interval up to refusal
The laboratory tests part of this job contract comprised of the following-
bull I) Grain Size Analysis
bull ii) Atterburgrsquos Limits
bull iii) Dry Density
bull iv) Directs Shear Test
bull v) Specific Gravity
bull vi) Natural Moisture content
bull vii) Field Density
Page 7 of 20
FACTOR OF SAFETY
For safety against bearing capacity failure a factor of safety of 3 is
recommended under the probable maximum loads For structures of minor
importance and in sub soils of uniform character whose properties are very well
known a smaller factor of safety may be used A factor of safety of three is
comparable with the value commonly used for the design of super structure
Effect of water table
The water table has a marked influence on the bearing capacity of Silty and
Clay soil if it rises above a level depth of which below the footing equals its width
the bearing capacity progressively reduces until it becomes about half when the
level of water table reaches the level of the footing
Page 8 of 20
Chapter Chapter Chapter Chapter 4444
FIELD amp LABORATORY TESTS
Two bore were selected by Engineer Incharge of Ms Enaltech Labs Pvt
Ltd In the one bore holes Standard Penetration Tests (SPT) were conducted in
accordance with IS 2131(1981) - Method of Standard Penetration Test for Soils A
Split Spoon Sampler 508 mm Outer diameter and 35 mm internal diameter are
driven in to the undisturbed soil at the bottom of hole under the blows of 65kg
hammer falling through a height of 75 cm The Number of blows required to drive the
sampler 30 cm beyond sitting drive of 15 cm is termed as Standard Penetration
Resistance denoted by lsquoNrsquo The result of Standard Penetration Tests has been
shown in Table 1
The rock drilling and rock core correction was done in accordance with IS 6926
(1996) ndashDiamond Core Drilling Site Investigation for River Valley Project-Code of
Practice and IS 4464 (1985) Code of Practice for Presentation of drilling
Information and Core Description and Foundation Investigation From the bore
holes disturbed and undisturbed samples were collected for lab test On the sample
collected grain size analysis Atterbergs limits specific gravity and shear strength
test were conducted The result of soil test given in Table 1 amp 2
Page 9 of 20
Chapter Chapter Chapter Chapter 5555 DISCUSSION ampINTERPRATION OF LAB TESTS
Geotechnical investigation was done at the site of Ms Enaltech Labs Pvt
Ltd at Plot no Plot no 825-826 Sector III Industrial area Pithampur Distt Dhar
(MP) The location of Bore Hole was decided by the party From Bore Holes
disturbed amp undisturbed samples were collected the soil profile from Bore Holes is
shown from Fig 1 amp 2 Samples collected from Bore were used for Grain Size
Analysis test Atterbergs limits Specific Gravity density amp moisture content was
conducted in the laboratory Direct shear test was also conducted
SOIL amp ROCK PROFILE
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 200 m Filled up material was seen from 200 to
270 mtr Black Soil from 270 to 650 Light Yellow Soil 650 to 1300 mtr yellow
Silty Soil was encountered The standard Penetration test conduct at 150m interval
and Results ldquoNrdquo Value shown on table no 1 The grain size distribution curve is
shown in Fig 4
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 270 mtr Black Soil from 270 to 650 Light Yellow
Soil 650 to 1300 mtr yellow Silty Soil was encountered The standard Penetration
test conduct at 150m interval and Results ldquoNrdquo Value shown on table no 1 The grain
size distribution curve is shown in Fig 5
Page 10 of 20
CCCChapter hapter hapter hapter 6666
COMPUTATIONS OF SAFE BEARING CAPACITY
(I) BASED ON SHEAR CONSIDERATION
Box shear test in undrained condition was performed to get shear parameters The
Safe Bearing Capacity is calculated as per IS 6403- 1981 (determination of bearing
capacity of shallow foundations) For local shear failure the ultimate bearing capacity
is given as follows
In case of General shear failure
qd = C NcSc dcic+q (Nq-1) Sqdqiq+ frac12 B γ Nγdγiγ W
In case of local shear failure
qd = 23 C NrsquocSc dcic+q (Nrsquoq-1) Sqdqiq+ frac12 B γ Nrsquoγdγiγ W
Where qd = Ultimate bearing capacity
C = Cohesion (Non cohesive material C = 0)
φ = Angle of internal friction
φrsquo = tan-1(067 tan (Oslash)) for local shear failure
γ = Average density of over burden
NcNqNγ = Bearing Capacity factors for General Shear Failure
NrsquocNrsquoqNrsquoγ = Bearing Capacity factors for Local Shear Failure
ScSqSγ = Shape factors
dc dqdγ =depth factors
iciqiγ =inclination factors ( 1 in the case of vertical loads)
Page 11 of 20
q = Effective surcharge at depth ofrdquo Xrdquo Mt below ground level
W = Water Table correction factor is frac12 (When WT is at base of
footing)
B = Width of footing in Mts
FS = Factor of safety considered as 3
For BH-1 at 300 m depth
c = 0356 Kgcm2 φ = 1800deg γ = 1648 gmcc
since φlt 28deg Local shear failure shall be considered Substituting the values of all
other parameters SBC is calculated as 1570 Tm2 Similarly for other cases also
SBC may be evaluated in the same fashion
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible sett
values and the results of shear parameters
The open foundation in the form of isolated footing may be provided at a minimum
depth of 300 m which safe bearing capacity of
basis of shear parameter
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible settlements etc The soil properties along with the SPT
the results of shear parameters are shown in the Table- 1
The open foundation in the form of isolated footing may be provided at a minimum
which safe bearing capacity of 1500 Tm2 may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
Page 12 of 20
Chapter Chapter Chapter Chapter 7777
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
along with the SPT
The open foundation in the form of isolated footing may be provided at a minimum
may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Apron Test Labs amp Consult
for reposing confidence and award work
Production unit at Plot no
Distt Dhar (MP)
ACKNOWLEDGEMENT
Apron Test Labs amp Consultants Pvt Ltd is grateful to Ms Enaltech Lab Pvt Ltd
reposing confidence and award work of Soil Investigation for Construction
no Plot no 825-826 Sector III Industrial area
Hitesh S Jaiswal (Sr Manager)
Page 1 of 20
Enaltech Lab Pvt Ltd
Construction of API
ial area Pithampur
Hitesh S Jaiswal (Sr Manager)
Page 2 of 20
Chapter 1Chapter 1Chapter 1Chapter 1
INTRODUCTION
Ms Enaltech Labs Pvt Ltd has proposed the construction of API Production
unit at Plot no Plot no 825-826 Sector III Industrial area Pithampur Distt Dhar
(MP) assigned to ATLCPL to conduct the soil investigation work
The report presents the complied data of test results of geotechnical
investigation The observed data of field investigations and laboratory tests are
presented and used to access the nature of subsoil strata and to evaluate the soil
parameters required for the detailed design of proposed API Production unit
Ms Apron Test Labs amp Consultants Pvt Ltd (ATLCPL) Indore under took
aforesaid Geotechnical Investigation Job Ms ATLCPLrsquos Geotechnical Engineers
conducted the test at the proposed site and has collected the primary information
about proposed site
Page 3 of 20
Chapter 2Chapter 2Chapter 2Chapter 2
SITE TOPOGRAPHY
The site is located at Plot no Plot no 825-826 Sector III Industrial area
Pithampur Distt Dhar (MP) The investigations are required for construction of API
Production unit Pithampur is an industrial city and has close proximity to Indore
Once called Detroit of India Pithampur houses major industries and companies of
Madhya Pradesh The city of Indore covers an area of 214 square kilometers and is
It is situated at Lat 22deg37rsquo15rdquo north and long 75deg34rsquo 22rdquo The site is perched at an
average height of 545 meters above the sea level The site lies in seismic zone ndash III
The maximum Temperature during summer season reaches 45degC and the minimum
temperature during winter falls to 10ordm C The humidity ranges between 85 to 20
GEOLOGICAL CROSS-SECTION IN THE AREA
The surface observations and geophysical studies reveal the following
general x-section in the study area
Depth from GL Type of Strata
BH ndash 1 BH - 2
0 to 200 m Filled up material Black Soil
200 to 270 m Black Soil Black Soil
270 to 650 Light Yellow Soil Light Yellow Soil
650 to 1300 m Silty Yellow Soil Silty Yellow Soil
Page 4 of 20
AIMS OF INVESTIGATION
The subject of Safe bearing capacity of soils is of great importance to
Engineers who have to design foundations for buildings and structures which are
heavy large and tall Such structures are required to be put to meet the varying
requirements which have come about in the work of substantial More important the
structure is greater need to give attention to design and construction of its
foundation
The design and construction of foundation of heavy structure is not an easy
task It calls for ability and experience The most important factor which influences
design of foundations is the load bearing capacity of soils met with Therefore in
arriving at the safe load bearing capacity of soils the properties and characteristics
of the soil at site is required to be determined
It has many times been experienced that not only the design of foundation is
difficult task the pre- requisite for which are the proper site investigation field test
and laboratory testing but the actual construction of foundation also poses difficult
Problems It is therefore necessary to conduct the detail investigations at site are
essential before a design can be finalized The object of subsurface and related site
investigations is to provide the engineer Architect with as much information as
possible about the existing conditions for example the exposed overburden the
course of a stream nearby a rock outcrop or a hillock vegetation and other
geological features of the area It is equally important to know the sub soil conditions
below a proposed structure
Page 5 of 20
The methods of sub surface investigation enable vertical sections of the strata
to be drawn and samples to be tested on the site or in a laboratory for determining
Shear strength parameters bearing capacity of the soils water table type
classification and other geophysical information in the field This information together
With the normal topographical survey provides the Engineer with complete details of
the site and enables him to know the complexity of natural deposits No one method
of exploration is best for all situations Site reconnaissance would help in deriving
program of field investigations that is to assess the need for preliminary or detailed
investigations
Page 6 of 20
Chapter 3Chapter 3Chapter 3Chapter 3
SCOPE OF WORK
bull The present scope of work is related to Geotechnical Investigation and Ms
Enaltech Labs Pvt Ltd placed order to Ms ATLCPL Indore to carryout
Investigation within very short span of time conducting of SPT at every 150
mtr Interval in Soil and collection of disturbed amp undisturbed soil samples for
laboratory tests
bull The laboratory test includes grain size analysis Liquid amp plastic limits
classification shear parameters one in each borehole with recommendation
and report submission As Mentioned within the framework of this job
contract the field investigations comprised of the following-
a) Boring of two borehole of 150mm diameter up to the 130 mtr
bull b) Collection of representative disturbed amp undisturbed soil samples
c) Carrying out standard penetration tests as per IS2131 - 1981 in each bore
hole and Subsequently preparation of penetration charts depth-wise for each
bore hole The SPT has been performed at 15m interval up to refusal
The laboratory tests part of this job contract comprised of the following-
bull I) Grain Size Analysis
bull ii) Atterburgrsquos Limits
bull iii) Dry Density
bull iv) Directs Shear Test
bull v) Specific Gravity
bull vi) Natural Moisture content
bull vii) Field Density
Page 7 of 20
FACTOR OF SAFETY
For safety against bearing capacity failure a factor of safety of 3 is
recommended under the probable maximum loads For structures of minor
importance and in sub soils of uniform character whose properties are very well
known a smaller factor of safety may be used A factor of safety of three is
comparable with the value commonly used for the design of super structure
Effect of water table
The water table has a marked influence on the bearing capacity of Silty and
Clay soil if it rises above a level depth of which below the footing equals its width
the bearing capacity progressively reduces until it becomes about half when the
level of water table reaches the level of the footing
Page 8 of 20
Chapter Chapter Chapter Chapter 4444
FIELD amp LABORATORY TESTS
Two bore were selected by Engineer Incharge of Ms Enaltech Labs Pvt
Ltd In the one bore holes Standard Penetration Tests (SPT) were conducted in
accordance with IS 2131(1981) - Method of Standard Penetration Test for Soils A
Split Spoon Sampler 508 mm Outer diameter and 35 mm internal diameter are
driven in to the undisturbed soil at the bottom of hole under the blows of 65kg
hammer falling through a height of 75 cm The Number of blows required to drive the
sampler 30 cm beyond sitting drive of 15 cm is termed as Standard Penetration
Resistance denoted by lsquoNrsquo The result of Standard Penetration Tests has been
shown in Table 1
The rock drilling and rock core correction was done in accordance with IS 6926
(1996) ndashDiamond Core Drilling Site Investigation for River Valley Project-Code of
Practice and IS 4464 (1985) Code of Practice for Presentation of drilling
Information and Core Description and Foundation Investigation From the bore
holes disturbed and undisturbed samples were collected for lab test On the sample
collected grain size analysis Atterbergs limits specific gravity and shear strength
test were conducted The result of soil test given in Table 1 amp 2
Page 9 of 20
Chapter Chapter Chapter Chapter 5555 DISCUSSION ampINTERPRATION OF LAB TESTS
Geotechnical investigation was done at the site of Ms Enaltech Labs Pvt
Ltd at Plot no Plot no 825-826 Sector III Industrial area Pithampur Distt Dhar
(MP) The location of Bore Hole was decided by the party From Bore Holes
disturbed amp undisturbed samples were collected the soil profile from Bore Holes is
shown from Fig 1 amp 2 Samples collected from Bore were used for Grain Size
Analysis test Atterbergs limits Specific Gravity density amp moisture content was
conducted in the laboratory Direct shear test was also conducted
SOIL amp ROCK PROFILE
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 200 m Filled up material was seen from 200 to
270 mtr Black Soil from 270 to 650 Light Yellow Soil 650 to 1300 mtr yellow
Silty Soil was encountered The standard Penetration test conduct at 150m interval
and Results ldquoNrdquo Value shown on table no 1 The grain size distribution curve is
shown in Fig 4
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 270 mtr Black Soil from 270 to 650 Light Yellow
Soil 650 to 1300 mtr yellow Silty Soil was encountered The standard Penetration
test conduct at 150m interval and Results ldquoNrdquo Value shown on table no 1 The grain
size distribution curve is shown in Fig 5
Page 10 of 20
CCCChapter hapter hapter hapter 6666
COMPUTATIONS OF SAFE BEARING CAPACITY
(I) BASED ON SHEAR CONSIDERATION
Box shear test in undrained condition was performed to get shear parameters The
Safe Bearing Capacity is calculated as per IS 6403- 1981 (determination of bearing
capacity of shallow foundations) For local shear failure the ultimate bearing capacity
is given as follows
In case of General shear failure
qd = C NcSc dcic+q (Nq-1) Sqdqiq+ frac12 B γ Nγdγiγ W
In case of local shear failure
qd = 23 C NrsquocSc dcic+q (Nrsquoq-1) Sqdqiq+ frac12 B γ Nrsquoγdγiγ W
Where qd = Ultimate bearing capacity
C = Cohesion (Non cohesive material C = 0)
φ = Angle of internal friction
φrsquo = tan-1(067 tan (Oslash)) for local shear failure
γ = Average density of over burden
NcNqNγ = Bearing Capacity factors for General Shear Failure
NrsquocNrsquoqNrsquoγ = Bearing Capacity factors for Local Shear Failure
ScSqSγ = Shape factors
dc dqdγ =depth factors
iciqiγ =inclination factors ( 1 in the case of vertical loads)
Page 11 of 20
q = Effective surcharge at depth ofrdquo Xrdquo Mt below ground level
W = Water Table correction factor is frac12 (When WT is at base of
footing)
B = Width of footing in Mts
FS = Factor of safety considered as 3
For BH-1 at 300 m depth
c = 0356 Kgcm2 φ = 1800deg γ = 1648 gmcc
since φlt 28deg Local shear failure shall be considered Substituting the values of all
other parameters SBC is calculated as 1570 Tm2 Similarly for other cases also
SBC may be evaluated in the same fashion
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible sett
values and the results of shear parameters
The open foundation in the form of isolated footing may be provided at a minimum
depth of 300 m which safe bearing capacity of
basis of shear parameter
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible settlements etc The soil properties along with the SPT
the results of shear parameters are shown in the Table- 1
The open foundation in the form of isolated footing may be provided at a minimum
which safe bearing capacity of 1500 Tm2 may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
Page 12 of 20
Chapter Chapter Chapter Chapter 7777
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
along with the SPT
The open foundation in the form of isolated footing may be provided at a minimum
may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 2 of 20
Chapter 1Chapter 1Chapter 1Chapter 1
INTRODUCTION
Ms Enaltech Labs Pvt Ltd has proposed the construction of API Production
unit at Plot no Plot no 825-826 Sector III Industrial area Pithampur Distt Dhar
(MP) assigned to ATLCPL to conduct the soil investigation work
The report presents the complied data of test results of geotechnical
investigation The observed data of field investigations and laboratory tests are
presented and used to access the nature of subsoil strata and to evaluate the soil
parameters required for the detailed design of proposed API Production unit
Ms Apron Test Labs amp Consultants Pvt Ltd (ATLCPL) Indore under took
aforesaid Geotechnical Investigation Job Ms ATLCPLrsquos Geotechnical Engineers
conducted the test at the proposed site and has collected the primary information
about proposed site
Page 3 of 20
Chapter 2Chapter 2Chapter 2Chapter 2
SITE TOPOGRAPHY
The site is located at Plot no Plot no 825-826 Sector III Industrial area
Pithampur Distt Dhar (MP) The investigations are required for construction of API
Production unit Pithampur is an industrial city and has close proximity to Indore
Once called Detroit of India Pithampur houses major industries and companies of
Madhya Pradesh The city of Indore covers an area of 214 square kilometers and is
It is situated at Lat 22deg37rsquo15rdquo north and long 75deg34rsquo 22rdquo The site is perched at an
average height of 545 meters above the sea level The site lies in seismic zone ndash III
The maximum Temperature during summer season reaches 45degC and the minimum
temperature during winter falls to 10ordm C The humidity ranges between 85 to 20
GEOLOGICAL CROSS-SECTION IN THE AREA
The surface observations and geophysical studies reveal the following
general x-section in the study area
Depth from GL Type of Strata
BH ndash 1 BH - 2
0 to 200 m Filled up material Black Soil
200 to 270 m Black Soil Black Soil
270 to 650 Light Yellow Soil Light Yellow Soil
650 to 1300 m Silty Yellow Soil Silty Yellow Soil
Page 4 of 20
AIMS OF INVESTIGATION
The subject of Safe bearing capacity of soils is of great importance to
Engineers who have to design foundations for buildings and structures which are
heavy large and tall Such structures are required to be put to meet the varying
requirements which have come about in the work of substantial More important the
structure is greater need to give attention to design and construction of its
foundation
The design and construction of foundation of heavy structure is not an easy
task It calls for ability and experience The most important factor which influences
design of foundations is the load bearing capacity of soils met with Therefore in
arriving at the safe load bearing capacity of soils the properties and characteristics
of the soil at site is required to be determined
It has many times been experienced that not only the design of foundation is
difficult task the pre- requisite for which are the proper site investigation field test
and laboratory testing but the actual construction of foundation also poses difficult
Problems It is therefore necessary to conduct the detail investigations at site are
essential before a design can be finalized The object of subsurface and related site
investigations is to provide the engineer Architect with as much information as
possible about the existing conditions for example the exposed overburden the
course of a stream nearby a rock outcrop or a hillock vegetation and other
geological features of the area It is equally important to know the sub soil conditions
below a proposed structure
Page 5 of 20
The methods of sub surface investigation enable vertical sections of the strata
to be drawn and samples to be tested on the site or in a laboratory for determining
Shear strength parameters bearing capacity of the soils water table type
classification and other geophysical information in the field This information together
With the normal topographical survey provides the Engineer with complete details of
the site and enables him to know the complexity of natural deposits No one method
of exploration is best for all situations Site reconnaissance would help in deriving
program of field investigations that is to assess the need for preliminary or detailed
investigations
Page 6 of 20
Chapter 3Chapter 3Chapter 3Chapter 3
SCOPE OF WORK
bull The present scope of work is related to Geotechnical Investigation and Ms
Enaltech Labs Pvt Ltd placed order to Ms ATLCPL Indore to carryout
Investigation within very short span of time conducting of SPT at every 150
mtr Interval in Soil and collection of disturbed amp undisturbed soil samples for
laboratory tests
bull The laboratory test includes grain size analysis Liquid amp plastic limits
classification shear parameters one in each borehole with recommendation
and report submission As Mentioned within the framework of this job
contract the field investigations comprised of the following-
a) Boring of two borehole of 150mm diameter up to the 130 mtr
bull b) Collection of representative disturbed amp undisturbed soil samples
c) Carrying out standard penetration tests as per IS2131 - 1981 in each bore
hole and Subsequently preparation of penetration charts depth-wise for each
bore hole The SPT has been performed at 15m interval up to refusal
The laboratory tests part of this job contract comprised of the following-
bull I) Grain Size Analysis
bull ii) Atterburgrsquos Limits
bull iii) Dry Density
bull iv) Directs Shear Test
bull v) Specific Gravity
bull vi) Natural Moisture content
bull vii) Field Density
Page 7 of 20
FACTOR OF SAFETY
For safety against bearing capacity failure a factor of safety of 3 is
recommended under the probable maximum loads For structures of minor
importance and in sub soils of uniform character whose properties are very well
known a smaller factor of safety may be used A factor of safety of three is
comparable with the value commonly used for the design of super structure
Effect of water table
The water table has a marked influence on the bearing capacity of Silty and
Clay soil if it rises above a level depth of which below the footing equals its width
the bearing capacity progressively reduces until it becomes about half when the
level of water table reaches the level of the footing
Page 8 of 20
Chapter Chapter Chapter Chapter 4444
FIELD amp LABORATORY TESTS
Two bore were selected by Engineer Incharge of Ms Enaltech Labs Pvt
Ltd In the one bore holes Standard Penetration Tests (SPT) were conducted in
accordance with IS 2131(1981) - Method of Standard Penetration Test for Soils A
Split Spoon Sampler 508 mm Outer diameter and 35 mm internal diameter are
driven in to the undisturbed soil at the bottom of hole under the blows of 65kg
hammer falling through a height of 75 cm The Number of blows required to drive the
sampler 30 cm beyond sitting drive of 15 cm is termed as Standard Penetration
Resistance denoted by lsquoNrsquo The result of Standard Penetration Tests has been
shown in Table 1
The rock drilling and rock core correction was done in accordance with IS 6926
(1996) ndashDiamond Core Drilling Site Investigation for River Valley Project-Code of
Practice and IS 4464 (1985) Code of Practice for Presentation of drilling
Information and Core Description and Foundation Investigation From the bore
holes disturbed and undisturbed samples were collected for lab test On the sample
collected grain size analysis Atterbergs limits specific gravity and shear strength
test were conducted The result of soil test given in Table 1 amp 2
Page 9 of 20
Chapter Chapter Chapter Chapter 5555 DISCUSSION ampINTERPRATION OF LAB TESTS
Geotechnical investigation was done at the site of Ms Enaltech Labs Pvt
Ltd at Plot no Plot no 825-826 Sector III Industrial area Pithampur Distt Dhar
(MP) The location of Bore Hole was decided by the party From Bore Holes
disturbed amp undisturbed samples were collected the soil profile from Bore Holes is
shown from Fig 1 amp 2 Samples collected from Bore were used for Grain Size
Analysis test Atterbergs limits Specific Gravity density amp moisture content was
conducted in the laboratory Direct shear test was also conducted
SOIL amp ROCK PROFILE
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 200 m Filled up material was seen from 200 to
270 mtr Black Soil from 270 to 650 Light Yellow Soil 650 to 1300 mtr yellow
Silty Soil was encountered The standard Penetration test conduct at 150m interval
and Results ldquoNrdquo Value shown on table no 1 The grain size distribution curve is
shown in Fig 4
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 270 mtr Black Soil from 270 to 650 Light Yellow
Soil 650 to 1300 mtr yellow Silty Soil was encountered The standard Penetration
test conduct at 150m interval and Results ldquoNrdquo Value shown on table no 1 The grain
size distribution curve is shown in Fig 5
Page 10 of 20
CCCChapter hapter hapter hapter 6666
COMPUTATIONS OF SAFE BEARING CAPACITY
(I) BASED ON SHEAR CONSIDERATION
Box shear test in undrained condition was performed to get shear parameters The
Safe Bearing Capacity is calculated as per IS 6403- 1981 (determination of bearing
capacity of shallow foundations) For local shear failure the ultimate bearing capacity
is given as follows
In case of General shear failure
qd = C NcSc dcic+q (Nq-1) Sqdqiq+ frac12 B γ Nγdγiγ W
In case of local shear failure
qd = 23 C NrsquocSc dcic+q (Nrsquoq-1) Sqdqiq+ frac12 B γ Nrsquoγdγiγ W
Where qd = Ultimate bearing capacity
C = Cohesion (Non cohesive material C = 0)
φ = Angle of internal friction
φrsquo = tan-1(067 tan (Oslash)) for local shear failure
γ = Average density of over burden
NcNqNγ = Bearing Capacity factors for General Shear Failure
NrsquocNrsquoqNrsquoγ = Bearing Capacity factors for Local Shear Failure
ScSqSγ = Shape factors
dc dqdγ =depth factors
iciqiγ =inclination factors ( 1 in the case of vertical loads)
Page 11 of 20
q = Effective surcharge at depth ofrdquo Xrdquo Mt below ground level
W = Water Table correction factor is frac12 (When WT is at base of
footing)
B = Width of footing in Mts
FS = Factor of safety considered as 3
For BH-1 at 300 m depth
c = 0356 Kgcm2 φ = 1800deg γ = 1648 gmcc
since φlt 28deg Local shear failure shall be considered Substituting the values of all
other parameters SBC is calculated as 1570 Tm2 Similarly for other cases also
SBC may be evaluated in the same fashion
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible sett
values and the results of shear parameters
The open foundation in the form of isolated footing may be provided at a minimum
depth of 300 m which safe bearing capacity of
basis of shear parameter
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible settlements etc The soil properties along with the SPT
the results of shear parameters are shown in the Table- 1
The open foundation in the form of isolated footing may be provided at a minimum
which safe bearing capacity of 1500 Tm2 may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
Page 12 of 20
Chapter Chapter Chapter Chapter 7777
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
along with the SPT
The open foundation in the form of isolated footing may be provided at a minimum
may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 3 of 20
Chapter 2Chapter 2Chapter 2Chapter 2
SITE TOPOGRAPHY
The site is located at Plot no Plot no 825-826 Sector III Industrial area
Pithampur Distt Dhar (MP) The investigations are required for construction of API
Production unit Pithampur is an industrial city and has close proximity to Indore
Once called Detroit of India Pithampur houses major industries and companies of
Madhya Pradesh The city of Indore covers an area of 214 square kilometers and is
It is situated at Lat 22deg37rsquo15rdquo north and long 75deg34rsquo 22rdquo The site is perched at an
average height of 545 meters above the sea level The site lies in seismic zone ndash III
The maximum Temperature during summer season reaches 45degC and the minimum
temperature during winter falls to 10ordm C The humidity ranges between 85 to 20
GEOLOGICAL CROSS-SECTION IN THE AREA
The surface observations and geophysical studies reveal the following
general x-section in the study area
Depth from GL Type of Strata
BH ndash 1 BH - 2
0 to 200 m Filled up material Black Soil
200 to 270 m Black Soil Black Soil
270 to 650 Light Yellow Soil Light Yellow Soil
650 to 1300 m Silty Yellow Soil Silty Yellow Soil
Page 4 of 20
AIMS OF INVESTIGATION
The subject of Safe bearing capacity of soils is of great importance to
Engineers who have to design foundations for buildings and structures which are
heavy large and tall Such structures are required to be put to meet the varying
requirements which have come about in the work of substantial More important the
structure is greater need to give attention to design and construction of its
foundation
The design and construction of foundation of heavy structure is not an easy
task It calls for ability and experience The most important factor which influences
design of foundations is the load bearing capacity of soils met with Therefore in
arriving at the safe load bearing capacity of soils the properties and characteristics
of the soil at site is required to be determined
It has many times been experienced that not only the design of foundation is
difficult task the pre- requisite for which are the proper site investigation field test
and laboratory testing but the actual construction of foundation also poses difficult
Problems It is therefore necessary to conduct the detail investigations at site are
essential before a design can be finalized The object of subsurface and related site
investigations is to provide the engineer Architect with as much information as
possible about the existing conditions for example the exposed overburden the
course of a stream nearby a rock outcrop or a hillock vegetation and other
geological features of the area It is equally important to know the sub soil conditions
below a proposed structure
Page 5 of 20
The methods of sub surface investigation enable vertical sections of the strata
to be drawn and samples to be tested on the site or in a laboratory for determining
Shear strength parameters bearing capacity of the soils water table type
classification and other geophysical information in the field This information together
With the normal topographical survey provides the Engineer with complete details of
the site and enables him to know the complexity of natural deposits No one method
of exploration is best for all situations Site reconnaissance would help in deriving
program of field investigations that is to assess the need for preliminary or detailed
investigations
Page 6 of 20
Chapter 3Chapter 3Chapter 3Chapter 3
SCOPE OF WORK
bull The present scope of work is related to Geotechnical Investigation and Ms
Enaltech Labs Pvt Ltd placed order to Ms ATLCPL Indore to carryout
Investigation within very short span of time conducting of SPT at every 150
mtr Interval in Soil and collection of disturbed amp undisturbed soil samples for
laboratory tests
bull The laboratory test includes grain size analysis Liquid amp plastic limits
classification shear parameters one in each borehole with recommendation
and report submission As Mentioned within the framework of this job
contract the field investigations comprised of the following-
a) Boring of two borehole of 150mm diameter up to the 130 mtr
bull b) Collection of representative disturbed amp undisturbed soil samples
c) Carrying out standard penetration tests as per IS2131 - 1981 in each bore
hole and Subsequently preparation of penetration charts depth-wise for each
bore hole The SPT has been performed at 15m interval up to refusal
The laboratory tests part of this job contract comprised of the following-
bull I) Grain Size Analysis
bull ii) Atterburgrsquos Limits
bull iii) Dry Density
bull iv) Directs Shear Test
bull v) Specific Gravity
bull vi) Natural Moisture content
bull vii) Field Density
Page 7 of 20
FACTOR OF SAFETY
For safety against bearing capacity failure a factor of safety of 3 is
recommended under the probable maximum loads For structures of minor
importance and in sub soils of uniform character whose properties are very well
known a smaller factor of safety may be used A factor of safety of three is
comparable with the value commonly used for the design of super structure
Effect of water table
The water table has a marked influence on the bearing capacity of Silty and
Clay soil if it rises above a level depth of which below the footing equals its width
the bearing capacity progressively reduces until it becomes about half when the
level of water table reaches the level of the footing
Page 8 of 20
Chapter Chapter Chapter Chapter 4444
FIELD amp LABORATORY TESTS
Two bore were selected by Engineer Incharge of Ms Enaltech Labs Pvt
Ltd In the one bore holes Standard Penetration Tests (SPT) were conducted in
accordance with IS 2131(1981) - Method of Standard Penetration Test for Soils A
Split Spoon Sampler 508 mm Outer diameter and 35 mm internal diameter are
driven in to the undisturbed soil at the bottom of hole under the blows of 65kg
hammer falling through a height of 75 cm The Number of blows required to drive the
sampler 30 cm beyond sitting drive of 15 cm is termed as Standard Penetration
Resistance denoted by lsquoNrsquo The result of Standard Penetration Tests has been
shown in Table 1
The rock drilling and rock core correction was done in accordance with IS 6926
(1996) ndashDiamond Core Drilling Site Investigation for River Valley Project-Code of
Practice and IS 4464 (1985) Code of Practice for Presentation of drilling
Information and Core Description and Foundation Investigation From the bore
holes disturbed and undisturbed samples were collected for lab test On the sample
collected grain size analysis Atterbergs limits specific gravity and shear strength
test were conducted The result of soil test given in Table 1 amp 2
Page 9 of 20
Chapter Chapter Chapter Chapter 5555 DISCUSSION ampINTERPRATION OF LAB TESTS
Geotechnical investigation was done at the site of Ms Enaltech Labs Pvt
Ltd at Plot no Plot no 825-826 Sector III Industrial area Pithampur Distt Dhar
(MP) The location of Bore Hole was decided by the party From Bore Holes
disturbed amp undisturbed samples were collected the soil profile from Bore Holes is
shown from Fig 1 amp 2 Samples collected from Bore were used for Grain Size
Analysis test Atterbergs limits Specific Gravity density amp moisture content was
conducted in the laboratory Direct shear test was also conducted
SOIL amp ROCK PROFILE
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 200 m Filled up material was seen from 200 to
270 mtr Black Soil from 270 to 650 Light Yellow Soil 650 to 1300 mtr yellow
Silty Soil was encountered The standard Penetration test conduct at 150m interval
and Results ldquoNrdquo Value shown on table no 1 The grain size distribution curve is
shown in Fig 4
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 270 mtr Black Soil from 270 to 650 Light Yellow
Soil 650 to 1300 mtr yellow Silty Soil was encountered The standard Penetration
test conduct at 150m interval and Results ldquoNrdquo Value shown on table no 1 The grain
size distribution curve is shown in Fig 5
Page 10 of 20
CCCChapter hapter hapter hapter 6666
COMPUTATIONS OF SAFE BEARING CAPACITY
(I) BASED ON SHEAR CONSIDERATION
Box shear test in undrained condition was performed to get shear parameters The
Safe Bearing Capacity is calculated as per IS 6403- 1981 (determination of bearing
capacity of shallow foundations) For local shear failure the ultimate bearing capacity
is given as follows
In case of General shear failure
qd = C NcSc dcic+q (Nq-1) Sqdqiq+ frac12 B γ Nγdγiγ W
In case of local shear failure
qd = 23 C NrsquocSc dcic+q (Nrsquoq-1) Sqdqiq+ frac12 B γ Nrsquoγdγiγ W
Where qd = Ultimate bearing capacity
C = Cohesion (Non cohesive material C = 0)
φ = Angle of internal friction
φrsquo = tan-1(067 tan (Oslash)) for local shear failure
γ = Average density of over burden
NcNqNγ = Bearing Capacity factors for General Shear Failure
NrsquocNrsquoqNrsquoγ = Bearing Capacity factors for Local Shear Failure
ScSqSγ = Shape factors
dc dqdγ =depth factors
iciqiγ =inclination factors ( 1 in the case of vertical loads)
Page 11 of 20
q = Effective surcharge at depth ofrdquo Xrdquo Mt below ground level
W = Water Table correction factor is frac12 (When WT is at base of
footing)
B = Width of footing in Mts
FS = Factor of safety considered as 3
For BH-1 at 300 m depth
c = 0356 Kgcm2 φ = 1800deg γ = 1648 gmcc
since φlt 28deg Local shear failure shall be considered Substituting the values of all
other parameters SBC is calculated as 1570 Tm2 Similarly for other cases also
SBC may be evaluated in the same fashion
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible sett
values and the results of shear parameters
The open foundation in the form of isolated footing may be provided at a minimum
depth of 300 m which safe bearing capacity of
basis of shear parameter
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible settlements etc The soil properties along with the SPT
the results of shear parameters are shown in the Table- 1
The open foundation in the form of isolated footing may be provided at a minimum
which safe bearing capacity of 1500 Tm2 may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
Page 12 of 20
Chapter Chapter Chapter Chapter 7777
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
along with the SPT
The open foundation in the form of isolated footing may be provided at a minimum
may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 4 of 20
AIMS OF INVESTIGATION
The subject of Safe bearing capacity of soils is of great importance to
Engineers who have to design foundations for buildings and structures which are
heavy large and tall Such structures are required to be put to meet the varying
requirements which have come about in the work of substantial More important the
structure is greater need to give attention to design and construction of its
foundation
The design and construction of foundation of heavy structure is not an easy
task It calls for ability and experience The most important factor which influences
design of foundations is the load bearing capacity of soils met with Therefore in
arriving at the safe load bearing capacity of soils the properties and characteristics
of the soil at site is required to be determined
It has many times been experienced that not only the design of foundation is
difficult task the pre- requisite for which are the proper site investigation field test
and laboratory testing but the actual construction of foundation also poses difficult
Problems It is therefore necessary to conduct the detail investigations at site are
essential before a design can be finalized The object of subsurface and related site
investigations is to provide the engineer Architect with as much information as
possible about the existing conditions for example the exposed overburden the
course of a stream nearby a rock outcrop or a hillock vegetation and other
geological features of the area It is equally important to know the sub soil conditions
below a proposed structure
Page 5 of 20
The methods of sub surface investigation enable vertical sections of the strata
to be drawn and samples to be tested on the site or in a laboratory for determining
Shear strength parameters bearing capacity of the soils water table type
classification and other geophysical information in the field This information together
With the normal topographical survey provides the Engineer with complete details of
the site and enables him to know the complexity of natural deposits No one method
of exploration is best for all situations Site reconnaissance would help in deriving
program of field investigations that is to assess the need for preliminary or detailed
investigations
Page 6 of 20
Chapter 3Chapter 3Chapter 3Chapter 3
SCOPE OF WORK
bull The present scope of work is related to Geotechnical Investigation and Ms
Enaltech Labs Pvt Ltd placed order to Ms ATLCPL Indore to carryout
Investigation within very short span of time conducting of SPT at every 150
mtr Interval in Soil and collection of disturbed amp undisturbed soil samples for
laboratory tests
bull The laboratory test includes grain size analysis Liquid amp plastic limits
classification shear parameters one in each borehole with recommendation
and report submission As Mentioned within the framework of this job
contract the field investigations comprised of the following-
a) Boring of two borehole of 150mm diameter up to the 130 mtr
bull b) Collection of representative disturbed amp undisturbed soil samples
c) Carrying out standard penetration tests as per IS2131 - 1981 in each bore
hole and Subsequently preparation of penetration charts depth-wise for each
bore hole The SPT has been performed at 15m interval up to refusal
The laboratory tests part of this job contract comprised of the following-
bull I) Grain Size Analysis
bull ii) Atterburgrsquos Limits
bull iii) Dry Density
bull iv) Directs Shear Test
bull v) Specific Gravity
bull vi) Natural Moisture content
bull vii) Field Density
Page 7 of 20
FACTOR OF SAFETY
For safety against bearing capacity failure a factor of safety of 3 is
recommended under the probable maximum loads For structures of minor
importance and in sub soils of uniform character whose properties are very well
known a smaller factor of safety may be used A factor of safety of three is
comparable with the value commonly used for the design of super structure
Effect of water table
The water table has a marked influence on the bearing capacity of Silty and
Clay soil if it rises above a level depth of which below the footing equals its width
the bearing capacity progressively reduces until it becomes about half when the
level of water table reaches the level of the footing
Page 8 of 20
Chapter Chapter Chapter Chapter 4444
FIELD amp LABORATORY TESTS
Two bore were selected by Engineer Incharge of Ms Enaltech Labs Pvt
Ltd In the one bore holes Standard Penetration Tests (SPT) were conducted in
accordance with IS 2131(1981) - Method of Standard Penetration Test for Soils A
Split Spoon Sampler 508 mm Outer diameter and 35 mm internal diameter are
driven in to the undisturbed soil at the bottom of hole under the blows of 65kg
hammer falling through a height of 75 cm The Number of blows required to drive the
sampler 30 cm beyond sitting drive of 15 cm is termed as Standard Penetration
Resistance denoted by lsquoNrsquo The result of Standard Penetration Tests has been
shown in Table 1
The rock drilling and rock core correction was done in accordance with IS 6926
(1996) ndashDiamond Core Drilling Site Investigation for River Valley Project-Code of
Practice and IS 4464 (1985) Code of Practice for Presentation of drilling
Information and Core Description and Foundation Investigation From the bore
holes disturbed and undisturbed samples were collected for lab test On the sample
collected grain size analysis Atterbergs limits specific gravity and shear strength
test were conducted The result of soil test given in Table 1 amp 2
Page 9 of 20
Chapter Chapter Chapter Chapter 5555 DISCUSSION ampINTERPRATION OF LAB TESTS
Geotechnical investigation was done at the site of Ms Enaltech Labs Pvt
Ltd at Plot no Plot no 825-826 Sector III Industrial area Pithampur Distt Dhar
(MP) The location of Bore Hole was decided by the party From Bore Holes
disturbed amp undisturbed samples were collected the soil profile from Bore Holes is
shown from Fig 1 amp 2 Samples collected from Bore were used for Grain Size
Analysis test Atterbergs limits Specific Gravity density amp moisture content was
conducted in the laboratory Direct shear test was also conducted
SOIL amp ROCK PROFILE
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 200 m Filled up material was seen from 200 to
270 mtr Black Soil from 270 to 650 Light Yellow Soil 650 to 1300 mtr yellow
Silty Soil was encountered The standard Penetration test conduct at 150m interval
and Results ldquoNrdquo Value shown on table no 1 The grain size distribution curve is
shown in Fig 4
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 270 mtr Black Soil from 270 to 650 Light Yellow
Soil 650 to 1300 mtr yellow Silty Soil was encountered The standard Penetration
test conduct at 150m interval and Results ldquoNrdquo Value shown on table no 1 The grain
size distribution curve is shown in Fig 5
Page 10 of 20
CCCChapter hapter hapter hapter 6666
COMPUTATIONS OF SAFE BEARING CAPACITY
(I) BASED ON SHEAR CONSIDERATION
Box shear test in undrained condition was performed to get shear parameters The
Safe Bearing Capacity is calculated as per IS 6403- 1981 (determination of bearing
capacity of shallow foundations) For local shear failure the ultimate bearing capacity
is given as follows
In case of General shear failure
qd = C NcSc dcic+q (Nq-1) Sqdqiq+ frac12 B γ Nγdγiγ W
In case of local shear failure
qd = 23 C NrsquocSc dcic+q (Nrsquoq-1) Sqdqiq+ frac12 B γ Nrsquoγdγiγ W
Where qd = Ultimate bearing capacity
C = Cohesion (Non cohesive material C = 0)
φ = Angle of internal friction
φrsquo = tan-1(067 tan (Oslash)) for local shear failure
γ = Average density of over burden
NcNqNγ = Bearing Capacity factors for General Shear Failure
NrsquocNrsquoqNrsquoγ = Bearing Capacity factors for Local Shear Failure
ScSqSγ = Shape factors
dc dqdγ =depth factors
iciqiγ =inclination factors ( 1 in the case of vertical loads)
Page 11 of 20
q = Effective surcharge at depth ofrdquo Xrdquo Mt below ground level
W = Water Table correction factor is frac12 (When WT is at base of
footing)
B = Width of footing in Mts
FS = Factor of safety considered as 3
For BH-1 at 300 m depth
c = 0356 Kgcm2 φ = 1800deg γ = 1648 gmcc
since φlt 28deg Local shear failure shall be considered Substituting the values of all
other parameters SBC is calculated as 1570 Tm2 Similarly for other cases also
SBC may be evaluated in the same fashion
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible sett
values and the results of shear parameters
The open foundation in the form of isolated footing may be provided at a minimum
depth of 300 m which safe bearing capacity of
basis of shear parameter
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible settlements etc The soil properties along with the SPT
the results of shear parameters are shown in the Table- 1
The open foundation in the form of isolated footing may be provided at a minimum
which safe bearing capacity of 1500 Tm2 may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
Page 12 of 20
Chapter Chapter Chapter Chapter 7777
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
along with the SPT
The open foundation in the form of isolated footing may be provided at a minimum
may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 5 of 20
The methods of sub surface investigation enable vertical sections of the strata
to be drawn and samples to be tested on the site or in a laboratory for determining
Shear strength parameters bearing capacity of the soils water table type
classification and other geophysical information in the field This information together
With the normal topographical survey provides the Engineer with complete details of
the site and enables him to know the complexity of natural deposits No one method
of exploration is best for all situations Site reconnaissance would help in deriving
program of field investigations that is to assess the need for preliminary or detailed
investigations
Page 6 of 20
Chapter 3Chapter 3Chapter 3Chapter 3
SCOPE OF WORK
bull The present scope of work is related to Geotechnical Investigation and Ms
Enaltech Labs Pvt Ltd placed order to Ms ATLCPL Indore to carryout
Investigation within very short span of time conducting of SPT at every 150
mtr Interval in Soil and collection of disturbed amp undisturbed soil samples for
laboratory tests
bull The laboratory test includes grain size analysis Liquid amp plastic limits
classification shear parameters one in each borehole with recommendation
and report submission As Mentioned within the framework of this job
contract the field investigations comprised of the following-
a) Boring of two borehole of 150mm diameter up to the 130 mtr
bull b) Collection of representative disturbed amp undisturbed soil samples
c) Carrying out standard penetration tests as per IS2131 - 1981 in each bore
hole and Subsequently preparation of penetration charts depth-wise for each
bore hole The SPT has been performed at 15m interval up to refusal
The laboratory tests part of this job contract comprised of the following-
bull I) Grain Size Analysis
bull ii) Atterburgrsquos Limits
bull iii) Dry Density
bull iv) Directs Shear Test
bull v) Specific Gravity
bull vi) Natural Moisture content
bull vii) Field Density
Page 7 of 20
FACTOR OF SAFETY
For safety against bearing capacity failure a factor of safety of 3 is
recommended under the probable maximum loads For structures of minor
importance and in sub soils of uniform character whose properties are very well
known a smaller factor of safety may be used A factor of safety of three is
comparable with the value commonly used for the design of super structure
Effect of water table
The water table has a marked influence on the bearing capacity of Silty and
Clay soil if it rises above a level depth of which below the footing equals its width
the bearing capacity progressively reduces until it becomes about half when the
level of water table reaches the level of the footing
Page 8 of 20
Chapter Chapter Chapter Chapter 4444
FIELD amp LABORATORY TESTS
Two bore were selected by Engineer Incharge of Ms Enaltech Labs Pvt
Ltd In the one bore holes Standard Penetration Tests (SPT) were conducted in
accordance with IS 2131(1981) - Method of Standard Penetration Test for Soils A
Split Spoon Sampler 508 mm Outer diameter and 35 mm internal diameter are
driven in to the undisturbed soil at the bottom of hole under the blows of 65kg
hammer falling through a height of 75 cm The Number of blows required to drive the
sampler 30 cm beyond sitting drive of 15 cm is termed as Standard Penetration
Resistance denoted by lsquoNrsquo The result of Standard Penetration Tests has been
shown in Table 1
The rock drilling and rock core correction was done in accordance with IS 6926
(1996) ndashDiamond Core Drilling Site Investigation for River Valley Project-Code of
Practice and IS 4464 (1985) Code of Practice for Presentation of drilling
Information and Core Description and Foundation Investigation From the bore
holes disturbed and undisturbed samples were collected for lab test On the sample
collected grain size analysis Atterbergs limits specific gravity and shear strength
test were conducted The result of soil test given in Table 1 amp 2
Page 9 of 20
Chapter Chapter Chapter Chapter 5555 DISCUSSION ampINTERPRATION OF LAB TESTS
Geotechnical investigation was done at the site of Ms Enaltech Labs Pvt
Ltd at Plot no Plot no 825-826 Sector III Industrial area Pithampur Distt Dhar
(MP) The location of Bore Hole was decided by the party From Bore Holes
disturbed amp undisturbed samples were collected the soil profile from Bore Holes is
shown from Fig 1 amp 2 Samples collected from Bore were used for Grain Size
Analysis test Atterbergs limits Specific Gravity density amp moisture content was
conducted in the laboratory Direct shear test was also conducted
SOIL amp ROCK PROFILE
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 200 m Filled up material was seen from 200 to
270 mtr Black Soil from 270 to 650 Light Yellow Soil 650 to 1300 mtr yellow
Silty Soil was encountered The standard Penetration test conduct at 150m interval
and Results ldquoNrdquo Value shown on table no 1 The grain size distribution curve is
shown in Fig 4
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 270 mtr Black Soil from 270 to 650 Light Yellow
Soil 650 to 1300 mtr yellow Silty Soil was encountered The standard Penetration
test conduct at 150m interval and Results ldquoNrdquo Value shown on table no 1 The grain
size distribution curve is shown in Fig 5
Page 10 of 20
CCCChapter hapter hapter hapter 6666
COMPUTATIONS OF SAFE BEARING CAPACITY
(I) BASED ON SHEAR CONSIDERATION
Box shear test in undrained condition was performed to get shear parameters The
Safe Bearing Capacity is calculated as per IS 6403- 1981 (determination of bearing
capacity of shallow foundations) For local shear failure the ultimate bearing capacity
is given as follows
In case of General shear failure
qd = C NcSc dcic+q (Nq-1) Sqdqiq+ frac12 B γ Nγdγiγ W
In case of local shear failure
qd = 23 C NrsquocSc dcic+q (Nrsquoq-1) Sqdqiq+ frac12 B γ Nrsquoγdγiγ W
Where qd = Ultimate bearing capacity
C = Cohesion (Non cohesive material C = 0)
φ = Angle of internal friction
φrsquo = tan-1(067 tan (Oslash)) for local shear failure
γ = Average density of over burden
NcNqNγ = Bearing Capacity factors for General Shear Failure
NrsquocNrsquoqNrsquoγ = Bearing Capacity factors for Local Shear Failure
ScSqSγ = Shape factors
dc dqdγ =depth factors
iciqiγ =inclination factors ( 1 in the case of vertical loads)
Page 11 of 20
q = Effective surcharge at depth ofrdquo Xrdquo Mt below ground level
W = Water Table correction factor is frac12 (When WT is at base of
footing)
B = Width of footing in Mts
FS = Factor of safety considered as 3
For BH-1 at 300 m depth
c = 0356 Kgcm2 φ = 1800deg γ = 1648 gmcc
since φlt 28deg Local shear failure shall be considered Substituting the values of all
other parameters SBC is calculated as 1570 Tm2 Similarly for other cases also
SBC may be evaluated in the same fashion
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible sett
values and the results of shear parameters
The open foundation in the form of isolated footing may be provided at a minimum
depth of 300 m which safe bearing capacity of
basis of shear parameter
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible settlements etc The soil properties along with the SPT
the results of shear parameters are shown in the Table- 1
The open foundation in the form of isolated footing may be provided at a minimum
which safe bearing capacity of 1500 Tm2 may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
Page 12 of 20
Chapter Chapter Chapter Chapter 7777
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
along with the SPT
The open foundation in the form of isolated footing may be provided at a minimum
may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 6 of 20
Chapter 3Chapter 3Chapter 3Chapter 3
SCOPE OF WORK
bull The present scope of work is related to Geotechnical Investigation and Ms
Enaltech Labs Pvt Ltd placed order to Ms ATLCPL Indore to carryout
Investigation within very short span of time conducting of SPT at every 150
mtr Interval in Soil and collection of disturbed amp undisturbed soil samples for
laboratory tests
bull The laboratory test includes grain size analysis Liquid amp plastic limits
classification shear parameters one in each borehole with recommendation
and report submission As Mentioned within the framework of this job
contract the field investigations comprised of the following-
a) Boring of two borehole of 150mm diameter up to the 130 mtr
bull b) Collection of representative disturbed amp undisturbed soil samples
c) Carrying out standard penetration tests as per IS2131 - 1981 in each bore
hole and Subsequently preparation of penetration charts depth-wise for each
bore hole The SPT has been performed at 15m interval up to refusal
The laboratory tests part of this job contract comprised of the following-
bull I) Grain Size Analysis
bull ii) Atterburgrsquos Limits
bull iii) Dry Density
bull iv) Directs Shear Test
bull v) Specific Gravity
bull vi) Natural Moisture content
bull vii) Field Density
Page 7 of 20
FACTOR OF SAFETY
For safety against bearing capacity failure a factor of safety of 3 is
recommended under the probable maximum loads For structures of minor
importance and in sub soils of uniform character whose properties are very well
known a smaller factor of safety may be used A factor of safety of three is
comparable with the value commonly used for the design of super structure
Effect of water table
The water table has a marked influence on the bearing capacity of Silty and
Clay soil if it rises above a level depth of which below the footing equals its width
the bearing capacity progressively reduces until it becomes about half when the
level of water table reaches the level of the footing
Page 8 of 20
Chapter Chapter Chapter Chapter 4444
FIELD amp LABORATORY TESTS
Two bore were selected by Engineer Incharge of Ms Enaltech Labs Pvt
Ltd In the one bore holes Standard Penetration Tests (SPT) were conducted in
accordance with IS 2131(1981) - Method of Standard Penetration Test for Soils A
Split Spoon Sampler 508 mm Outer diameter and 35 mm internal diameter are
driven in to the undisturbed soil at the bottom of hole under the blows of 65kg
hammer falling through a height of 75 cm The Number of blows required to drive the
sampler 30 cm beyond sitting drive of 15 cm is termed as Standard Penetration
Resistance denoted by lsquoNrsquo The result of Standard Penetration Tests has been
shown in Table 1
The rock drilling and rock core correction was done in accordance with IS 6926
(1996) ndashDiamond Core Drilling Site Investigation for River Valley Project-Code of
Practice and IS 4464 (1985) Code of Practice for Presentation of drilling
Information and Core Description and Foundation Investigation From the bore
holes disturbed and undisturbed samples were collected for lab test On the sample
collected grain size analysis Atterbergs limits specific gravity and shear strength
test were conducted The result of soil test given in Table 1 amp 2
Page 9 of 20
Chapter Chapter Chapter Chapter 5555 DISCUSSION ampINTERPRATION OF LAB TESTS
Geotechnical investigation was done at the site of Ms Enaltech Labs Pvt
Ltd at Plot no Plot no 825-826 Sector III Industrial area Pithampur Distt Dhar
(MP) The location of Bore Hole was decided by the party From Bore Holes
disturbed amp undisturbed samples were collected the soil profile from Bore Holes is
shown from Fig 1 amp 2 Samples collected from Bore were used for Grain Size
Analysis test Atterbergs limits Specific Gravity density amp moisture content was
conducted in the laboratory Direct shear test was also conducted
SOIL amp ROCK PROFILE
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 200 m Filled up material was seen from 200 to
270 mtr Black Soil from 270 to 650 Light Yellow Soil 650 to 1300 mtr yellow
Silty Soil was encountered The standard Penetration test conduct at 150m interval
and Results ldquoNrdquo Value shown on table no 1 The grain size distribution curve is
shown in Fig 4
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 270 mtr Black Soil from 270 to 650 Light Yellow
Soil 650 to 1300 mtr yellow Silty Soil was encountered The standard Penetration
test conduct at 150m interval and Results ldquoNrdquo Value shown on table no 1 The grain
size distribution curve is shown in Fig 5
Page 10 of 20
CCCChapter hapter hapter hapter 6666
COMPUTATIONS OF SAFE BEARING CAPACITY
(I) BASED ON SHEAR CONSIDERATION
Box shear test in undrained condition was performed to get shear parameters The
Safe Bearing Capacity is calculated as per IS 6403- 1981 (determination of bearing
capacity of shallow foundations) For local shear failure the ultimate bearing capacity
is given as follows
In case of General shear failure
qd = C NcSc dcic+q (Nq-1) Sqdqiq+ frac12 B γ Nγdγiγ W
In case of local shear failure
qd = 23 C NrsquocSc dcic+q (Nrsquoq-1) Sqdqiq+ frac12 B γ Nrsquoγdγiγ W
Where qd = Ultimate bearing capacity
C = Cohesion (Non cohesive material C = 0)
φ = Angle of internal friction
φrsquo = tan-1(067 tan (Oslash)) for local shear failure
γ = Average density of over burden
NcNqNγ = Bearing Capacity factors for General Shear Failure
NrsquocNrsquoqNrsquoγ = Bearing Capacity factors for Local Shear Failure
ScSqSγ = Shape factors
dc dqdγ =depth factors
iciqiγ =inclination factors ( 1 in the case of vertical loads)
Page 11 of 20
q = Effective surcharge at depth ofrdquo Xrdquo Mt below ground level
W = Water Table correction factor is frac12 (When WT is at base of
footing)
B = Width of footing in Mts
FS = Factor of safety considered as 3
For BH-1 at 300 m depth
c = 0356 Kgcm2 φ = 1800deg γ = 1648 gmcc
since φlt 28deg Local shear failure shall be considered Substituting the values of all
other parameters SBC is calculated as 1570 Tm2 Similarly for other cases also
SBC may be evaluated in the same fashion
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible sett
values and the results of shear parameters
The open foundation in the form of isolated footing may be provided at a minimum
depth of 300 m which safe bearing capacity of
basis of shear parameter
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible settlements etc The soil properties along with the SPT
the results of shear parameters are shown in the Table- 1
The open foundation in the form of isolated footing may be provided at a minimum
which safe bearing capacity of 1500 Tm2 may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
Page 12 of 20
Chapter Chapter Chapter Chapter 7777
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
along with the SPT
The open foundation in the form of isolated footing may be provided at a minimum
may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
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Page 7 of 20
FACTOR OF SAFETY
For safety against bearing capacity failure a factor of safety of 3 is
recommended under the probable maximum loads For structures of minor
importance and in sub soils of uniform character whose properties are very well
known a smaller factor of safety may be used A factor of safety of three is
comparable with the value commonly used for the design of super structure
Effect of water table
The water table has a marked influence on the bearing capacity of Silty and
Clay soil if it rises above a level depth of which below the footing equals its width
the bearing capacity progressively reduces until it becomes about half when the
level of water table reaches the level of the footing
Page 8 of 20
Chapter Chapter Chapter Chapter 4444
FIELD amp LABORATORY TESTS
Two bore were selected by Engineer Incharge of Ms Enaltech Labs Pvt
Ltd In the one bore holes Standard Penetration Tests (SPT) were conducted in
accordance with IS 2131(1981) - Method of Standard Penetration Test for Soils A
Split Spoon Sampler 508 mm Outer diameter and 35 mm internal diameter are
driven in to the undisturbed soil at the bottom of hole under the blows of 65kg
hammer falling through a height of 75 cm The Number of blows required to drive the
sampler 30 cm beyond sitting drive of 15 cm is termed as Standard Penetration
Resistance denoted by lsquoNrsquo The result of Standard Penetration Tests has been
shown in Table 1
The rock drilling and rock core correction was done in accordance with IS 6926
(1996) ndashDiamond Core Drilling Site Investigation for River Valley Project-Code of
Practice and IS 4464 (1985) Code of Practice for Presentation of drilling
Information and Core Description and Foundation Investigation From the bore
holes disturbed and undisturbed samples were collected for lab test On the sample
collected grain size analysis Atterbergs limits specific gravity and shear strength
test were conducted The result of soil test given in Table 1 amp 2
Page 9 of 20
Chapter Chapter Chapter Chapter 5555 DISCUSSION ampINTERPRATION OF LAB TESTS
Geotechnical investigation was done at the site of Ms Enaltech Labs Pvt
Ltd at Plot no Plot no 825-826 Sector III Industrial area Pithampur Distt Dhar
(MP) The location of Bore Hole was decided by the party From Bore Holes
disturbed amp undisturbed samples were collected the soil profile from Bore Holes is
shown from Fig 1 amp 2 Samples collected from Bore were used for Grain Size
Analysis test Atterbergs limits Specific Gravity density amp moisture content was
conducted in the laboratory Direct shear test was also conducted
SOIL amp ROCK PROFILE
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 200 m Filled up material was seen from 200 to
270 mtr Black Soil from 270 to 650 Light Yellow Soil 650 to 1300 mtr yellow
Silty Soil was encountered The standard Penetration test conduct at 150m interval
and Results ldquoNrdquo Value shown on table no 1 The grain size distribution curve is
shown in Fig 4
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 270 mtr Black Soil from 270 to 650 Light Yellow
Soil 650 to 1300 mtr yellow Silty Soil was encountered The standard Penetration
test conduct at 150m interval and Results ldquoNrdquo Value shown on table no 1 The grain
size distribution curve is shown in Fig 5
Page 10 of 20
CCCChapter hapter hapter hapter 6666
COMPUTATIONS OF SAFE BEARING CAPACITY
(I) BASED ON SHEAR CONSIDERATION
Box shear test in undrained condition was performed to get shear parameters The
Safe Bearing Capacity is calculated as per IS 6403- 1981 (determination of bearing
capacity of shallow foundations) For local shear failure the ultimate bearing capacity
is given as follows
In case of General shear failure
qd = C NcSc dcic+q (Nq-1) Sqdqiq+ frac12 B γ Nγdγiγ W
In case of local shear failure
qd = 23 C NrsquocSc dcic+q (Nrsquoq-1) Sqdqiq+ frac12 B γ Nrsquoγdγiγ W
Where qd = Ultimate bearing capacity
C = Cohesion (Non cohesive material C = 0)
φ = Angle of internal friction
φrsquo = tan-1(067 tan (Oslash)) for local shear failure
γ = Average density of over burden
NcNqNγ = Bearing Capacity factors for General Shear Failure
NrsquocNrsquoqNrsquoγ = Bearing Capacity factors for Local Shear Failure
ScSqSγ = Shape factors
dc dqdγ =depth factors
iciqiγ =inclination factors ( 1 in the case of vertical loads)
Page 11 of 20
q = Effective surcharge at depth ofrdquo Xrdquo Mt below ground level
W = Water Table correction factor is frac12 (When WT is at base of
footing)
B = Width of footing in Mts
FS = Factor of safety considered as 3
For BH-1 at 300 m depth
c = 0356 Kgcm2 φ = 1800deg γ = 1648 gmcc
since φlt 28deg Local shear failure shall be considered Substituting the values of all
other parameters SBC is calculated as 1570 Tm2 Similarly for other cases also
SBC may be evaluated in the same fashion
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible sett
values and the results of shear parameters
The open foundation in the form of isolated footing may be provided at a minimum
depth of 300 m which safe bearing capacity of
basis of shear parameter
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible settlements etc The soil properties along with the SPT
the results of shear parameters are shown in the Table- 1
The open foundation in the form of isolated footing may be provided at a minimum
which safe bearing capacity of 1500 Tm2 may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
Page 12 of 20
Chapter Chapter Chapter Chapter 7777
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
along with the SPT
The open foundation in the form of isolated footing may be provided at a minimum
may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
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Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
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Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
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Page 8 of 20
Chapter Chapter Chapter Chapter 4444
FIELD amp LABORATORY TESTS
Two bore were selected by Engineer Incharge of Ms Enaltech Labs Pvt
Ltd In the one bore holes Standard Penetration Tests (SPT) were conducted in
accordance with IS 2131(1981) - Method of Standard Penetration Test for Soils A
Split Spoon Sampler 508 mm Outer diameter and 35 mm internal diameter are
driven in to the undisturbed soil at the bottom of hole under the blows of 65kg
hammer falling through a height of 75 cm The Number of blows required to drive the
sampler 30 cm beyond sitting drive of 15 cm is termed as Standard Penetration
Resistance denoted by lsquoNrsquo The result of Standard Penetration Tests has been
shown in Table 1
The rock drilling and rock core correction was done in accordance with IS 6926
(1996) ndashDiamond Core Drilling Site Investigation for River Valley Project-Code of
Practice and IS 4464 (1985) Code of Practice for Presentation of drilling
Information and Core Description and Foundation Investigation From the bore
holes disturbed and undisturbed samples were collected for lab test On the sample
collected grain size analysis Atterbergs limits specific gravity and shear strength
test were conducted The result of soil test given in Table 1 amp 2
Page 9 of 20
Chapter Chapter Chapter Chapter 5555 DISCUSSION ampINTERPRATION OF LAB TESTS
Geotechnical investigation was done at the site of Ms Enaltech Labs Pvt
Ltd at Plot no Plot no 825-826 Sector III Industrial area Pithampur Distt Dhar
(MP) The location of Bore Hole was decided by the party From Bore Holes
disturbed amp undisturbed samples were collected the soil profile from Bore Holes is
shown from Fig 1 amp 2 Samples collected from Bore were used for Grain Size
Analysis test Atterbergs limits Specific Gravity density amp moisture content was
conducted in the laboratory Direct shear test was also conducted
SOIL amp ROCK PROFILE
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 200 m Filled up material was seen from 200 to
270 mtr Black Soil from 270 to 650 Light Yellow Soil 650 to 1300 mtr yellow
Silty Soil was encountered The standard Penetration test conduct at 150m interval
and Results ldquoNrdquo Value shown on table no 1 The grain size distribution curve is
shown in Fig 4
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 270 mtr Black Soil from 270 to 650 Light Yellow
Soil 650 to 1300 mtr yellow Silty Soil was encountered The standard Penetration
test conduct at 150m interval and Results ldquoNrdquo Value shown on table no 1 The grain
size distribution curve is shown in Fig 5
Page 10 of 20
CCCChapter hapter hapter hapter 6666
COMPUTATIONS OF SAFE BEARING CAPACITY
(I) BASED ON SHEAR CONSIDERATION
Box shear test in undrained condition was performed to get shear parameters The
Safe Bearing Capacity is calculated as per IS 6403- 1981 (determination of bearing
capacity of shallow foundations) For local shear failure the ultimate bearing capacity
is given as follows
In case of General shear failure
qd = C NcSc dcic+q (Nq-1) Sqdqiq+ frac12 B γ Nγdγiγ W
In case of local shear failure
qd = 23 C NrsquocSc dcic+q (Nrsquoq-1) Sqdqiq+ frac12 B γ Nrsquoγdγiγ W
Where qd = Ultimate bearing capacity
C = Cohesion (Non cohesive material C = 0)
φ = Angle of internal friction
φrsquo = tan-1(067 tan (Oslash)) for local shear failure
γ = Average density of over burden
NcNqNγ = Bearing Capacity factors for General Shear Failure
NrsquocNrsquoqNrsquoγ = Bearing Capacity factors for Local Shear Failure
ScSqSγ = Shape factors
dc dqdγ =depth factors
iciqiγ =inclination factors ( 1 in the case of vertical loads)
Page 11 of 20
q = Effective surcharge at depth ofrdquo Xrdquo Mt below ground level
W = Water Table correction factor is frac12 (When WT is at base of
footing)
B = Width of footing in Mts
FS = Factor of safety considered as 3
For BH-1 at 300 m depth
c = 0356 Kgcm2 φ = 1800deg γ = 1648 gmcc
since φlt 28deg Local shear failure shall be considered Substituting the values of all
other parameters SBC is calculated as 1570 Tm2 Similarly for other cases also
SBC may be evaluated in the same fashion
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible sett
values and the results of shear parameters
The open foundation in the form of isolated footing may be provided at a minimum
depth of 300 m which safe bearing capacity of
basis of shear parameter
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible settlements etc The soil properties along with the SPT
the results of shear parameters are shown in the Table- 1
The open foundation in the form of isolated footing may be provided at a minimum
which safe bearing capacity of 1500 Tm2 may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
Page 12 of 20
Chapter Chapter Chapter Chapter 7777
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
along with the SPT
The open foundation in the form of isolated footing may be provided at a minimum
may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
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- Annexure - 3pdf
- Annexure - 4pdf
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- Factory licensepdf
- Lease deedpdf
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- Annexure - 5pdf
-
Page 9 of 20
Chapter Chapter Chapter Chapter 5555 DISCUSSION ampINTERPRATION OF LAB TESTS
Geotechnical investigation was done at the site of Ms Enaltech Labs Pvt
Ltd at Plot no Plot no 825-826 Sector III Industrial area Pithampur Distt Dhar
(MP) The location of Bore Hole was decided by the party From Bore Holes
disturbed amp undisturbed samples were collected the soil profile from Bore Holes is
shown from Fig 1 amp 2 Samples collected from Bore were used for Grain Size
Analysis test Atterbergs limits Specific Gravity density amp moisture content was
conducted in the laboratory Direct shear test was also conducted
SOIL amp ROCK PROFILE
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 200 m Filled up material was seen from 200 to
270 mtr Black Soil from 270 to 650 Light Yellow Soil 650 to 1300 mtr yellow
Silty Soil was encountered The standard Penetration test conduct at 150m interval
and Results ldquoNrdquo Value shown on table no 1 The grain size distribution curve is
shown in Fig 4
BH ndash 1
The soil profile and details of bore logging are shown in Fig1 from the
existing ground level to a depth 270 mtr Black Soil from 270 to 650 Light Yellow
Soil 650 to 1300 mtr yellow Silty Soil was encountered The standard Penetration
test conduct at 150m interval and Results ldquoNrdquo Value shown on table no 1 The grain
size distribution curve is shown in Fig 5
Page 10 of 20
CCCChapter hapter hapter hapter 6666
COMPUTATIONS OF SAFE BEARING CAPACITY
(I) BASED ON SHEAR CONSIDERATION
Box shear test in undrained condition was performed to get shear parameters The
Safe Bearing Capacity is calculated as per IS 6403- 1981 (determination of bearing
capacity of shallow foundations) For local shear failure the ultimate bearing capacity
is given as follows
In case of General shear failure
qd = C NcSc dcic+q (Nq-1) Sqdqiq+ frac12 B γ Nγdγiγ W
In case of local shear failure
qd = 23 C NrsquocSc dcic+q (Nrsquoq-1) Sqdqiq+ frac12 B γ Nrsquoγdγiγ W
Where qd = Ultimate bearing capacity
C = Cohesion (Non cohesive material C = 0)
φ = Angle of internal friction
φrsquo = tan-1(067 tan (Oslash)) for local shear failure
γ = Average density of over burden
NcNqNγ = Bearing Capacity factors for General Shear Failure
NrsquocNrsquoqNrsquoγ = Bearing Capacity factors for Local Shear Failure
ScSqSγ = Shape factors
dc dqdγ =depth factors
iciqiγ =inclination factors ( 1 in the case of vertical loads)
Page 11 of 20
q = Effective surcharge at depth ofrdquo Xrdquo Mt below ground level
W = Water Table correction factor is frac12 (When WT is at base of
footing)
B = Width of footing in Mts
FS = Factor of safety considered as 3
For BH-1 at 300 m depth
c = 0356 Kgcm2 φ = 1800deg γ = 1648 gmcc
since φlt 28deg Local shear failure shall be considered Substituting the values of all
other parameters SBC is calculated as 1570 Tm2 Similarly for other cases also
SBC may be evaluated in the same fashion
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible sett
values and the results of shear parameters
The open foundation in the form of isolated footing may be provided at a minimum
depth of 300 m which safe bearing capacity of
basis of shear parameter
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible settlements etc The soil properties along with the SPT
the results of shear parameters are shown in the Table- 1
The open foundation in the form of isolated footing may be provided at a minimum
which safe bearing capacity of 1500 Tm2 may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
Page 12 of 20
Chapter Chapter Chapter Chapter 7777
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
along with the SPT
The open foundation in the form of isolated footing may be provided at a minimum
may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 10 of 20
CCCChapter hapter hapter hapter 6666
COMPUTATIONS OF SAFE BEARING CAPACITY
(I) BASED ON SHEAR CONSIDERATION
Box shear test in undrained condition was performed to get shear parameters The
Safe Bearing Capacity is calculated as per IS 6403- 1981 (determination of bearing
capacity of shallow foundations) For local shear failure the ultimate bearing capacity
is given as follows
In case of General shear failure
qd = C NcSc dcic+q (Nq-1) Sqdqiq+ frac12 B γ Nγdγiγ W
In case of local shear failure
qd = 23 C NrsquocSc dcic+q (Nrsquoq-1) Sqdqiq+ frac12 B γ Nrsquoγdγiγ W
Where qd = Ultimate bearing capacity
C = Cohesion (Non cohesive material C = 0)
φ = Angle of internal friction
φrsquo = tan-1(067 tan (Oslash)) for local shear failure
γ = Average density of over burden
NcNqNγ = Bearing Capacity factors for General Shear Failure
NrsquocNrsquoqNrsquoγ = Bearing Capacity factors for Local Shear Failure
ScSqSγ = Shape factors
dc dqdγ =depth factors
iciqiγ =inclination factors ( 1 in the case of vertical loads)
Page 11 of 20
q = Effective surcharge at depth ofrdquo Xrdquo Mt below ground level
W = Water Table correction factor is frac12 (When WT is at base of
footing)
B = Width of footing in Mts
FS = Factor of safety considered as 3
For BH-1 at 300 m depth
c = 0356 Kgcm2 φ = 1800deg γ = 1648 gmcc
since φlt 28deg Local shear failure shall be considered Substituting the values of all
other parameters SBC is calculated as 1570 Tm2 Similarly for other cases also
SBC may be evaluated in the same fashion
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible sett
values and the results of shear parameters
The open foundation in the form of isolated footing may be provided at a minimum
depth of 300 m which safe bearing capacity of
basis of shear parameter
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible settlements etc The soil properties along with the SPT
the results of shear parameters are shown in the Table- 1
The open foundation in the form of isolated footing may be provided at a minimum
which safe bearing capacity of 1500 Tm2 may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
Page 12 of 20
Chapter Chapter Chapter Chapter 7777
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
along with the SPT
The open foundation in the form of isolated footing may be provided at a minimum
may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
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plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
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Page 11 of 20
q = Effective surcharge at depth ofrdquo Xrdquo Mt below ground level
W = Water Table correction factor is frac12 (When WT is at base of
footing)
B = Width of footing in Mts
FS = Factor of safety considered as 3
For BH-1 at 300 m depth
c = 0356 Kgcm2 φ = 1800deg γ = 1648 gmcc
since φlt 28deg Local shear failure shall be considered Substituting the values of all
other parameters SBC is calculated as 1570 Tm2 Similarly for other cases also
SBC may be evaluated in the same fashion
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible sett
values and the results of shear parameters
The open foundation in the form of isolated footing may be provided at a minimum
depth of 300 m which safe bearing capacity of
basis of shear parameter
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible settlements etc The soil properties along with the SPT
the results of shear parameters are shown in the Table- 1
The open foundation in the form of isolated footing may be provided at a minimum
which safe bearing capacity of 1500 Tm2 may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
Page 12 of 20
Chapter Chapter Chapter Chapter 7777
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
along with the SPT
The open foundation in the form of isolated footing may be provided at a minimum
may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible sett
values and the results of shear parameters
The open foundation in the form of isolated footing may be provided at a minimum
depth of 300 m which safe bearing capacity of
basis of shear parameter
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
CONCLUSION amp RECOMMENDATION
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
foundation permissible settlements etc The soil properties along with the SPT
the results of shear parameters are shown in the Table- 1
The open foundation in the form of isolated footing may be provided at a minimum
which safe bearing capacity of 1500 Tm2 may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Technical Director
Apron Test Labs amp Consultants Pvt Ltd
Page 12 of 20
Chapter Chapter Chapter Chapter 7777
The safe bearing capacity depends many factors like type of soil the way
of stratification presence of water table load coming on the foundation type of
along with the SPT
The open foundation in the form of isolated footing may be provided at a minimum
may be adopted on the
The effect of earth quake forces must be considered for very tall structures
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 13 of 20
REFERENCE CODES amp STANDARDS
Unless specifically mentioned otherwise the following latest revision of the
applicable codes and standards of Bureau of Indian Standards shall be followed
Sr No CODE NO TITLE OF CODE
1 IS 18881982 Method of load tests on soils
2 IS 18921979 Code practice for subsurface investigations
for foundations
3 IS21321986 Code practice for thin walled tube sampling
of soils
4 IS2720 PART 1 to PART31 amp
IS2720 PART 33 to PART 41
Methods of test of soils
5 IS 30431987 Code practice of earthling
6 IS 44641985 Code practice for presentation of drilling
information and core description in
foundation investigation
7 IS 52491992 Method of test for determination of dynamic
properties of soil
8 IS 69351973 Method of determination of water level in
bore hole
9 IS64031981 Code of practice for determination of bearing
capacity of shallow foundations
10 IS80091981 part I Code of practice for calculation of settlement
of foundation part - 1Shallow foundations
11 IS80091981 part II Code of practice for calculation of settlement
of foundation part-II-Deep foundations
12 IS2720 (part IV)-1985 Grain Size Analysis
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 14 of 20
Sr No CODE NO TITLE OF CODE
13 IS80091981 part I Code of practice for calculation of settlement of
foundation part - 1Shallow foundations
14 IS80091981 part II Code of practice for calculation of settlement of
foundation part-II-Deep foundations
15 IS2720 (part IV)-1985
Reaffirmed 1995
Grain Size Analysis
16 IS2720 (part V)-1985
Reaffirmed 1995
Consistency limits
17 IS 2720 (part IIISec 2)-
1980 Reaffirmed 1997
Specific gravity
18 IS 2720 (part II)-1973
Reaffirmed 1997
Natural moisture content
19 IS 2720 (part-XIII)-1986 Direct shear test
20 IS 1498 (1970) IS soil classification
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 15 of 20
Fig 1 Showing the SoilRock Profile in BH ndash 01
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 16 of 20
Fig 2 Showing the SoilRock Profile in BH ndash 02
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 17 of 20
Fig 3- Showing the Location of Bore Holes
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 18 of 20
Table1 Properties of Soil Sample Collected From Bore Holes
Bore Hole No
Sample No (Depth)
Type of Soil SPT ldquoNrdquo
Value
Grain Size Analysis Atterburgrsquos
Limits IS Classification
NMC
Sp Gr
Density Shear
Parameter SBC
Gravel
Sand
Silt Clay LL PI
gmcm3 C
Φ˚ Tm2 kgcm2
BH - 1 S - 1300 Light
Yellow Soil 14 000 2153 2591 5256 3760 2260 CL 1880 236 1648 0356 1800 1570
BH - 2 S - 2300 Light
Yellow Soil 15 000 2372 2805 4823 3650 2180 CL 1830 236 1654 0352 1850 1609
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 19 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 50 252 252 9748
6 0600 68 342 594 9406
7 0425 51 254 848 9152
8 0300 103 517 1365 8635
9 0150 86 431 1796 8204
10 0075 71 357 2153 7847
11 0060 299 1495 3648 6352
12 0002 219 1096 4744 5256
Gravel Sand Silt Clay
BH - 1
000 2153 2591 5256 Fig 4 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Page 20 of 20
Grain Size Analysis
Sr No SIEVE (mm) WET RET OF WR CUM WR PASS
1 20 0 0 0 100
2 10 0 000 000 100
3 475 0 000 000 100
4 236 0 000 000 100
5 118 69 343 343 9657
6 0600 31 155 498 9502
7 0425 43 216 714 9286
8 0300 163 813 1527 8473
9 0150 76 379 1906 8094
10 0075 93 466 2372 7628
11 0060 407 2035 4407 5593
12 0002 154 770 5177 4823
Gravel Sand Silt Clay
BH - 2
000 2372 2805 4823 Fig 5 Grain Size Distribution Curve at 300 mtr Depth
0
10
20
30
40
50
60
70
80
90
100
0001 001 01 1 10
P
assin
g
Sieves Size mm
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
NAME OF PRODUCTS AND QUANTITY PER ANNUM
SrNo Name of the products Production Quantity Annum in kg
1 Atorvastatin 30000
2 Dexketoprofen 12000
3 Montelukast 12000
4 Dapoxetine 1200
5 Losartan potassium 2400
6 Glimepiride 1800
7 Desloratidine 6000
8 Escitalopram 6000
9 Febuxostat 12000
10 Lymecyclin 12000
11 Moxifloxacin 36000
12 Nitazoxanide 24000
13 Risperidone 1200
14 Topiramate 6000
15 Rupatadine 3600
16 Rosuvastatin 12000
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
SrNo Name of the products Production Quantity Annum in kg
17 Alcaftadine 6
18 Bromfenac sodium 60
19 DarifenacinHydrobromide 36
20 Dronedarone Hydrochloride 360
21 Oxcarbazepine 1200
22 Solifenacin succinate 24
23 Tazarotene 60
24 Clonidine HCL 12
25 Dimethyl fumarate 120
26 Flavoxate hydrochloride 120
27 Fluvoxamine maleate 120
28 OlmesartanMedoxomil 600
29 OlopatadineHCl 12
30 Pramipexoledihydrochloride 12
31 Roflumilast 12
32 Tolperisone HCL 1200
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
SrNo Name of the products Production Quantity Annum in kg
33 Cinacalcet hydrochloride 84
34 Clopidogrelbisulfate 6000
35 Dalfampridin 12
36 Milrinone 6
37Nepafenac
48
38Olanzapine
600
39 Pitvastatin Calcium 120
40 Teriflunomide 120
41Tetrabenazine
180
42 TimololMeleate 120
43 Trospium chloride 300
44Brimonidinetartarate
120
45 Agomelatine 120
46 PrasugrelHCl 300
Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
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plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
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Atorvastatin calcium
Brief Description of Manufacturing Process
Stage-A
Hydrogenation of (4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate in presence of Raney-nickel Methanol to give Stage-A
Stage-B
Stage-A reacts with 4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide Pivalic acid using Cyclo hexane as a solvent followed byisolation in Isopropyl alcohol to give Stage-B
Stage-Final
Stage-B under goes acid hydrolysis with Conc HCl and further hydrolysis with Sodiumhydroxide and finally reacts with Calcium acetate to give Atorvastatin calcium
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Route of synthesis
H2N
OO O
CH3 CH3
O
CH3
CH3
CH3
NH
O
N
CH3CH3
OO
CH3 CH3
F
O
O
CH3
CH3
CH3
Sodium hydroxideCalcium acetate
N
CH3CH3
O
O-
OH OHO
NH
F
2
Ca++
tert-butyl 2-(6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Conc HCl
tert-butyl 2-((4S6S)-6-(2-aminoethyl)-22-dimethyl-13-dioxan-4-yl)acetate
Atorvastatin calciumChemical Formula (C33H34FN2O5)2Ca
Molecular Weight115536
Chemical Formula C40H47FN2O5Molecular Weight 65481
Stage-A
Stage-B
O O
O
O
NC
(4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Chemical Formula C14H23NO4Molecular Weight 26934
Chemical Formula C14H27NO4Molecular Weight 27337
O
F
O
HN
O
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzene butaneamide
Chemical Formula C26H24FNO3Molecular Weight 41747
Raney nickel
Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
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MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
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Mass Balance -
Oty UOM OUTPUT Qty UOM
1 Kg
03 Kg
025 Kg
56 Kg
2 Kg
3 Kg
04 Kg Solid waste 23 Kg
Filtrate 9 Kg
Evaporation loss 025 Kg
Distillate-Methanol 5 Kg
Evaporation loss 1 Kg
Stage-A 1 Kg
1 Kg011 Kg
125 Kg
01 Kg
10 Kg
72 Kg
011 Kg
Filtrate 15 Kg
08 Kg Evaporation loss 242 Kg
Evaporation loss 01 Kg
Stage-B 12 Kg
12 Kg
035 Kg
56 Kg
02 Kg
04 Kg
02 Kg
04 Kg
5 Kg
AqFiltrate ETP 7 Kg
Evaporation loss 1 Kg
Evaporation loss 02 Kg
Output 1 Kg
4647 Kg 4647 Kg
Raney nickelAqueous ammonia solutionMethanol
CyclohexanePivalic acid
4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-Nbeta-diphenylbenzenebutaneamide
Methanol
HyfloWater
Morpholine
Drying
Filtration
Distillation
Methanol
Methanol
Reaction
Stage-A
Calcium acetateMethanolPurified water
Filtration
Drying
Filtration
Stage-B
Total
ATORVASTATIN CALCIUM
INPUT OPERATION4RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
Reaction
Conc HClMethanol
Sodium hydroxideMethanol
Stage-A
TBAHS
Reaction
Work-Up
Stage-B
Reactionwork up
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
14RCis)-11-dimethylethyl-cyanomethyl-22-dimethyl-13-dioxane-4-acetate
26934 1 371 1 Startingmaterial 0 8333 8333
2 Methanol 124 Solvent 0 103333 1033333 Hydrochloric acid 035 Reagent 0 2917 29174 Sodium hydroxide 40 02 5 135 Reagent 0 1666 16665 Raney nickel 85675 03 35 094 Catalyst 0 2499 24996 MTBE 125 Reagent 0 10416 10416
7 Aqueous ammoniasolution
025 Reagent 0 2083 2083
8 Calcium acetate 15817 02 127 034 Reagent 0 1666 16669 Hyflo 2 0 16666 16666
10 Pivalic acid 102132 01 098 026 Reagent 0 833 83311 Cyclohexane 10 Solvent 0 83333 8333312 Isopropyl alcohol 8 Solvent 0 66666 66666
Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
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- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
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- Factory licensepdf
- Lease deedpdf
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- Annexure - 5pdf
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Nitazoxanide
Brief Description of Manufacturing Process
Stage-Final
2-hydroxy-N-(5-nitrothiazol-2-yl) benzamide reacts with Thionyl chloride in presence ofmethanol to give crude form of Nitazoxanide and further isolated with water to give pure form ofNitazoxanide as stage- final
Route of synthesis
O
O
HN
O
S
N
NO2
O
NH
S
N
O2N
HO
2-hydroxy-N-(5-nitrothiazol-2-yl)benzamideChemical Formula C10H7N3O4S
Molecular Weight 26525
Thionyl chloride
Methanol
Water
2-(5-nitrothiazol-2-ylcarbamoyl)phenyl acetateChemical Formula C12H9N3O5S
Molecular Weight 30728
Nitazoxanide
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Mass Balance
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Sr No InputComponent
Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
ProposedconsumptionMTDay
TotalconsumptionMTDay
1Nitro Comp 26525 080 3051 1 Starting
material 0 106666 106666
2 DMF 003 Solvent 0 399 3993 SOCI2 11897 110 925 303 Reagent 0 14667 146674 MDC 390 Solvent 0 51999 519995 Asiprin 180157 152 84373 277 Reagent 0 202667 2026676 TEA 10119 069 682 222 Reagent 0 9199 91997 Ethyl acatate 333 Solvent 0 443999 4439998 Charcoal 003 0 399 3999 Hyflow 1 0 1333333 1333333
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Dexketoprofen
Brief Description of Manufacturing Process
Stage-A
2-(3-benzoylphenyl) propanoicacid (Ketoprofen) reacts with N-Octyl-D-glucamine in presence ofToluene amp water to give Stage-A
Stage-B
Stage-A reacts with Sodium hydroxide in presence of water amp then treated with diluteHydrochloric acid to give Stage-B
Stage-Final
Stage-B was reacts with2-Amino-2-hydroxymethyl-propane-1 3-diol (Tris buffer)in presence of methanol amp water to give crude which is purified in ethyl acetate tooffered pure form of DexketoprofenTromethamol
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Route of synthesis
Ketoprofen
O
COOH
CH3 HO NH
OH
OH OH
OH
O
COO
CH3
HONH2
OH
OH OH
Sodium hydroxideHCl
O
COOH
CH3
HO OH
HO
H2N
O
COO
CH3
HO OH
HO
H3N
Chemical Formula C16H14O3Molecular Weight 25428
N-Octyl-D-glucamine
Chemical Formula C31H47NO7Molecular Weight 54771
Stage-A
(S)-2-(3-benzoylphenyl)propanoic acidChemical Formula C16H14O3
Molecular Weight 25428
Stage-B
Chemical Formula C20H25NO6Molecular Weight 37542
Dexketoprofen Trometamol
2-amino-2-(hydroxymethyl)propane-13-diolChemical Formula C4H11NO3
Molecular Weight 12114
Chemical Formula C14H31NO5Molecular Weight 2934
OH
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Ketoprofen 25428 222 873 1 Startingmaterial 0 7399 7399
2N-octyl-D-Glucamine
2934 179 61 07 Reagent 0 5966 5966
3 Toluene 3500 Solvent 0 116667 1166674 Sodium hydroxide 40 014 35 04 Reagent 0 467 4675 Conc HCl 061 Reagent 0 2033 20336 Ethyl Acetate 1300 Solvent 0 43333 433337 Methanol 250 Solvent 0 8333 83338 Tri Buffer 034 Reagent 0 1133 1133
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Montelukast sodium
Brief Description of Manufacturing Process
Stage ndash A
2-(2-(3S-(2-(7-chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol is mesylated in presence of Mesyl chloride Di-isopropyl ethylamine Methylenedichloride to give intermediate of Stage-A then react with 2-(1-mercaptomethyl)cyclopropyl) acetic acid in presence of Dimethyl sulphoxide Sodiummethoxide and Toluene to give Stage-A
Stage-Final
Stage-A was treated with sodium hydroxide in presence of Methanol then isolate inpresence of Toluene and n-heptane to give pure form of Montelukast sodium
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Route of synthesis
NCl
OH
OH
CH3CH3
NCl
O
OH
CH3CH3
S
CH2
CH2
CH3
NCl
S
OH
CH3CH3COOH
NCl
S
OH
CH3CH3COONa
HS COOH
Chemical Formula C35H35ClNNaO3SMolecular Weight 60817
Montelukast Na
(SE)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid
Chemical Formula C35H36ClNO3SMolecular Weight 58618
2-(1-mercaptomethyl)cyclopropyl) acetic acidChemical Formula C6H10O2S
Molecular Weight 14621
2-(2-(3S-(2-(7-chloro-2-quinolinyl)- ethenyl-phenyl)-3-hydroxy-propyl)phenyl)-2-propanol
Chemical Formula C29H28ClNO2Molecular Weight 45799
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Mass Balance
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1Diol Intermediate
45799 200 437 1Startingmaterial 0 6666 6666
2 Mesy1 Chloride 055 Reagent 0 1833 18333 DIPEA 090 Solvent 0 2999 29994 MDC 1100 Solvent 0 36666 366665 Mercapto Intermediate 14621 140 958 219 Reagent 0 4666 46666 Dimethy Sulphoxide 640 Solvent 0 21333 21333
725 Sodium Methoxidesolution in methanol 226 Reagent 0 7533 7533
8Aqueous 40 Sodiumhydroxide 240 Reagent 0 7999 7999
9 Toluene 1350 Solvent 0 44999 44999
10Acetic Acid Solution 128 010 Reagent 0 333 333
11 n-Heptane 110 Solvent 0 3666 366612 Ethylacetate 452 Solvent 0 15067 1506713 Petether 952 Solvent 0 31733 3173314 Activated Charcoal 001 0 033 03315 Methanol 550 Solvent 0 18333 1833316 Sodium hydroxide 40 100 25 572 Reagent 0 3333 333317 Hyflow 200 0 6666 6666
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Febuxostat
Brief Description of Manufacturing Process
Stage ndashFinal
Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate was hydrolysedwith lithium hydroxide in tertahydrofuron methanol to give crude form of febuxostatand further purified in Isopropyl alcohol to give pure form of Febuxostat
Route of synthesis
ROS
FEBUXOSTAT
ON
S O
O
NCN
S
CH3
COOHTHF
LIOHH2O
O
H3C
H3C
NC
ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylateChemical Formula C18H20N2O3SMolecular Weight 34443
Chemical Formula C16H16N2O3SMolecular Weight 31637
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Mass Balance ndash
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Sr No Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark Existingconsumption
MTDay
Proposedconsumption
MTDay
Totalconsumption
MTDay
1 Ethyl-2(3-cyano)-4Isobutoxyphenyl 4-methyl-5-Thiazole
carboxylate
34443 125 363 1 Startingmaterial
0 4166 4166
2 Tetrahydrofuran 55 Solvent 0 18333 183333 Lithium Hydroxide 2395 026 1085 299 Reagent 0 866 8664 Hyflo 100 0 3333 33335 Methanol 83 Solvent 0 2766666 27666666 Conc HCl 075 Reagent 0 249999 249999
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Lymecycline
Brief Description of Manufacturing Process
Stage ndash Final
Tetracycline hydrochloride treated with tri ethyl amine in presence of THF and further reactswith L-lysine hydrochloride and formaldehyde in presence of water and IPA to givehydrochloride salt of Lymecycline which is further treated with tri ethyl amine in presence ofmethanol to give pure form of Lymecycline
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Route of synthesis
H3C OH
OH
NH2
O
OOHOOHOH
HCl
Tetracycline HCl
TetrahydrofuranTriethylamine
DM water
FormaldehydeIsopropyl alcohol
H2N
NH2
O
OH
HCl
Chemical Formula C6H15ClN2O2Molecular Weight 18265
L-Lysine Hydrochloride
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
HCl
Chemical Formula C29H39ClN4O10Molecular Weight 63909
LymecyclineHCl
OH
OH
NH
O OH O
CH3OH
OH
NCH3 CH3
H H
H
O
NH
H NH2
CO2H
Chemical Formula C29H38N4O10Molecular Weight 60263
MethanolLiquor ammonia
Lymecycline
H HN
H3C CH3
Chemical Formula C22H25ClN2O8Molecular Weight 4809
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Mass Balance -
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Sr No Input Component Molecular wt
Amount In Kg
Moles MolarRatio
Remark Existingconsumption MTDay
Proposedconsumption MTDay
Totalconsumption MTDay
1 Tetracycline HCl 4809120
2495 1 Startingmaterial 0 199999 199999
2 Tetrahydrofuran 461 Solvent 0 768333 7683333 Triethylamine 10119 019 188 075 Reagent 0 31666 316664 L-lysine HCl 18265 043 2354 094 Reagent 0 71666 716665 Formaldehyde 30031 022 73257 2936 Reagent 0 36666 366666 Isopropanol 2974 Solvent 0 4956666 49566667 Methanol 2657 Solvent 0 4428333 44283338 Liq ammonia 032 Reagent 0 53333 53333
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
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Mob 8982215048
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Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Rosuastatin Calcium
Brief Description of Manufacturing Process
Stage-A
(4R-cis)-[(acetyloxy)-methyl-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethylester is hydrolyzed in presence of potassium carbonate in MDC to give tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetate (alcohol intermediate)It was oxidized with sodium hypochlorite solution in presence of potassium bromide togive tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetate (Aldehydeintermediate) Further treated with N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methyl methane sulfonamideTPP salt are condensed in presence ofpotassium carbonate in DMSO to give stage-A
Stage-B
Stage-A was deprotected in presence of hydrochloric acid and followed by hydrolysisusing sodium hydroxide amp react with monomethylamine to give monomethylamine saltof rosuvastatin as stage-D
Stage-Final
Stage-B was treated with sodium hydroxide to get free base of rosuvastatin followed bysalt formation using calcium chloride affords pure form of Rosuvastatin calcium
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Route of synthesis
OH3C
O
O O
O
O
CH3
CH3H3C
H3C CH3
HO
O O
O
O
CH3
CH3H3C
H3C CH3
OHC
O O
O
O
CH3
CH3
H3C
H3C CH3
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
O O O
CH3H3C
Stage-A
F
N
NCH3
CH3
OCH3
CH3H3C
N
H3C
SH3C O
O
OH HO O
F
N
NCH3
CH3
O- NH3+-CH3
N
H3C
SH3C O
O
HO OH O
F
N
NCH3
CH3
N
H3C
SH3C O
O
HO OH O
Stage-B
Stage-Final
O-
Ca2+
Empierical Formula (C22H27FN3O6S)2CaMolecular Weight 100114
(4R-cis)-[(acetyloxy)-methyl-2 2-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester
Chemical Formula C15H26O6Molecular Weight 30236
tert-butyl 2-((4R6S)-6-(hydroxymethyl)-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H24O5
Molecular Weight 26033
tert-butyl 2-((4R6S)-6-formyl-22-dimethyl-13-dioxan-4-yl)acetateChemical Formula C13H22O5
Molecular Weight 25831
F
N
N CH3H3C
S OO
CH3
CH3
PPh
Ph
Ph
Chemical Formula C35H35FN2O2PSBrMolecular Weight 6777
Br
tert-butyl 2-((4R6S)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-22-dimethyl-13-dioxan-4-
yl)acetateChemical Formula C29H40FN3O6S
Molecular Weight 57771
(3R5SE)-tert-butyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C26H36FN3O6SMolecular Weight 53764
methanaminium (3R5SE)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-35-dihydroxyhept-6-enoate
Chemical Formula C23H33FN4O6SMolecular Weight 51259
2ROSUVASTATIN CALCIUM
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
Mass Balance
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
SrNo
Input Component Molecularwt
AmountIn Kg
Moles MolarRatio
Remark ExistingconsumptionMTDay
Proposedconsumption MTDay
TotalconsumptionMTDay
1
(4R-cis)-[(Acetyloxy)-methyl]-22-dimethyl-13-dioxane-4-aceticacid-11-dimetyl ethyl ester (KSM)
30236 25 8268 1 Startingmaterial 0 83333 83333
2
N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropylpyrimidin-2-yl]-N-methylmethane sulfonamideTPP salt
429Startingmaterial 0 14299 14299
3 Potassium carbonate13820
5 134 9667 1169 Reagent 0 44533 44533
4 Dimethylsulphoxide 1634 Solvent 0 544444 5444445 Toluene 2463 Solvent 0 8211099 82110996 Sodium chloride 5844 215 3685 446 Reagent 0 71778 717787 Methanol 2950 Solvent 0 983333 9833338 Calcium chloride 11098 030 27 033 Reagent 0 9999 99999 Hydrochloric acid 015 Reagent 0 0499 0499
10 Sodium hydroxide pellets 39997 015 375 045 Reagent 0 0499 0499
11 Potassium bromide11900
2 020 168 02 Reagent 0 6667 6667
12 Sodium bicarbonate 84007 1 11904 144 Reagent 0 33333 3333313 IPA 86 Solvent 0 287778 28777814 Methylene chloride 276 Solvent 0 921111 92111115 Catalyst 00 Catalyst 0 01333 0133316 Sodium hypochlorite solution 75 Reagent 0 249999 24999917 Acetone 160 Solvent 0 533333 53333318 Ethyl acetate 45 Solvent 0 149999 149999
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
NoIA-J-110114152017-IA-II(I)
Goverment of India
Minister of EnviromentForest and Climate Change
Impact Assessment Division
Indira Paryavaran Bhavan
Vayu Wing3rd FloorAliganj
Jor Bagh RoadNew Delhi-110003
29 Sep 2017
To
Ms ENALTEC LABS PVT LTD
Plot no - 825 826 Pitampur Industrial Area Sector - III Taluka - Dhar District - Dhar State
- Madhya Pradesh
Thane-400705
Maharashtra
TelNo022-67507000 Emaildhananjayphalakenalteccom
SirMadam
This has reference to the proposal submitted in the Ministry of Environment Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification 2006 For this purpose the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report The details of the proposal are
given below
1 Proposal No IAMPIND2675092017
2 Name of the Proposal
Environmental Clearance for API Manufacturing
plant of Enaltec Labs Pvt Ltd at Pitampur
Industrial AreaMadhya Pradesh
3 Category of the Proposal Industrial Projects - 2
4 ProjectActivity applied for 5(f) Synthetic organic chemicals industry (dyes
amp dye intermediates bulk
5 Date of submission for TOR 18 Aug 2017
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
In this regard under the provisions of the EIA Notification 2006 as amended the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5(f)STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYEINTERMEDIATES BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS SYNTHETIC RUBBERSBASIC ORGANIC CHEMICALS OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIAEMP REPORT
A STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i Details of the EIA Consultant including NABET accreditation
ii Information about the project proponent
iii Importance and benefits of the project
3) Project Description
i Cost of project and time of completion
ii Products with capacities for the proposed project
iii If expansion project details of existing products with capacities and whether adequate landis available for expansion reference of earlier EC if any
iv List of raw materials required and their source along with mode of transportation
v Other chemicals and materials required with quantities and storage capacities
vi Details of Emission effluents hazardous waste generation and their management
vii Requirement of water power with source of supply status of approval water balance diagramman-power requirement (regular and contract)
viii Process description along with major equipments and machineries process flow sheet(quantative) from raw material to products to be provided
ix Hazard identification and details of proposed safety systems
x Expansionmodernization proposals
c Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEFSEIAA shall be attached as an Annexure A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided In
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
addition status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report
d In case the existing project has not obtained environmental clearance reasons for nottaking EC under the provisions of the EIA Notification 1994 andor EIA Notification2006 shall be provided Copies of Consent to EstablishNo Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006 CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted Further compliancereport to the conditions of consents from the SPCB shall be submitted
4) Site Details
i Location of the project site covering village TalukaTehsil District and State Justificationfor selecting the site whether other sites were considered
ii A toposheet of the study area of radius of 10km and site location on 150000125000 scaleon an A3A2 sheet (including all eco-sensitive areas and environmentally sensitive places)
iii Details wrt option analysis for selection of site
iv Co-ordinates (lat-long) of all four corners of the site
v Google map-Earth downloaded of the project site
vi Layout maps indicating existing unit as well as proposed unit indicating storage area plantarea greenbelt area utilities etc If located within an Industrial areaEstateComplex layoutof Industrial Area indicating location of unit within the Industrial areaEstate
vii Photographs of the proposed and existing (if applicable) plant site If existing showphotographs of plantationgreenbelt in particular
viii Landuse break-up of total land of the project site (identified and acquired) governmentprivate - agricultural forest wasteland water bodies settlements etc shall be included (notrequired for industrial area)
ix A list of major industries with name and type within study area (10km radius) shall beincorporated Land use details of the study area
x Geological features and Geo-hydrological status of the study area shall be included
xi Details of Drainage of the project upto 5km radius of study area If the site is within 1 kmradius of any major river peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided (mega green fieldprojects)
xii Status of acquisition of land If acquisition is not complete stage of the acquisition processand expected time of complete possession of the land
xiii RampR details in respect of land in line with state Government policy
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
5) Forest and wildlife related issues (if applicable)
i Permission and approval for the use of forest land (forestry clearance) if any andrecommendations of the State Forest Department (if applicable)
ii Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)
iii Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted
iv The projects to be located within 10 km of the National Parks Sanctuaries Biosphere ReservesMigratory Corridors of Wild Animals the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-agrave-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon
v Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna if any exists in the study area
vi Copy of application submitted for clearance under the Wildlife (Protection) Act 1972 to theStanding Committee of the National Board for Wildlife
6) Environmental Status
i Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature relative humidity hourly wind speed and directionand rainfall
ii AAQ data (except monsoon) at 8 locations for PM10 PM25 SO2 NOX CO and otherparameters relevant to the project shall be collected The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction population zoneand sensitive receptors including reserved forests
iii Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov 2009 along with - min max average and 98 values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report
iv Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCBMoEFampCC guidelines
v Whether the site falls near to polluted stretch of river identified by the CPCBMoEFampCC ifyes give details
vi Ground water monitoring at minimum at 8 locations shall be included
vii Noise levels monitoring at 8 locations within the study area
viii Soil Characteristic as per CPCB guidelines
ix Traffic study of the area type of vehicles frequency of vehicles for transportation of materialsadditional traffic due to proposed project parking arrangement etc
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
x Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare endemic and endangered species If Schedule-I fauna are found within the study area a Wildlife Conservation Plan shall be prepared andfurnished
xi Socio-economic status of the study area
7) Impact and Environment Management Plan
i Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features In case the project is located on a hilly terrain theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed Details ofthe model used and the input data used for modelling shall also be provided The air qualitycontours shall be plotted on a location map showing the location of project site habitationnearby sensitive receptors if any
ii Water Quality modelling - in case of discharge in water body
iii Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided In this regard options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined
iv A note on treatment of wastewater from different plant operations extent recycled and reusedfor different purposes shall be included Complete scheme of effluent treatment Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules
v Details of stack emission and action plan for control of emissions to meet standards
vi Measures for fugitive emission control
vii Details of hazardous waste generation and their storage utilization and management Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded EMP shall include the concept of waste-minimization recyclereuserecovertechniques Energy conservation and natural resource conservation
viii Proper utilization of fly ash shall be ensured as per Fly Ash Notification 2009 A detailedplan of action shall be provided
ix Action plan for the green belt development plan in 33 area ie land with not less than1500 trees per ha Giving details of species width of plantation planning schedule etc shallbe included The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated
x Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources
xi Total capital cost and recurring costannum for environmental pollution control measuresshall be included
xii Action plan for post-project environmental monitoring shall be submitted
xiii Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control Disaster management plan should belinked with District Disaster Management Plan
8) Occupational health
i Plan and fund allocation to ensure the occupational health amp safety of all contract and casualworkers
ii Details of exposure specific health status evaluation of worker If the workers health is beingevaluated by pre designed format chest x rays Audiometry Spirometry Vision testing (Faramp Near vision colour vision and any other ocular defect) ECG during pre placement andperiodical examinations give the details of the same Details regarding last month analyzeddata of above mentioned parameters as per age sex duration of exposure and departmentwise
iii Details of existing Occupational amp Safety Hazards What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL) If these are not within PELwhat measures the company has adopted to keep them within PEL so that health of the workerscan be preserved
iv Annual report of heath status of workers with special reference to Occupational Health andSafety
9) Corporate Environment Policy
i Does the company have a well laid down Environment Policy approved by its Board ofDirectors If so it may be detailed in the EIA report
ii Does the Environment Policy prescribe for standard operating process procedures to bringinto focus any infringement deviation violation of the environmental or forest norms conditions If so it may be detailed in the EIA
iii What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions Details of this system may be given
iv Does the company have system of reporting of non compliances violations of environmentalnorms to the Board of Directors of the company and or shareholders or stakeholders atlarge This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FORPROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
10) Details regarding infrastructure facilities such as sanitation fuel restroom etc to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase
11) Enterprise Social Commitment (ESC)
i Adequate funds (at least 25 of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included Socio-economic development activities need to beelaborated upon
12) Any litigation pending against the project andor any directionorder passed by any Court of Lawagainst the project if so details thereof shall also be included Has the unit received any noticeunder the Section 5 of Environment (Protection) Act 1986 or relevant Sections of Air and WaterActs If so details thereof and complianceATR to the notice(s) and present status of the case
13) A tabular chart with index for point wise compliance of above TOR
B SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES amp DYE INTERMEDIATESBULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS SYNTHETIC RUBBERS BASIC ORGANICCHEMICALS OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)
1 Detailsonsolvents to be usedmeasuresfor solventrecovery and for emissions control
2 Details of process emissions from the proposed unit and its arrangement to control
3 Ambient air quality data should include VOC otherprocess-specificpollutants like NH3 chlorineHCl HBr H2S HFetc(-asapplicable)
4 Work zone monitoring arrangements for hazardous chemicals
5 Detailed effluent treatment scheme including ssegregation of effluent streams for units adoptingZero liquid discharge
6 Action plan for odour control to be submitted
7 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solidhazardous waste generated
8 AuthorizationMembership for the disposal of liquid effluent in CETP and solidhazardous waste inTSDF if any
9 Action plan for utilization of MEEdryers salts
10 Material Safety Data Sheet for all the Chemicals are being usedwill be used
11 AuthorizationMembership for the disposal of solidhazardous waste in TSDF
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
STANDARD TERMS OF REFERENCE (TOR) FOR EIAEMP REPORT FOR PROJECTSACTIVITIES REQUIRING ENVIRONMENT CLEARANCE
12 Details of incinerator if to be installed
13 Risk assessment for storage and handling of hazardous chemicalssolvents Action plan for handlingamp safety system to be incorporated
14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
EDS
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
सलन उपरोतानसार कत एमपीऔकवन(ई)ल
plant 2 ltplant2enalteccomgt
(no subject) 2 messages
Water Bill ltakvnwaterbillgmailcomgt Tue Aug 8 2017 at 106 PMTo plant2enalteccom
-- REGARDS -
Mob 8982215048
MP AUDYOGIK KENDRA VIKAS NIGAM (INDORE) LIMITED FREE PRESS HOUSE FIRST FLOOR 354 PRESS COMPLEX AGRA-MUMBAI MARG INDORE - 452008
MP Audyogik Kendra Vikas Nigam (Indore) Ltd354 Press Complex Free Press House Agra-Mumbai Road Indore(MP)
Phone 0731-4070976 0731-2557363 Fax (0731) 2572629 Email akvnwaterbillgmailcom indoreakvngmailcom
औकवनईजलदाय
त
सहायक यीकनठ यी (जल दाय)
औयोगीक Pithampur-3-Bagdoon
वषय मसस Enaltec Labs Pvt Ltd औयोगीक Pithampur-3-Bagdoon को जल सयोजन क सदभ म | मसस EnaltecLabs Pvt Ltd वारा भखड Plot no 825 amp 826 औयोगीक Pithampur-3-Bagdoonम जल सयोजन क लएननानसार राश रसीद 303 दनाक 26-07-2017 वारा जमा करा द गई ह -
१ सयरट डपॉिज़ट 87500
२ सयोजन शक 2250
3 आवदन शक 50-
योग - 89800
इकाई वारा दनाक 26-07-2017 को आन लाईन आवदन कया गया ह अनबध दनाक 05-08-2017 को नपादन कया जा चका ह |
अतः इकाई को 150000 लटर तदन जल दाय हत फल साइज़ दया जाना वीकत कया जाता ह | कपया सलन ाप अनसार एक सताह म जानकार तत कर | इकाई क अनबध क एक त सलन ह |
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-
कायपालन यी (जल दाय )
ी स तकाल सपक कर जल सयोजन हत आवयक कायवाह कर |
कायपालन यी (जल दाय )
मसस Enaltec Labs Pvt Ltd क ओर सचनाथ | कपया सहायक यी
This is a computer-generated document and it does not require a signature
Disclaimer The data belongs to MP AKVN Indore(Ltd) For any communication related to the published dataPleasecontact above address
plant 2 ltplant2enalteccomgt Tue Aug 8 2017 at 416 PMTo Sandeep Chheda ltsandeepchhedaenalteccomgt Dhananjay Phalak ltdhananjayphalakenalteccomgt Parin Chhedaltparinchhedaenalteccomgt Shamkant Suryawanshi ltshamkantsuryawanshienalteccomgt
[Quoted text hidden]
- Annexure - 1pdf
- Annexure - 2pdf
- Annexure - 2pdf
- Annexure - 3pdf
- Annexure - 4pdf
-
- Factory licensepdf
- Lease deedpdf
-
- Annexure - 5pdf
-