pre- feasibility report -...

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PRE- FEASIBILITY REPORT

ACTIVE PHARMACEUTICAL INGREDIENTS

[API]

[ AT - 82/A, KIADB INDUSTRIAL AREA,

JIGANI ANEKAL TALUK, BANGALORE RURAL

DISTRICT – 562106 ]

Prepared by

H I K A L L I M I T E D

1

CONTENTS

CHAPTER 1: OVERVIEW OF THE PROJECT

1.1 Executive summary

1.2 Product and capacity details

1.3 Water and Waste Water Management

1.4 Air Management

1.5 Hazardous Waste Management

1

CHAPTER 2 : INTRODUCTION OF THE PROJECT 11

2.1 INTRODUCTION 11

2.2 PROMOTOTERS AND THEIR BACKGROUND 11

2.3 OUR AREAS OF SPECILIZATION 11

2.4 BRIEF DISCRIPTION OF NATURE OF THE PROJECT. 12

2.5 NEED FOR THE PROJECT 13

2.6 DEMAND SUPPLY GAP 14

2.7 IMPORT VS INDIGINEOUS 15

2.8 EMPLOYMENT GENERATION 15

CHAPTER 3 : PROJECT DESCRIPTION 16

3.1 TYPE OF PROJECT 16

2

3.2 LOCATION OF THE PROJECT 19

3.3 DETAILS OF SITES 19

3.4 ALTERNATE SITES 24

3.5 SIZE AND MAGNITUDE OF PROJECT 24

3.6 PROJECT DESCRIPTION 24

3.7 COMPLETE PROCESS DETAILS 24

3.8 THE PROPOSED PRODUCTS 35

3.9 MAJOR RAW MATERIALS 154

3.10 AVAILABILITY OF WATER ITS SOURCE, ENERGY /POWER

REQRUIMENT AND SOURCE DETAILS 161

3.11 WASTE GENERATION AND MANAGEMENT 169

3.12 POWER REQUIREMENTS 175

3.13 SAFETY AND FIRE FIGHTING 176

CHAPTER 4 : PLANNING BRIEF

4.1 PLANNING CONCEPT

4.2 POPULATION PROJECTION

4.3 LAND USE PLANNING

4.4 ASSESSMENT OF INFRASTRUCTURE DEMAND

4.5 FACILITIES

CHAPTER 5 : PROPOSED INFRASTRUCTURE

177

177

177

178

184

185

196

3

5.1 AREA 186

5.2 GREEN BELT 186

5.3 SOCIAL INFRASTRUCTURE 187

5.4 CONNECTIVITY 188

CHAPTER 6 : REHABILITATION AND RESETTLEMENT 189

CHAPTER 7 : ANALYSIS OF PROPOSAL 191

7.1 SOCIAL BENEFITS

7.2 OTHER BENEFITS

191

192

1

CHAPTER – 1

OVERVIEW OF THE PROJECT

Sl. No. Item Details

01 Plot/Survey/Khatha No. 82/A, KIADB Industrial , Jigani Anekal Taluk , Bangalore ,

Rural Dist – 562106

02 Contact details Phone :- +91 80-30239299 ,Mobile: +91 9538007950

03 E Mail ID [email protected]

04 Village Jigani

05 Hobli/Taluk Anekal Taluk

06 District Bengaluru Rural

07 State Karnataka

08 Project Type Expansion and modification for manufacturing of Bulk drugs

09 Latitude & Longitude

Latitude:

12°45'59.3"N 77°38'17.8"E

12°46'02.5"N 77°38'23.4"E

12°46'13.8"N 77°38'16.6"E

12°46'10.6"N 77°38'11.2"E

10 Nearest Highway NH 7 towards East @ 7.86 km

11 Nearest Railway station Heelalige Railway Station : 12.2 Km

12 Nearest Airport Kempegouda International Airport : 64.5 Km

13 Major Industries near

the plant site

Adarsh steel Pvt Ltd , Kumar Organics ,Southern batteries

India Ltd, Cipla Limited, Micro Labs, Bill Forge India Ltd ,

MyLan Pharmaceutical , ACE bright (India) Pharma Pvt. Ltd

14 Water Bodies with in

10kms radius

VM Halli Lake, Jigani Lake

15 Nearest Hospital Manju Shree Multi Specialty Hospital towards South 1 KM,

Suhas General and Charitable Hospital towards North 1 KM.

mailto:[email protected]

2

EXECUTIVE SUMMARY

M/s. Hikal Pharmaceuticals Ltd., Unit I, Hikal was incorporated in 1988, with equity

participation of Hiremath, Kalyani Group. The manufacturing activities started at Mahad in

1991, at Taloja in 1998 in collaboration with Merck & Co, Inc. USA and at Panoli in 2000

acquired from Novartis India Limited. Bangalore R&D, Jigani plant acquired from Wintac

Ltd in 2001. State of art R&D facility in Pune established in 2004. The Executive Summary

M/s. Hikal Pharmaceuticals Ltd., Unit I, proposed to expand its existing Bulk Drugs and

intermediate Manufacturing facility from 1388 TPA to 4827.3 TPA located at 82/A, KIADB

Industrial, Jiagani Anekal Taluk, Bangalore, Rural District – 562106. Company has about

18.01 acres of land. The site is having a longitude 12°45'59.3"N and Latitude 77°38'17.8"E

The site is surrounded by internal road in north, East, and West and open land in South. The

nearest human settlement from the site is Jigani village located at distance of 1 km from the

site. There are no ecologically sensitive areas like national parks, sanctuaries within 10 km

radius of the site.

PRODUCTS AND CAPACITY DETAILS

3

PRODUCT DETAILS (EXPANSION OF EXISTING AND PROPOSED

ADDITIONS) CAS

Number

Therapeutic

Category SL. NO. NAME OF THE PRODUCT

EXISTIN

G

EXPANSION

(MTPA)

TOTAL

(MTPA)

1 GABAPENTINE 700

1300 2000 60142-96-3 Anticonvulsant

2 BURPROPION HCL 50

25 75 31677-93-7 Antihyperlipoproteinemic

3 CINNARIZENE 5

15 20 298-57-7 Antihistaminic, vasodilator

4

ONDANSETRON HCL 1

1

103639-04-

9

Antiemetic

5

ACEBUTALOL - HCL 15

15

34381-68-5 Antihypertensive,

Antianginal and

Antiarrhythmtic

6 P- BENZYLOXY ANILINE

HCL 40 40

51388-20-6 Intermediates

7

ONDANSETRON API 1

1

103639-04-

9

Antiemetic

8 OXYPENTIFYLLINE 5

70 75 6493-05-06 Vasodilator

9

TRIPOLIDINE - HCL 4

4

5050-70-9 Histamine H1-receptor

antagonist

10

GEMFIBROZIL 300 (- 120) 180

25812-30-0 Antihyperlipoproteinemic

11

DECOQUINATE 75

200 275

18507-89-6 Antiprotozoal: Agent

against coccidiosis

12

LEVETIRACETAM 8.8

10.0

102767-28-

2

Anticonvulsant

13

VERAPAMIL 20

20

152-11-4 Antianginal,

Antiarrhythmic

Antihypertensive

14

VALPROIC ACID 50

50

99-66-1 Anticonvulsant (Treatment

of Epilepsy)

15

SODIUM VALPROATE 50

50


of Epilepsy)

16

DI-VALPROEX SODIUM 20 20


4

of Epilepsy)

17 MAGNESIUM

VALPROATE 10

10

62959-43-7 Epilepsy & Migraines

18

TOPIRAMATE 20

20


of Epilepsy)

19

T-LUCINE 12 12


20

FLUNARAZINE 1.2 10.8 12

PROPOSED PRODUCT TO BE ADDED (NEW )

52468-60-7 Calcium channel blocke

21

VENLAFLAXINE HCl

-- 40 40

99300-78-4 Antidepressant

22

NEOTAME

--

50 50

165450-17-

9

Artificial sweetener

23

PIRACETAM

--

650 650

7491-74-9 Psycho stimulants and

nootropics

24

ETIRACETAM FRESH

-- 500 500


25

ETIRACETAM RACEMIC

150 150 33996-58-6

Intermediates

26

TPCA.HCL

-- 10 10

Intermediates

27

CMMDT

-- 10 10

17661.72 Intermediates

28 TRI-FLUROMETHYL

CINNAMIC ACID

-- 10 10


29

MEMANTINE HCl

-- 10 10


30 PIPERAZINENITRO HCl

-- 50 50

Intermediates

31 SEVELAMER CARBONATE --

100 100

845273-93-

0

Phosphate binding drug used

to chronic kidney disease.

32 COLESEVALAM

HYDROCHLORIDE

--

100 100 182815-44-7

Treatment of

dyslipidemia

33

PREGABLIN

--

100 100

148553-50-

8

Treatment Neuropathic

pain

34

SITAGLIPTIN

--

10 10

486460-32-

6 antihyperglycemic

http://www.rxlist.com/script/main/art.asp?articlekey=2940

5

(antidiabetic drug)

35

VILDAGLIPTIN

--

10 10

274901-16-

5 Antidiabetics

36

LACOSAMIDE

--

20 20

175481-36-

4 Anticonvulsant

37 VALOCYCLOVIR

HYDROCHLORIDE

--

50 50

124832-27-

5 Antiviral

38

OLMESARTAN

--

10 10

144689-63-

4 Cardiovascular Agent

39 DONEPEZIL HYDROCHLORIDE

DIHYDRATE

--

2 2

884740-09-

4 Anti-Alzheimer's agent

40

QUETIAPINE FUMURATE

--

40 40

111974-72-

2 Schizophrenia

41 PRASUGREL (TPPO)

-- 10 10

42 BUTRAPHANOL

-- 0.3 0.3

43 METHIMAZOLE

-- 5 5

BY PRODUCTS

S.No. Name of the By Product

Quantity

per annum

(MT)

Disposal

1 Spent Potassium

54.5 Sale

6

carbonate

2

Palladium Carbon

catalyst 4.6

Returned to the

supplier

3 Raney Nickle Catalyst 28.8 Returned to supplier

4 Aqueous Ammonia 1389.31 Sale

5 Sodium sulphate 8.7 TSDF/ sale

6 Sodium bicarbonate 7.4 TSDF/ sale

7

NaCl Salts from

Gabapentine 3572.0

TSDF/ sale

8 Gaba lactum 1557.1 Internal consumption

Total Generation Tons per Annum 6622.4

1 Recovered solvents

68406.3 Internal consumption/

Sale

Total Generation Tons per Annum 75028.7

WATER AND WASTE WATER MANAGEMENT

Water consumed

for

Existing

Consump

tion

KL per

Day

Proposed

Consumpt

ion

KL per

Day

Total Existing

Discharge KL

per day

Proposed

Discharge

KL per day

Total Disposal Method

7

(a) Domestic Use

(Toilet, Canteen

etc.)

28 17 45 28 12 40 Treated in existing STP plant

capacity of 50 KLD,

(b) Industrial

purpose

(1) Process*

40 135 175 89 135 224

Effluent Shall be treated in ETP

followed by MEE and ATFD. The

Distillate along with RO permeate

given to cooling tower make up

(2) Washings* and

scrubbers 42 47 89 42 47 89

(3) Boiler feed

make up water 154 166 320 66 72 138

Blow Down Shall be treated in

DM plant and reused for Boiler

feed.

(4) Cooling tower

make up 248 175 423 80 57 137 Blow Down Shall be treated in

ETP of 500 KLD followed by RO

and reused for CT make up

(5) Others

(Specify)

1 105 106 35 70 105

RO reject TDS is <1500 ppm,

Same water Used for gardening,

road cleaning , floor washings, fire

hydrant make up, toilet flushing

(RO REJECT

Water )

TOTAL

513 645 1158 340 393 733

Note : * Present Cooling tower circulation rate is 2600 m3/Hr (Capacity of 4850 TR) and proposed

circulation rate is 1716 m3/Hr (Capacity of 3150 TR).

*Total Cooling towers capacity will be 8000 TR with circulation rate is 4316 m3/Hr

* Cooling tower losses and Boiler Losses are made up from Treated effluent

AIR MANAGEMENT

8

Chim

ney

No.

Chimney

attached to

Minimum chimney height to be provided above ground level(AGL)/

above roof level (ARL)

Rate of

emission

Nms/Hr.

Constituents

to be

controlled

in the

emission

Tolerance

limits

mg/Nms as

per CFO

Air pollution Control

equipment to

be installed, in addition to

chimney height as

per Col.(3)

Existing Air pollution Sources and control equipments

1 2 3 4 5 6 7

1 2.8 TPH Boiler 30.5 m AGL - SO2 - Chimney

as per

Col.3

2 6.3 TPH Boiler 38 m AGL - SO2 - Chimney

as per

Col.3

3 6.3 TPH Boiler & 2

Lakh K. Cal Thermic

Fluid Heaters

Common chimney

of 38 m AGL

SO2 - Chimney

as per

Co1.3

4 Process emissions

from all the reactors- 7

Nos.

Individual

chimneys of 5 m

ARL connected with

Scrubbers

Acid Mist

SO2

35

-

Chimney as

per Col.3 with

Scrubber

5 DG Set — 750

KVA.

16 m AC, - SO2 - Chimney as per

Col.3 with

Acoustic

Enclosures 6 DG Set —

1500KVA.

30 m AGL - SO2 - Chimney as per

Col.3 with

Acoustic

Enclosures 7 DG Set-275

KVA.

6 m ARL - SO2 - Chimney as per

Col.3 with

Acoustic

Enclosures

8 Boiler-14 MT/Hr

(Briquette fired)

35 in AGL - SO2 - Chimney as per

Col.3 with ESP

Proposed Air pollution Sources and control equipment’s

9 DG SET 2000 KVA 30 m AGL - SO2 - Chimney as per

Col.3 with

Acoustic

9

1

0

Process emissions from all

the reactors- 8 Nos.

Individual

chimneys of 5 m

ARL connected with

Scrubbers

Acid Mist ,

SO2

35

-

Chimney as

per Col.3 with

Scrubber

HAZARDOUS WASTE MANAGEMENT

Sl.

No

Type Category Quantity in Total Method of handling/disposal

Existing Proposed

1 Used oil

5.1 2KL/A 4KL/A 6KL/A Shall be collected in a leak proof

containers & disposed only to

KSPCB registered authorized re-

processors provided the oil meets

the standards as per schedule-5

part A of the rules

2 Oil soaked cotton

waste

Oil filters

5.2 0.2MT/A

30Nos /A

0.4MT/A

60Nos /A

0.6MT/A

90Nos /A

Shall be store in a secured manner

& handed over to KSPCB

authorized incinerators / co-

processing in cement kiln

3 Spent carbon, fy flow

mixtures, & carbon

soot

28.2 72.5MT/A 182.5 MT/A 255 MT/A Shall be store in a secured manner

and handed over to KSPCB

authorized incinerators / co-


4 Mixed solvents &

Spent solvent from

process

28.5 241MT/A 6527 MT/A 6768 MT/A Shall be store in a secured manner


authorized recyclers.

5 Discarded containers 33.3 11.7MT/A

Shall be represented

in Numbers

50.4 MT/A

50400 nos

62.1 MT/A

62100 nos



authorized recyclers after wash

only

6 ETP sludge,

Multiple effect

evaporator salt

34.3 198MT/A

1398.6MT/A

396 MT/A

3401.4 MT/A

594MT/A

4800 MT/A


and handed over to TSDF/ Co-


7 Distillation residue

from contaminated

organic solvents

36.4 350MT/A 127 MT/A 477 MT/A



authorized incinerators / Co-


8 RO resins (membrane

) and chemical resins

1.5 MT/A 1.5 MT/A Shall be store in a secured manner



10

(MB plant) processing in cement kiln

9 Expired or Off

specific drugs /

Chemicals

------- 2.0 MT/A 2.0 MT/A Shall be store in a secured manner




SOLID WASTE MANAGAMENT

Sl. No Type of waste Quantity Method of handling/disposal

Existing Proposed Total

1 General office waste 8TPA 8TPA 16 TPA

Shall be stored in accordance to

KSPCB Guidelines and disposed to

authorized scrap dealers

2

Non-contaminated carboys

& glasses

5000 Nos /A

1.0 MT/A

7000 Nos/A

1.0MT/A

12000

Nos/A

2 MT/A

3 Wood packings 24 TPA 40 TPA 64 TPA

4 Sludge from STP 7.2 TPA 5.8 TPA 13 TPA

5 Non contaminated plastic

waste 20 MT/A 25 TPA 45 TPA

6 Aprons –Cloth waste 0.5 TPA 1.0 TPA 1.5 TPA

7 Glass wears 0.5 TPA 2.0 TPA 2.5 TPA

9 Cogen Boiler Ash 2592 TPA ------ 2592

TPA


KSPCB guidelines and disposed to

Bricks & Compost manufacturers

Note: STP Sludge used for gardening.

CHAPTER – 2

INTRODUCTION OF THE PROJECT

11

2.1: INTRODUCTION:

Hikal was incorporated in 1988, with equity participation of Hiremath, Kalyani Group. The

manufacturing activities started at Mahad in 1991, at Taloja in 1998 in collaboration with

Merck & Co, Inc. USA and at Panoli in 2000 acquired from Novartis India Limited.

Bangalore R&D, Jigani plant acquired from Wintac Ltd in 2001. State of art R&D facility in

Pune established in 2004.

We had obtained Environmental clearance for the production of Bulk drugs on EC No:

SEIAA: 14: IND: 2007, Dated on 18th

June 2008. Now we are seeking environmental

clearance for modification and expansion for manufacturing unit of Active Pharmaceutical

Ingredient (API) and Drug Intermediates.

OVER VIEW:

Hikal is a partner of choice to the global pharmaceutical industry. We support the

pharmaceutical industry from the early lead generation stage till the launch of new chemical

entities. Hikal's specialization spans the entire spectrum from conventional synthesis to

complex chiral chemistry and is backed by state-of-the-art Analytical facilities. Intermediates

are manufactured at Panoli, Gujarat and Active Ingredients are manufactured in Bangalore

meeting regulated markets (US, Europe and Japan) standards.

Hikal undertakes custom manufacturing projects in intermediates and APIs for multinational

companies. Hikal has expertise in custom synthesis and contract research, with capabilities

scaling up from gram to kilo and ton level of production.

R&D is a core competency of Hikal. We assign top most priority to investments in world-

class scientists and laboratory instrumentation. Our R&D team is mentored by a Scientific

Advisory Board of eminent scientists. We have an impressive R&D record. Our scientists

have published several publications and received patents. They have developed several

innovative and cost effective processes for several well-known APIs. The Hikal R&D Center

provides process research of API’s and intermediates involving Multi-step synthesis. We

http://www.hikal.com/aboutus/advisor_board.htm

http://www.hikal.com/aboutus/advisor_board.htm

http://www.hikal.com/pharma/products.htm

12

have a successful track record in developing non-infringing processes and scaling up from

lab to kilo to commercialization. Our expertise in discovery research, Analytical method

development, synthesis of impurities, scale-up and technology transfer enables us to develop

new products and meet the needs of life science companies worldwide.

2.2 PROMOTORS AND THEIR BACKGROUND:

List of Promoters

Sl.

No

Promoters name Destination

1 Jai Hiremath, Chairman and Managing Director

2 Sameer Hiremath, President and Joint Managing Director

3 Baba Kalyani, Board Member

4 Kannan Unni, Board Member

5 Dr. Peter Pollak, Board Member

6 Prakash Mehta, Board Member

7 Shivkumar Kheny, Board Member

8 Sugandha Hiremath, Board Member

9 Dr. Wolfgang Welter, Board Member

10 Amit Kalyani, Director

11 Prof Axel Kleemann Professor

2.3 OUR AREAS OF SPECIALIZATION

Discovery Research Support

We supply molecules for discovery research on a contract basis. We are the preferred partner

of leading multinational companies in different phases of new drug discovery and

development. Backed by state-of-the-art instrumentation and an experienced team of

scientists, we focus on research on new molecules.

13

Process Development

We have a successful track record in developing non-infringing processes and scaling them

up from laboratory to kilo scale to commercial scale production. Our engineering expertise

enables us to successfully set up chemical plants, manage and develop a wide range of

processes that conform to stringent quality and safety guidelines.

Analytical Method Development

We undertake method validation of new substances. The activities include in-process

analysis, identification and quantification of impurities.

Custom Manufacturing

We undertake custom manufacturing of key intermediates and active substances for

pharmaceutical and agrochemical companies worldwide. Our products are being used in new

candidate drugs in Phase 1, Phase 2 and Phase 3 stage of clinical trials as well as in

commercialized drugs.

2.4 BRIEF DESCRIPTION OF NATURE OF THE PROJECT

The synthetic organic chemicals manufacturing will involve series of chemical reactions to

get the final Product. The products of reaction are purified, filtered and dried before packing

the final product. The Chemical reactions require various supporting services like Heating,

Cooling and Agitation.

14

This is an optimum site as it is already existing site. Also it is manageable both from

production, pollution control and quality assurance point of view. All necessary

infrastructures for this capacity are conveniently available.

The expansion cum Modification shall meet with the required Environment Health and

Safety & GMP norms. Company’s corporate policy focuses primarily on Product Quality,

Customer Satisfaction and adherence to high level of Environment protection and Safety.

The company has a state of art R&D center, located at Pune and has a continuous process

development activity in the existing facility

2.5 NEED FOR THE PROJECT AND ITS IMPORTANCE TO THE COUNTRY AND OR

REGION:

M/s.Hikal is an established API and Drug Intermediates manufacturing unit. The company

wishes to modify their process to increase the volumes of some or the key products and

additional new products in the new block as well as Drug Intermediates at existing

manufacturing facility to augment the infrastructure utilization. These API’s & Intermediates

are used in the manufacture of medicines, most of which are life saving Drugs. The demand

of such products is tremendous in India and abroad and there is a huge gap in the demand and

supply chain. The market of these products has a fast progressing growth and there is ample

opportunity in indigenous as well as export market. Current manufacturing facility has all

necessary Infrastructure and Man power to handle the new products with the modification in

the process equipments and storage areas. This expansion will help the company to compete

the market globally as well as increase revenue to the state. Due to the above reasons, hence

it is justified to enhance the volume and addition of new products at the current facility.

.

Also need for the project and its importance to the country and or region: World population is

growing at an alarming rate. In the Indian sub-continent population growth is more than that

of developed countries. To meet the needs and comforts of ever-growing population

15

industrialization became inevitable. For the growing population the needs of health care

substitutes are also increasing.

In the last few decades, India’s population is skyrocketing and so is the demand for Drugs to

support this population. In order to satisfy this need, more production of bulk drugs and

active Pharma ingredients is needed. The expansion of the industry will be beneficial to the

region. The company will bring new job opportunities for the local people. They will,

therefore, become economically stronger. Our commitment lies in providing the required

quality API's and Intermediates to our existing customers worldwide. We cater to a cross

section of clients in Asia, Europe, North and South America.

Our inherent strength lies in producing cutting edge intermediates, for new as well as off

patent API's within the requisite time frame stipulated by our customers. Fifty percent of our

business has evolved from custom synthesis projects, which start from gram level and rise to

multi ton supplies.

Bangalore has developed as a major manufacturing hub for bulk drugs due to the operations

of many major Pharmaceutical Industries, besides a large number of medium and small

industries manufacturing bulk drugs of all kinds. In support of this growth, many basic

chemical units and drug intermediate units have also come up to meet the input requirements

of Bulk Drug manufacturing Companies. Large numbers of pharma units are still dependent

on supply of basic chemicals mainly from Mumbai, Gujarat and other parts of the country.

2.6 DEMANDS-SUPPLY GAP

The project is envisaged to meet the demand supply gap in both domestic market and export

market, as API demand is increasing day by day. The demand for APIs and API

intermediates is a derived demand. It gets derived from the demand for various medicinal

formulations (final administrable drugs) for the formulation industry.

The APIs and API intermediates being manufactured by basic drug manufacturers are

exported as such or used by domestic formulators in their production processes. The

16

formulation firms further produce final medicines and export these as well as sell these in the

domestic market. There is a wide gap in the demand and availability of cheap and quality

medicines in India and the world over.

Generic medicines and off patent drugs have significant potential to increase access to

cheap and effective medicines to poor people and in general to bridge the demand supply

gap.

Indian basic drug manufacturers are playing a significant role in increasing access to

affordable off patent drugs.

The products envisaged include third generation antibiotics, anticancer, antipsychotic, etc

drugs which address the problems associated with present day stressful lifestyles and demand

for these outstrips their demand and is increasing by the day.

2.7 IMPORTS VS. INDIGENOUS PRODUCTION

The project shall enhance the foreign exchange reserves in view of the proposed products.

The finished goods will be sold in domestic and export market and would be largely exported

to the Regulated International Market as per demand. The products shall cater to both

domestic and export markets.

2.8: EMPLOYMENT GENERATION (DIRECT AND INDIRECT) DUE TO THE PROJECT:

During the construction phase, workers strength of 20 labors will be deployed

depending on the construction phase. These people will largely be based in local areas within

reachable limits and not likely to impact either the social fabric or create additional pressures

17

on the local resources of nearby villages. The project will therefore provide employment to

many families and will result into major positive impact due to the proposed activity.

The project can definitely improve the regional, state and national economy. Industrial

growth is an indication of all-round Socio-Economic Development – by generating local

Employment and Business Opportunities. The implementation of this project will definitely

improve the physical and social infrastructure of the surrounding area.

Proposed expansion project will result in considerable growth and up liftmen of local

community in the nearby villages by providing the employment. The proposed project will

generate direct and indirect employment to the nearby villages and the unavailable technical

persons will be recruited from outside.

It is predicted that socio-economic impact due to this project will positively increase

the chance of more employment opportunities for local peoples. There are no Resettlement

and Rehabilitation issues involved in this project. The project infrastructures will be of use to

people of the area. The revenue of the village will be definitely increasing due to the project.

CHAPTER – 3

PROJECT DESCRIPTION

This chapter encompasses the details of the proposed project, material and resource

requirement for existing and for proposed operation phases, utilities, sources of waste

generation, estimation of pollution loads and associated infrastructures etc.

M/s. Hikal is proposing an expansion by adding new products and enhancement of

already approved products in existing manufacturing blocks that will produce ,existing

and proposed new products (Bulk drug and intermediate) at the existing Plot.

18

M/Hikal was initially set up a API manufacturing unit with a capacity of 1388 MT/Annum

along with by-products. Hikal is desirous to propose their Products in this Large Scale

Industrial unit

M/s. Hikal now proposed to add new API (Bulk drug and intermediate) at existing

plant. The proposed additional production will be 3439.3 MT/ Annum ( total volume of

4827.3 MT/A) along with by-products of capacity 6622.4 MT/A + 68406 MTPA Solvents by

products. On screening it is necessary for Hikal to approach designated Authority from

State Environment Department for Environment Clearance for this unit.

This Pre-feasibility report however, is prepared for forming a framework for EIA study,

Scoping and finalizing the Terms of Reference, as may be required.

The government has an objective to improve economic status of Bangalore Rural and has

encouraged for expansion , In order to have a sustainable development, the pollution

generation from this industry is finally made insignificant having taken all the precautions

right from raw material selection up to low or no waste generation and conversion. Major

contributions from our process development activity facilitated the process.

3.1 TYPE OF PROJECT

M/s. Hikal Limited is proposed to increase the capacity of existing product as well as

addition of new drug products for API manufacturing. M/s. Hikal Limited has the necessary

concrete structures for the expansion which is located adjacent to the existing building for the

new proposed plant and for material storage area. Existing civil structure will be used for

Ware house and adjacent buildings will be used for storage of Solid fuel, Engineering stores,

Project workshop and ash storage.

19

The total site area of the proposed project is 18.11 acres including the existing facility is 13

acres. The office space will comprise of 925 m2 with total area of 7280 m

2 having amenities

such as first aid center, guest room, meeting room, kitchen with dining facility, R & D center

store room for keeping of office records, reception facilities etc. There is adequate space &

provision for present operations and for proposed production and for material storage. The

overall facilities under the project broadly consist of the following elements/operations;

Plant and Machinery & Utilities

Production units

Safety and Pollution control facilities associated with the production of the above.

Supporting services such as Boiler and for DG sets utilities

S.No Description Acres

1 Unit-1: 82/A 25824 Sq mt / 6.38 Acres

2 Unit-1/Gate III & IV 12513 Sq mt / 3.092 Acres

3 SRU/ETP/Deco 13157.04 Sq mt/ 3.25 Acres

4 New ware House 4353 Sq mt / 1.1 Acre

5 Project work shop 16264 Sq mt/ 4.01 Acres

Total Unit-1 17.83 Acres

BUILTUP AREA DETAILS:

Facility Present facility

(Sq mtr)

Proposed facility

(Sq mtr)

Total area

(Sq mtr)

Production plant 8515 2355 10870

Electrical house 635 0 635

20

Boiler House 1090 0 1090

Guard house 50 0 50

Solvent yard 684 0 684

Wastewater ttt

plant

2022 0 2022

Scrap house 883 0 883

HW storage 216 0 216

Admin block &

Canteen

925 246 246

Transformer 1990 0 1990

PROJECT COST

There is an additional project cost as it is a proposed expansion unit. Cost of the project for

expansion and modification is Rs. 80 Crores. The details are listed in the table below.

BREAKUP OF PROJECT

Sl. No. Description Investment (Crores)

01 Land Existing

02 Building 17 Cr

03 Plant and Machinery 60 Cr

04 Office equipment 2 Cr

05 Furniture and fixture 1 Cr

06 Vehicles NA

21

Grand Total 80 Cr

3.2 LOCATION OF THE PROJECT

The project is at plot no 82/A, KIADB Industrial Area, Jigani Anekal Taluk, Bangalore Rural

District – 562106; The Geographical Location of this Industry is an elevation of 920 m (3036

ft) above mean sea level (MSL).

The proposed project is capacity enhancement of existing product and addition of new drug

products for API manufacturing. Its an modification and expansion of Bulk drugs

manufacturing industry is located at 82/A, KIADB Industrial Area, Jigani Anekal Taluk,

Bangalore Rural District – 560105. which is meant for these types of Industries KIADB has

provided all infrastructure like assured electrical power, continuous potable water supply

from water works having RSF (Rapid Sand Filtration) and disinfection, the internal road

network, external approach road, and networking with Common Hazardous Waste

Storage Treatment and Disposal Facility) at KIADB Dabaspet in vicinity established with

support of Ramky Enviro Engineers and KSPCB

3.3 DETAILS OF SITES

Sl.

No

.

Particulars Details

1 Plant site coordinates Latitude : 12.768309

Longitude: 77.638656

2 Plant Site Elevation 920 mtr above MSL

3 Climatic Conditions (IMD,

Bengaluru)

Avg. Annual Max. Temp: 34o C

Avg. Annual Min. Temp: 12o C

Annual Avg. rainfall: 1000 mm

2 Land use at the proposed

project site

Industrial land developed by KIADB

22

3 Nearest Highway Bannerghatta main Road :6.2 Km

4 Nearest Railway Station Anekal Railway Station 13.6 Km

5 Nearest Airport Kempegowda International Airport – 78.8 Km

6 Nearest village Haragadde Village : 2.4 Km, Vaderamanchana

Halli: 2.6 Km

7 Nearest major city Anekal : 13.5 Km

9 Nearest water bodies Hennagara Lake – 5.4 Km

Hebbaka Reservoir- 8.09 Km

10 Nearest major hill range Nil

11 Ecologically sensitive zones

or Protected areas as per

Wildlife Protection Act, 1972

Nil

12 Critically polluted areas as

per CPCB Notification

No

13 Historical and cultural

important places

Nil

14 Defense installations Nil

24

12046’13.8”N

77038’16.5”E

12046’02.4”N

77038’23.5”E

12046’10.6”N

77038’11.0”E

12046’05.8”N

77038’10.7”E

12046’59.5”N

77038’17.7”E

26

3.4 ALTERNATE SITES

This is a proposed expansion project for existing and new products, on existing plot.

There is ample area available for expansion and current site is in approved KIADB area and

is well connected to get raw material by road / railway and carry on the proposed

manufacturing activities

3.5 SIZE AND MAGNITUDE OF THE PROJECT

The maximum proposed capacity is 4829.1 MT/A and by-products

3.6. PROJECT DESCRIPTION

The proposed project is capacity enhancement of existing product and addition of new drug

products for API manufacturing. Modification and expansion of manufacturing unit of Bulk

drugs is located at 82/A, KIADB Industrial Area, Jigani Anekal Taluk, Bangalore Rural

District – 562106.

There are no archaeological, historical sites located nearby. Therefore, the project site does

not offer any negative impact on the local area, but rather has a positive impact on socio

economic conditions of the habitants around it.

The manufacturing process of Bulk Drug & Intermediates consists of chemical synthesis

extending to stages of processing involving different type of chemical reactions. Total

production capacity of Existing is 1388 TPA and Proposal will be 3439.3 TPA. (Given in

Table Below). The unit will take adequate control measures for storage and handling of Raw

materials, solvents and cylinders with in factory premises.

3.7 COMPLETE PROCESS DETAILS

PROCESS FLOW CHART

27

The flowchart along with material balance of the manufacturing process is as shown below.

The description of the manufacturing process is described in brief in the next section.

MATERIAL BALANCE FOR EXISTING PRODUCTS

1. GABAPENTINE

Input Quantity

in Kgs per

batch

Output Quantity in

Kgs per batch

Lactam 1700 Product : Gabapentine 989

HCl – 30% 1938 Solvent Recovery

Toluene 3997 Acetone 4361

Acetone 4660 Toluene 3596

NaOH Flakes 1209 Methanol 3664

Methanol 3857 IPA 5085

IPA 5352 Raw Material Recovery

Water for process 5857 Lactam Recovery 770

Sodium Carbonate 216 Waste Streams

Carbon 9 High TDS stream to MEE 10112

Hyflow 4 Low TDS stream 11591

Water for cleaning equipments 7727 Air Emission

Scrubber water make up 3864 CO2 90

Solvent – Fugitive emission 12

Hazardous Waste

28

Spent Carbon + Hyflow Supercel with moisture 35

Residue of solvent distillation – Tarry waste 85

TOTAL INPUT 40390 TOTAL OUTPUT 40390

2. BUPROPION HCl

Input Quantity in

Kgs

Output Quantity in Kgs

per batch per batch

Bupropion – 1 1400 Product : Bupropion HCl 1000

TBA 2160 Solvent Recovery

Toluene 2695.68 Methanol 2500

HCL CP 1311 IPA+ Methanol 900

Acetone 480 TBA 1000

Methanol 2488.35 TBA + Toluene 750

IPA 2574.8 Waste Streams

Hyflow 12 High TDS stream to MEE

Act Carbon 40 Low TDS stream 6000

Purified water 7030 High COD Stream 4500

NaoH flakes for Scubber 225 Air Emission

Water for scrubber 2500 Particulate matter 5

Volatile Solvent – Fugitive emission 60

Hazardous Waste

Spent Carbon 45

Hyflow supercel 17

29

IPA MLR spent 2640

Toluene layer spent 3000

Acetone Spent 500

Residue of distillation 0


3. CINNARIZINE

Input Quantity in

Kgs per

batch

Output Quantity in

Kgs per batch

Benzydrol 300 Product Cinnarizine 320

Piperzine Anhydrous 686 Solvent Recovery

Triethyl Amine 152 MEK 1000

Catalyst - E 2.1 Toluene 3250

Catalyst B 7.3

Water for process 2552 Waste Streams

Toluene 3313.4 High TDS stream to MEE 1550

Hyflo 16 Low TDS stream 3500

Caustic soda 411

Carbon 20.8 Air Emission

Methanol 572 Solvent – Fugitive emission 56

MEK 1022.35 Hazardous Waste

HCl 1832.14 Spent Carbon + Hyflow Supercel 67

Cinnamic Acid 205 Mixed Solvent for sale

Methanol MLR Spent 600

30

Piperazine Spent 650



4. ONDANSETRON HCL

Input Quantity in Kgs

per batch


per batch

Mannich HCl 240 Product : Ondansetron

Base (ONDT-07)

235

2-Methyl Immidazole 240 Solvent Recovery

Purified water 5760 Waste Streams

Low TDS stream 6000

Air Emission

Particulate Matter 5


ONDANSETRON BASE

(ONDT-07)

105 Product ONDT- HCl 97

CHCl3 3765 Solvent Recovery

HCl – LR grade 48 CHCl3 3665

IPA 24

Carbon 21 Waste Streams

Hyflosupercel 24 Low TDS stream 1950

Water for process 1840 Air Emission


Hazardous Waste

Spent Carbon + Hyflow

Supercel

75


5. ACEBUTALOL-HCl

Input Quantity in

Kgs per

batch

Output Quantity in

Kgs per

batch Ace-4 450 Product Acebutalol - stage V 450

M – IPA (Isopropyl

Amine)

612 Solvent Recovery

Water for process 3050 MIPA 606

31

Sodium bicarbonate 45 Waste Streams

Sodium hydroxide 90 Low TDS stream 3288

HCl CP Grade 206 Air Emission


Hazardous Waste

Spent Sodium bicarbonate 98


Acebutolol - sage V 260 Product Acebutalol - HCl 200

Acetone Fresh 3619 Solvent Recovery

Water for process 70 Acetone from process 3350

recovery & drying operation 180

HCl CP grade 91 Waste Streams

Carbon 32 High TDS stream to MEE 0


Air Emission


Hazardous Waste

Spent Carbon + Hyflo Supercel 99



6. P-BENZYLOXY ANILINE HCL

Input Quantity in Output Quantity in Kgs

per batch Kgs per batch

p-Nitro phenol sodium

salt(ODB) in put

500 Product PBA-HCl 550

DMF 291.4 Solvent Recovery

FeCl3 36 Toluene spent 2510

32

Carbon 60 IPA Spent 100

Hydrazine Hydrate (80%) 480

Water 2200 Waste Streams

Hyflosupercel 20 High TDS stream to MEE Nil

Toluene 1814 Low TDS stream 2300

HCl in IPA 480 High COD stream 1000

IPA 94 Air Emission

Catalyst-A 12.5 Solvent – Fugitive emission 20

Benzyl chloride 482 Hazardous Waste

Casutic soda flakes 219 Spent Carbon + Hyflow Supercel+ FeCl3 209

Mixed Solvent for sale Nil



7. ONDANSETRON API


per batch


per batch ONDT- HCl Di hydrate 140 Product ONDT- API 100

Methanol 1770 Mixed Solvent for Sale

TEA 52 Methanol +IPA 1650

Water for process 4200 Waste Streams

IPA 120 High TDS stream to MEE NIL

Carbon 8 Low TDS stream 4500

Hyflo supercel 3 Air Emission


Hazardous Waste

33


Supercel

18

Residue of distillation NIL


8. OXYPENTIFYLLINE

Input Quantity in Kgs per

batch

Output Quantity in Kgs per

batch Theobromine 450 Product : Pentoxifylline 550

Chlorohexanone 384 Solvent Recovery

DMF 1416 DMF recovered 1342

Pot carbonate 278 Methanol MLR Pure 1800

Methanol 3558 Waste Streams

Charcoal 28.5

Hyflo 6 Air Emission

Particulate matter 5

Volatile Solvent – Fugitive

emission

50

Hazardous Waste

Spent Carbon 45

Hyflow supercel 9

Spent Pottassium carbonate 400

Methanol MLR Crude 1920



9. TRIPROLIDINE – HCl


per batch


per batch TRI – 3

(Intermediate)

125 Product Triprolidine HCl 150

Sulphuric Acid

Cpgrade

606 Solvent Recovery

Water 13414.5 Toluene (MLR Spent) 540

Formic Acid 37.5 Acetone (MLR) 810

NaOH Flakes 520 Effluent Streams

HCl LR grade 69 High TDS stream to MEE 4500

Low TDS stream 10000

Acetone 793.6 Air Emission

Toluene 536.1 Solvent – Fugitive

emission

55

Carbon 20 Hazardous Waste

34

Hyflosupercel 6 Spent Carbon + Hyflow

Supercel

73

Mixed Solvent for sale


10. GEMFIBROZIL


batch


batch Gem – 1

(Intermediate)

600 Product Gemfibrozil 420

Isobutanol 868 Solvent Recovery

Methanol 850 Isobutanol 824

Toluene 240 Methanol 834

NaOH 120 Toluene 233

Water 15270

30% HCl 245 Waste Streams

Carbon 54 High COD stream to MEE 3565

Hyflosupercel 12 Low TDS stream 12112

Air Emission


Hazardous Waste


Supercel with moisture

120



11. DECOQUINATE


batch


per batch

Deco – stage - 4 660 Product Decoquinate 591

Toluene 452.4 Solvent Recovery

Pd / Catalyst 2.75 Recovered Diphyl 16157.85

Hydrogen gas 17.8 Recoverd Methanol 6963

Water 9 Washed Methanol 7314.61

EMME 460 Toluene 450

Diphyl 16288 Diphyl Spent (light dense) 235

Methanol 7408.0 Catalyst recovery & Recycle

Washed Methanol 7314.61 Pd / Catalyst 6

Aerosil 5.5 Waste Streams

35

High TDS stream

(Nustche filter methanol + water MLR-

methanol qty)

115

Low TDS stream 120

Air Emission


Hazardous Waste

Spent Carbon + Hyflow Supercel Nil

Dust colletor material 3

Final mill cleaning Discard 1

Unused Black mill cleaned 3

Mixed Solvent (Dryer distillate) for Sale 365



12. LEVETRACETAM

Input Quantity in Output Quantity in

Kgs per

batch

Kgs per batch

2 (2-oxopyrolodinene Butryic

acid)

48 Product: Levetracetam 35

TEA 38 Solvent Recovery

Ethyl Chloroformate 38 MDC 490

Ammonia Gas 15 Acetone 162

MDC 580 Waste Streams

36

Acetone 180 High TDS stream to MEE Nil

Sodium Carbonate 20 Low TDS stream (Water + 247

Sodium Carbonate +

organics)

Carbon 3.5 Air Emission

Water 136 Solvent – Fugitive emission 4

CO2 11

Hazardous Waste

Spent Carbon 5



TOTAL INPUT 1058.5 TOTAL OUTPUT 1058.5

13. VERAPAMIL

Input Quantity in Tons

per annum

Output Quantity in

Tons per

annum

NMHVA 12.346 Product Verapamil 20

Bromochloropropane 12.757 Solvent Recovery

NaOH 3.498 Toluene 117

TBAB (Catalyst-A) 0.123 Methanol 0.2

Toluene 120.284 Toluene / Ethyl Acetate 224.8

Water 28.891 Waste Streams

1 PHVN 12.346 High TDS stream to MEE (Water +

Sodium Carbonate + organics)

57

NaN2 2.469 Low TDS stream Nil

Acetic Acid 0.37 Air Emission

Methanol 0.34 Solvent – Fugitive emission 1

Toluene / Ethyl Acetate 232.378 Hazardous Waste

Conc. HCl 4.198 Mixed Solvent for sale Nil

37



This product is a campaign product, developed by R&D division of HIKAL and has never been tried

at pilot scale, however based on consumption co-efficient the following are the inputs and outputs.

14. VALPROIC ACID

Input Quantity in

Tons / annum

Output Quantity in Tons/

annum

VAL - 2 133 Product Valproic Acid 100

Solvent Recovery Nil

Waste Streams

High TDS stream to MEE Nil

Low TDS stream Nil

Air Emission

CO2 Emission 33

Hazardous Waste Nil


Residue of distillation Nil

TOTAL 133 TOTAL OUTPUT 133

This product is a campaign product, developed by R&D division of HIKAL and has never been tried at pilot scale, however

based on consumption co-efficient the following are the inputs and outputs.

In this Product this RM is heated under controlled condition to drive out one mole of CO2 for every mole of RM. No water is

used in the process. However at the end of the production of desired quantity about max 100 KL will be used for cleaning of the

equipment.

15. SODIUM VALPROATE

Input Quantity in

Tons / annum

Output Quantity in Tons /

annum

Valproic Acid 45.5 Product Sodium Valproate 50

NaOH 12.5 Solvent Recovery

Methanol 105 Methanol 99


Carbon 0.3 High TDS stream to MEE Nil

Hyflow 0.15 Low TDS stream (Water +

Sodium Carbonate +

organics)

137

Air Emission


Hazardous Waste

38

Carbon & Hyflow 0.45



TOTAL 288.45 TOTAL OUTPUT 288.45



16. DI – VALPROEX SODIUM

Input Quantity in Tons / annum Output Quantity in Tons /

annum

Valproic Acid 19.2 Product Di – Valproex Sodium 20

NaOH Flakes 2.6 Solvent Recovery

Methanol 8.6 Methanol 8


Activated Carbon 0.12 High TDS stream to MEE Nil

Hyflow 0.06 Low TDS stream (Water +


51.85

Air Emission

Solvent – Fugitive emission 0.05

Hazardous Waste



Residue of distillation 0.5


This product is a campaign product, developed by R&D division of HIKAL and has never been tried at pilot scale,

however based on consumption co-efficient the following are the inputs and outputs.

17. MAGNESIUM VALPROATE

Input Quantity in Tons / annum Output Quantity in Tons /

annum

Valproic Acid 8.772 Product Magnesium Valproate 10

Magnesium Metal 1.228 Solvent Recovery

Methanol 43.905 Methanol 40

Activated Carbon 0.075 Waste Streams

Hyflow 0.02 High TDS stream to MEE Nil

Low TDS stream Nil

Air Emission


Hazardous Waste

39







18. TOPIRAMATE

Input Quantity in

MT/ annum

Output Quantity in

MT/ annum D-Fructose 25.2 Product Topiramate 20

Conc. H2SO4 22.4 Solvent Recovery

NaOH Flakes 30.4 Acetone 196

Acetone 206 MDC 332

Hexane 225.2 Hexane 214

Sulphuryl Chloride 15 IPA 90

Pyridine 10 Waste Streams

Citric Acid 5.8 High TDS stream to MEE (Water + Sodium

Carbonate + organics)

942

1,4 Dioxane 163 Low TDS stream Nil

Ammonia 5.8 Air Emission

IPA 93.8 Solvent – Fugitive emission 0.1

Carbon 4 Ammonia Gas 5

Hyflow 1.4 Hazardous Waste

Water 688.7 Carbon & Hyflow 5.4






19. T- LUCINE

Input Quantity MT/annum Output Quantity in MT/

annum L-tert-Leucine 3.922 Product T- Lucine 12

Dicyclohaxlanine 5.42 Solvent Recovery

Benzyl Chloroformate 5.918 Toluene 39

Toluene 41.3 Waste Streams

Conc. HCl 3.082 High TDS stream to MEE (Water +


51

40

Sodium Hydroxide 2.765 Low TDS stream Nil

Water 41.893 Air Emission


Hazardous Waste






20. FLUNARAZINE

Input Quantity in

Kgs per batch Output Quantity in Kgs

per batch

4,4 di fluoro benzophenone

piperazine

200 Product- Flunarazine 200

Cinamic alcohol 130 Solvent recovery

Sodium Borohydride 16 Toluene 1150

Triethyl amine ( TEA ) 130 Waste streams

Methanol 1630 High TDS stream to MEE 400

Activated carbon 12 Low TDS stream(

TEA.HCL(1.0kg)+TEA(1.0kg)

3500

Huflo Supercel 12 High COD stream 2300

HCL In IPA 217 Air Emission

Toluene 1222 Solvent - Fugative emission 100

Piperazine Anhydrous 400 Loss HCL into scrubber 5

IPA 1860 Hazardous waste

RO water 2220 Spent carbon+hyflow 69

purified water 700

HCL 1140 Methanol MLR Spent 1550

Catalyst-B 7 Piperazine Spent 550 Catalyst-A 8 Residue of distillation 170 Caustic Soda 90

Total input 9994 Total output 9994

3.8 THE PROPOSED PRODUCTS

The following flowchart along with material balance of the manufacturing process is as shown

below are proposed product to be introduced in expansion phase. The description of the

manufacturing process is described in brief in the next section

MATERIAL BALANCE

41

1. VENLAFLAXIN HCL


per batch Output

Quantity in Kgs per

batch

VNF-Base 300 Product

Methanol 483 Venlaflaxin 311

Ethyl acetate 3176 Solvent Recovery

Anhydrous HCL 45 Methanol 462

Ethyl acetate 3033

Raw Material Recovery

Effluent

High TDS stream to MEE

containing --- kgs

Low TDS stream

Air Emission

Solvent - Fugitive emission 164

Hazardous Waste


Supercel)

Residue of solvent distillation -

Tarry waste

35


2. NEOTAME


per batch


per batch

Aspartame 300 Product: NEOTAME 285

Methanol 2923 Neotame - tech 360

Palladium catalyst 3.5 Solvent Recovery

Water 2200 Methanol 2352

Hydrogen 4.46 Methanol MLR (mixed solvent) 2000

DMBA 98.6 Raw Material Recovery

Catalyst 10

Neotame -tech 360 Effluent

High TDS stream to MEE 70

Low TDS stream 800

42

Air Emission



Hazardous Waste

Spent Carbon + Hyflow Supercel)

Residue of solvent distillation - Tarry waste


3. PIRACETUM


per batch


batch

Ethyl 2- pyrrolidone N

acetate (PAE)

1500 Product

Methanol 806 Piracetam 1180

Ammonia 340 Solvent recovery

RO water 1000 Methanol 417

Aqs.Ammonia 1370

Effluent

High TDS stream to MEE containing 0

Air Emission 0

Solvent- Fugitive emission 48.5

Dust Emission


Hazardous waste

Methanol MLR Spent 629


4. ETIRACETAM

Input Quantity in

Kgs per batch


per batch Ethyl 2 (2)-

Pyrrolidone butarate

(2PBE)

1800 Product

Methanol 2271 Etiracetam Fresh 1170

Sodium Methoxide 18 Recovery

Ammonia 459 Aqs.Ammonia 1450

RO water 1000 Effluent


Low TDS stream 0

43

Air Emission

Solvent- Fugitive emission 59.5

Dust Emission


Hazardous waste

Methanol spent 2866

Residue of solvent distillation - Tarry

waste


5. ETIRACETAM RACEMIC


per batch


batch Etiracetam -L060 1600 Product

Methanol 2890 Etiracetam Racemic 1180

Sodium Methoxide 9.6 Solvent recovery

Methanol 1584

Effluent


Low TDS stream 0

Air Emission

Solvent- Fugitive emission 68

Dust Emission


Hazardous waste

Methanol spent 1665


6. TPCA HCL


per batch


batch

TPB Ts OH 130 Product

Caustic Soda 26 TPCA.HCL 60

Toluene 2260 Solvent Recovery

CO2 28 Toluene 1571

44

Sodium Chloride 33 Effluent

THF 780 High TDS stream to MEE

Hexane 26 Low TDS stream

n-butyl lithium 172 Air Emission

HCl LR grade 99 Solvent - Fugitive emission 43

Methanol 780 Hazardous Waste

Sodium Sulphate 5 Toluene +Hexane spent 1800

THF+Methanol Spent 850

Sodium sulphate spent 14


7. CMMDT


per batch Output

Quantity in Kgs per

batch

CMMDT-1 110 Product

HCL 607 CMMDT 80

Dichloromethane 800 Solvent Recovery

Tetrbutyl ammonium

bromide 14 Dichloromethane 760

Sodium sulphate 9.5 Hexane 810

Hexane 850 Hepatne 2030

Formaldehyde 167 Effluent

Hyflo 9 High TDS stream to MEE

containing--- kgs

Heptane 2133 Low TDS stream 1013

Activated charcol 6 Air Emission

water 200 Solvent - Fugitive emission 183

Hazardous Waste


Supercel)

15

Residue of solvent distillation -

Tarry waste 15


8. TRIFLUOROMETHYL CINNAMIC ACID


per batch Output

Quantity in Kgs per

batch

Trifluorobenzaldehyde 200 Product

Malonic acid 120 Trifluoromethyl cinnamic acid 250

45

Pyridine 9 Solvent Recovery

Toluene 600 Toluene 575

Raw Material Recovery

Effluent

Low TDS stream

Air Emission

CO2 50


Hazardous Waste

Residue of solvent

distillation - Tarry waste 29


9. MEMANTINE HCl


per batch Output

Quantity in Kgs

per batch

1-bromo-Actamido

adamantane 17 Product

O-Xylene 229 Memantine HCl 14

Benzyl Alcohol 26 Solvent Recovery

Caustic Flakes 19 Ethyl acetate 110

LR grade HCl 11 O-Xylene+Benzyl Alchohol 245

EthylAcetate 114 Effluent

Water 1167

High TDS stream to MEE containing

--- kgs


Air Emission


Hazardous Waste

Spent Carbon + Hyflow Supercel) 1

Residue of solvent distillation - Tarry

waste 15


10. PIPERAZINE NITRO HCL

46

Input Quantity in

Kgs per

batch

Output Quantity in

Kgs per batch

Piperazine-1 Carboxylate

Methyl piperazine Carboxy late Acetate

salt

70 Piperazine-1 Carboxylate 49

Methylene Chloride(MDC) 476

Sodium sulphate anhydrous 5

RO Water 920

Caustic soda Flakes 15

Methyl Piperazine-1 Carboxylate 49 Piperazine Nitro HCL 91

2-Fluoro 3-Nitro Tolune 48

N-Bromo Succinimide 88 Solvent Recovery

Benzoyl peroxide 3 MDC 448

Acetic Acid 261 Toluene 400

Phosphorous Acid 3 Methanol 14

N,N Diisopropyl Ethylamine 26 IPA 761

Toluene 417


Caustic soda Flakes 22 High TDS stream to MEE 1600

Methyl piperazine-2-Carboxy late 49 Low TDS stream 600

Sodium Bi Carbonate 22

Hydro chloric acid(CP Grade) 41 Air Emission

Di Ethyl Phosphate 20

Ammonium chloride 48 CO2

IPA 793 Solvent – Fugitive

emission

20

Water for Cleaning equipments 500

Scrubber water make up 100 Hazardous Waste

Spent sodium sulphate with

moisture

7

Residue of solvent

distillation – Tarry waste

0


47

11. SEVELAMER CARBONATE

Input Quantity in

Kgs per batch


per batch

Poly allyl amine 600 Sevelamer carbonate 210

Epichlorohydrin 35 Solvent Recovery

Iso propyl alcohol 943 IPA 868

Water 47000

Sodium hydroxide 90 Waste Streams

Sodium carbonate 390 High TDS stream to MEE 8016

Low TDS stream 42051


Hazardous Waste

Water for Cleaning equipments 2000 Activate carbon+Hyflow Supercel with

moisture

0

Scrubber water make up 100 Spent catalyst 0


12. COLESEVELAM HYDROCHLORIDE


per batch


per batch Stage-1

Poly allyl amine 500 Colesevelam Stage-1 140

Epichlorohydrin 15

Iso propyl alcohol 2761 Solvent Recovery

Water 12865 Recovered IPA 1975

Sodium hydroxide 75 Recovered Methanol 9524

Stage-2

Colesevelam Stage-1 140 Colesevelam HCL 350


6-bromohexyl trimethyl Ammonium

bromide 227 High TDS stream to MEE 24617

Bromo Decane 155 Low TDS stream 12330

Water 19663

48

Sodium hydroxide 63 Hazardous Waste

Hydrochloric acid 132 Activate carbon+Hyflow Supercel with

moisture

Sodium chloride 658 Spent catalyst

Scrubber water make up 100



13. PREGABLIN


per batch

Output Quantity in

Kgs per batch

S Ester 270 Pregabalin -Tech 175

KOH 122


Raney Nickle Catalyst 40 High TDS stream to MEE 2740

Activated carbon 4 Low TDS stream 1576

Acetic Acid 160 Solvent Recovery

Hyflosupercel 6 Spent Methanol 3150

Nitrogen cylinder- (28 cum) IPA 784

Hydrogen gas cylinders (42 cum) Air Emission

Purified water 2350 CO2 0

IPA 800 Solvent – Fugitive emission 43

Hazardous Waste

Water for Cleaning equipments 1000 Activate carbon+Hyflow

Supercel with moisture 20

Scrubber water make up 250 Spent Raney Nickle catalyst 50


49

14. SITAGLIPTIN

Input Quantity in

Kgs per batch


per batch

Stage-1

(3R)-3(tetra butoxy carbonylamino)-4-

(2,4,5, trifluoro phenyl) butanoic acid. 50.1 Stage-1 out put 52.8

3-(trifluoro methyl)-5,6,7,8-tetrahydro-

(1,2,4)triazolo(4,3-a)Pyrazine.

28.9

Dicyclohexyl carbodiimide 31 Solvent Recovery

MDC 250 Recovered IPA 193

IPA 200 Recovered Methanol 338

Di-isopropyl ethyl amine 2 MDC 242

1-hydroxyl benzotriazole 5

Nacl 0.5

Water 200 Air Emissions

Stage-2 Solvent – Fugitive emission 2.0

Stage-1 52.8 Sitagliptin 50

Phosphoric Acid 10.2 Waste Streams

Methanol 350 High TDS stream to MEE 350

Carbon 2 Low TDS stream 600

Hyflo 1

Water 50 Hazardous Waste

Activate carbon+Hyflow Supercel with

moisture

6

Scrubber water make up 100 Organic Residues 92



15. VILDAGLIPTIN

50

Input Quantity in

Kgs per batch


per batch

Stage-1

1-(Chloroacetyl)-(S)-Proline methyl

ester(RSM-02)

6.0 Vildagliptin stage-1 7.4

3-Amino-Adamantan-1-OL 6.12 Solvent Recovery

Methylene Chloride (MDC) 237

Potassium Carbonate 12 Methanol 34.0

Potassium Iodide 0.48 MDC 254.0

Acetic Acid 5.53 Ethyl Acetate 23.5

Liquor Ammonia 6.37 IPA 2.9

Sodium Chloride 3.70

Methanol 14.26

RO water for process 40.50

Stage-2

Vildagliptin stage-1 7.4 Vildagliptin stage-2 2.9

Ammonia gas 9.57

Methanol 21.22 Waste Streams

Methylene Chloride (MDC) 30.37 High TDS stream to MEE 194.6

Methyl tertiary butyl Ether 6.61 Low TDS stream 62.0

2 Methyl Tetrahydrofuran 7.66

Stage-3

Vildagliptin stage-2 2.9 Vildagliptin -API 1.3

2 Methyl Tetrahydrofuran 12.4

Trifluoro Acetic Acid 3.1 Air Emission

Phosphorous Pentoxide 1.3 CO2 20.0

Trifluoro Acetic Acid Anhydride 3.8 Solvent – Fugitive emission 30.0

Potassium Carbonate 12.5 Aq Ammonia 3.0

Citric Acid 5.7

Ethyl Acetate 24.3

Methylene Chloride (MDC) 71.0 Hazardous Waste

IPA 2.8 Hyflow Supercel with moisture 5.0

Hyflosupercel 4.5 Residue of solvent distillation – Tarry

waste

1.0

RO water 58.3

Water for cleaning equipments 25.0


51

16. LACOSAMIDE

Input Quantity in

Kgs per batch


per batch

D-Serine 20.0 Product Lacosamide 18.0

Di-Tert-Butyl Di Carbonate 45.7

Caustic soda flakes 64.4 Solvent Recovery

18-Crown-6-Ether 2.8 Ethyl Acetate 741.0

HCL(33%) 112.1 Toluene 1290.0

Ethyl Acetate 756.0 MDC 587.0

4-Methyl Morpholine 21.1

Isobutyl Chloroformate 27.3 Waste Streams

Benzylamine 21.5 High TDS stream to MEE 1852.2

Toluene 1316.3 Low TDS stream 600.0

Sodium Bi Carbonate 20.5

Sodium Chloride 51.3 Air Emission

Di-Methyl Sulphate 45.0

Methylene Chloride (MDC) 782.0 CO2 0.0

Acetic Anhydride 15.8 Solvent – Fugitive emission 38.0

RO Water for process 1228.0

Activated Carbon 1.8 Hazardous Waste

Hyflosupercel 5.0 Spent Carbon + Hyflow Supercel with

moisture 10.0

Water for cleaning equipments 500.0 Residue of solvent distillation – Tarry 0.0

52

waste

Scrubber water make up 100.0


17. VALOCYLOVIR HYDROCHLORIDE

Input Quantity in

Kgs per batch

Output Quantity in

Kgs per

batch

Stage-1

L-Valine 33.00 Valacyclovir Stage-1 67.0

Sodium Hydroxide flakes 28.00 Solvent Recovery

Conc. HCl 49.20 Recovered Toluene 140.2

Benzyl chloroformate 57.40 Recovered Dimethyl formamide 61.1

Toluene 143.06 Effluent waste streams

Dimethylformamide 62.30 Low TDS stream 240

RO water 337.00 High TDS & COD Stream 199

Air Emission

Stage-2 Solvent – Fugitive emission 2.6

Valacyclovir Stage-1 67.00 Valacyclovir Stage-2 34.9

Dimethylformamide 267.15 Solvent Recovery

Acyclovir 20.00 Methanol 341.5

Dicyclohexyl Carbodiimide 28.40 Isopropyl Alcohol 15.4

N, N-Dimethyl amino pyridine 1.30 Dimethyl formamide 267.2

Methanol 348.48 Air Emission

Isopropyl Alcohol 15.70 Solvent – Fugitive emission 7.3

Water 160.00 Effluent waste streams

High TDS & COD Stream 241.8

Stage-3

Valacyclovir Stage-2 34.00 Valacyclovir Stage-2 Pure 30.8

Dimethylformamide 97.28 Solvent Recovery

Norit charcoal 0.68 Dimethyl formamide 97.3

Hyflo 1.05 Air Emission


Hazardous Waste

Hyflow Supercel with moisture 1.8

Stage-4

Stage-2 pure 30.0 Valacyclovir 21.0

10% Palladium on carbon (ODB) 0.8 Solvent Recovery

Water 800.0 Recovered IPA 315.4

Isopropyl Alcohol 321.9 Effluent waste streams

53

Liquor Ammonia 1.0 High TDS & COD Stream 823.0

Conc.HCl (CP grade) 12.0 LTDS effluent 700

Norit charcoal 0.9 Air Emission

Hyflo 2.0 Solvent – Fugitive emission 3.0

Hazardous Waste

Water for cleaning equipments 500.0 Carbon & Hyflow Supercel 4.0

Scrubber water make up 200.0 Spent catalyst 2.0

3619 3619

18. OLEMESARTAN MEDOXOMIL

Input Quantity in

Kgs per batch

Output Quantity in

Kgs per batch

Stage-1 35 39

Ethyl 4-(1-Hydroxy-1-Methylethyl)2-Propyl

Imidazole-5-Carboxylate

35 Stage -1 Out put 95.8

Potasium Carbonate(Powder) 49

N-(Triphenylmethyl)-5-(4-

(Bromomethyl)Biphenyl-2-Yltetrazole(TTBB) 92.8 Solvent Recovery

Tetra butylammonium bromide 8.4 Acetone 1093.0

Toluene 1138.0

Acetonitrile 812.0

Hexane 510.0

Stage-2 MDC 996.0

Stage-1 95.8 Methanol 470.0

Potasium Tertiary Butoxide 18.7 Stage -2 Out put 81.4

Sodium Bi carbonate 21.2 Waste Streams

Tetrabutyl ammonium bromide 8.6 High TDS stream to MEE 3187.6

4-Chloromethyl -5-Methyl-1,3-Dioxal-2-one 26.4 Low TDS stream 600.0

Toluene 1161.5

Acetonitrile 829.5 Air Emission

Hyflosupercel(Filter Aid) 8.0 CO2 0.0

Process Water 961.5 Solvent – Fugitive emission 35.0

Stage-3

Stage -2 81.4 Stage -3 Out put 49.2

Methanol 479.9

HCL(CP Grade) 17.9

Sodium Bi carbonate 13.2 Hazardous Waste

Hexane(168) 521.1 Hyflow Supercel with moisture 15.0

Methylene Chloride(MDC) 1328.4 Residue of solvent distillation –

Tarry waste

20.0

Acetone 229.0

54

NaCl 32.6

Process Water 1582.8

Stage-4

Stage -3 out put 49.2 Olemesartan medoxomil 39.4

Acetone 886.5

Hyflosupercel(Filter Aid) 3.8




19. DONEPEZIL HYDROCHLORIDE DIHYDRATE

Input Quantity in

Kgs per batch


per batch DPZ-5 Tech

5,6-Dimethoxy Indanone Pure 15 DPZ-5 Tech 24

N-Benzyl Piperidine-4-

Carboxaldehyde pure(DPZ-Stage 2

pure)

16

Caustic soda flakes 65 Solvent Recovery

Sulphuric Acid (CP Grade) 60 Methanol 403

Methanol 135 Toluene 130

RO Water for process 843 DMF 45

IPA 163

Waste Streams

High TDS stream to MEE 1244

DPZ-5 pure Low TDS stream 632

DPZ-5 Tech 24 DPZ-5 pure 20.80

DMF 46

Methanol 19

Donepezil Hydrochloride

DPZ-5 pure 21.0 Donepezil Hydrochloride 13

Methane Sulphonic Acid 6

Raney Nickle catalyst 1

Hydrogen gas- 1no

Nitrogen cylinder- 1no

Methanol 284

Toluene 133 Air Emission

55

IPA 165

HCL (in IPA) 7 CO2

Acetic acid 0.2 Solvent – Fugitive emission 31

Sodium carbonate 6

Hyflosupercel 14 Hazardous Waste

Activated Carbon 4 Spent Carbon + Hyflow Supercel with

moisture

20

Water for process 265 Residue of solvent distillation – Tarry

waste

1

Water for cleaning equipments 500 Spent Raney nickle Catalyst 1



20. QUETAPINE FUMARATE

Input Quantity in

Kgs per batch

Output Quantity in

Kgs per

batch QTP-2 188.0 QTP-4 233

N,N Dimethyl aniline 60.2 Solvents recovary 0

Phosphorus oxy chloride (POCL3) 150.4 Toluene+IPA MLS 2200

Toluene 2090.6 Acetone MLS 286

NaHCO3 1.9 Air Emission 0

NaCl 282.0 Solvent – Fugitive emission 25

Water 3421.6 Waste Streams 0

Piperzine anhydrous 251.9 High TDS stream to MEE 3806

IPA HCl 157.9 Low TDS stream 327

Acetone 293.3 0

Sodium Sulphate 18.8 Hazardous Waste 0

Hyflow 9.4 Hyflow Supercel with moisture 19

Spent sodium sulphate with moisture 30

QTP-IV HCl (11-piperazinyl-

dibenzo(b,f)(1,4) thiazepine hydrochloride) 233

Product : Quatapine fumarate 247

2-(chloroethoxy) ethanol 113.7 Solvent Recovery

Sodium carbonate 149.1 Toluene 590

Sodium Hydroxide 38.2 Methanol 1818

Sodium iodide 2.1 Waste Streams

N-Methyl-2-pyrrolidone 108.1 High TDS stream to MEE 500

Toluene 598.3 Low TDS stream 3809

Fumaric acid 42.1 High COD Stream 300

Hyflow 3.0

Activated charcoal 5.8 Air Emission

56

Methanol 1824.1 Volatile Solvent – Fugitive emission 24

Process Water 2680

Hazardous Waste

Water for cleaning equipments 1000 Spent Carbon 6

Scrubber water make up 500 Hyflow supercel 4


21. BUTORPHANOL TARTARATE

Input Quantity in

Kgs per batch


per batch

Cyclohexanyl ethylamine 38 Product Butorphanol Tartarate 30

4-Methoxy phenyl acetic acid 38 Solvent Recovery

Sodium borohydride 114 Toluene 250

Toluene 312.5 IPA 197

celite 5 Acetone 40

m-Chloro perbenzoic acid 6 Waste Streams

Aq Ammonia 40 High TDS stream to MEE Nil

IPA 220 Low TDS stream 1753

Dichloromethane 3 Air Emission

Phosphoric acid 4 Solvent – Fugitive emission 2

Water for process 919.5 Hazardous Waste

Acetone 50 Celite + Hyflow Supercel 12





22. METHIMAZOLE


per batch

Output Quantity in

Kgs per batch Bromoacetal 60 Product :Methimazole 17

Methanol 300 Solvent Recovery

Methyl amine 53 Acetone 180

potassium thiocyanate 26

Ethanol 220 Waste Streams

Hydrochloric acid 22 High TDS stream to MEE Nil

Acetone 200 Low TDS stream 1392

Carbon 2 Air Emission

57

Hyflosupercel 4 Solvent – Fugitive emission 2

Water for process 120 Hazardous Waste

Scrubber water make up 100 Spent Carbon + Hyflow Supercel 6

Water for Cleaning

equipments

500 Residue of distillation 10


23. PRASUGREL (TPPO)

This product is a campaign product, developed by R&D division of HIKAL and has never been tried

at pilot scale,

PRODUCTS AND CAPACITY

List of products produced and its quantity in existing and proposed production facility is given in

the below table

As per the earlier consent company manufacturing of following products;

PRODUCT DETAILS (EXPANSION OF EXISTING AND PROPOSED ADDITIONS)

SL. NO. NAME OF THE PRODUCT EXSITING EXPANSION(MTPA) TOTAL(MTPA)

1 GABAPENTIN 700 1300 2000

2 BURPROPION HCL 50 25 75

3 CINNARIZENE 5 15 20

4 ONDANSETRON HCL 1 1

5 ACEBUTALOL - HCL 15 15

6 P- BENZOXY ANILINE HCL 40 40

7 ONDANSETRON API 1 1

8 OXYPENTIFYLLINE 5 70 75

9 TRIPOLIDINE - HCL 4 4

10 GEMFIBROZIL 300 (-180) 180

11 DECOQUINATE 75 200 275

12 LEVETIRACETAM 10 10

13 VERAPAMIL 20 20

14 VALPROIC ACID 50 50

15 SODIUM VALPROATE 50 50

16 DI-VALPROEX SODIUM 20 20

17 MAGNESIUM VALPROATE 10 10

18 TOPIRAMATE 20 20

19 T-LUCINE 12 12

Proposed Product to be Added

20 FLUNARAZINE -- 12 12

21 VENLAFLAXINE

-- 40 40

58

22 NEOTAME

-- 75 75

23 PIRACETAM

-- 650 650

24 ETIRACETAM

-- 500 500

25 ETIRACETAM RECEMIC

-- 150 150

26 TPCA.HCL

-- 10 10

27 CMMDT

-- 10 10

28 TRI-FLUROMETHYL CINNAMIC ACID

-- 10 10

29 MEMANTINE HCl

-- 10 10

30 PIPERAZINENITRO HCl --

50 50

31 SEVELAMER CARBONATE --

50 50

32 COLESEVALAM HYDROCHLORIDE --

50 50

33 PREGABLIN --

100 100

34 SITAGLIPTIN --

10 10

35 VILDAGLIPTIN --

10 10

36 LACOSAMIDE --

20 20

37 VALOCYCLOVIR HYDROCHLORIDE --

50 50

38 OLMESARTAN --

10 10

39 DONEPEZIL HYDROCHLORIDE

DIHYDRATE

-- 2 2

40 QUETIAPINE FUMURATE --

40 40

41 PRASUGREL (TPPO) --

10 10

42 BUTRAPHANOL --

0.3 0.3

43 METHIMAZOLE --

5 5

Existing Products Process Flow Charts

GABAPENTINE

Capacity: 2000 MTPA

Batch Size: 989 Kgs

59

No of Batches: 2022

Brief Process:

Gabalactam is made reacted with HCl & obtained cake is washed with Acetone. The cake is

neutralized in water with caustic & isolated and purified with IPA & Methanol and dried.

Synthesis:

Material Flow Diagram:

Part - I

60

II Part

62

BUPROPION HCL

Capacity: 75 MTPA

Batch Size: 1000 Kgs

No of Batches: 75

Brief Process:

BUP-1 is treated with tertiary butyl amine followed by acidification & purification and dried

Synthesis:

63


64

CINNARIZINE

Capacity: 20 MTPA

Batch Size: 320 Kgs

No of Batches: 63

Brief Process:

Cinnarizine stage-2 is condensed with cinnamyl chloride in presence of catalyst –E in

Toluene media & triethly amine, the obtained cake is purified with methanol & MEK and

dried

65

Synthesis:


67

ONDENSETRON HCL

Capacity: 1 MTPA

Batch Size: 97 Kgs

No of Batches: 10

Brief Process:

Mannich HCL is made to react with 2-Methyl imidazole in aqueous media, basified with

caustic and isolated as Ondensetron stage-7. this is acidified with HCL, purified and dried.

68

Synthesis:


71

ACEBUTOLOL HCL

Capacity: 15 MTPA

Batch Size: 200 Kgs

No of Batches: 75

Brief Process:

Acebutolol stage-4 material is made to react with Mono-isopropyl amine and cake is isolated

and dried as Acebutolol stage-5. This is acidified in acetone media with HCL and the cake

obtained is purified and dried.

Synthesis:

72


ACE-4

RO Water

MIA + Water

Water MLR to ETP

Acebutalol Base (ACE-5)

Acetone

Act Carbon

Spent Hyflo+

Reactor

Centrifugation

Reactor

Filtration

73

Charcoal

HCL

Acetone

Acetone MLR

Recovery

HCL + IPA

Acetone

Purified Water

Act Carbon & Hiflo

Spent Hyflo+ Charcoal

Acetone MLR

for Recovery

Acidification

Centrifugation

Acebutolol HCl -Tech

Wet

Charcoalization

Filtration

Crystallization

Centrifuging

74

Acebutalol HCL

P-BENZYLOXY ANILIN HCL (PBA-HCL)

Capacity: 40 MTPA

Batch Size: 244 Kgs

No of Batches: 164

Brief Process:

P-Benzylloxy Nitrobenzene (PBNB) is reacted with hydrazine hydrate, acidified with HCL in

IPA and the cake is isolated and dried to PBA-HCL

Synthesis:

75


77

ONDANSETRON API

Capacity: 1 MTPA

Batch Size: 100Kg

No of Batches: 10

Brief Process:

Ondansetron HCL is made to react with Triethyl amine in methanol media and thus material

is obtained. This is washed with water and dried.

Synthesis: This is only a purification process and there is no change in the chemical

composition

78


Ondensetron Base:

ONDT HCL

Methanol

TEA

Methanol + TEA MLR

Water Tech-1 Wet Material

water

Water MLR

Tech-2 Wet Material

Water

Water MLR

Tech-3 Wet Material

Water

IPA

Water+IPA

MLR

Final Wet Material - Drying

Reactor

Reactor

Reactor

Reactor

79

ONDANSETRON API

OXYPENTIFYLLINE

Capacity: 75 MTP

Batch Size: 550 Kgs

No of Batches: 136

Brief Process:

Theobromine is made to react with haloketone in DMF media & the cake is isolated, purified

and dried.

Synthesis:

80


DMF

Theobromine

Pot. Carbonate

Chorohexenone

Methanol Inorganic Salts

Act Carbon

Hyflo

Spent Carbon+Hyflo

Methanol MLR

Reactor

Reactor

81

Final Wet Material

OXPENTIFYLLINE

TRIPROLIDINE HCL

Capacity: 4 MTPA

Batch Size: 150 Kg

No of Batches: 27

Brief Process:

TRI-3 is reacted with farmic acid in sulphuric acid media, than basified and id made to react

with oxalic acid and the cake is isolated as TRI-4.

TRI-4 is basified and acidified with HCL in IPA and the cake is isolated and dried.

Synthesis:

Drying

82


Dil H2SO4

83

Farmic Acid

TRI-3

Water

NaoH Sol

Toluene

Aq Layer to ETP

Water

NaCL Sol

Oxalic Acid Aq Layer to ETP

Acetone

Reactor

Quenching

Basification

Extraction

Reactor

Organic Layer

84

Toluene MLR for

Recovery

Acetone

Acetone MLR for

Recovery

Triprolidine - 4 (Oxalate) Wet

Triprolidine - 4 (Oxalate) Dry

RO Water

Act Carbon

Precipitation

Centrifugation

Tech Product

Centrifugation

Reactor

Filter

85

Spent Hyflo + Charcoal

Aq Ammonia

Aq MLR to ETP

HCL in IPA

Ethyl Acetate

Ethyl Acetate MKR for

Recovery

Acetone

Acetone MLR for Recovery

Triprolidine HCL

Basification

Centrifugation

Acidification

Centrifugation

Crystallization

Centrifugation

86

GEMFIBROZIL

Capacity: 180 MTPA

Batch Size: 420 Kg

No of Batches: 429

Brief Process:

Gembutyl ester is made to react with potassium hydroxide in methanol media, and then

acidified and the cake is isolated. This cake is water washed, purified and dried.

Synthesis:

87

PROCESS FLOW DIAGRAM OF GEMFIBROZIL

Gem butyl ester

Sodium Hydroxide Spent Catalyst

flakes

Isobutanol & Water

Toluene bed Aqueous MLR to ETP

Wash

Purified water

Dissolution

CP grade HCl

Purified water

Hydrolysis Reaction

Temperature maintenance

Sodium salt Isolation and

chilling

Centrifugation

Dissolution and

Charcolisation

Filtration

Filtrate removal of toluene

traces and acidification

and chill

Gemfibrozil Tech isolation

and dissolution in

methanol

88

Purified water

DECOQUINATE

Methanolic solution

Filtration

Charcolisation

Gemfibrozil Isolation

Gemfibrozil wet

product Drying

Milling

Drying

Milling

Sifting

Packing

Milling and

packing

89

Capacity: 275 MTPA

Batch Size: 591 Kgs

No of Batches: 465

Brief Process:

Deco 4 Intermediate (1 Decyl 2 Methoxy 4 Nitro Benzene) is hydrogenated in Toluene

medium in the presence of a catalyst to get Stage V Intermediate which reacts with Diethyl

ethoxy methylene malonate to get Stage VI Intermediate. This on cyclisation gives

Decoquinate.Synthesis:

90

PROCESS FLOW DIAGRAM OF DECOQUINATE

Deco Stage IV

Toluene Hydrogen gas

Pd/C Filtration

EMME

Diphyl

2500C Cyclisation

Filtration/Drying

Hydrogenation

(Pressure reaction)

Concentration

Stage VI

Decoquinate

Decoquinate

91

LEVETIRACETAM

Capacity: 10 MTPA

Batch Size: 35 Kgs

No of Batches: 286

BRIEF PROCESS DESCRIPTION:

2(2- Oxo pyrrolidine) butyric acid is treated with ethyl chloro formate in presence of triethyl

amine at -30 to -500C and the resultant mixed anhydride is treated with ammonia gas to give

crude Levetiracetam. The crude levetiracetam is purified by acetone crystallization.

Synthesis:

92

PROCESS FLOW DIAGRAM OF LAVETIRACETAM

93

VERAPAMIL

94

Capacity: 20 MTPA


N-Methyl – 3,4- Dimethoxy phenyl ethylamine (NMVA) is treated with Bromo -3- chloro

Propane (CBP) in presence of aqueous sodium hydroxide solution to get a mixture N-3-

Chloro/Bromopropyl-N-methyl -3,4- dimethoxy phenyl ethylamine (Chloro Base) which is

treated with α-Isopropyl -3,4- dimethoxy phenyl acetonitrile (IVC) in presence of sodamide to

get Verapamil base. The base is treated with aqueous hydrochloric acid in ethyl acetate to

get crude Verapamil HCl, which is purified by crystallization with aqueous ethyl acetate.

Synthesis:

95

VALPROIC ACID

Capacity: 50 MTPA


The manufacturing process of VALPROIC ACID involves a single step, wherein the starting

material dipropyl malonic acid is heated to about 1400 – 1500C to obtain crude valproic acid,

which is on distillation at higher temperature between 1600-1700C produces VALPROIC

ACID confirming the release specification of BP/EP.

Synthesis:

96

SODIUM VALAPROATE

Capacity: 50 MTPA


The manufacturing process of SODIUM VALPROATE involves a single step, wherein the

starting material Valproic Acid is treated with NaOH solution at 50-550C in presence of

methanol. Upon complete distillation of methanol followed by distillation of water at 80-850C

under vacuum, Sodium Valproate in the form of white powder is obtained which is dried

under vaccum at 100-1050C to get SODIUM VALPROATE confirming the release

specification of BP/EP.

Synthesis:

97

DI-VALPROEX SODIUM

Capacity: 20 MTPA


The manufacturing process of DIVALPROEX SODIUM involves a single step, wherein the

starting material Valproic Acid is treated with NaOH solution at 50-550C in presence of

methanol. Upon complete distillation of methanol followed by distillation of water at 80-850C

under vacuum, Divalproex Sodium in the form of white powder is obtained which is dried

under vacuum at 80-850C to get DIVALPROEX SODIUM confirming the release

specification.

Synthesis:

98

MAGNESIUM VALPROATE

Capacity: 10 MTPA


The manufacturing process of MAGNESIUM VALPROATE involves a single step, wherein

the starting material Valproic Acid is reacted with Magnesium in methanol at 55-600C. Upon

complete distillation of methanol, Magnesium Valproate in the form of white powder is

obtained which is dried under vacuum at 100-1050C to get MAGNESIUM VALPROATE

confirming the release specification.

Synthesis:

99

TOPIRAMATE

Capacity: 20 MTPA


The manufacturing process of Topiramate involves following step, wherein the starting

material D-Fructose reacted with acetone to get 2,3:4,5-Bis-O- [methylethylidine]-β-D-

fructopyranose (Topicetal) which is treated subsequently with Sulphurylchloride in Pyridine

and DCM to get 2,3,4,5-Bis-O-(1-methylethylidine)- sulfonyl chloride (chlorosulfate). This

intermediate in 1,4-Dioxan with Ammonia gas at 10 – 200C gives crude Topiramate.

Above crude product is purified in organic solvents to get purified Topiramate meeting

required specifications.

Synthesis:

100

TERTIARY LUCINE

Capacity: 12 MTPA


Z-tert-Leucine suspended in water and Benzylchloroformate is added to this and Sodium

Hydroxide is added to this slowly and pH is maintained at around 11. To this product

Dicyclohexylamine is added to get the product. Product is isolated by filtration.

Synthesis:

101

FLUNARIZINE

Capacity: 12.0 MTPA

Batch Size: 200 Kgs

No of Batches: 60

Brief process description:

Conversion of 4,41 difluoro benzhydryl piperazine to Flunaraize dihydrochloride.

4,41 difluoro benzhydryl piperazine reacts with cinnamyl chloride in presence of triethyl amine to

give the flunarizine base.

The flunarizine base recats with hydrochloric acid in isopropyl alchohol to give the hydrochloride

salt, which is recrystallised with methanol/IPA to give Flunarizine dihydrochloride final substance.

103

FLUNARIZINE PROCESS FLOW CHART

Heating

Flu-3 in toluene Water

Teri ethylamine (TEA)

Cinnamyl chloride Separation of Aq.layer

IPA

IPA Wet material

HCl

Reaction mass

Charcolisation for organic layer

Distillation of Toluene

Distillation of IPA+ Toluene

Heat the mass and cool

Dissolution, Cooling and

Chilling

Centrifuge

104

Methanol charcoal Crude wet

Slurry stir for 30min

Bed washing with hot Methanol

Distill of 50% Methanol

Wash Bed with filtered

Methanol

Reflux for 1 hr

Centrifuge

Distillation

Cool the mass and chill

Milling

Sifting and packing

Drying

105

New Products Process Flow Charts

VENLAFAXINE HYDROCHLORIDE

Capacity: 40 MTPA

Batch Size: 311 Kgs

No of Batches: 129


1-[2-Dimthylamino-1-(4-methoxy phenyl) ethyl] cyclohexanol (Venlafaxine base) is dissolved in a

mixture of ethyl acetate and methanol and converted to HCl salt using HCL gas.

Reaction scheme:

OH

N

CH3

CH3

MeO

HCl

OH

N

CH3

CH3

MeO

Venlafaxine hydrochloride1[2-Dimethylamino-1-(4-methoxy-

phenyl)-ethyl]-cyclohexanol Mol Wt: 277.4 Mol Wt: 313.9

106

PROCESS FLOW DIAGRAM OF VENLAFAXINE HCl

Venlafaxine base

Ethyl Acetate

Methanol

IPA / HCl

Ethyl Acetate

Dissolution

pH Adjustment

Filtration

Distillation

Refluxing

Cooling & Temperature

Maintenance

Centrifugation

Drying

Milling

Shifting

Packing

Reaction mass

Temp.maintenance

107

NEOTAME

Capacity: 50 MTPA

Batch Size: 285 Kgs

No of Batches: 175


Aspartame and 3,3 Dimethylbutyraldehyde is hydrogenated in presence of

hydrogen using Palladium on Charcoal as catalyst.

Reaction scheme:

NHMeOOC

O

NH2

HOOC

+

Aspartame

CHO

NHMeOOC

O

NH

COOH

Neotame

+ H2O

3,3 Dimethylbutyraldehyde

108

PROCESS FLOW DIAGRAM OF NEOTAME

Aspartame

Methanol

Palladium carbon Spent Catalyst

Ammonia

Methanol Distillate

Water

Mother Liquors (

MLR

Water Filtration losses

Water Evaporation

Hydrogenation &

Filtrations

Distillation

Crystallization

Filtration

Drying

Packing

109

Neotame

PIRACETAM

Capacity: 650 MTPA


3No of Batches: 551


Ethyl-2-Pyrrolidine-N Acetate (2-PAE) Is reacted with ammonia under

pressure in methanol to give Piracetam.

Reaction scheme:

110

PROCESS FLOW DIAGRAM OF PIRACETUM

Methanol

HPP-799/PAE Excess Ammonia for Rec

Ammonia

Fresh Methanol Washing Mother Liquors (Ethanol+Methanol)

Washed Methanol (Reused in next

Batch)

Methanol Evaporation

Piracetum

Ammonolysis

Cooling

Filtration/Cake Washing

Drying

Sieving & Packing

111

ETIRACETAM & ETIRACETAM RECEMIC

Capacity: 650 MTPA


No of Batches: 554


Ethyl-2-(2-Pyrrolidine)-Butyrate is reacted with ammonia under pressure to

give Etiracetam

Reaction scheme:

N

NH2

ON

OEt

ONH3

MeOH

Ethyl-2-(2-Pyrrolidine)- Butyrate(2-PBE)Etiracetam

112

PROCESS FLOW DIAGRAM OF ETIRACETUM

Methanol

2-PBE Excess Ammonia

Sodium Methoxide

Ammonia

Chilled Methanol Mother Liquors

Washing Washed Methanol (Disposal)

Ammonolysis

Cooling

Filtration/Cake Washing

Drying

Dry Crude HBP-529

Step-2a

113

Methanol

Crude HBP-529

Chilled Methanol Mother Liquors

Washing Washed Methanol (Recycle)

Dissolution

Cooling

Filtration

Drying

Packing

Step-3

114

TPCA.HCl

Capacity: 10 MTPA

Batch Size: 60 Kgs

No of Batches: 167


TBP.TsOH is reacted with Carbon dioxide using n-Butyl Lithium as the base in

Tetrahydrofuran as the solvent. Finally the product is converted to its

hydrochloride using HCl.

Reaction scheme:

N

N

SCH3

Br

N

N

SCH3OH

OCO2

BuLi

TBP.TsOH TPCA

N

N

SCH3OH

O

HCl

TPCA.HCl

HCl

TsOH

115

TPCA .HCL MATERIAL FLOW DIAGRAM

116

CMMDT

Capacity: 10 MTPA

Batch Size: 80 Kgs

No of Batches: 125


CMDT-1 is reacted with formaldehyde and HCl to give CMMDT.

Reaction scheme:

O

O

O

O Cl

HCHO/HCl

DCM

CMDT-1CMMDT

Mol Wt: 136.14Mol Wt: 184.6

117

PROCESS FLOW DIAGRAM OF CMMDT

118

4-TRIFLUROMETHYL CINNAMIC ACID

Capacity: 10 MTPA

Batch Size: 250 Kgs

No of Batches: 40


4-Trifluoro methyl benzaldehyde is reacted with malonic acid in presence of pyridine to give

4-Trifluoro methyl cinnamic acid.

Reaction scheme:

OH

O

F

FF

+COOH

COOH

N

F

FF

COOH

4-Trifluoromethyl benzaldehyde

Malonic acid

4-Trifluoromethyl cinnamic acid

Mol Wt:174 Mol Wt: 216

110 deg C

Pyridine

Mol Wt: 104

119

PROCESS FLOW DIAGRAM OF 4-TRIFLUROMETHYL CINNAMIC ACID

120

MEMANTINE HCl

Capacity: 10 MTPA

Size: 14 Kgs

No of Batches: 714


1-Acetamido 3,5-Dimethyl adamentane is hydrolysed using sodium hydroxide and converted to HCl

salt HCl.

Reaction scheme:

NH

O

NH2 HCl

1. NaOH/O-Xylene/Benzyl alcohol

2. HCl

1-Acetamido-3,5 dimethyl adamentane

Mol Wt: 221.34

Memantine HCl

Mol Wt: 215.76

121

PROCESS FLOW DIAGRAM OF MEMANTINE HCl

122

QUETIAPINE FUMARATE

Capacity: 40 MTPA

Batch Size: 247 Kg

No of Batches: 162

Brief Process:

QTP-II is refluxed with POCl3 in toluene at 109-112°C for 3-4hrs to obtain QTP-III. This compound

was further used in next step without isolation. The obtained QTP-III is further reacted with

anhydrous piperazine to achieve QTP-IV which is isolated in the form of pure hydrochloride salt.

Reaction scheme

N

S

Cl

1

NH

S

O

N

S

N

NH.HCl

NH

NH

1. POCl3

2. N,N-Dimethyl aniline

Toluene

109°C-112°CQTP-II QTP-IIINot isolated

QTP-IV

75-80°C, 3 - 4 hHCl in IPA

123

Material Flow Diagram

125

OLEMESARTAN MEDOXOMIL

Capacity: 10 MTPA

Batch Size: 40 Kg

No of Batches: 250

STAGE-I OLMESARTAN

OLMESARTAN STAGE-II

126

OLMESARTAN STAGE-III

127

OLEMASARTAN PROCESS FLOW CHART

133

VILDAGLIPTIN

Capacity: 10 MTPA

Batch Size: 2 Kg

No of Batches: 5000

Vildagliptin Stage-I

Reaction scheme:

Synthesis of Vildagliptin stage-I [(S)-1-[N-(3-hydroxy-1-adamantyl) glycyl] methyl pyrrolidine-2-

carboxylate (Vilda-ester)]:

Brief out line of process:

3-amino-adamantan-1-ol(RSM-01) is reacted with (S)-1-(2-chloro-acetyl)-pyrrolidine-2-carboxylic

acid methyl ester (RSM-02) in presence of potassium carbonate and potassium iodide in dichloro

methane to provide (S)-1-[N-(3-hydroxy-1-adamantyl) glycyl] methyl pyrrolidine-2-carboxylate

(Vilda-ester).

134

Vildagliptin Stage-II

Reaction scheme:

Synthesis of Vildagliptin stage-II [(S)-1-[N-(3-hydroxy-1-adamantyl) glycyl] pyrrolidine-2-

carboxyamide (Vildamide-4)]:


(S)-1-[N-(3-hydroxy-1-adamantyl) glycyl] methyl pyrrolidine-2-carboxylate (Vilda-ester) is treated

with ammonia in methanol to give [(S)-1-[N-(3-hydroxy-1-adamantyl) glycyl] pyrrolidine-2-

carboxyamide (Vildamide-4)].

Vildagliptin

Synthesis of Vildagliptin :


135

(S)-1-[N-(3-hydroxy-1-adamantyl) glycyl] methyl pyrrolidine-2-carboxyamide (Vildamide) is treated

with TFAA in presence of TFA in 2-Me THF as solvent followed by treatment with aq. K2CO3. Crude

product is purified by acid-base purification using aq.citric acid to give Vildagliptin.

VILDAGLIPTIN PROCESS FLOW CHART

139

VALACYCLOVIR HCl

Capacity: 50 MTPA

Batch Size: 21Kg .

No of Batches: 2381

Process Brief description:

Stage -1 : L- valine is converted as Cbz-L- Valine by using Benzyl chloroformate and Dimethyl

formamide .

Preparation of Cbz-valacyclovir (Stage-2)

Cbz-L-Valine is condensed with acyclovir in presence of dicyclohexyl carbodiimide and 4-

dimethylamino pyridine to give Cbz-valacyclovir.

Purification of Cbz-valacyclovir (Stage-2 pure)

Cbz-valacyclovir wet sample was dissolved in DMF and it was treated with charcoal followed by hyflo

filtration, DMF distillation and isolation with water. Further this material was slurried with water

containing DMF and filtered to get pure valcyclovir stage-2.

Preparation of valacyclovir hydrochloride hydrate

Cbz-valacyclovir (stage-2) is hydrogenolysised using palladium on carbon under hydrogen pressure

in IPA / dilute HCl. The product is isolated after removing palladium charcoal by filtration and then

diluted with IPA.

Reaction Scheme:

141

VALACYCLOVIR HCL PROCESS FLOW CHART

144

LACOSAMIDE

Capacity: 20 MTPA

Batch Size: 18Kg

No of Batches: 1111

Brief Process Description:

Stage-1

Stage -1 A: preparation of BOC –D-SERINE [comp.]

Reaction of D serine with di-tert –butyl dicorbnate[Boc anhydride] in presence of 18 –crown -6-

either as a phase transfer catalyst in water to produce Boc-D-serine[comp 2]

Stage-1 Prepration of Boc-d-serine benzyl [LAC-1 or comp.4]

Benzylation reaction of comp.2 in presence or 4-Methyl morpholine, isobutyl chloroformate and

benzyl amine followed by isolution/purification in toluene to get the comp.4.This includes stage-1B,

which is in situ reaction followed by stage-1

145

Stage2A:

Lacosamide Stage-II (tech)

Stage-2A: Preparation of [R]-tert-butyl 1-[benzyl amino ]-3-methoxy-1-oxopropan-2-yl carbamate

[comp.5]

Boc-D-serine benzyl amide[comp.2]on reaction with dimethyl sulphate and aq.Sodium hydroxide

solution by using 18-crown-6- as phase transfer catalyst in toluene at 10-15 deg C to provide

comp.5.

Stage-2B: Preparation of -2 –[R]-Amino-N-benzyi-3-methoxypropionamide[comp.6]

Deprotection of Boc group from [R]-tert-Butyl 1-[benzyl amino] -3- methoxy-1-oxopropan -2-yl

carbmate [comp.5] by using of aq.hydrochloric acid in toluene to give -2- [R]-Amino-N-benzyl-3-

methoxypropionamide [comp.6.]

Stage2: Preparation of lacosamide tech [comp.7]

On acylation of 2-[R] Amino-N-benzyl -3-methoxy propinamide with acetic anhydride in

Dichloromethane [DCM] followed by isolation /purification using Toluene to get lacosamide tech

[comp.7.]

146

.

Lacosamide pure

Stage-3: Preparation of lacosamide [comp.8]

Purification of lacosamide tech using ethyl acetate to produce lacosamide.

Stage3: purification of [R]-2-acetamido –N- benzyl-3-methoxypropanamide [comp.7] and to get

desired polymorph [form-1] of lacosamide [comp.8.]

Reaction Scheme:

148

Lacosamide process flow chart

152

Toluene Lot-5

MLR For solvent recovery

Filtration & Washing

153

Lcosamide - tech

Stage-3

Drying under vacuum

154

PREGABALIN

Capacity: 100 MTPA

Batch Size:175 Kg

No of Batches:571


Comp-7(S-Cyano ester) is hydrogenated in the presence of KOH using hydrogen & Raney

nickle used as a catalyst. Tech Reaction mass neutralization with acetic acid.

Pregabalin Pure is the purification of the pregabalin tech by charcoal treatment in Iso propyl

alcohol.

155

PREGABALIN PROCESS FLOW CHART

156

SITAGLIPTIN

Capacity: 10 MTPA

Batch Size: 50 Kg

No of Batches: 200

Process Description:

Reaction Scheme:

158

DONEPEZIL HYDROCHLORIDE DIHYDRATE

Brief Process :

Preparation process for DPZ-5

5,6-dimethoxy indanone is condensed with N-benzyl piperidene-4-carboxaldehyde in the presence

of sodium hydroxide in methanol. The crude product is isolated from methanol and washed with

water. The wet product is treated with dilute sulphuric acid . The tech product is isolated after

basification from water . The wet tech DPZ is dried after water slurry and then purified with

dimethyl formamide .

Preparation process for DPZ HCl

The DPZ -5 Pure is hydrogenated in presence of Methane sulphonic acid / Methanol and Raney

Nickel is used as catalyst. The reaction mass is neutralized and the methanol is evaporated. The free

DPZ base is extracted with toluene. Toluene layer after water wash followed by charcoal treatment

treated with HCl in IPA. The product is isolated from toluene / IPA medium. The product is further

purified by IPA leaching.

Reaction scheme:

159

DPZ - 5

O

O

O

+

N

OHC O

O

O

N

5,6-Dimethoxy indanone

N-Benzyl piperidine-4-carboxaldehyde

1. NaOH / Methanol

2. Dilute . H2SO4

3. DMF purification

DPZ - 5

DPZ .HCl

O

O

O

N

HCl

Methanol / Methane sulphonic acid

Toluene / IPA / HCl . IPA

O

O

O

N

DPZ-5

H2 / Raney Ni

DONEPEZIL HYDROCHLORIDE DIHYDRATE PROCESS FLOW CHART

164

METHIMAZOLE

Brief Process:

(Methyl amino) acetaldehyde dimethyl acetal is reacted with potassium thiocyanate in presence of

hydrochloric acid at elevated temperature condition to form Methimazole. Methimazole is isolated

from acetone after work up, purified and dried.

Synthesis:

NMeO

OMe

NNH

S

NNH

S

MeO

OMe

Br KSCN, HCl

Methanol, reflux

1 2

4

acetone

CH3NH2

KOH

3

MeOH

165


167

BUTORPHANOL TARTRATE

Brief Process:

Coupling of 1 & 2 followed by treatment with sulfuric acid hydrolysis, resulting compound

was cyclised and demethylated and salt formation to give product.

Synthesis:

COOH

MeO

NH2

NH

MeO

NH

MeO

OH

OH

PPA

MeO

N

OH

N

OH

OH

HBr in AcOH

N

OH

OH

OH

OH

COOH

COOH

H2SO

4

MeOH / Acetone

Xylene

Reflux

1 2 3

56

Stage-1Stage-2

Stage-3 Stage-4

Stage-5

MW= 166.18MW= 125.22 MW= 257.38

MW= 291.39

MW= 477.55MW= 327.47

MW= 341.50

4

7

168


169

3.9. MAJOR RAW MATERIALS

Many raw materials are required for the chemical synthesis processes used by the industry. These

include organic and inorganic compounds and are used in gas, liquid, and solid forms. During

transportation of the raw material the procedures given in the MSDS will be followed. The mode

of transport is on roads. The raw materials and their quantities to be used in proposed production

facility are mentioned in the table below.

The basic raw material for this key product capacity are submitted herein below and for the

details are given for all reactants, solvents and work up support chemicals.

STORAGE & TRANSPORTATION OF RAW MATERIALS & PRODUCTS

Raw material are stored in containers in the storage area, Products are stored in

product house. Raw materials are transported through trucks to the plant and within the plant

small vehicles such as forklifts are used to move the raw materials. Products are transported

through vehicles according to the requirement and capacity of the customer requirement.

STORAGE:

Industry will provide adequate and proper storage facilities for all the raw materials

and finished products. Corrosive substances will be stored away from the moisture. Solid raw

material will be stored in covered area and liquid raw material will be stored in closed

horizontal tank. Hazardous chemicals and solid wastes will be stored away from other plant

activities. The storage yard of chemicals will be isolated and it will be equipped with all

necessary safety measures. In cover-shed area provide natural ventilation system, which

consider as 15% open area of all covered area.

HANDLING:

All the raw materials, finished products and by - products will be handled as per the

standard practice. For proper handling, company will adapt good housekeeping technology to

entire shed. To avoid any leakage or spillage of chemicals from all storage tanks, third party

inspects transfer lines, valves, fittings and every joint periodically.

TRANSPORTATION:

All the necessary precautions will be taken while carrying out transport of the above

materials as per the Hazardous Rules of transportation. The vehicles for transportation of raw

materials, by - products and products will be parked at specified loading facilities where

170

there will be a provision of fire extinguishers. The finished product will be transported by

road, rail and ship route.

Raw materials to be used in the manufacturing process (emerging scenario)

(per annum)

Sl.No. Raw Materials

Existing

Capacity

MPTA

Proposed

Capacity

MPTA

Total

MPTA

1 Gaba Lactum 1203.44 2234.96 3438.40

2 Bupropion-1 67.05 33.52 100.57

3 2(2-Oxopyrolodinene Butyric acid) 12.07 0.00 12.07

4 Ethyl Chloro formate 9.55 0.00 9.55

5 CIN-2 15.39 46.17 61.56

6 CIN-3 6.41 19.22 25.63

7 ONDT-6 2.56 0.00 2.56

8 2-METHYL IMIDAIZOLE 2.56 0.00 2.56

9 ACE-4(Epoxide) 22.88 0.00 22.88

10 M-IPA(Isopropyl amine) 9.49 0.00 9.49

11 PBNB 49.18 0.00 49.18

12 Hydrazine Hydrate 49.18 0.00 49.18

13` ONDT -HCL 1.39 0.00 1.39

14 THEOBROMINE 4.16 58.20 62.35

15 CHLOROHEXANONE 1.92 0.00 1.92

16 TRI-3 4.44 0.00 4.44

17 GEM-1 428.57 0.00 257.14

18 Deco-4 Melt 83.76 223.35 307.11

19 EMME 32.74 87.31 120.05

20 4,4 DI FLUORO BENZOPHENONE PIPERAZINE 1.16 10.45 11.61

171

21 CINAMYL CHLORIDE 0.59 5.31 5.90

22 PYRIDINE 10.00 0.36 10.36

23 NMHVA 12.35 0.00 12.35

24 Bromochloropropane 12.76 0.00 12.76

25 TBAB (Catalyst-A) 0.12 0.00 0.12

26 1 PHVN 12.35 0.00 12.35

27 NaN2 2.47 0.00 2.47

28 VAL - 2 133.00 0.00 133.00

29 D-Fructose 25.20 0.00 25.20

30 1,4 Dioxane 163.00 0.00 163.00

31 L-tert-Leucine 3.92 0.00 3.92

32 Dicyclohaxlanine 5.42 0.00 5.42

33 Benzyl Chloroformate 5.92 0.00 5.92

34 ETHYL 2-(2-PYROLIDONE)-

BUTYRATE(HPP-529/2-PBE) 0.00 1008.75 1008.75

35 SODIUM METHOXIDE 0.00 9.86 9.86

36 ETHYL 2- PYROLIDONE-N-ACETATE(HPP-

799/2-PAE 0.00 878.38 878.38

37 ASPARTAME 0.00 53.10 53.10

38 DIMETHYL BUTYRALDEHYDE 0.00 17.52 17.52

39 VNF BASE 0.00 38.59 38.59

40 TRIFLUOROBENZALDEHYDE 0.00 8.00 8.00

41 MALONIC ACID 0.00 4.80 4.80

42 1-BROMO-ACTAMIDO ADAMANTANE 0.00 12.14 12.14

43 TPB TS OH 0.00 21.82 21.82

44 CMMDT-1 0.00 13.75 13.75

172

45 TETRBUTYL AMMONIUM BROMIDE 0.00 1.75 1.75

46 D-Serine 0.00 22.2 22.2

47 Di-Tert-Butyl Di Carbonate 0.00 50.8 50.8

48 18-Crown-6-Ether 0.00 3.1 3.1

49 4-Methyl Morpholine 0.00 23.4 23.4

50 Isobutyl Chloroformate 0.00 30.3 30.3

51 Benzylamine 0.00 23.9 23.9

52 Di-Methyl Sulphate 0.00 50.0 50.0

53 Acetic Anhydride 0.00 17.6 17.6

54 1-(Chloroacetyl)-(S)-Proline methyl ester(RSM-

02) 0.00 30.0 30.0

55 3-Amino-Adamantan-1-OL 0.00 30.6 30.6

56 Vildagliptin stage-1 0.00 37.0 37.0

57 Methyl tertiary butyl Ether 0.00 33.0 33.0

58 2 Methyl Tetrahydrofuran 0.00 100.2 100.2

59 Trifluoro Acetic Acid 0.00 15.4 15.4

60 Trifluoro Acetic Acid Anhydride 0.00 19.2 19.2

61 Valacyclovir stage-1 0.00 90.5 90.5

62 N,N-Dicyclohexyl carbodimide 0.00 41.8 41.8

63 N,N-Dimethyl Amino Pyridine 0.00 1.9 1.9

64 Acyclovir 0.00 29.4 29.4

65 5,6-Dimethoxy Indanone Pure 0.00 2.3 2.3

66 N-Benzyl Piperidine-4-Carboxaldehyde

pure(DPZ-Stage 2 pure) 0.00 2.5 2.5

67 Methane Sulphonic Acid 0.00 3.2 3.2

68 QTP-2 0.00 35.7 35.7

173

69 N,N Dimethyl aniline 0.00 11.4 11.4

70 Piperzine anhydrous 0.00 47.8 47.8

71 11-Piperazinyl-

Dibenzo(B.F)(1,4)Thiazepinre.Hydrochloride 0.00 44.3 44.3

72 N-Methyl-2-Pyrrolidinone 0.00 20.7 20.7

73 Methyl piperazine Carboxy late Acetate salt 0.00 38.4 38.4

74 Methyl Piperazine-1 Carboxylate 0.00 26.6 26.6

75 2-Fluoro 3-Nitro Tolune 0.00 26.3 26.3

76 N-Bromo Succinimide 0.00 48.4 48.4

77 Benzoyl peroxide 0.00 1.6 1.6

78 N,N Diisopropyl Ethylamine 0.00 14.3 14.3

79 Methyl piperazine-2-Carboxy late 0.00 26.6 26.6

80 Di Ethyl Phosphate 0.00 10.8 10.8

81 Ethyl 4-(1-Hydroxy-1-Methylethyl)2-Propyl

Imidazole-5-Carboxylate 0.00 8.8 8.8

82 N-(Triphenylmethyl)-5-(4-

(Bromomethyl)Biphenyl-2-Yltetrazole(TTBB) 0.00 23.2 23.2

83 Tetra butylammonium bromide 0.00 2.1 2.1

84 Potasium Tertiary Butoxide 0.00 4.7 4.7

85 Tetrabutyl ammonium bromide 0.00 2.1 2.1

86 4-Chloromethyl -5-Methyl-1,3-Dioxal-2-one 0.00 6.6 6.6

87 Pregabalin-tech(comp-7) 0.00 144.8 144.8

88 Poly allyl amine 0.00 428.6 428.6

89 Epichlorohydrin 0.00 21.0 20.9

90 6-bromohexyl trimethyl Ammonium bromide 0.00 64.9 32.5

91 Bromo Decane 0.00 44.3 22.2

92 (3R)-3(tetra butoxy carbonylamino)-4-(2,4,5,

0.00 10.02 10.02

174

trifluoro phenyl) butanoic acid.

93 3-(trifluoro methyl)-5,6,7,8-tetrahydro-

(1,2,4)triazolo(4,3-a)Pyrazine. 0.00 5.78 5.78

94 Dicyclohexyl carbodiimide 0.00 6.2 6.2

95 Di-isopropyl ethyl amine 0.00 0.4 0.4

96 1-hydroxyl benzotriazole 0.00 1 1

97 Cyclohexanyl ethylamine 0.00 0.38 0.38

98 4-Methoxy phenyl acetic acid 0.00 0.38 0.38

99 m-Chloro perbenzoic acid 0.00 0.06 0.06

100 Bromoacetal 0.00 17.64 17.64

101 Valproic Acid 73.42 0.00 73.42

102 Methyl amine 0.00 15.582 15.582

103 HCL-30% 1772.18 2725.30 4497.48

104 Conc. HCl 7.28 0.00 7.28

105 Phosphoric Acid 0.00 2.08 2.08

106 Phosphorous Acid 0.00 1.4 1.4

107 H2SO4 21.27 9.20 30.47

108 Conc. H2SO4 22.40 0.00 22.40

109 Citric Acid 5.80 28.40 34.20

110 Acetic acid 0.37 259 259.37

111 FORMIC ACID 1.33 95.50 96.84

112 OXALIC ACID 1.56 0.00 1.56

113 NaCl 1.33 218.25 219.59

114 Sulphuryl Chloride 15.00 0.00 15.00

115 NaOH Flakes 1079.61 1775.14 2854.74

116 KOH 0.00 65.60 65.60

175

117 Sodium carbonate 158.47 498.98 657.44

`118 Sodium sulphate 0.00 8.40 8.40

119 Sodium bicarbonate 0.00 43.6 43.6

120 Sodium Iodide 0.00 0.4 0.4

121 Potassium Iodide 0.00 2.4 2.4

122 K2CO3 2.56 108.31 110.87

123 FeCl3 2.95 0.00 2.95

124 Ammonium Chloride 0.00 26.3 26.3

125 Phosphorus oxy chloride (POCL3) 0.00 28.6 28.6

126 FORMALDEHYDE 0.00 20.88 20.88

127 Phosphorous Pentoxide 0.00 6.4 6.4

128 potassium thiocyanate 0.00 7.644 7.644

129 Sodium borohydride 0.00 1.14 1.14

130 Aqeous AMMONIA 9.78 32.30 42.08

131 AMMONIA Gas 538.00 466.22 1004.22

132 Hydogen gas 1.27 24.62 25.89

133 Raney Nickle catalyst 0.00 44.6 44.6

134 PALLADIUM CARBON 0.25 4.93 5.18

135 Cat-E 0.04 0.13 0.18

136 Magnesium Metal 1.23 0.00 1.23

137 Activated Carbon 60.47 12.39 72.86

138 Hyflo 18.69 98.83 117.52

139 celite 0.00 0.05 0.05

Total 6190.3 13224.0 19188.1

176

3.10: AVAILABILITY OF WATER ITS SOURCE, ENERGY

/POWER REQRUIMENT AND SOURCE DETAILS

The proposed production activity falls in the project activity 5(f) as per the schedule of the

EIA Notification-2006. The project being located within notified industrial estate falls under

category B. As per para, 7(i) III (i) (b) of the EIA Notification, 2006, public consultation is

not required as the project is situated in the notified industrial estate.

The Fresh water requirement will increase from existing the proposed expansion as per the

water balance and it will be sourced from Bore well, KIADB and Also through tankers.

However actual fresh water requirement will be 1158 KL/day as they will reuse recovered

steam condensate & condensate water from MEE through from RO plant of treated effluent

around 733 KLD

Power Requirement Power requirement of proposed EXPANSION project will be made

available through BESCOM FROM EXSTING feeder. Total power requirement of proposed

expansion of the plant shall be 2000 KVA. Three No’s of D. G. sets of capacity 1500 KVA,

750 KVA &275 KVA, Cogen Turbine 1750 KVA are available to meet emergency power

requirement of the plant.

3.4.3 Fuel Requirement

The unit –I has FO based boiler as well as briquette based boiler cum cogen plant. Total fuel

requirement will be around 25 TPD of FO and Briquette 78 TPD is procured form local

sources. HSD fro DG sets procured from the local source time to time.

QUANTITY OF WASTES TO BE GENERATED (LIQUID AND SOLID) AND

SCHEME OF THEIR MANAGAMENT AND DISPOSAL DETAILS

177

Industrial waste water generation will increase as per the water balance chart after the

proposed expansion. In present scenario, the effluent is been treated in existing 2 stream

effluent treatment scheme one for HTDS effluent shall be treated in exiting MEE .ATFD

followed by common Biological treatment plant consisting of 2 stage aeration 500 KLD

biological treatment followed with RO plant Industry has already adopting zero effluent

discharge treatment scheme.

The proposed expansion, the effluent will be segregated in different streams. Low COD, Low

TDS effluent ( 129 KL/day) , High COD & High TDS effluent stream.(95 KL/day) and from

utilities (137 KL/day) & 138 KL from Boiler .

Treatment facility followed by RO plant. The RO permeate (319 KL) will be reused, whereas

R.O. reject (36 KL/day) will be fed to the MEE (Multiple Effect Evaporator). The Existing

Capacity of the RO system & MEE plant will be 350 KL/day & 120 KL/day respectively.

High COD/TDS Bearing Stream (95 KL/day) after solvent stripping and pH correction will

be sent to MEE and ATFD. The effluent will be stripped by using steam in steam stripping

column to recover the solvent and the rest will be sent to Evaporation system. Condensate

(100 KLD) from the MEE will be reused in cooling tower and boiler make up after biological

treatment and followed with RO. Concentrate from evaporation system is subjected to

cooling, crystallization and filtration to recover salts. Mother liquor will be recycled back to

evaporator feed.

Water for domestic and operation phases will be procured through Tankers. Average fresh

water daily water requirement and waste water generation during operation phase is

estimated as attached water balance chart

The breakup of daily and annual water requirement for operation phase and wastewater

generation is given in below table.

BREAKUP OF DAILY WATER REQUIREMENT- OPERATION PHASE

178

Sl.

No

Utility Fresh Water

consumption

KL per day

Recycle water

Consumption

KL per day

Total

Consumption

per day

01 (a) Domestic Use (Toilet,

Canteen etc.) 45

1820

02 (b) Industrial purpose

03 (1) Process* 175 -----

04 (2) Washings* & Scrubbers 89 105

05 (3) Boiler feed make up water 320 138

06 (4) Cooling tower make up

water 423 419

07 (5) Others (Specify)

Scrubber (Fire hydrant & Fresh

water RO reject) 106

TOTAL

1158 662

DAILY WATER &WASTEWATER GENERATION

Water consumed

for

Existing

Consump

tion

KL per

Day

Proposed

Consumpt

ion

KL per

Day

Total Existing

Discharge KL

per day

Proposed

Discharge

KL per day

Total Disposal Method

(a) Domestic Use

(Toilet, Canteen

etc.)

28 17 45 28 12 40 Treated in existing STP plant

capacity of 50 KLD,

(b) Industrial

purpose

(1) Process*

40 135 175 89 135 224 Effluent Shall be treated in ETP

followed by MEE and ATFD. The

Distillate along with RO permeate

given to cooling tower make up (2) Washings* and 42 47 89 42 47 89

179

scrubbers

(3) Boiler feed

make up water 154 166 320 66 72 138

Blow Down Shall be treated in

DM plant and reused for Boiler

feed.

(4) Cooling tower

make up 248 175 423 80 57 137 Blow Down Shall be treated in

ETP of 500 KLD followed by RO

and reused for CT make up

(5) Others

(Specify)

1 105 106 35 70 105

RO reject TDS is <1500 ppm,

Same water Used for gardening,

road cleaning , floor washings, fire

hydrant make up, toilet fliushings

(RO REJECT

Water )

TOTAL

513 645 1158 340 393 733

The effluent is treated with RO & MEE facility for LTDS & HTDS. LTDS effluent is

treated in biological treatment plant followed by Reverse Osmosis; R.O Permeate shall be

completely recycled for cooling purpose. RO rejects shall be treated in MEE and ATFD.

HTDS & RO rejects shall be treated in MEE and ATFD. The condensate proposed for

treatment of process waste water. The RO reject is sent to MEE along with HTDS effluent for

further process.

EFFLUENT TREATMENT PLANT

WATER BALANCE CHART

3.11. WASTE GENERATION AND MANAGEMENT

DESIGN OF SEWAGE TREATMENT UNITS:

The domestic sewage is treated in sewage treatment plant of 50 KLD capacities

RAW SEWAGE CHARACTERISTICS

Parameter Before Treatment After Treatment

BOD 300 – 350 mg/lt Less than 20 mg/lt

pH 7.0 – 7.5 7.0-7.5

Suspended Solids 250 – 400 mg/lt less than 30 mg/lt

E-coli 106-10

8 none

Turbidity 30 less than 2 NTU

Residual Cl2 less than 1.0 mg/liters

SIZES OF TREATMENT UNITS:

Sl. No. Description Size (meters) Capacity

1 Bar Screen Chamber 1.2 x 0.6 mtr Adequate depth

2 Equalization tank 2.7x 2.7x 2.7 (0.5 free board) 22 KL

3 Sequencing batch reactor 4.0 x 4.0 x 3 mtr (0.5 FB) 48 KL

4 Pre-filtration tank 3x 3 x 3.0 mtr (0.5 FB) 27 KL

5 Sludge holding tank 2.58 x 2.58 x 3.0 mtrs (0.5 FB) 20 KL

6 Final holding tank 3.65 x 3.65 x 3.0 mtr (0.5 FB) 40 KL

MECHANICAL ITEMS: EQUIPMENT/PIPING/VALVES/ELECTRICAL

SL. No. Items Specification No of. Units

1 Raw effluent pump 3 HP Each 2

2 Sludge Recirculation pump 3 HP Each 3

3 Diffuser 1 mt & 0.5mt long 16 + 12

4 Air blowers 220 cum//hr 2

5 Filter feed pump 5 HP Each 2

6 Clarifier water pump 5 HP Each 3

7 Pressure Sand Filter 1.04 m dia X 2.0 m HOS 1

8 Activated Carbon Filter 1.04 m dia X 2.0 m HOS 1

9 Chlorine dosing tank 100 lt. and dosing pump 1 lot

10 Inter plant piping &valves 3” dia PVC and sluice type GM valves 1 lot

11 Electrical Control panel and cable etc. 1 lot

EFLEUNT TREATMENT PLANT

THE DESIGNED CAPACITY FOR THE BIOLOGICAL TREATMENT PLANT IS 500 KLD

The sizes of exiting Effluent treatment plant OF 500 KLD with ATFD & MEE (120 KLD)

and RO (320 KLD)

SI No. Name of the tank Tank Tag no Capacity

1 High TDS effluent collection tank T-9001 100 M3

2 High TDS effluent equalization tank T-9002 30 M3

3 Flash mixer tank (High TDS tank ) T-9003 1 M3

4 Clarifier tank (high TDS effluent ) T-9004 17 M3

5 MEE feed tank T-9005 68 M3

6 Screen chamber T-9021 2 M3

7 Solvent arrester tank T-9022 32 M3

8 Equalization cum Neutralization tank T-9023 A/B 415 M3

9 Oil and grease tank T-9024 A/B 4.8 M3

10 Neutralization Tank T-9025 A/B 24 M3

11 Flash mixer Tank T-9026 2 M3

12 Primary Clarifier T-9027 65 M3

13 Sludge holding tank T-9028 12.5 M3

14 PH correction tank T-9029 100 M3

15 Aeration tank T-9030 A/B/c 1500 M3

16 First stage clarifier T-9031 91 M3

17 Aeration tank T-9032 500 M3

18 Second stage clarifier T-9033 91 M3

19 Flash Mixer T-9034 2 M3

20 Tertiary settling tank T-9035 40 M3

21 Polishing tank T-9036 30 M3

22 Treated effluent holding tank T-9037 60 M3

23 Sludge drying bed T-9038 A/B/C/D/E 148 M3

24 RO permeate holding tank T-9039 100 M3

25 ETP collection tank T-9040 4.5 M3

SOLID AND HAZARDOUS WASTE MANAGEMENT:

Construction Phase:

The expected solid waste generated during construction phase will include two types of

wastes i.e. construction debris and domestic solid waste. The type and quantities of the solid

waste generation during construction phase is detailed in table below

Solid waste generation during construction phase

Sl.

No.

Waste Estimated quantity Disposal arrangement

01 Construction

Debris

0.1 tons per Day

Construction debris will be used to level

low lying areas within the project site

and in road construction.

02 Domestic solid

Waste

50 Kgs per day

About 70% of the domestic waste is

expected to be biodegradable waste

from kitchen/food waste. It will be

disposed of for use for piggeries.

Remaining waste will be disposed of at

a site as approved by local authority.

03 Waste/ Used Oil 0.2 m3/year To be disposed to KSPCB and CPCB

authorized Vendors

04 Waste steel 15 tons To be sold to scrap dealers

05 Cement bags 1800 bags To be sold to scrap dealers

06 Packaging Waste

Containing

cardboard,

wood, etc.

5 tons

To be sold to scrap dealers

The potential health hazard expected from construction debris can be due to dust particulates

in the ambient air or handling of friable materials. To mitigate adverse impacts of health due

to dust in ambient air, the Project will ensure the following: Use of personal protective

equipment including dust mask, hand gloves, safety goggles and helmet;

Proper covering of loose construction material during transportation;

Onsite storage provided with a tarpaulin cover sheet; and

Sprinkling of water on loose construction debris.

Operation Phase

The total solid waste generation during operation phase is expected to be approximately 250

kg per day, considering 0.3 kg/day/capita for solid waste generation from offices (as per

National Building Code 2005) and considering 390 direct and indirect employees. It also

includes canteen waste and other general packaging and other waste which will be sold back

as recyclables. The detail of solid waste generation is given in table as follows:

Sl. No Type of waste Quantity Method of handling/disposal

Existing Proposed Total

1 General office waste 8TPA 8TPA 16 TPA


KSPCB Guidelines and disposed to

authorized scrap dealers

2

Non-contaminated carboys

& glasses

5000 Nos /A

1.0 MT/A

7000 Nos/A

1.0 MT/A

12000

Nos/A

2 MT/A

3 Wood packings 24 TPA 40 TPA 64 TPA

4 Sludge from STP 7.2 TPA 5.8 TPA 13 TPA

5 Non contaminated plastic

waste 20 MT/A 25 TPA 45 TPA

6 Aprons –Cloth waste 0.5 TPA 1.0 TPA 1.5 TPA

7 Glass wears 0.5 TPA 2.0 TPA 2.5 TPA

9 Cogen Boiler Ash 2592 TPA ------ 2592

TPA


KSPCB guidelines and disposed to

Bricks & Compost manufacturers

HAZARDOUS WASTES GENERATION AND DISPOSAL

Operation Phase:

The detail of hazardous waste generation is given in below table as follows:

HAZARDOUS WASTE GENERATION DURING OPERATION PHASE OF THE PROPOSED

PROJECT

Sl.

No

Type Category Quantity in Total Method of handling/disposal

Existing Proposed

1 Used oil

5.1 2KL/A 4KL/A 6KL/A Shall be collected in a leak proof

containers & disposed only to KSPCB

registered authorized re-processors

provided the oil meets the standards as

per schedule-5 part A of the rules

2 Oil soaked cotton

waste &

Oil filters

5.2 0.2MT/A

30Nos /A

0.4MT/A

60Nos /A

0.6MT/A

90Nos /A

Shall be store in a secured manner &

handed over to KSPCB authorized

incinerators / co-processing in cement

kiln

3 Spent carbon, fy

flow mixtures, &

carbon soot

28.2 72.5MT/A 182.5 MT/A 255 MT/A Shall be store in a secured manner and

handed over to TSDF

4 Spent solvent &

Mixed solvents

from process

28.5 241MT/A 6527 MT/A 6768

MT/A

Shall be store in a secured manner and

reprocessed back using environmental

sound technology

5 Discarded

containers

33.3 11.7MT/A 23.4 MT/A 35.1 MT/A Shall be store in a secured manner and


recyclers after wash only

6 ETP sludge,

Multiple effect

evaporator salt

34.3 198MT/A

1398.6MT/A

396 MT/A

3401.3

MT/A

594MT/A

4800

MT/A

Shall be store in a secured manner and

handed over to TSDF/ co-processing in

cement kiln

7 Distillation residue

from contaminated

organic solvents

36.4 350MT/A 127 MT/A 477 MT/A

Shall be store in a secured manner &


incinerators / co-processing in cement

kiln

8 RO resins (membrane

) and chemical resins

(MB plant)

1.5 MT/A 1.5 MT/A Shall be store in a secured manner &


incinerators / Co-processing in cement kiln

9 Expired or Off

specific drugs /

Chemicals

------- 2.0 MT/A 2.0 MT/A Shall be store in a secured manner &


incinerators / Co-processing in cement kiln

AIR EMISSION AND POLLUTION CONTROL :

Source of air emission includes stacks attached to Air Handling units and DG sets. Details of

gases emission from project activities are provided in table.

Chim

No.

Chimney

attached to

Minimum chimney height to be provided above ground level(AGL)/

above roof level (ARL)

Rate of

emission

Nms/Hr.

Constituents

to be

controlled

in the

emission

Tolerance

limits

mg/Nms

Air pollution Control

equipment to

be installed, in addition to

chimney height as

per Col.(3)

Existing Air pollution control equipments

1 2 3 4 5 6 7

1 2.8 TPH Boiler 30.5 m AGL - SO2 - Chimney

as per

Col.3

2 6.3 TPH Boiler 38 m AGL - SO2 - Chimney

as per

Col.3

3 6.3 TPH Boiler & 2

Lakh K. Cal Thermic

Fluid Heater

Common chimney

of 38 m AGL

SO2 - Chimney

as per

Co1.3

4 Process emissions

from all the reactors- 7

Nos.

Individual

chimneys of 5 m

ARL

Acid Mist

SO2

35

-

Chimney as

per Col.3 with

Scrubber

5 DG Set — 750

KVA.

16 m AC, - SO2 - Chimney as per

Col.3 with

Acoustic

Enclosures

6 DG Set —

I 500KVA.


Col.3 with

Acoustic

Enclosures

7 DG Set-275

KVA.

6 m ARL - SO2 - Chimney as per

Col.3 with

Acoustic

Enclosures

8 Boiler-14 MT/Hr

(Briquette fired)

35 in AGL - SO2 - Chimney as per

Col.3 with ESP

Proposed Air pollution control equipments

9 DG Set —

2000KVA.*2 nos


Col.3 with

Acoustic

Enclosures

10 Process emissions from all

the reactors- 8 Nos. Individual

chimneys of 5 m

ARL connected with Scrubbers

Acid Mist ,

SO2 35

- Chimney as

per Col.3 with

Scrubber

NOISE MANAGEMENT

For the proposed project impact on noise environment can be due to:

Noise from the plant operations, machinery and utilities with the immediate receptors

exposed to occupational noise levels; and

Noise generation due to plying of vehicles on the roads for staff commitment and for

bringing raw material and taking finished products.

Some typical noise sources include the following:

Operation of DG sets;

Operation of pumps

Operation in other utility areas.

Noise level for various equipment will be in the range of 70 dB (A) to 80 dB (A).

Provision of personal protective equipment will made for personnel working in high noise

generation area. Acoustic measures or isolation will be taken up for equipment generating

noise level greater than 75 dB(A). A green belt/landscape planned all around project covering

33% of the total area under green cover. This will considerably reduce fence level noise level.

3.12. POWER REQUIREMENT

Power demand during operation phase is estimated to be around 4000 kVA (4.0 MW). The

supply of power would be met through BESCOM and 1750 kVA ( Turbo generator 1.2 MW)

co-gen plant.

The back up power supply would be through diesel generators existing capacity is 275 KVA,

750 KVA and 1500 KVA (Total :2.02 MW) and proposed back up will be 2000 KVA (1.6MW)

. Solidly Earthling system. The variation for voltage and frequency shall be:

High Voltage: 66kV + 10%

Low Voltage: 400 V + 10%

Frequency: 50 Hz + 3%

Outdoor installation will be through a 275 KVA, 750 KVA and 1500 KVA overhead HT line

with switch yard accessories. Metering provided by BESCOM in 275 KVA, 750 KVA and

1500 KVA switch yard. Sub-station located at boundary of the Project site. Power supply from

BESCOM will be used for office and other utility system.

3.13 SAFETY AND FIRE FIGHTING

The firefighting system will be designed considering the following codes, manuals and

guidelines:

National Building Code of India (NBC);

Latest relevant NFPA Codes, USA like NFPA-13,14, 20 &22;

Industrial Risk Insured (IRI) guidelines;

As per the requirement of fire officer/local fire approving authorities;

As per Indian Standard Code for Fire Protection (IS Codes) Following portable type

fire extinguishers shall be provided as per the requirements:

Dry chemical powder type of 5kg capacity as per IS: 2171;

CO2 type of 4.5kg capacity as per IS2878;

Water Type; and

Foam Type;

CHAPTER 4

PLANNING BRIEF

4.1. PLANNING CONCEPT:

The total site area of the proposed project including the existing facility 6.88 acre

The detailed area details as follows

Total plot area 17.83 acre

Ground coverage area

Existing + expansion

Phase 2

35%

Open area- parking, paving, roads etc. 27055 sq. mtrs

Landscape area 24130.92 sq mtrs

The overall facilities proposed under the project broadly consist of the following

elements/operations;

Plant and Machinery & Utilities

Production units

Safety and Pollution control facilities associated with the production of the above.

Supporting services such as Boiler and for DG sets utilities

4.2. LAND USE PLANNING:

Vegetation is the natural extension of the soil ecosystem on a site. It can provide summer

shade, wind protection, and a low-maintenance landscape that is adapted to the local

environment. Unfortunately, the common practice is to remove the existing landscape cover

and replace with a generic, water and maintenance-intensive lawn.

It is proposed to develop a minimum 30% of the total site area as greenbelt area which

amounts to about 24130.92 m2

of total site area, as the total site area of the project is 72111

sq.m

33 % total plot area has been earmarked for developing green belt all along the boundary.

Avenue trees will also be raised along the road side.

Necessary landscaping will be done to enhance the aesthetic view of the unit.

Native trees will be planted where ever required.

LIST OF TREE SPECIES

Large Size Trees: Common Name

Anthocephaluscadamba Kadwal/Bale/Kadamba

Azadarichtaindica Neem / Beveeniamara

Ficusinfectoria / virens Karibasuri/Basari

Pterospermumacerifolium Muchkund/kanakChampa

Mimusopselengi Pokkalathu

Saracaindica Asoka/Ashunkar

Tamarindusindica Hunshemara

Fruit Bearing Trees: Common Name

Aeglemarmelos Bilvapatre

Artocarpusintegrifolia Alasa/Halasu/Gujja/Panasero

Embelicaofficinalis Nelli/Dadi/Dhanya

Eugenia jambolana Narala, Nerula, Neeram

Moringaoleifera Nugge/drumstick tree

Ficuscarica Anjura/Simeyatti

Medium Size Trees: Common Name

Averrhoacarambola Komarakmara

Bauhinia variegate Kanchivalado

Buteamonosperma Muttuga

Cassia nodosa Pink Mohur

Cassia renigera Pink cassia

Erythrinaindica Ippi/Allipe

Lagerstroemia flos-reginae Challa

Madhucaindica Ippi/Allipe

Micheliachampaka Sampige

Millingtoniahortensis Beratu/Biratumara

Phyllanthusemblica Nelli/Dadi/Dhanya

Pongamiaglabra Honge/Hungay

RAIN WATER HARVESTING

Typical rain water recharge structures as below will be constructed in the propose site to

harvest the rain water & to maintain the storm drainage from the proposed site.

Figure: Details of rain water recharge pit with bore hole with dimensions.

Figure: Details of rain water recharge trench pit with dimensions.

The Volume of rain water available from the paved & open region will be around 60 cum &

hence adequate nos. of recharge pit & trench with above dimensions will be constructed at the

site for effective storm water management.

Rain water Harvesting potential for the proposed site during operation period:

Month

Rainfall Open area available Roof top area available Paved area available

Tota

l mm m

Sq.

meter

Run off

coefficie

nt

Cum

of

water

Sq.

meter

Run off

coefficient

Cum of

water

Sq.

meter

Run off

coefficient

Cum of

water

May 111.9 0.112 24130

.92 0.2

540.5

2193

7.2 0.8

1965.5

2705

5 0.7

2121.1

4626.

8

June 79.7 0.079 24130

.92 0.2

381.26

2193

7.2 0.8

1386.4

2705

5 0.7

1496.1

3263.

76

July 109.7 0.109 24130

.92 0.2

526

2193

7.2 0.8

1913

2705

5 0.7

2064 4503

Augus

t

138.8 0.138

24130

.92 0.2

666

2193

7.2 0.8

2421.8

2705

5 0.7

2613.5

5701.

3

Septe

mber 185.9 0.186

24130

.92 0.2

897`.6

2193

7.2 0.8

3264.2

2705

5 0.7

3522.5

7684.

3

Octob

er 161.7 0.161

24130

.92 0.2

777

2193

7.2 0.8

2825

2705

5 0.7

3049 6651

Potential Annual Total, m3 3788.3

6

13776

14866.

2

3243

0.56

Potential Daily Recharge

of Rainwater, m3 10.37 37.74 40.72 88.85

Volume (v) in cubic meters (cum)

of the storage tank required is = Error! Reference source not found.

=32430.56 KLD / 60 days = 540.5 m3

A collection tank of 150 cum will be constructed for collecting only the roof top water with

pre filtration system attached to the collecting pipes.

4.3. ASSESSMENT OF INFRASTRUCTURE DEMAND

Project benefit focused on those points which become beneficial to the surrounding area or

community in terms of infrastructural development, social development, boosting

employment and other tangible benefits due to upcoming or proposed activities in form side

benefits.

The upcoming proposed expansion project will bring overall improvements in the locality,

neighborhood and to the state by bringing industry, roads, water supply, drainage facility,

power supply, employment for skilled, semi skilled and unskilled labour, thereby uplifting the

living standards of local communities and economic growth as well as it also stimulates the

growth in small and medium scale industries like residential developments, hotels, shopping

complexes, retail shops, health centre’s, educational institutes, recreational centers etc., may

be further developed as a consequence.

4.4.1. IMPROVEMENT IN PHYSICAL INFRASTRUCTURE

The proposed expansion project is expected to yield a positive impact on the socio-economic

environment. It helps in sustainable development of this area including further development of

physical infrastructural facilities. The following physical infrastructure facilities will improve

due to proposed project:

Road transport facilities

Water supply and sanitation

4.4.2. IMPROVEMENT IN SOCIAL INFRASTRUCTURE

Due to proposed project activity Social Infrastructure will improve by means of

Civilization, standard of living, education, Vocational Training, and Basic Amenities.

Additional benefits will be arrived from the proposed project like: residential apartment,

healthcare, educational facilities to the community, community hall, sports centre’s,

recreational centers, industrial developments, shopping malls, public services in the

surrounding area

Better education facilities, proper health care, road infrastructure and drinking water facilities

are basic social amenities for better working standard of human being. Proposed project will

further increase the above amenities directly/indirectly either by providing or by improving

the existing facilities in the area, which will help in uplifting the living standards of local

communities. Due to this project development adaptation of new technologies and other

infrastructural facilities will improve which will indirectly boost the civilization of the

surrounding people. The project is going to have positive impact on consumption behavior by

way of raising average consumption and income through multiplier effect. The following

change in socio-economic status is expected to take place with this project.

Education facilities

Banking facilities

Post offices and communication facilities

Medical facilities

Recreational facilities

Business establishment

4.4. FACILITIES:

The proposed project is likely to have other tangible benefits as given below –

Indirect employment opportunities to local people in contractual works like housing

construction, transportations, sanitation, for supply of goods and services to that

project and other community services

Additional housing demand for rental accommodation will increases

Market and bossiness establishment facilities will also increase

Cultural, recreation and aesthetic facilities will also improve

Improvement in communication, transport, education, community development and

medical facilities

The project will contribute additional revenue to the state and central exchequer in the

form different kind of taxes.

CHAPTER -5

PROPOSED INFRASTRUCTURE

Available infrastructure consideration in the selection of site are as detailed below,

• Availability of infrastructure facilities such as State Highway road access to the

proposed project site for ease of transportation of workforce, plant equipment and fuel

etc.,

• Availability of facilities like medical, education, civic amenities and railway station

within reasonable distance from the site.

5.1. AREA

S.No Description Acres

1 Unit-1 25824 Sq mt / 6.38 Acres

2 Unit-1/Gate III & IV 12513 Sq mt / 3.092 Acres

3 SRU/ETP/Deco 13157.04 Sq mt/ 3.25 Acres

4 New ware House 4353 Sq mt / 1.1 Acre

5 Adjacent Land 16264 Sq mt / 4.01 Acres

Total area 17.832 Acres

5.2 GREEN BELT

The Tree Plantation is one of the effective remedial measures to control the air pollution and

Noise pollution. It also causes aesthetics and climatologically improvement of area as well as

sustains and supports the biosphere. It is an established fact that the trees and vegetation acts

as a vast natural sink for the gaseous as well as particulate air pollutants. Due to enormous

surface area of the leaves, it also helps to attenuate the ambient noise level. The plantation

around the pollution sources control the air pollution by filtering the air pollutant and interact

with gaseous pollutant before it reaches to the ground. The tree plantation also acts as buffer

and absorber against accidental release of pollutants. The selection of tree species suitable for

plantation at the industry shall be governed by guiding factors as stated below.

The tree shall tolerant to air pollutants present in the area

The tree is able to grow and thrive on the soil of the area, be evergreen, inhabitant,

having minimum of leaf fall.

The tree is tall in peripheral curtain plantation and with large and spreading canopy in

primary and secondary attenuation zone.

The tree posse’s extensive foliar area to provide maximum impinging surface for

continued efficient adsorption and absorption of pollutants.

The tree are fast growing and indigenous, and shall maintain ecological, land and

hydrological balance of the region.

5.3. SOCIAL INFRASTRUCTURE

Due to proposed project activity Social Infrastructure will improve by means of Civilization,

standard of living, education, Vocational Training, and Basic Amenities. Additional benefits

will be arrived from the proposed project like: residential apartment, healthcare, educational

facilities to the community, community hall, sports centre’s, recreational centers, industrial

developments, shopping malls, public services in the surrounding area










Education facilities

Banking facilities

Post offices and communication facilities

Medical facilities

Recreational facilities

Business establishment

5.4. CONNECTIVITY:

Sl.

No.

Particulars Details

1 Plant site coordinates

2 Plant Site Elevation

3 Nearest Highway N. H. 7

4 Nearest Railway Station Bangalore city railway station.

5 Nearest Airport Kempegowda International Airport

6 Nearest village Haragadde

7 Nearest major city Bangalore City

9 Nearest water bodies Kubaranahalli lake

10 Nearest major hill range Nandi hills

http://wikiedit.org/India/Haragadde/218344/

CHAPTER - 6

REHABILITATION AND RESETTLEMENT

(R&R PLAN)

The Tree Plantation is one of the effective remedial measures to control the air pollution and

Noise pollution. It also causes aesthetics and climatologically improvement of area as well as

sustains and supports the biosphere. It is an established fact that the trees and vegetation acts

as a vast natural sink for the gaseous as well as particulate air pollutants. Due to enormous

surface area of the leaves, it also helps to attenuate the ambient noise level. The plantation

around the pollution sources control the air pollution by filtering the air pollutant and interact

with gaseous pollutant before it reaches to the ground. The tree plantation also acts as buffer

and absorber against accidental release of pollutants. The selection of tree species suitable for

plantation at the industry shall be governed by guiding factors as stated below.

The tree shall tolerant to air pollutants present in the area

The tree is able to grow and thrive on the soil of the area, be evergreen, inhabitant,

having minimum of leaf fall.

The tree is tall in peripheral curtain plantation and with large and spreading canopy in

primary and secondary attenuation zone.

The tree posse’s extensive foliar area to provide maximum impinging surface for

continued efficient adsorption and absorption of pollutants.

The tree are fast growing and indigenous, and shall maintain ecological, land and

hydrological balance of the region.

The proposed project is likely to have other tangible benefits as given below Indirect employment opportunities to local people in contractual works like housing







medical facilities


form different kind of taxes .

Due to proposed project activity Social Infrastructure will improve by means of Civilization,

standard of living, education, Vocational Training, and Basic Amenities. Additional benefits

will be arrived from the proposed project like: residential apartment, healthcare, educational

facilities to the community, community hall, sports centre’s, recreational centers, industrial

developments, shopping malls, public services in the surrounding area










CHAPTER 7

ANALYSIS OF PROPOSAL

The proposed expansion project is expected to yield a positive impact on the socio-economic

environment. It helps in sustainable development of this area including further development of

physical infrastructural facilities. The following physical infrastructure facilities will improve

due to proposed project:

Road transport facilities

Water supply and sanitation

7.1. SOCIAL BENEFITS:

Due to proposed project activity Social Infrastructure will improve by means of

Civilization, standard of living, education, Vocational Training, and Basic Amenities.

Additional benefits will be arrived from the proposed project like: residential apartment,

healthcare, educational facilities to the community, community hall, sports centre’s,

recreational centers, industrial developments, shopping malls, public services in the

surrounding area










7.2 OTHER BENEFITS:

The proposed project is likely to have other tangible benefits as given below

Indirect employment opportunities to local people in contractual works like housing







medical facilities


form different kind of taxes.

pre- feasibility report -...

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