agenda item no:04 m/s. optimus drugs pvt. limited, unit ii ... · fluorobenzyl ketone 16.67...

AGENDA ITEM NO:04

Date:18.09.2019

M/s. Optimus Drugs Pvt. Limited, Unit –II, (formerly M/s. Veerchemie &

Aromatics Pvt. Ltd.,) Plot No.76 & 76/A, JN Pharmacity, Parawada,

Visakhapatnam District.- CFO & HWA (Expansion) – Reg.

M/s. Optimus Drugs Pvt. Limited, Unit –II, (formerly M/s. Veerchemie & Aromatics Pvt. Ltd.,) Plot

No.76 & 76/A, JN Pharmacity, Parawada, Visakhapatnam – Applications for Water and Air Consents

& HW Authorization for Expansion.

The details of the Bulk Drugs manufacturing unit as reported by the RO, Visakhapatnam is as

follows:

1. Line of Activity: This is a Bulk Drugs manufacturing unit with a Total project cost of Rs.63.33(as per application) i.e., Existing: Rs.28.45Cr & Expansion: Rs. 34.88 Cr, under Red-Haz category. 2. EC Status:

Environmental clearance is not required as the industry was established in the Ramky Pharmacity(I) Pvt, Ltd., Parawada,.

3. CFE Status : 1. CFE Order No. 358/APPCB/CFE/RO-VSP/HO/2015 - 392, dated 16.04.2015.

2. CFE (Exp) Order No. 358/APPCB/CFE/RO-VSP/HO/2015 -, dated 12.03.2019.

Industry’s CFO - Expansion applications received through OCMMS vide application No 1073309, dated 17.08.2019. 4. CFO & HWA Status: 1. CFO & HWA Order No. APPCB/VSP/VSP/358/HO/CFO/2017, dated 06.07.2017.

Now, the industry applied for CFO (Expansion) received through OCMMS vide application No 1073309, dated 17.08.2019.

5. Details of Present CFO application: The industry has applied for Water and Air Consents & HW Authorization (Expansion) for a period upto 30.05.2022.

Date of receipt of CFO application at RO 17.08.2019

Date of receipt of additional information at RO --

Date of RO inspection 24.08.2019

Date of forwarding of CFO verification reports to Head Office 03.09.2019

Date of commissioning of industry June, 2017

Project Cost:

Total project cost of Rs.63.33(as per application) i.e., Existing: Rs.28.45Cr & Expansion: Rs. 34.88

Cr. Fee details:

The industry has paid fee of Rs. 3,75,000/- vide receipt no 657362165 on the increased project of

proposed expansion of Rs. 34.88/- Cr. The industry paid CFO fee up to 30.05.222

6. Raw materials: The industry is using different chemicals & solvents, as per the EMP.

7. Products & By Products: As per CFO & HWA Order No. APPCB/VSP/VSP/358/HO/CFO/2017, dated 06.07.2017.

S. No

Name of the Product

Capacity (Tons/Day)

No. of stages

Raw materials Quantity of Raw

materials (Kg/Day)

1 Niacinamide 4.00 1 3 – Cyano pyridine 3478.00

2 Nicotinic acid 4.00 2 3 – Cyano pyridine 3448.27

3 Pottasium Nitrate 4.00 1 Potassium Hydroxide 2460.00

Total ( at any point of time)

4.0* Tons/day

*The industry shall manufacture any one product or combination of all three products, so that the maximum production shall not exceed 4T/day.

As Per CFE (Exp) order dated 12.03.2019:

Sl.

No. Product name

Production

Quantities

(Kg/day)

Starting Raw Material &

Molecular formula

Daily

Consumption

of Starting

Raw Material

(Kg)

No.

of

Stag

es

1. Niacinamide

(Existing product) 4000 3-Cyano Pyridine 3478.26 1

2. Nicotinic acid

(Existing product) 3470

3-Cyano Pyridine 2991.38 1

3. Pregabalin 165 Isovalaraldehyde 181.5 5

4. Linezolid 470

2-[(2S)-Oxiran-2-yl-

methyl]-1H-isoindole-

1,3 (2H)-dione

566.4 2

5. Rosuvastatin Calcium 100

N-[5-(Bromomethyl)-4-

(-4-Fluorophenyl)-6-

propan-2-yl) pyrimidin-

2-yl]-N-methyl

methanesulfonamide

phosphonium salt

271.64

2

6. Rifaximin 266.67 Rifamycin-O 316.8 1

7. Lornoxicam 66.67

5-Chloro-3-

(methoxycarbonyl

methylsulfamoyl)-

thiophene-2-carboxylic

acid methyl ester

160.2

2

8. Sertaconazole

Nitrate 66.67

1-(2,4-Dichlorophenyl-2-

(1H-imidazole -1-yl)-

ethanol

55.9

2

9. Tioconazole 66.67 2-Chloro-3-

methylthiophene 120.1 2

10. Clopidogrel Bisulfate 125

(S)-Methyl-2-(2-

chlorophenyl)-2-((2-

(thiophen-2-yl)ethyl)

amino)acetate

Hydrochloride

231.3

2

11. Canagliflozin

Hemihydrate 66.67

2-(5-Bromo-2-

methylbenzyl)-5-(4-

fluorophenyl) thiophene

81.6 2

12. Dimethyl Fumarate 66.67 Maleic Anhydride 81.6 2

13. Eletriptan

Hydrobromide 16.67

(R)-5-Bromo-((1-methyl

pyrrolidin-2-yl)methyl)-

1H-indole

32.93 3

14. Fenticonazole

Nitrate 66.67

4-(Phenylthio) benzyl

alcohol 42.0 2

15. Prasugrel

Hydrochloride 30

2-Bromo-1-cyclopropyl-

2-

(2-fluorophenyl)

ethanone

76.1 3

16. Dabigatran Etexilate

Mesylate 66.67

Ethyl-3-{[3-amino-4-

(methylamino)

benzoyl](pyridin-2-

yl)amino} propanoate

55.8

4

17. Rivaroxaban 166.67 4-(4-Aminophenyl) 113.3 4

Sl.

No. Product name

Production

Quantities

(Kg/day)


Molecular formula

Daily

Consumption

of Starting

Raw Material

(Kg)

No.

of

Stag

es

morpholin-3-one

18. Dexlansoprazole 166.67

2-(((3-Methyl-4-(2,2,2-

trifluoro ethoxy)pyridin-

2-yl)methyl) thio)-1H-

benzo[d]imidazole

265.6 1

19. Apixaban 95

1-(4-Iodophenyl)-3-

morpholine-4-yl-5,6-

dihydro-1H-pyridin-2-

one

212.8 3

20. Montelukast Sodium 166.67

(S,E)-1-(3-(2-(7-

Chloroquinolin-2-

yl)vinyl)phenyl)-3-(2-(2-

hydroxy propan-2-

yl)phenyl) propan-1-ol

154.2

2

21. Luliconazole 166.67

(S)-1-(2,4-

Dichlorophenyl)-2-

chloroethanol

158.3 2

22. Abiraterone Acetate 16.67 17-Iodo androsta-5,16-

diene-3-β-ol 40.8 2

23. Imatinib Mesylate 16.67

6-Methyl-N1-(4-(pyridin-

3-yl) pyrimidin-2-

yl)benzene-1,3-diamine

14 2

24. Cabazitaxel 3.33

(2aR,4S,4aS,6R,9S,11S,1

2S,12aR,12bS)-12b-

acetoxy-9-(((2R,3S)-3-

((tert-butoxy carbonyl)

amino)-3-phenyl-2-

((triethylsilyl)oxy)propa

noyl)oxy)-11-hydroxy-

4,6-dimethoxy-

4a,8,13,13-tetramethyl-

5-oxo-

2a,3,4,4a,5,6,9,10,11,1

2,12a,12b-dodecahydro-

1H-7,11-

methanocyclodeca

[3,4]benzo [1,2-b]oxet-

12-yl benzoate

5 1

25. Gefitinib 13.33

4-Chloro-6-(3-

chloropropoxy)-7-

methoxyquinazoline

14.0 2

26. Erlotinib 20 6,7-Bis(2-methoxy

ethoxy) quinazoline 24 2

27. Dasatinib 6.67

2-((6-Chloro-2-

methylpyrimidin-4-

yl)amino)-N-(2-chloro-6-

methyl phenyl)thiazole-

5-carboxamide

7 1

28. Teriflunomide 3.33 5-Methyl isoxazole-4-

carboxylic acid 2.5 2

29. Pomalidomide 3.33 3-Nitrobenzene-1,2-

dicarboxylic acid 6 3

30. Lenalidomide 6.67 2-(Bromomethyl)-3- 10.9 2

Sl.

No. Product name

Production

Quantities

(Kg/day)


Molecular formula

Daily

Consumption

of Starting

Raw Material

(Kg)

No.

of

Stag

es

nitrobenzoic acid

31. Latanoprost 8.83

[(Z)-7-(1R,2R,3R, 5S)-5-

Hydroxy-2

[(3R)Trimethyl silyloxy-

5-(phenyl-1-pentyl)-3-

trimethyl silyloxy]

cyclopentyl-5-hept-

enoic acid]

19.1 2

32.

Ethyl chloro[(4-

methoxyphenyl)

hydrazono] acetate

16.67 4-Methoxyaniline 19 1

33.

3-Chloro-5,6-

dihydro-1-(4-

nitrophenyl)-2(1H)-

pyridinone

16.67 1-(4-Nitrophenyl)

piperidin-2-one 23.9 2

34.

3-Morpholin-4-yl-5,6-

dihydro-1H-pyridin-

2-one

16.67 Piperidin-2-one 20 1

35.

3-(4-Morpholinyl)-1-

(4-nitrophenyl)-5,6-

dihydro-2(1H)-

pyridinone

16.67

3-Chloro-5,6-dihydro-1-

(4-nitrophenyl)-2(1H)-

pyridinone

16.7 1

36.

(3β,8ξ,9ξ,14ξ)-17-

Iodoandrosta-5,16-

dien-3-ol

6.67 Dehydroepiandrosterone 8 2

37.

3-

(Diethylboryl)pyridin

e

33.33 3-Bromopyridine 61.1 1

38.

N’-(4-Pyridin-2-yl-

benzyl)-hydrazine

carboxylic acid butyl

ester

33.33 4-(Pyridin-3-

yl)benzaldehyde 32.0 2

39.

Carbamic acid, N-

[(1S)-1-[(2R)-2-

oxiranyl]-2-

phenylethyl]-, 1,1-

dimethylethyl ester

33.33

(S)-tert-Butyl-(4-chloro-

3-oxo-1-phenylbutan-2-

yl) carbamate

107.1 3

40. N-Methoxycarbonyl-

L-tert-leucine 66.67 L-tert-Leucine 56 1

41.

N,N-Dimethyl-3-(2-

methylphenoxy)-3-

phenylpropan-1-

amine Oxalate

8.33 Acetophenone 12.0 4

42. Methyl-5-bromo-2-

methyl-benzoate 8.33

5-Bromo-2-

methylbenzoic acid 9.0 1

43.

2-[(5-Bromo-2-

methylphenyl)

methyl]-5-(4-

fluorophenyl)

thiophene

16.67

2-(5-Bromo-2-

methylphenyl)(5-(4-

fluorophenyl)thiophene-

2-yl) methanone

19 1

44.

3-[(3-amino-4-

methylamino-

benzoyl)-pyridin-2-

16.67 4-Methylamino-3-nitro-

benzoic acid 24 2

Sl.

No. Product name

Production

Quantities

(Kg/day)


Molecular formula

Daily

Consumption

of Starting

Raw Material

(Kg)

No.

of

Stag

es

yl-amino]-propionic

acid ethyl ester

45. N-(4-Cyanophenyl)-

glycine 16.67 4-Aminobenzonitrile 1.9 1

46.

(2S,3S)-1,2-Epoxy-3-

(Boc-amino)-4-

phenylbutane

33.33

tert-Butyl [(2S)-4-

chloro-3-oxo-1-

phenylbutan-2-

yl]carbamate

46 2

47.

Carbonic acid-2,5-

dioxo-1-pyrrolidinyl

[(3R,3aS,6aR)-

hexahydrofuro[2,3-

b]furan-3-yl] ester

33.33

(3aS,4S,6aR)-

tetrahydro-4-methoxy

[3,4-b]furan-2(3H)-one

27 2

48.

2-(2-Hydroxyphenyl)-

4H-Benzo [e] [1,3]

oxazin-4-one

66.67 Salicylic acid 83.0 1

49.

(2-Butyl-5-

nitrobenzofuran-3-

yl)(4-hydroxyphenyl)

methanone

33.33 2-Butyl-5-

nitrobenzofuran 35.0 2

50.

(R)-5-Bromo-3-((1-

methylpyrrolidin-2-

yl) methyl)-1H-

indole

33.33

(R)-1-((Benzyloxy)

carbonyl) pyrrolidine-2-

carboxylic acid and 5-

bromo-1H indole

41.7 3

51. Phenyl Vinyl Sulfone 33.33 Thiophenol 83.1 2

52.

4-[(2-Cyanopropan-

2-yl)amino]-2-fluoro-

N-methylbenzamide

8.33

4-[(2-Cyanopropan-2-

yl)amino]-2-fluoro-N-

methylbenzamide

11.0 2

53.

4-Isothiocyanato-2-

(trifluoromethyl)ben

zonitrile

8.33

4-Amino-2-

(trifluoromethyl)

benzonitrile

8.5 1

54.

Ethyl (4-amino-2-

nitrophenyl)carbama

te

25

Ethyl (4-(1,3-

dioxoisoindolin-2-

yl)phenyl)carbamate

65 2

55.

(3aR, 4S, 7R, 7aS)-

4,7-methano-1H-

isoindole-1,3-(2H)-

dione

25

Cis-5-Norbornene-exo-

2,3-dicarboxylic

anhydride

29 2

56.

(1R,2R)-

Cyclohexane-1,2-

dibis(methylene)

dimethylsulfonate

16.67 (1R,2R)-Cyclohexane-

1,2-diyldimethanol 10 1

57.

(1R)-2-{[2-(4-

Nitrophenyl)ethyl]a

mino}-1-

phenylethanol

Hydrochloride

33.33 (R)-(−)-Mandelic acid 34.03 2

58.

(R)-2-[2-(4-

Aminophenyl)-

ethylamino]-1-

phenyl-ethanol

Hydrochloride

33.33

(1R)-2-{[2-(4-

Nitrophenyl)ethyl]

amino}-1-phenylethanol

Hydrochloride

48.0 1

59. 5,6,7,7a- 16.67 4,5,6,7- 32.9 3

Sl.

No. Product name

Production

Quantities

(Kg/day)


Molecular formula

Daily

Consumption

of Starting

Raw Material

(Kg)

No.

of

Stag

es

Tetrahydrothieno[3,

2-c]pyridine-2(4H)-

one Hydrochloride

Tetrahydrothieno[3,2-c]

pyridine Hydrochloride

60. Cyclopropyl-2-

fluorobenzyl ketone 16.67

2-(2-

Fluorophenyl)acetic

acid (Crude)

40.9 2

61.

2-Fluoro-a-

cyclopropyl

carbonylbenzyl

Bromide

16.67 2-Fluorophenyl Acetic

acid 13.3 2

62.

2-(1-Cyano-3-Methyl-

Butyl)-,1,3-Diethyl

ester Propanedioic

acid

833.33 Isovalaraldehyde 370.4 2

63.

(+/-)-3-

(Aminomethyl)-5-

methylhexanoic acid

325 Isovalaraldehyde 272.4 3

64.

3-Isobutyl-

pentanedioic acid

dimethyl ester

100 Isovalaraldehyde 40 1

65. 4-Amino-3-

Fluorophenol 16.67 3-Fluoro-4-Nitrophenol 23 1

66.

4-(4-

Aminophenyl)morpho

lin-3-one

66.67 2-(Phenylamino)ethanol 92 3

67.

3-

Cyclopropylmethoxy-

4-difluoromethoxy-

benzoic acid

16.67 4-(Difluoromethoxy)-3-

hydroxy benzaldehyde 22 2

68.

4-Difluoromethoxy-

3-

hydroxybenzaldehyd

e

16.67 3,4-

Dihydroxybenzaldehyde 22 1

69.

(S)-1-Phenyl-1,2,3,4-

Tetrahydro

isoquinoline

58 2-Phenylethanamine 125 5

70.

(+/-)-1-Phenyl-

1,2,3,4-Tetrahydro

isoquinoline

133.33 2-Phenylethanamine 144 3

71.

4,6-Dichloro-5-

amino-2-

(propylthio)pyrimidi

ne

16.67 2-Propylsulfanyl

pyrimidine-4,6-diol 34.9 3

72. 5-Methylisoxazole-4-

carboxylic acid 16.67 Ethyl Acetoacetate 41.9 3

73.

3-(4-Chlorobutyl)-

1H-indole-5-

carbonitrile

33.33 1H-Indole-5-carbonitrile 60.1 2

74.

5-(Piperazin-1-

yl)benzofuran-2-

carboxamide

33.33

Ethyl-5-nitro-1-

benzofuran-2-

carboxylate

74.1 3

75. 5-(1-Piperazinyl)-2-

Benzofurancarboxyli33.33

Ethyl-5-

nitrobenzofuran-2-260.3 2

Sl.

No. Product name

Production

Quantities

(Kg/day)


Molecular formula

Daily

Consumption

of Starting

Raw Material

(Kg)

No.

of

Stag

es

c acid ethyl ester

Hydrochloride

carboxylate

76.

Ethyl-5-amino-1-

benzofuran-2-

carboxylate

Hydrochloride

16.67

Ethyl-5-nitro-1-

benzofuran-2-

carboxylate

18 1

77.

2-(2-Ethoxyphenyl)-

5-methyl-7-

propylimidazole [5,1

f] [1,2,4] triazin-4-

(3H)-one

16.67

N-(1-(3-(2-

Ethoxyphenyl)-5-oxo-

4,5-dihydro-1,2,4-

triazin-6-

yl)ethyl)butyramide

0.7 1

78.

5-Chloro-2, 4-

dichlorosulfonyl

anline

300 m-Chloroaniline 150 2

79. R&D Products 5 --- --- ---

**Maximum any 6 products

at a time along R&D )

9403

Kgs/day

Applied as per CFO application: The industry applied for CFO(expansion) to manufacture

only 50 % of the products permitted in CFE (expansion) order in first phase. The applied

quantities are as follows:

Sl.

No. Product name

Production

Quantities

(Kg/day)


Molecular formula

Daily

Consumption

of Starting

Raw Material

(Kg)

No. of

Stages

1. Niacinamide

(Existing product) 2000.0 3-Cyano Pyridine 1739.13 1

2. Nicotinic acid

(Existing product) 1735.0

3-Cyano Pyridine 1495.69 1

3. Pregabalin 82.5 Isovalaraldehyde 90.75 5

4. Linezolid 235.0

2-[(2S)-Oxiran-2-yl-

methyl]-1H-isoindole-

1,3 (2H)-dione

283.2 2

5. Rosuvastatin Calcium 50.0

N-[5-(Bromomethyl)-4-

(-4-Fluorophenyl)-6-

propan-2-yl) pyrimidin-

2-yl]-N-methyl

methanesulfonamide

phosphonium salt

135.82 2

6. Rifaximin 133.34 Rifamycin-O 158.4 1

7. Lornoxicam 33.34

5-Chloro-3-

(methoxycarbonyl

methylsulfamoyl)-

thiophene-2-carboxylic

acid methyl ester

80.1 2

8. Sertaconazole

Nitrate 33.34

1-(2,4-Dichlorophenyl-2-

(1H-imidazole -1-yl)-

ethanol

27.95 2

9. Tioconazole 33.34 2-Chloro-3-

methylthiophene 60.05 2

Sl.

No. Product name

Production

Quantities

(Kg/day)


Molecular formula

Daily

Consumption

of Starting

Raw Material

(Kg)

No. of

Stages

10. Clopidogrel Bisulfate 62.5

(S)-Methyl-2-(2-

chlorophenyl)-2-((2-

(thiophen-2-yl)ethyl)

amino)acetate

Hydrochloride

115.65 2

11. Canagliflozin

Hemihydrate 33.34

2-(5-Bromo-2-

methylbenzyl)-5-(4-

fluorophenyl) thiophene

40.8 2

12. Dimethyl Fumarate 33.34 Maleic Anhydride 40.8 2

13. Eletriptan

Hydrobromide 8.34

(R)-5-Bromo-((1-methyl

pyrrolidin-2-yl)methyl)-

1H-indole

16.46 3

14. Fenticonazole

Nitrate 33.34

4-(Phenylthio) benzyl

alcohol 21 2

15. Prasugrel

Hydrochloride 15.0

2-Bromo-1-cyclopropyl-

2-

(2-fluorophenyl)

ethanone

38.05 3

16. Dabigatran Etexilate

Mesylate 33.34

Ethyl-3-{[3-amino-4-

(methylamino)

benzoyl](pyridin-2-

yl)amino} propanoate

27.95 4

17. Rivaroxaban 83.34 4-(4-Aminophenyl)

morpholin-3-one 56.65 4

18. Dexlansoprazole 83.34

2-(((3-Methyl-4-(2,2,2-

trifluoro ethoxy)pyridin-

2-yl)methyl) thio)-1H-

benzo[d]imidazole

132.8 1

19. Apixaban 47.5

1-(4-Iodophenyl)-3-

morpholine-4-yl-5,6-

dihydro-1H-pyridin-2-

one

106.4 3

20. Montelukast Sodium 83.34

(S,E)-1-(3-(2-(7-

Chloroquinolin-2-

yl)vinyl)phenyl)-3-(2-(2-

hydroxy propan-2-

yl)phenyl) propan-1-ol

77.1 2

21. Luliconazole 83.34

(S)-1-(2,4-

Dichlorophenyl)-2-

chloroethanol

77.1 2

22. Abiraterone Acetate 8.34 17-Iodo androsta-5,16-

diene-3-β-ol 79.15 2

23. Imatinib Mesylate 8.34

6-Methyl-N1-(4-(pyridin-

3-yl) pyrimidin-2-

yl)benzene-1,3-diamine

7.0 2

24. Cabazitaxel 1.67

(2aR,4S,4aS,6R,9S,11S,1

2S,12aR,12bS)-12b-

acetoxy-9-(((2R,3S)-3-

((tert-butoxy carbonyl)

amino)-3-phenyl-2-

((triethylsilyl)oxy)propa

noyl)oxy)-11-hydroxy-

4,6-dimethoxy-

2.5 1

Sl.

No. Product name

Production

Quantities

(Kg/day)


Molecular formula

Daily

Consumption

of Starting

Raw Material

(Kg)

No. of

Stages

4a,8,13,13-tetramethyl-

5-oxo-

2a,3,4,4a,5,6,9,10,11,1

2,12a,12b-dodecahydro-

1H-7,11-

methanocyclodeca

[3,4]benzo [1,2-b]oxet-

12-yl benzoate

25. Gefitinib 6.67

4-Chloro-6-(3-

chloropropoxy)-7-

methoxyquinazoline

7.0 2

26. Erlotinib 10.0 6,7-Bis(2-methoxy

ethoxy) quinazoline 12.0 2

27. Dasatinib 3.34

2-((6-Chloro-2-

methylpyrimidin-4-

yl)amino)-N-(2-chloro-6-

methyl phenyl)thiazole-

5-carboxamide

3.5 1

28. Teriflunomide 1.67 5-Methyl isoxazole-4-

carboxylic acid 1.25 2

29. Pomalidomide 1.67 3-Nitrobenzene-1,2-

dicarboxylic acid 3.0 3

30. Lenalidomide 3.34 2-(Bromomethyl)-3-

nitrobenzoic acid 5.45 2

31. Latanoprost 4.42

[(Z)-7-(1R,2R,3R, 5S)-5-

Hydroxy-2

[(3R)Trimethyl silyloxy-

5-(phenyl-1-pentyl)-3-

trimethyl silyloxy]

cyclopentyl-5-hept-

enoic acid]

9.55 2

32.

Ethyl chloro[(4-

methoxyphenyl)

hydrazono] acetate

8.34 4-Methoxyaniline 9.5 1

33.

3-Chloro-5,6-

dihydro-1-(4-

nitrophenyl)-2(1H)-

pyridinone

8.34 1-(4-Nitrophenyl)

piperidin-2-one 11.95 2

34.

3-Morpholin-4-yl-5,6-

dihydro-1H-pyridin-

2-one

8.34 Piperidin-2-one 10.0 1

35.

3-(4-Morpholinyl)-1-

(4-nitrophenyl)-5,6-

dihydro-2(1H)-

pyridinone

8.34

3-Chloro-5,6-dihydro-1-

(4-nitrophenyl)-2(1H)-

pyridinone

8.35 1

36.

(3β,8ξ,9ξ,14ξ)-17-

Iodoandrosta-5,16-

dien-3-ol

3.34 Dehydroepiandrosterone 4.0 2

37.

3-

(Diethylboryl)pyridin

e

16.67 3-Bromopyridine 30.55 1

38. N’-(4-Pyridin-2-yl-

benzyl)-hydrazine 16.67

4-(Pyridin-3-

yl)benzaldehyde 16.0 2

Sl.

No. Product name

Production

Quantities

(Kg/day)


Molecular formula

Daily

Consumption

of Starting

Raw Material

(Kg)

No. of

Stages

carboxylic acid butyl

ester

39.

Carbamic acid, N-

[(1S)-1-[(2R)-2-

oxiranyl]-2-

phenylethyl]-, 1,1-

dimethylethyl ester

16.67

(S)-tert-Butyl-(4-chloro-

3-oxo-1-phenylbutan-2-

yl) carbamate

53.55 3

40. N-Methoxycarbonyl-

L-tert-leucine 33.34 L-tert-Leucine 28.0 1

41.

N,N-Dimethyl-3-(2-

methylphenoxy)-3-

phenylpropan-1-

amine Oxalate

4.17 Acetophenone 6.0 4

42. Methyl-5-bromo-2-

methyl-benzoate 4.17

5-Bromo-2-

methylbenzoic acid 4.5 1

43.

2-[(5-Bromo-2-

methylphenyl)

methyl]-5-(4-

fluorophenyl)

thiophene

8.34

2-(5-Bromo-2-

methylphenyl)(5-(4-

fluorophenyl)thiophene-

2-yl) methanone

9.5 1

44.

3-[(3-amino-4-

methylamino-

benzoyl)-pyridin-2-

yl-amino]-propionic

acid ethyl ester

8.34 4-Methylamino-3-nitro-

benzoic acid 12.0 2

45. N-(4-Cyanophenyl)-

glycine 8.34 4-Aminobenzonitrile 0.95 1

46.

(2S,3S)-1,2-Epoxy-3-

(Boc-amino)-4-

phenylbutane

16.67

tert-Butyl [(2S)-4-

chloro-3-oxo-1-

phenylbutan-2-

yl]carbamate

23.0 2

47.

Carbonic acid-2,5-

dioxo-1-pyrrolidinyl

[(3R,3aS,6aR)-

hexahydrofuro[2,3-

b]furan-3-yl] ester

16.67

(3aS,4S,6aR)-

tetrahydro-4-methoxy

[3,4-b]furan-2(3H)-one

13.5 2

48.

2-(2-Hydroxyphenyl)-

4H-Benzo [e] [1,3]

oxazin-4-one

33.34 Salicylic acid 41.5 1

49.

(2-Butyl-5-

nitrobenzofuran-3-

yl)(4-hydroxyphenyl)

methanone

16.67 2-Butyl-5-

nitrobenzofuran 17.5 2

50.

(R)-5-Bromo-3-((1-

methylpyrrolidin-2-

yl) methyl)-1H-

indole

16.67

(R)-1-((Benzyloxy)

carbonyl) pyrrolidine-2-

carboxylic acid and 5-

bromo-1H indole

41.7 3

51. Phenyl Vinyl Sulfone 16.67 Thiophenol 41.55 2

52.

4-[(2-Cyanopropan-

2-yl)amino]-2-fluoro-

N-methylbenzamide

4.17

4-[(2-Cyanopropan-2-

yl)amino]-2-fluoro-N-

methylbenzamide

5.5 2

53. 4-Isothiocyanato-2-

(trifluoromethyl)ben4.17

4-Amino-2-

(trifluoromethyl) 4.25 1

Sl.

No. Product name

Production

Quantities

(Kg/day)


Molecular formula

Daily

Consumption

of Starting

Raw Material

(Kg)

No. of

Stages

zonitrile benzonitrile

54.

Ethyl (4-amino-2-

nitrophenyl)carbama

te

12.5

Ethyl (4-(1,3-

dioxoisoindolin-2-

yl)phenyl)carbamate

32.5 2

55.

(3aR, 4S, 7R, 7aS)-

4,7-methano-1H-

isoindole-1,3-(2H)-

dione

12.5

Cis-5-Norbornene-exo-

2,3-dicarboxylic

anhydride

14.5 2

56.

(1R,2R)-

Cyclohexane-1,2-

dibis(methylene)

dimethylsulfonate

8.34 (1R,2R)-Cyclohexane-

1,2-diyldimethanol 5.0 1

57.

(1R)-2-{[2-(4-

Nitrophenyl)ethyl]a

mino}-1-

phenylethanol

Hydrochloride

16.67 (R)-(−)-Mandelic acid 17.01 2

58.

(R)-2-[2-(4-

Aminophenyl)-

ethylamino]-1-

phenyl-ethanol

Hydrochloride

16.67

(1R)-2-{[2-(4-

Nitrophenyl)ethyl]

amino}-1-phenylethanol

Hydrochloride

24.0 1

59.

5,6,7,7a-

Tetrahydrothieno[3,

2-c]pyridine-2(4H)-

one Hydrochloride

8.34

4,5,6,7-

Tetrahydrothieno[3,2-c]

pyridine Hydrochloride

16.45 3

60. Cyclopropyl-2-

fluorobenzyl ketone 8.34

2-(2-

Fluorophenyl)acetic

acid (Crude)

20.45 2

61.

2-Fluoro-a-

cyclopropyl

carbonylbenzyl

Bromide

8.34 2-Fluorophenyl Acetic

acid 6.65 2

62.

2-(1-Cyano-3-Methyl-

Butyl)-,1,3-Diethyl

ester Propanedioic

acid


63.

(+/-)-3-

(Aminomethyl)-5-

methylhexanoic acid


64.

3-Isobutyl-

pentanedioic acid

dimethyl ester


65. 4-Amino-3-

Fluorophenol 8.34 3-Fluoro-4-Nitrophenol 11.5 1

66.

4-(4-

Aminophenyl)morpho

lin-3-one

33.34 2-(Phenylamino)ethanol 46.0 3

67.

3-

Cyclopropylmethoxy-

4-difluoromethoxy-

benzoic acid

8.34 4-(Difluoromethoxy)-3-

hydroxy benzaldehyde 11.0 2

68. 4-Difluoromethoxy- 8.34 3,4- 11.0 1

Sl.

No. Product name

Production

Quantities

(Kg/day)


Molecular formula

Daily

Consumption

of Starting

Raw Material

(Kg)

No. of

Stages

3-

hydroxybenzaldehyd

e

Dihydroxybenzaldehyde

69.

(S)-1-Phenyl-1,2,3,4-

Tetrahydro

isoquinoline

29.0 2-Phenylethanamine 62.5 5

70.

(+/-)-1-Phenyl-

1,2,3,4-Tetrahydro

isoquinoline

66.67 2-Phenylethanamine 72.0 3

71.

4,6-Dichloro-5-

amino-2-

(propylthio)pyrimidi

ne

8.34 2-Propylsulfanyl

pyrimidine-4,6-diol 17.45 3

72. 5-Methylisoxazole-4-

carboxylic acid 8.34 Ethyl Acetoacetate 20.95 3

73.

3-(4-Chlorobutyl)-

1H-indole-5-

carbonitrile

16.67 1H-Indole-5-carbonitrile 30.05 2

74.

5-(Piperazin-1-

yl)benzofuran-2-

carboxamide

16.67

Ethyl-5-nitro-1-

benzofuran-2-

carboxylate

37.05 3

75.

5-(1-Piperazinyl)-2-

Benzofurancarboxyli

c acid ethyl ester

Hydrochloride

16.67

Ethyl-5-

nitrobenzofuran-2-

carboxylate

130.15 2

76.

Ethyl-5-amino-1-

benzofuran-2-

carboxylate

Hydrochloride

8.34

Ethyl-5-nitro-1-

benzofuran-2-

carboxylate

9.0 1

77.

2-(2-Ethoxyphenyl)-

5-methyl-7-

propylimidazole [5,1

f] [1,2,4] triazin-4-

(3H)-one

8.34

N-(1-(3-(2-

Ethoxyphenyl)-5-oxo-

4,5-dihydro-1,2,4-

triazin-6-

yl)ethyl)butyramide

0.35 1

78.

5-Chloro-2, 4-

dichlorosulfonyl

anline

150.0 m-Chloroaniline 75.0 2

79. R&D 5.0 -- -- --

The industry applied for CFO expansion to manufacture only 50 % of the products and total quantity

of R&D- 5 Kg/day as permitted in CFE (Expansion) order in phase - I.

As per CFE the industry has to manufacture maximum any 6 products at a time along R&D is 9403

Kg/day. Therefore the industry may be permitted to manufacture 50% of permitted quantity as per

CFE(expansion) order as maximum any 6 products at a time along R&D -4704.17 Kg/day.

1. The industry has obtained CFO vide order dated 06.07.2017 with 3 no. of products and to manufacture any one product or combination of all three products, with a maximum production quantity of 4 TPD. The CFO is valid up to 31.05.2022.

2. Further the industry obtained CFE (Expansion) on 12.03.2019 and applied for CFO (Exp) of the Board for increased capacities with the following changes:

i. Dropped 1 existing product (Potassium Nitrate @ 4.0 TPD) ii. Decreased the production quantity of existing product i.e., Nicotinic acid iii. Proposed 76 New products including 1 No. of R&D product. iv. After expansion, the total products are 79 including 1 No. R & D Product. v. The industry produces any 6 Products on campaign basis along with R&D at any point of

time with a maximum production capacity of 9403 Kg/day (282.1 TPM).

3. The industry applied for CFO expansion to manufacture only 50 % of the products and total quantity of R&D- 5 Kg/day as permitted in CFE (Expansion) order. As per CFE the industry has to manufacture maximum any 6 products at a time along R&D is 9403 Kg/day. Therefore the industry may be permitted to manufacture 50% of permitted quantity as per CFE(expansion) order as maximum any 6 products at a time along R&D -4704.17 Kg/day.

4. The industry is not in operation since, 2017. At present the industry carrying out only R& D activity.

The industry is under construction of production block proposed for expansion. The industry

applied for CFO to manufacture 50% of the products permitted in CFE order.

8. Water consumption: 1760 KLD.

1. Source of Water supply as per EC : ---

2. Source of Water supply as per CFE : JNPC

3. Present Source of Water supply : JNPC

S.

No. Purpose

As per CFO dated

06.07.2017 (KLD)

As per CFE

(Expansion) order

dated 12.03.2019

Applied as per

application

1. Process 6.80 39.73 20.16

2. Washings 1.00 43.00 23.0

3. Boiler makeup 10.00 90.00 37.5

4. Cooling Towers

Makeup

19.00 126.00 63.0

5. Scrubbers System 3.00 4.50 2.5

6. DM Plant -- 4.00 2.0

7. Domestic 2.00 5.00 2.5

8. Gardening 15.00 15.00 8.0

Total 56.80 327.23 158.66

The industry’s average water consumption during the period February, 2019 to July, 2019 is 3.0

KLD against the permitted quantity of 56.80 KLD. The industry is utilizing water only for R& D

activity and domestic purpose.

9. Waste Water Generation:

S.

No Purpose

Qty. as per CFO Order

dated 06.07.2017

KLD Quantity(KLD)

Quantity as per CFE

(Expansion) order

dated 12.03.2019 and

applied as per CFO

(Exp) application

Applied as per

application

HTDS LTDS Total HTDS LTDS Total HTDS LTDS Total

1 Process 8.98 0.00 8.98 47.0 0.0 47.0 23.67 -- 23.67

2 Washings 0.00 1.00 1.00 --- 43.0 43.0 -- 20.16 20.16

3 Boiler blow

down

2.50 0.00 2.50 --- 9.0 9.0 -- 4.0 4.0

4 Cooling tower

blow down

0.00 3.50 3.50 --- 16.0 16.0 -- 8.0 8.0

5 DM Plant 0.00 0.00 0.00 --- 4.0 4.0 -- 2.5 2.5

6 Scrubbers

System

3.00 0.00 3.00 4.50 0 4.5 -- 2.0 2.0

Domestic 0.00 1.50 1.50 4.0 4.0 -- 2.5 2.5

Total 14.48 6.00 20.48 51.50 76.0 127.5 23.67 39.16 62.83

The industry’s average wastewater generation during the period February, 2019 to July, 2019 is

2.72 KLD against the permitted quantity of 20.48 KLD. The industry is utilizing water for R& D

activity and domestic purpose.

10. Out let – as per CFO order dated 06.07.2017

Out let No.

Outlet Description Max Daily Discharge

(KLD) Point of Disposal

1. Process – 8.98 KLD, Boiler makeup – 2.5 KLD and Scrubber System – 3.0 KLD.

14.48 To MEE of CETP, Pharmacity for Evaporation and further disposal.

2

Washings – 1.0 KLD, Cooling tower blow down – 3.5 KLD and Domestic 1.5 KLD after pre-treatment - LTDS

6.0 To the CETP, Pharmacity for further treatment and disposal

Treatment & disposal:

Source Treatment Mode of final disposal

HTDS-Process, Boiler

blow down, DM Plant &

Scrubbers System –

14.48 KLD

Collection tank – Neutralization

tank – storage tank

To MEE M/s. JN pharmacity for

further treatment and disposal

LTDS- Washings &

Cooling blow down – 4.5

KLD

Collection tank – Neutralization

tank – storage tank

To the CETP of M/s. JN

pharmacity for further treatment

and disposal

Domestic – 1.5 KLD Septic tank. The over flow from the septic

tank to the CETP of M/s. JN

Pharmacity for further treatment

and disposal.

Out let – CFE (Exp) Order dated 12.03.2019:

Out let No.

Outlet Description Max Daily

Discharge (KLD)

Treatment Point of Disposal

1.

Process – 47.0 KLD and Scrubber System – 4.5 KLD.

51.50 Pretreatment (Neutralization)

To MEE of CETP, Pharmacity for Evaporation and further disposal.

2

Washings – 43.0 KLD, Boiler – 9.0 KLD, Cooling tower blow down – 16.0 KLD, DM Plant – 4.0 KLD and Domestic 4.0 KLD

76.0

Pretreatment (Neutralization)

To the CETP, Pharmacity for further treatment and disposal

11. ETP Details & Mode of Disposal:

i. Outlet No. 1

a. Stream Details: b. Treatment unit’s details.

c. Point of disposal

Process & Scrubber system

HDPE Tank – 1 No X 3 KL near production block, above

ground RCC Tank 2 X 100 KL for HTDS.

The neutralized effluent is sent to the MEE, CETP of

Pharmacity.

ii. Outlet No. 2 :

a. Stream Details:

b. Treatment unit’s details.

c. Point of disposal

Washings, Boiler makeup, Cooling tower blow down &

DM Plant

HDPE Tank – 1 No X 3 KL near production block, above

ground RCC Tank 2 Nos X 100 KL for LTDS.

The neutralized effluent is sent to the CETP of

Pharmacity.

iii. For Domestic waste water: The industry send treated effluents to CETP of

Pharmacity.

b) Standards as per CFO. Board Monitoring Data

Out let

Parameters Concentration in mg/l

2

pH 6.50 – 8.50

Temperature 0C < 450 C

TDS 12,000 mg/l

TSS 600 mg/l

BOD 3,000 mg/l

COD 8,000 mg/l

Oil and Grease 20 mg/l

Chromium Hexavalent (as Cr+6)

2 mg/l

Chromium (total) as Cr) 2 mg/l

Ammonical Nitrogen (as N) 30 mg/l

Cynide (as CN) 0.20 mg/l

Lead (as Pb) 1 mg/l

Nickel (as Ni) 3 mg/l

Zinc (as Zn) 15 mg/l

Arsenic (as As) 0.20 mg/l

Mercury (as Hg) 0.01 mg/l

The industry is segregating the

HTDS and LTDS effluent streams

and sending effluents to CETP,

JNPC for further treatment.

CETP, JNPC considering the

effluents which are not meeting

the above standards of Low TDS

effluents are being treated as

HTDS effluents.

12. Water Cess:

The Board has to issue water cess assessment order.

12. Air pollution: a) Emissions from fuel burning: As per CFO Order dated 06.07.2017

S.

No.

Source of Pollution

Note:

Capacity should be

mentioned for each

unit

Control

equipment

provided

Flow rate

in

m3/hr.

Stack

height in

Mts -

above GL

Limiting

Standard

prescribed

by Board

Board

Monitoring

Data

1. 1 X 1.5 TPH Coal fired

Boiler

MDC & Pulse

jet bag filter

---- 30 M ----

b) As per CFE (Exp) Order dated 12.03.2019 and applied as per CFO (Exp) application

S.

No.

Source of Pollution

Note:

Capacity should be

mentioned for each

unit

Control

equipment

provided

Flow

rate in

m3/hr.

Stack

height in

Mts -

above GL

Limiting

Standard

Board

Monitoring

Data

1. 1 X 2.0 TPH +

1 X 3.0 TPH Coal

fired Boiler

Cyclone

separator

followed by

bag filter

-- 30 m 115

mg/Nm3

2. 1 X 8.0 TPH Coal

fired Boiler

Mechanical

Dust

collector

followed by

bag filter

-- 30 m 115

mg/Nm3

3 1x500 KVA DG Set Acoustic

enclosures

-- 5 m


enclosures

-- 6.5 m

The industry not installed 8 TPH & 3 TPH boilers proposed in expansion and CFO may be issued for

the following air emission sources:

S.

No.

Source of Pollution

Note:

Capacity should be

mentioned for each

unit

Control

equipment

provided

Flow

rate in

m3/hr.

Stack

height in

Mts -

above GL

Limiting

Standard

Board

Monitoring

Data

1. 1 X 2.0 TPH Cyclone

separator

followed by

bag filter

-- 30 m 115

mg/Nm3

--


enclosures

-- 5 m -- --

Process emissions:

Sl

No

b) Details of Process

Emissions:

Quantity in

Kg/day

Control Equipment

1 NH3 246.285 Scrubber with water

2 CO2 247.925 Dispersed into atmosphere

3 H2 25.89 Diffused with flame arrestor

4 HCl 121.42 Scrubber with water / caustic sol.

5 SO2 97.13 Scrubber with caustic sol.

6 O2 3.28 Dispersed into atmosphere

14. Fugitive emissions: Sources / outlets and control systems adopted:

a) Chilled brine circulation is carried out to effectively reduce the solvent losses into the atmosphere.

b) Transfer of solvents using pumps instead of manual handling. c) Closed centrifuges are used due to which solvent losses will be reduced drastically. d) Installation of secondary condensers has further reduced the solvent losses during

operations. 15. Hazardous chemicals used and their storage facilities:

Sl.No. Material MOC No. of tanks Capacity Position

1. Sulphuric Acid MS 1 30 KL Above Ground level.

2. Toluene MS 1 40 KL

3. Toluene MS 1 30 KL

4. Empty tanks MS 5 30 KL

*The industry has not installed bulk solvent tanks.

16. Hazardous Waste details:

Sl.

No. Source

Quantity as

per CFO

Order dated

06.07.2017

Kg/day

Qty. as per

CFE (Exp)

Order dated

12.03.2019

and CFO

(Exp) to be

issued for

Kg/day

Qty. (Exp) to

be issued for

Disposal

1.

Organic

residue --

2872.2

1441.11 To the authorized

cement industries for

co-processing (or)

TSDF, Parawada for

incineration. 2. Spent Carbon

69

105

53.38

3.

Inorganic Solid

Waste --

550.3

275.0

To TSDF, Parawada, for

Secured land filling

4. ETP Sludge

50

100

50

5.

Waste Oil &

Grease 20 LPA 100 LPA 50 LPA

To Supplier / APPCB

Authorized Agencies

6.

Empty barrels/

Containers &

liners

contaminated

with

Hazardous

chemicals /

Waste (Nos./

month)

250

No’s/Month

1000

No’s/Month

500

No’s/Month

To authorized agencies

after complete

Detoxification

7. Spent Solvents 0.5 KLM 1.0 KLM 1.0 KLM

Shall be recovered

within the premises to

authorized agency for

recovery

Non Hazardous Waste details:

S. No

Solid waste Quantity as

per CFO Order dated 06.07.2017

Qty. as per CFE (Exp) Order dated

12.03.2019 and CFO (Exp) to be issued

for

Method of disposal

1. Coal ash from boiler 2.4 TPD 3.2 TPD* To brick industries.

Note: *At present the industry installed 2 TPH boiler and not installed 3 TPH and 8 TPH coal

fired boiler proposed for expansion.

17. Compliance status of conditions stipulated in CFE order dated – already commissioned.

18. Compliance of the industry Schedule B Conditions of CFO & HWA Order No.

APPCB/VSP/VSP/358/HO/CFO/2017, dated 06.07.2017:

Sl.

No

Condition Compliance

1. The LTDS effluents sent to CETP, Pharmacity shall

not contain constituents in excess of the tolerance

limits mentioned below, as per their MoU with M/s

Ramky Pharma City.

Out

let

Parameter Concentration in mg/l

2 PH 6.50 – 8.50

Temperature oC < 450C

TDS 12,000 mg/l

TSS 600 mg/l

BOD 3,000 mg/l

COD 8,000 mg/l

Oil and Grease 20 mg/l

Chromium

Hexavalent

(as Cr+6)

2 mg/l

Chromium

( total ) (as Cr)

2 mg/l

Ammonical

Nitrogen (as N)

30 mg/l

Cyanide (as CN) 0.20 mg/l

Lead (as Pb) 1 mg/l

Nickel (as Ni) 3 mg/l

Zinc (as Zn) 15 mg/l

Arsenic (as As) 0.20 mg/l

Mercury (as Hg) 0.01 mg/l

(* The industry shall segregate the HTDS and LTDS

effluent streams and the effluents which are not

meeting the above standards shall be treated as

HTDS effluents and shall be sent CETP of Pharmacity

for evaporation.).

The industry has not started commercial

operations and sending effluents

generated from R&D activity to CETP, JN

Pharmacity, Parawada.

2. The source of water being JNPC Supply. The

following is the permitted water consumption:

Sl.

No.

Purpose Quantity

(KLD)

1 Industrial cooling, boiler

feed.

29.0

2 Domestic & Gardening

purposes.

17.0

3 Process, whereby water

gets polluted and

pollutants are easily bio

degradable.

…

4 Processing, whereby

water gets polluted and

the pollutants are not

easily bio – degradable.

10.8

Total 56.8 KLD

Separate meters with necessary pipe-line shall be

maintained for assessing the quantity of water used

for each of the purposes mentioned above for Cess

The industry is drawing water from M/s.

Ramky Phrmacity and installed 1 No. of

Meter to verify the water consumption.

The industry installed 2 Nos. of

electromagnetic flow meters for pumping

HTDS & LTDS to CETP, Jn Pharmacity,

Parawada.

assessment purpose.

3. The industry shall maintain containers detoxification

facility. Container & Container liners shall be

detoxified at the specified covered platform with

dyke walls and the wash wastewater shall be routed

to low TDS collection tank.

The industry has constructed

detoxification facility at effluent storage

area.

4. The LTDS and HTDS effluents shall be stored in above

ground collection tanks separately.

The industry is collecting effluents by

gravity in HDPE tanks.

5. The industry shall maintain HDPE tanks in the

effluent collection tank (both locations at block and

common collection point). The effluent shall be

connected to the HDPE tanks and from the HDPE

tanks, effluent shall be pumped to the ETP. Free

space shall be maintained around the HDPE tanks to

observe leakages if any.

The industry is collecting effluents by

gravity in HDPE tanks.

The industry has constructed above

ground tanks for effluent storage and

after neutralization proposed to send to

CETP, JNPC.

6. The industry shall submit the details of quantity of

High TDS and Low TDS effluents sent to CETP of

Pharmacity every month to the RO, Visakhapatnam.


operations and sending effluents

generated from R&D activity to CETP, JN

Pharmacity, Parawada.

7. The industry shall maintain proper manifest system

for effluent transported to CETP. They shall submit

monthly reports to the E.E., RO-Visakhapatnam.

Not submitted

8. Effluents shall not be discharged onland or any water

bodies or aquifers under any circumstances. Floor

washings shall be admitted into effluent collection

system only and shall not be allowed to find their

way into storm water drains or open areas.


operations.

The industry proposed to collect the flow

washings at collection tank at production

block.

9. The industry shall evaluate the performance of

solvent recovery system for each stream- wise and

shall furnish plan of action to maintain the efficiency

of solvent recovery more than 95% for each stream

wise.

The industry has not installed SRS system

and not started operations.

10. The industry shall comply with ambient air quality

standards of PM10 (Particulate Matter size less than

10µm) - 100 µg/ m3; PM2.5 (Particulate Matter

size less than 2.5 µm) - 60 µg/ m3; SO2 - 80 µg/

m3; NOx - 80 µg/m3, outside the factory premises

at the periphery of the industry.

Standards for other parameters as mentioned in the

National Ambient Air Quality Standards CPCB

Notification No.B-29016/20/90/PCI-I, dated

18.11.2009.

Noise Levels:

Day time : (6 AM to 10 PM) - 75 dB (A)

Night time : (10 PM to 6 AM) - 70 dB (A)

The industry has not started operations.

11. The industry shall comply with emission limits for DG

sets of capacity upto 800 KW as per the Notification

G.S.R.520 (E), dated 01.07.2003 and G.S.R.448(E),

dated 12.07.2004 under the Environment

(Protection) Act Rules. In case of DG sets of capacity

more than 800 KW shall comply with emission limits

as per the Notification G.S.R.489 (E), dated

09.07.2002 at serial no.96, under the Environment

(Protection) Act, 1986.

The industry has installed 1 X 500 KVA DG

Set with acoustic enclosures.

12. The industry shall install VOC analyzers with

recording facility and maintain records.

The industry has installed VOC meter with

data logger.

13. The evaporation losses in solvents shall be controlled

by taking suitable measures, which include:

i. Chilled brine circulation to effectively reduce

the solvent losses into the atmosphere.

ii. Transfer of solvents by using pumps and closed

conveyance instead of manual handling.

iii. Closed centrifuges be used due to which solvent

losses are reduced drastically.

Provided.

Proposed to transfer the major solvents

through closed conveyance.

iv. The reactor vents connected with primary &

secondary condensers to catch the solvent

vapours.

v. All the solvent storage tanks are connected with

vent condensers to prevent solvent vapours.

---

Provided

The industry informed that they will

comply.

14. The industry shall inform the Board before they start

their operations.


15. The industry shall install flow, web camera as per

CPCB direction and data connected to the CPCB and

APPCB.

The industry has installed flow meter and

web camera and same connected to CPCB

& APPCB.

16. The industry shall not manufacture new products

without CFE/CFO of the Board.


17. The industry shall install pH meter with data logger

to double stage scrubber and VOC meter with data

logger.

The industry has installed pH meter and

VOC meter and provided data logger.

18. The industry shall construct storm water drains and

rainwater runoff tank for collection and storage of

first flush storm water.

The industry has constructed 10 KL for 1st

flush storm water tank.

The industry has started laying roads and

construction of storm water drains which

will be completed within 1 month.

19. The industry shall dispose spent and mixed spent

solvents to APPCB authorized recyclers


20. The industry shall obtain PLI policy which includes

ERF immediately.

The industry has not started operations

and not obtained PLI Policy.

21. The industry shall construct shed for storage of

drums with dyke wall and leachate collection

system.

The industry proposed to construct shed

with dyke wall for storage of drums in the

expansion.

22. The industry shall construct shed for storage of

Hazardous waste.

The industry has provided provision for

storing the Hazardous underneath the

Effluent Storage tanks.

23. The industry shall construct storm water drain and

provide collection pit for the first flush during rains.

The industry has constructed 10 KL for 1st

flush storm water tank.

The industry has started laying roads and

construction of storm water drains which

will be completed within 1 month.

24. The industry shall cover the HTDS and LTDS storage

tanks and the vents shall be connected to the

scrubber to avoid smell nuisance at effluent storage

area.

The industry has not started operations

and proposed to construct hood on the

top of the effluent storage tanks with

scrubber in the proposed expansion

project.

25. The drums containing chemicals / solvents shall be

stored under a roof on elevated platform with a

provision to collect leakages / spillages in the

collection pit.

The industry proposed to construct shed

with dyke wall for storage of drums in the

expansion.

26. The industry shall comply with CPCB directions dated

05.02.2014 / 02.03.2015 and guidelines issued

regarding online monitoring systems issued from time

to time.

The industry has installed flow meter and

web camera and same connected to CPCB

& APPCB.

27. The industry shall maintain the following records and

the same shall be made available to the inspecting

officers of the Board:

i. Daily production details (ER-1 Central Excise

Returns).

ii. Quantity of Effluents generated, treated,

recycled/reused and disposed to CETP.

iii. Log Books for pollution control systems.

iv. Characteristics of effluents and emissions.

v. Hazardous/non hazardous solid waste

generated and disposed.

vi. Inspection book.


vii. Manifest copies of effluents / hazardous

waste.

28. The industry shall comply with the conditions

stipulated in the CFE order dated 16.04.2015.


follow.

29. The industry shall develop green belt in all the

vacant places. In future, excess green belt over and

above 33 % of total area can be utilized for

industrial activity as per requirement of industry.

The industry has developed green belt in

an extent of 1.50 Acres against required

3.41.

19. Compliance of the industry on CFE (Exp) order No. 358/APPCB/CFE/RO-VSP/HO/2015 - ,

dated 12.03.2019.

Sl.

No. Condition

Compliance

1. The proponent shall obtain Consent for Operation(CFO) from APPCB, as required Under Sec.25/26 of the Water (P&C of P) Act ,1974 and under sec.21/22 of the Air (P&C of P) Act, 1981, before commencement of the trail runs

1. The industry is having valid CFO & HWA Order No. APPCB/VSP/VSP/358/HO/CFO/2017, dated 06.07.2017 valid up to 31.05.2022.

2. The industry has obtained CFE (Exp) Order No. 358/APPCB/CFE/RO-VSP/HO/2015 - , dated 12.03.2019.

3. Now, the industry applied for CFO (Expansion)

2. The applicant shall provide separate energy meters for Effluent Treatment Plant (ETP) Air pollution control equipments to record energy consumed. An alternative electrical power source sufficient to operate all pollution control systems shall be provided.

Complied

3. The industry shall construct separate storm water drains and provide rainwater harvesting structures. No effluents shall be discharged in to the storm water drains.

The industry is under construction of storm water drains.

4. The source of water is JN Pharma city and the maximum permitted water consumption is as following:

Sl.

No. Purpose

As per CFE dt.

16.04.2015 (KLD)

Quantity after

CFE expansion

(KLD)

1 Process

60.80 39.73

2 Washings 1.0 43.0

3 Boiler make up 10.0 90.0

4 Cooling Towers make-up 19.0 126.0

5 Scrubber 3.0 4.50

6 DM Plant --- 4.0

7 Domestic 2.0 5.0

8 Gardening 15.0 15.0

Total 56.80 327.23

Separate meters with necessary pipeline shall be provided for assessing the quantity of water used for each of the purposes mentioned above.

Compliance:- As per the details, the industry’s average water consumption is 3.0 KLD for the

period from February, 2019 to July, 2019 as the industry carrying out only R&D activities and

not carrying out any production.

5. The maximum wastewater generation shall not exceed the following.

Sl.

No Source

As per CFE dt.

16.04.2015

(KLD)

Quantity after CFE

expansion (KLD)

HTDS LTDS Total HTDS LTDS Total

1 Process 8.98 0.00 8.98 47.0 0.0 47.0

2 Washings 0.00 1.00 1.00 --- 43.0 43.0

3 Boiler blow down 2.50 0.00 2.50 --- 9.0 9.0

4 Cooling tower blow down 0.00 3.50 3.50 --- 16.0 16.0

5 DM Plant --- 4.0 4.0

6 Scrubbers System 3.00 0.00 3.00 4.50 0 4.5

7 Domestic 0.00 1.50 1.50 4.0 4.0

Total 14.48 6.00 20.48 51.50 76.0 127.5

Treatment & Disposal:

Source Treatment Mode of final disposal

HTDS Pretreatment

(Neutralisation)

To M/s. Ramkey Pharmacity for

forced evaporation

LTDS Pretreatment

(Neutralisation)

To CETP of M/s.Ramkey

Pharmacity for further treatment

and disposal.

Domestic

waste water

------- The over flow of the septic tank

shall be sent to the CETP for

further treatment.

Compliance:- As per the details, the industry’s average wastewater discharge is 2.72 KLD

HTDS for the period from February, 2019 to July, 2019

6. The effluent shall not be discharged on land or into any water bodies or aquifers under any circumstances.

During the inspection, no discharge of wastewater was observed.

7. The industry shall properly operate and maintain online real time monitoring system along with web camera facilities and shall ensure that it is connected to APPCB / CPCB websites as per CPCB directions.

Provided

8. Floor washing shall be admitted into the effluent collection system only and shall not be allowed to find their way in storm drains or open areas. All pipes valves, sewers, drains shall be leak proof.

The industry yet to start its operations.

9. The industry shall comply with the following to control air pollution after expansion:

SI.No Details Stack 1 Stack 2 Stack 5

a) Attached to Coal fired boiler D.G.Sets

b) Capacity to 1x 2.0 TPH + 1x 3.0 TPH

1x 8.0 TPH 1 x 500 KVA & 1 x 1010 KVA

c) Fuel Indian Coal HSD

d) Stack height 30 m 5 m & 6.4 m each

e) Control Equipment

Cyclone

separator

followed by Bag

filter

Mechanical

Dust Collector

followed by

Bag filter

Silencer & Acoustic

enclosures

Compliance: The industry has installed 2 TPH Coal fired boiler and 500 KVA D.G.Set. The

industry provided Cyclone separator followed by Bag filter to the stack attached to 2 TPH

boiler.

10. A sampling port with removable dummy of not less than 15 cm diameter shall be provided in the stack at a distance of 8 times the diameter of the stack from the nearest constraint such as bends etc. A platform with suitable ladder shall be provided below 1 meter of sampling port to accommodate three persons with instruments. A 15 AMP 250 V plug point shall be provided on the platform.

Complied

11. The industry shall properly operate and maintain the monitoring system to all the stacks / vents in the plant. Regular monitoring shall be carried out and report shall be submitted to the Regional officer.

Complied

12. The industry shall properly operate and maintain multi-stage scrubbers to the process vents to control the process emissions. The industry shall ensure that online pH measuring facility with auto recording system is connected to the scrubbers.

Provided

13. The industry shall provide VOC monitoring system with auto recording facility.

The industry has installed VOC analyser with data logger.

14. The industry shall implement adequate measures to control all fugitive emissions from the plant.

The industry implemented following measures to control all fugitive emissions:

i. Chilled brine circulation is carried out to effectively reduce the solvent losses during process operations.

ii. Transfer of solvents using pumps instead of manual handling.

iii. Closed centrifuges are used due to which solvent losses will be reduced drastically.

iv. Installation of secondary condensers has further reduced the solvent losses during operations.

15. The proponent shall ensure compliance of the National Ambient Air quality standards notified by MoEF, GoI vide notification No.GSR.826(E), dated. 16.11.2009 during construction and regular operational phase of the project at the periphery. The generator shall be installed in a closed area with a silencer and suitable noise absorption systems. The ambient noise level shall not

The industry yet to start operations.

exceed 75 Db (A) during day time and 70 Db(A) during night time

16. The proponent shall not use or generate odour causing substances Or Mercaptans and cause odour nuisance in the surroundings.


17. The industry shall send the used /spent solvents to the recyclers (or) process them at their own solvent recovery facility within the premises.

Not installed solvent recovery facility

18. The evaporation losses in solvents shall be controlled by taking the following measures: i. Chilled brine circulation shall be carried out

to effectively reduce the solvent losses into the atmosphere.

ii. Transfer of solvents shall be done by using pumps instead of manual handling.

iii. Closed centrifuges shall be used to reduce solvent losses.

iv. All the solvent storage tanks shall be connected with vent condensers to prevent solvent vapours.

v. The reactor vents shall be connected with primary & secondary condensers to prevent escaping of solvent vapour emissions into atmosphere.

i. Provided

ii. The industry yet to start operations.

iii. Provided

iv. Not Provided. The industry submitted copy of the purchase order to procure 8 No.s of vent condensers.

v. Provided condenser.

19. The industry shall comply with the following for disposal of solid wastes:

Sl.

No. Source

Quantity as

per CFO

Order dated

16.04.2015

Qty. as per CFE

(Exp) Order

dated

12.03.2019 and

CFO (Exp) to be

issued for

Disposal

1. Organic residue --

2872.2

Kg/day To the authorized cement

industries for co-processing (or)

TSDF, Parawada for

incineration. 2.

Spent Carbon 69

Kg/day

105

Kg/day

3.

Inorganic Solid

Waste --

550.3

Kg/day To TSDF, Parawada, for Secured

land filling

4. ETP Sludge

50

kg/day

100

kg/day

5.

Waste Oil &

Grease 20 LPA 100 LPA

To Supplier / APPCB Authorized

Agencies

6.

Empty barrels/

Containers &

liners

contaminated

with

Hazardous

chemicals /

250

No’s/Month

1000

No’s/Month

To authorized agencies after

complete Detoxification

Waste (Nos./

month)

7. Spent Solvents 0.5 KLM 1.0 KLM

Shall be recovered within the

premises to authorized agency

for recovery

Compliance: The industry is having valid CFO for a period up to 31.05.2022 and applied for

CFO (Expansion). The industry yet to start operations.

20. The proponent shall place the chemical drums

and / or any drums in a shed provided with

concrete platform only. The Platform shall be

provided with sufficient dyke wall and effluent

collection system. The industry shall provide

containers detoxification facility. Container &

Container liners shall be detoxified at the

specified covered platform with dyke walls and

the wash wastewater shall be routed to low TDS

collection tank.

The industry has constructed shed for

storage of drums with dyke walls and

leachate collection pit.

21. The following rules and regulations notified by

the MoEF, GoI shall be implemented.

a) Hazardous waste and other wastes

(Management and Transboundary Movement) Rules, 2016.

b) Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989

c) Fly ash Notification, 2016 d) Batteries(Management &

Handling)Rules,2010 e) E – Waste (Management) Rules, 2016. f) Construction and Demolition waste

Management Rules,2016

The industry is having valid CFO for a

period up to 31.05.2022 and applied for

CFO (Expansion).

22. The industry shall comply with the following as

committed vide lr. dt. 28.02.2019:

Data logger to the pH meter and VOC analyzer

shall be installed within a

month.

PLI policy shall be obtained within a month.

Thick green belt shall be developed along the boundary and in vacant places to achieve 33% of greenbelt in the next monsoon season.

Shed to store the drums with dyke walls and leachate collection system shall be constructed along with the expansion project.

An agreement shall be entered with Cement Industries and TSDF for disposal of incinerable waste.

Hazardous waste shall be transported to Cement Industries with GPS mounted vehicle.

Provided

Not Obtained

Not developed 33% greenbelt.

Dyke walls and leachate collection

system under construction

Complied

No hazardous waste in the premises

23. The industry shall submit the information regarding usage of Ozone Depleting Substance once in six months to the Regional Office and Zonal Office of the Board.

---

24. Concealing the factual data or submission of false information/fabricated data and failure to

-----

comply with any of the conditions mentioned in this order and attract under the provisions of relevant pollution control acts.

25. Notwithstanding anything contained in this conditional consent, The board here by reserves its right and power under Sec.27 (2) of water (Prevention and control of pollution) Act, 1974 and under Sec.21 (4) of Air (Prevention and control of Pollution) Act, 1974 and under, review any or all the conditions imposed here in and to make such alteration as deemed fit and stipulate any additional conditions or revoke the order in the interest of environment protection.

-----

26. Any person aggrieved with this order may within thirty days from then data on which the order is communicated to him, prefer an appeal as per Andhra Pradesh water rules,1976 and air Rules,1982, to the Appellate Authority constituted under Section 28 of water (Prevention and Control of Pollution) Act,1974 and section 31 of the Air(Prevention and Control of Pollution )Act,1981.

-----

20. Compliance status of directions stipulated in Task Force order- The industry has applied for

CFO fresh.

21. Hazardous Waste Authorization details:

i) Particulars of Authorization obtained

under HW (M&H) Rules, 2003 (No. &

Validity date)

: 1. The industry is having valid CFO & HWA Order No. APPCB/VSP/VSP/358/HO/CFO/2017, dated 06.07.2017 valid up to 31.05.2022.

2. The industry has obtained CFE (Exp) Order No. 358/APPCB/CFE/RO-VSP/HO/2015 - , dated 12.03.2019.

3. Now, the industry applied for CFO (Expansion)

ii) Authorization issued for

(Transportation, reception, storage,

treatment and disposal)

: Transportation, reception, storage,

treatment and disposal

iii) Process in which the industry is

covered (Please give Sl. No of process

as per HW Rules)

:

iv) Description of Hazardous waste with

quantities and Stream No. as per HWM

Rules, 2003

:

Sl.

No. Source

Stream Qty. as per

CFE (Exp)

Order dated

12.03.2019

and CFO (Exp)

to be issued

for

Disposal

1.

Organic

residue

28.1 of

Schedule - I 1441.11 To the authorized cement

industries for co-processing

Kg/day (or) TSDF, Parawada for

incineration.

2. Spent Carbon

28.3 of

Schedule - I

53.38

Kg/day

3.

Inorganic Solid

Waste

28.1 of

Schedule - I

275.0

Kg/day To TSDF, Parawada, for

Secured land filling

4. ETP Sludge

35.3 of

Schedule – I

50

kg/day

5.

Waste Oil &

Grease

5.1 of Schedule

– I 50 LPA

To Supplier / APPCB

Authorized Agencies

6.

Empty

barrels/

Containers &

liners

contaminated

with

Hazardous

chemicals /

Waste (Nos./

month)

33.1 of

Schedule – I

500

No’s/Month

To authorized agencies after

complete Detoxification

7. Spent Solvents

28.6 of

Schedule – I 1.0 KLM

Shall be recovered within

the premises to authorized

agency for recovery

v) Particulars of on-site Secured Storage

(Capacity with dimensions) and

mention period for which secured

storage is sufficient.

: The industry has constructed shed for

storage of Hazardous waste.

Storage capacity – 168 tons(5 mts X 6 mts – 4

Nos and 8 mts X 6 mts – 1 No)

vi) Quantity of Haz Waste stored on-site

presently.

: The industry yet to start operations..

vii) Quantity of Hazardous waste disposed

for last six months

: The industry yet to start operations. No

hazardous waste stored in the premises.

viii) Whether industry has submitted

annual returns, date of latest

submission.

: NA.

ix) Whether industry has installed

incinerator or sending to common HW

Incinerator

: The industry obtained TSDF membership and

agreement with Bharathi Cements to send

incinerable waste to TSDF or Cement

industries for co-incineration.

x) Particular of own incinerator (if

applicable)

: ---

xi) Whether log books are maintained for

incinerator. (if applicable)

: ---

xii) Whether industry has taken adequate

steps to prevent contaminated runoff

from storage areas of Hazardous

: The industry is under construction of storm

water drains.

Waste.

xiii) Steps taken by industry towards waste

minimization and cleaner production.

: The industry informed that they will comply.

xiv) Future plan for waste minimization.

:

---

xv) Facilities available with, industry for

waste characterization.

: ---

xvi) Overall House Keeping within the

factory premises.

: The industry yet to start operations.

xviii) Details of disposal of lead acid

batteries along with nos. and agencies

to whom they are disposed

: The industry proposed to send lead acid

batteries on buy back system.

22. Compliance of the industry on previous Hazardous Waste Authorization conditions: CFO & HWA Order No. APPCB/VSP/VSP/358/HO/CFO/2017, dated 06.07.2017

Sl.No. Condition Compliance

1. All the rules and regulations notified by

Ministry of Environment and forests,

Government of India under the E(P) Act, 1986

in respect of management, handling,

transportation and storage of the Hazardous

wastes should be followed

The industry is having valid CFO for a

period up to 31.05.2022 and applied

for CFO (Expansion).

2. The industry shall not store hazardous waste

for more than 90 days as per the Hazardous

& Other Wastes (Management and

Transboundary Movement) Rules, 2016.


3. The industry shall store Used/Waste Oil and

Used Lead acid batteries in a secured way in

their premises till its disposal to the

Manufacturers/ dealers on buy back basis.


4. The industry shall maintain 6 copy manifest

system for transportation of waste generated

and a copy shall be submitted to concerned

regional office of APPCB. The driver who

transports Hazardous waste should be well

acquainted about the procedure to be followed

in case of an emergency during transit. The

transporter should carry a Transport Emergency

(TREM) Card.


comply.

5. The industry shall maintain proper records for

Hazardous & other wastes stated in

Authorization in Form – 3 i.e., quantity of

Incinerable waste, Land disposal waste ,

recyclable waste etc., and file annual return in

form – 4 as per Rule 6 (5) of the Hazardous &

Other Wastes (Management & Trans boundary


maintain and submit.

Movement) Rules, 2016 and amendment

thereof.

6. The industry shall submit the condition wise

compliance report of the conditions stipulated

in Schedule A, B & C of this Order on half

yearly basis to Board Office, Hyderabad and

concerned Regional Office.


comply.

23. Inspecting Officer’s Remarks:

Status of functioning of flow meters of water and effluent

The industry has applied for CFO fresh. Water meter provided to JNPC main line.

Status of energy meters in ETP and Air Pollution Control Equipment (APC)

Provided energy meter to APC.

Remarks on ETP performance and Analysis results The industry sending effluents generated from R & D activity to CETP, JNPC.

Remarks on APC equipment performance and Analysis results

The industry has not started operations and installed mechanical dust collector and bag filter to 2.0 TPH coal fired boiler.

Details of specific and serious non-compliance ---

Details of Court cases & Status ---

Details of complaints ---

Amendments required in the existing CFO/CFE order ---

Irrelevant Conditions that need deletion in view of present compliance / non-compliance

---

Additional conditions to be imposed

Specific comments on quantities of Hazardous Wastes as per application, existing CFO Order and actual generation

---

Details of non-hazardous solid waste generation and disposal details separately

---

Compliance of the industry with reference to Notifications under E(P) Act & Rules

a) Fly Ash Notification b) PLI Act Policy

c) Environmental Statement in Form – V

d) Other if any

The industry obtained PLI policy valid upto 06.08.2020. The industry yet to start commercial operations. --

Mitigation Measures (Where significant adverse effects are identified, description of the remedial measures to be taken to avoid, reduce those effects).

---

1. M/s. Veerchemie & aromatics Pvt. Ltd., has established bulk drug manufacturing unit at Plot No. 76 & 76/A, Thanam (V), Parawada (M), Visakhapatnam in an extent of 10.33 Acres. M/s. Veerchemie & aromatics Pvt. Ltd., has obtained CFE vide order dated 16.04.2015 and CFO vide order dated 06.07.2017 with 3 no. of products and to manufacture any one product or combination of all three products, with a maximum production quantity of 4 TPD. The CFO is valid up to 31.05.2022.

2. M/s. Optimus Drugs Pvt. Limited, Unit –II vide letter dated 18.02.2019, informed the Board that they have purchased M/s. Veerchemie & Aromatics Pvt. Ltd., and requested to issue CFE in the name of M/s. Optimus Drugs Pvt. Limited, Unit –II, Plot No.76 & 76/A, JN Pharmacity, Parawada, Visakhapatnam. M/s. Optimus Drugs Pvt. Limited, Unit –II has submitted Registered Sale deed pertaining to name change.

3. M/s. Optimus Drugs Pvt. Limited, has applied for the CFE(Exp) in the name of M/s. Optimus Drugs Pvt. Limited, and obtained CFE of the Board for expansion capacities. The industry applied for CFO(expansion) to manufacture only for 50 % of the products permitted in CFE (expansion) order in Phase-I

4. The industry was inspected and observed the following:

i. The industry has not started its operations till. The industry carrying out only R&d activities and wastewater generated sending to the CETP, Ramky.

ii. The industry is having 1 no. of production block, warehouse. The industry extending the existing production Block, which is under construction.

iii. The industry has installed HDPE tanks for collection effluents from production block and same pumped to above ground RCC storage tanks.

iv. The industry has installed 2 TPH coal fired boiler and provided mechanical dust collector and pulse jet bag filter as air pollution control equipment to boiler.

v. The industry has installed daga logger to pH meter and VOC meter.

vi. The industry has started laying roads and construction of storm water drains which will be completed within 1 month.

vii. The industry is having green belt of 1.5 Acre.

In view of the above the issuance of CFO (Change of product mix) to the industry may be

considered stipulating necessary conditions.

i. The industry shall not manufacture new products without CFE/CFO of the Board.

ii. The industry shall manufacture maximum any 6 products at a time along R&D -4701 Kg/day.

iii. The industry shall obtain PLI policy which includes ERF immediately.

iv. The industry shall develop 33% of green belt.

v. The industry shall submit the information regarding usage of Ozone Depleting Substance once in six months to the Board.

24. Recommendations of Environmental Engineer:

The CFO (Change of product mix) may be issued with suitable conditions.

25. Head Office Remarks:

1. M/s. Optimus Drugs Pvt. Limited, Unit –II, (formerly M/s. Veerchemie & Aromatics Pvt. Ltd.,) is operating a Bulk Drugs manufacturing Unit at Plot No.76 & 76/A, JN Pharmacity, Parawada, Visakhapatnam with a capital investment of Rs.63.33 Cr.(Existing: 28.45 Cr and Expansion: 34.88 Cr)

2. The Board vide order dated 06.07.2017 issued CFO & HWA to the industry with total (at any point of time) 4.0 Tons/day for a valid up to 30.05.2022 to the following:

S. No

Name of the Product

Capacity (Tons/Day)

No. of stages

Raw materials Quantity of Raw

materials (Kg/Day)

1 Niacinamide 4.00 1 3 – Cyano pyridine 3478.00

2 Nicotinic acid 4.00 2 3 – Cyano pyridine 3448.27

3 Pottasium Nitrate 4.00 1 Potassium Hydroxide 2460.00

Total ( at any point of time)

4.0* Tons/day

*The industry shall manufacture any one product or combination of all three products, so that the

maximum production shall not exceed 4T/day.

3. The Board vide order dated 12.03.2019 issued CFO Expansion to the industry with total production capacity (Maximum any 6 products at a time along R&D) is 9403 Kgs/day.

4. Now the industry applied for CFO(expansion) to manufacture only for 50 % of the products permitted in CFE (expansion) order in Phase-I by reducing the production quantity, water consumption, waste water generation and Hazardous waste generation.

5. As per the verification report the following non compliances were observed: a) The industry has not started its operations till. The industry carrying out only

R&d activities and wastewater generated sending to the CETP, Ramky.

b) The industry has installed 1 x 2.0 TPH coal fired boiler

c) Solvent storage tanks not connected with vent condensers to prevent solvent vapours.

d) The industry has not installed solvent recovery system.

e) The industry has not constructed storm water drains.

f) The industry has developed green belt in an extent of 1.50 Acres (14.5%) against required 3.41(33%) of the total area.

6. Observations/ non compliances during Randomized inspection are as follows:

a) At present the industry is not manufacturing the old consented products and is carrying out R&D products.

b) The industry has to provide online pH meter to the 2nd double stage scrubber. c) The industry shall provide separate flow meters for water used for scrubbers

and maintain records. d) The industry has to complete the internal cement roads. e) The industry shall develop further green belt in the premises.

7. Continues Effluent Quality Monitoring Status (CEQMS):

The industry is falls under 17 category industries and sending effluents to CETP, JNPC for further

treatment through closed pipeline. As per the CPCB directions, the industry has installed flow

meter for pumping HTDS and LTDS effluents to CETP, JNPC and web camera. The industry has

connected flow meters to CPCB & APPCB and web camera not connected.

The issue is placed before the CFO committee for review and recommendations.

***

agenda item no:04 m/s. optimus drugs pvt. limited, unit ii ... · fluorobenzyl ketone 16.67...

Documents