Pre-Feasibility Reportenvironmentclearance.nic.in/writereaddata/Online/TOR/01... · 2017. 4. 1. ·...

Pre-Feasibility Report

For

Proposed Expansion of the Bulk Drug Unit at SIPCOT, Industrial Estate, Gummidipoondi

by M/s Anjan Drug Private Limited, Tiruvallur District, Tamil Nadu

Submitted by

Anjan Drug Private Limited

Head Office 5th Floor, Nelson Towers, II Wing, 117, Nelson Manickam Road, Aminjikarai, Chennai, Tamil Nadu, India-600029

Plant M/s .Anjan Drug Private Ltd ·

85-88,105-109,112-116, .Export Promotion Industrial Estate SIPCOT,

Industrial Estate; Gummidipoondi Thiruvallur District,·Tamil Nadu

March 2017

of 36

Proponent Declaration

M/s Anjan Drug Private Limited, Tamil Nadu has prepared the “Pre- Feasibility Report

(PFR)” for Proposed Expansion of the Bulk Drug Unit at SIPCOT, Industrial Estate, Gummidipoondi at its existing facility

The PFR report preparations have been undertaken in compliance with the MoEF&CC.

Information and content provided in the report is factually correct for the purpose

and objective for such study undertaken.

We hereby declare the ownership of contents (information and data) of Form -1 and PFR Report.

On behalf of Anjan Drug Private Limited


by M/s Anjan Drug Private Limited, Tiruvallur District, Tamil

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Table of Contents 1. INTRODUCTION ......................................................................................................... 7

1.1. About the Company ................................................................................................ 7

1.2. Project of Interest .................................................................................................... 7

1.3. Existing Facility ...................................................................................................... 8

1.4. Project Location Details .......................................................................................... 8

1.5. Overview of the Proposed Project ......................................................................... 12

1.6. Need for the Proposed Products ............................................................................ 12

1.7. Environmental Friendly Operations ....................................................................... 13

1.8. Structure of the Report .......................................................................................... 13

2. DETAILS OF THE EXISITNG FACILITIES ............................................................. 14

2.1. Overview of the Existing Facilities........................................................................ 14

2.2. Manufacturing process of Existing Products .......................................................... 14

2.2.1. Manufacturing Process of Di-Ethyl Di-Proply Malonate (DEDPM) ............... 14

2.2.2. Manufacturing of n-Propyl Bromide (Currently not manufactured due to market

conditions although EC is obtained in 2008) ................................................................ 15

2.2.3. Manufacturing of Gabapentin ......................................................................... 16

2.3. By-Products Generation (Existing Operations) ...................................................... 17

2.4. Electrical Energy Use in the Existing .................................................................... 17

2.5. Existing Land area ................................................................................................ 17

2.6. Existing Environmental Management Plan & Environmental Clearance and

Compliance ..................................................................................................................... 18

2.7. Air Quality Management Plan ............................................................................... 18

2.8. Noise Levels in Existing Facility ........................................................................... 19

2.9. Water Consumption and Wastewater Generation ................................................... 19

2.10. Wastewater Treatment and Disposal .................................................................. 20

2.11. Generation of Solid waste, Treatment & Disposal .............................................. 21



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3. PROPOSED EXPANSION ACTIVITIES ................................................................... 23

3.1. Overview .............................................................................................................. 23

3.2. Manufacturing Process of Products ....................................................................... 24

3.2.1. Manufacturing of Gabapentin ......................................................................... 24

3.2.2. Manufacturing of Valproic Acid .................................................................... 25

3.2.3. Manufacturing of Pregabalin .......................................................................... 26

3.2.4. Manufacturing of ITO Pride HCl ................................................................... 28

3.3. Augmentation of Existing Plant and Machinery .................................................... 29

3.4. Water Consumption for the Proposed Expansion ................................................... 29

3.5. Wastewater Generation for the Proposed Expansion .............................................. 30

3.6. Solid Waste Generation and Disposal .................................................................... 31

3.7. Steam Demand and Fuel Requirements ................................................................. 31

3.8. Additional Man Power Required ........................................................................... 32

3.9. Power Requirement ............................................................................................... 32

4. PROPOSED ENVIRONMENTAL MANAGEMENT PLAN AND CLEARANCES

REQUIRED ........................................................................................................................ 33

4.1. Control of Air Emissions ....................................................................................... 33

4.2. Noise Control Measures ........................................................................................ 33

4.3. Additional Safety Measures Needed ...................................................................... 34

4.4. Hazardous Substances and Occupational Health Program ..................................... 34

5. Project Cost and Implementation ................................................................................. 36

5.1. Project Cost .......................................................................................................... 36

5.2. Project Timeline .................................................................................................... 36



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List of Tables

Table 1.1 List of Products Manufactured in the Existing Facility ........................................... 8

Table 1.2 Environmental Settings .......................................................................................... 9

Table 1.3 Details of the Existing Products and Proposed Products ....................................... 12

Table 2.1 Details of the Existing Products Manufactured at the Existing facility.................. 14

Table 2.2 Details of Land Use Breakup .............................................................................. 18

Table 2.3 Air Pollution Sources & Control Measures in the Existing Facility ..................... 19

Table 2.4 Water Requirement for the Existing Plant ........................................................... 19

Table 2.5 Existing ETP units ............................................................................................... 20

Table 2.6 Characteristics of Treated Effluent ....................................................................... 21

Table 2.7 Solid & Hazardous Waste Generation & Disposal Methods ................................ 22

Table 3.1 Details of the Existing and Proposed Products ..................................................... 23

Table 3.2 Details of Land Use Breakup ............................................................................... 29

Table 3.3 Wastewater Generation Details for Existing and Proposed ................................... 31

Table 3.4 Solid Hazardous Waste for Existing and Proposed .............................................. 31

Table 3.5 Steam Demand and Fuel Requirement for Existing & Proposed ........................... 32

Table 4.1 Existing and Proposed Emission Sources ............................................................. 33

Table 5.1 Bar Chart showing the Project Implementation .................................................... 36



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List of Figures Figure 1-1 Project Location ................................................................................................. 10

Figure 1-2 Google Earth Image of the Project...................................................................... 11

Figure 1-3 10km radius of the Project Site ........................................................................... 11

Figure 2-1 Manufacturing Process of Di-Ethyl Di-Proply Malonate (DEDPM) ................... 15

Figure 2-2 Manufacturing of n-Propyl Bromide................................................................... 16

Figure 2-3 Manufacturing of Gabapentin ............................................................................. 17

Figure 2-4 Water Balance for the Existing Facility .............................................................. 20

Figure 2-5 Zero Liquid Discharge System for the Exisitng Facility ..................................... 21

Figure 3-1 Manufacturing Process of Gabapentin ................................................................ 24

Figure 3-2 Manufacturing Process of Valproic Acid ............................................................ 25

Figure 3-3 Manufacturing Process of Pregabalin ................................................................. 27

Figure 3-4 Manufacturing Process of ITO Pride .................................................................. 28

Figure 3-5 Water Balance for the Proposed Expansion ........................................................ 30



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1. INTRODUCTION

1.1. About the Company

Anjan Drug Private Limited (ADPL) was founded in 1990 and has grown into a fully

integrated Pharmaceutical API manufacturing Organization, backed with immense

experience in development and manufacturing of bulk drugs. Anjan Drugs is now supplying

the Active Pharma Ingredients (API) to leading Formulation companies across the world. It

is committed for environmental protection as a drive for growth and contributes to value

creation with innovative and sustainable solutions for customers and for many industries form

different countries across the globe. At the same time, ADPL research and development is

focused on addressing the key trends for developing and producing quality ingredients which

are used for curing harmful diseases. Producing superior quality products by finding cost-

effective methods and environmental friendly operations for developing products, enables it

for providing better service.

1.2. Project of Interest

ADPL is operating one of its plants in SIPCOT Export Promotion, Industrial Park (EPIP),

Gummidipoondi, Tiruvallur District, Tamil Nadu for manufacturing bulk drugs. ADPL has

proposed to enhance the production of their existing products and addition of three new

products (Valproic Acid, Pregabalin and ITO pride HCl) based upon the present market

condition. The existing facility is located at the plot no. 85-88,105-109,112-116, SIPCOT

Export Promotion, Industrial Park (EPIP), Gummidipoondi, Tiruvallur District. The existing

land was leased form SIPOCT and the land lease agreement is attached as Annexure-1.The

total land available at facility is 12 acres in which existing facility is operated and proposed

expansion will be carried out within the same land. No additional land will be purchased for

this expansion.

The facility is mainly by surrounded foundries and power plant namely Vibromech-foundry,

RBA exports, Power point industries, JKM Ferro Tech, Abinava Aluminium(p)Ltd and OPG

power plant, Kamchi sponge and power palnt and other plants such as Hi- Tech carbon, etc.

Project site is located from the 9.2 km from the Eco-sensitive zone of Pilicat wildlife and bird

sanctuary as per the MoEF&CC notification S.O.22(E) dated 3/1/2014 and falls under

category A. The notification is attached as Appendix-1 for this report.



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1.3. Existing Facility

The existing was obtained environmental clearance letter vide no F.No. J-11011/1057/2007-

1A (II) in the year 2008 for manufacturing the bulk drugs presented in Table 1.1

Environmental Clearance obtained for the for the existing is attached as Annexure-2.

Presently the facility is manufacturing only DEDPM and Gabapentin. n-propyl Bromide was

not manufactured till date due to market conditions.

Table 1.1 List of Products Manufactured in the Existing Facility

S.No. Name of the Product Production Capacity

1 Di-Ehtyl Di-Propyle Malonate (DEDPM) 100MTPM 2 n-propyl Bromide* 100MTPM 3 Gabapentin 5 MTPM

*n-propoly Bromide is not manufactured till date due to market conditions although EC is obtained in 2008

The existing facility is designed to manufacture 205TPM of bulk drugs. Due to the market

conditions n-propyl Bromide is not manufactured till date. The production activities are

generally scheduled as per the market demand from time to time within the consented and

approved capacities. The existing facility is having permission to with draw sufficient

quantity of water from SIPCOT and the facility is also availed all the necessary regulatory

permissions such as Hazardous waste authorization and CTE and CTO form the concerned

authorities.

1.4. Project Location Details

The existing production facility of ADPL is located in the SIPCOT, Gummidipoondi,

Tiruvallur district, Tamil Nadu 601201. The Environmental setting of the project site is

presented in the Table 1.2. The general location of the project area is presented in Figure 1.1.

Google Earth imagery showing the project site is given in Figure 1.2. 10 km radius of the

project site is presented in Figure 1.3.



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Table 1.2 Environmental Settings

S. No. Particulars Details 1 Latitude 13°25'18.61"N 2 Longitude 80° 6'14.80"E 3 Site Elevation above MSL 17m 4 Topography Plain 5 Present land use at the site SIPCOT 6 Nearest highway NH 5 7 Nearest railway station Gummipoondi 8 Nearest airport Chennai Airport 9 Nearest town / city Gummidipoondi

10 Water body Pulicat Lake (10km from the project site) 11 Nearest Port Chennai port 12 Hills / valleys Nil 13 Archaeologically important places Nil 14 National parks / Wildlife Sanctuaries Pulicat bird Sanctuary 15 Reserved / Protected Forests Nil 16 Seismicity Zone III seismic zone map of India 2002 17 Defence Installations Nil

18 Industries Located in the SIPCOT complex

Vibromech-foundry, RBA exports, Power point industries, JKM Ferro Tech, Abinava Aluminium(p)Ltd and OPG powerplant, Kamchi sponge and power palnt and other plants such as Hi- Tech carbon



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Figure 1-1 Project Location



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Figure 1-2 Google Earth Image of the Project

Figure 1-3 10km radius of the Project Site

Scale

10 km



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1.5. Overview of the Proposed Project

The proposed project involves the increasing the production capacity for two products and

addition of three new products. The details of the existing and proposed products are

presented in Table 1.3. The proposed expansion will be carried out within the existing

production facility and new facility within the existing land will be utilized to manufacture

additional two new products.

The necessary infrastructure in terms of land, water and personnel are readily available. As

the proposed expansion will be carried out within the existing land which belongs to the

ADPL, rehabilitation and resettlement aspects are not envisaged for the proposed expansion.

There will be no significant adverse impact on the environment due to the project since all the

necessary measures are proposed to be adopted.

Table 1.3 Details of the Existing Products and Proposed Products

S. No. Name of Products

Production Capacity (Tons/Month)

Existing Additional Quantities (proposed)

Total After Expansion

Products (Tons/Month) 1. n-Propyl Bromide* 100 - 100 2. Di-Ethyl Di-Propyl Malonate 100 - 100 3. Gabapentin 5 45 50 4. Valproic Acid - 100 100 5. Pregabalin - 20 20 6. Ito Pride HCl - 10 10

Total Capacity 205 175 380

*n-propoly Bromide is not manufactured till date due to market conditions although EC is obtained in 2008.

1.6. Need for the Proposed Products

Bulk drugs manufactured in APDL are the raw material for many medicine manufacturers

around the globe. Enormous amount of bulk drug products from India are exported to Global

markets. To remain as a significant player in the market and to meet the increasing demand of

bulk drugs in India and abroad, ADPL has proposed the expansion of existing capacity along

with three new additional products in the category of bulk drug products.

Proposed Expansion Proposed Products Legend:



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1.7. Environmental Friendly Operations

The facility has been adopting a robust environmental management programs and have been

achieving the regulatory compliance in the existing facility. The facility was issued

environmental compliance by MOEF, vide letter no. F.No. J-11011/1057/2007-1A (II), dated

February 27th 2008 and obtained CTE, CTO from the concerned authority TNPCB are given

in Annexure 3.

The consent to operate under Air (Prevention) and Control of Pollution Act and Water

(Prevention) and Control of Pollution Act are obtained as per the norms and guidelines of the

Tamil Nadu Pollution Control Board (TNPCB) from time to time.

1.8.Structure of the Report

This Pre-feasibility report consists of five chapters:

Chapter 1: Introduction and Justification of the Project

Chapter 2: Details of Existing Facilities and Summary of Environmental Compliance

Chapter 3: Details of Proposed Expansion Activities

Chapter 4: Proposed Environmental Management Plan & Clearances Required

Chapter 5: Project Cost & Implementation



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2. DETAILS OF THE EXISITNG FACILITIES

2.1. Overview of the Existing Facilities

ADPL is having the capacities for producing 205 TPM of bulk drugs in the existing facility.

The details of the existing products are presented in Table 2.1. The summary of existing

facility and proposed project configuration is presented in Annexure 4. The existing peak

capacity is 205 TPM and current operating capacity is only 105TPM as the existing plant is

not manufacturing n-Propyl Bromide due to market conditions.

Table 2.1 Details of the Existing Products Manufactured at the Existing facility

S. No. Name of Products Production Capacity (Tons/Month)

Products (Tons/Month) 1. Di-Ethyl Di-Propyl Malonate 100 2. n-Propyl Bromide* 100 3. Gabapentin 5

Total Capacity 205 *n-propoly Bromide is not manufactured till date due to market conditions although EC is obtained in 2008.

2.2. Manufacturing process of Existing Products

2.2.1. Manufacturing Process of Di-Ethyl Di-Proply Malonate (DEDPM)

Diethyl Malonate react with n-Propyl Bromide in presence of NaOH to give Diethyl di propyl

malonate. After washing Sodium bromide isolated and DEDPM is separated. Sodium

Bromide formed during the process is isolated separately and packed for sales as by product.

C7H12O4 +2C3H7Br + 2NaOH C13H24O4 + 2 NaBr + H2O



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Total Process Hrs: 26.0 Hrs

1.0 Ton DEDPM preparation - outlet Effluent 1.455 (Tons) of sodium bromide in Aqueous

Medium.

Figure 2-1 Manufacturing Process of Di-Ethyl Di-Proply Malonate (DEDPM)

2.2.2. Manufacturing of n-Propyl Bromide (Currently not manufactured due to

market conditions although EC is obtained in 2008)

Propanol reacts with Sodium bromide (received from DEDPM) in the presence of sulphuric

acid medium to give n-Propyl Bromide. Sodium Sulphate formed during this process is

isolated separately and packed for sales as by product.

2C3H8O + 2NaBr + H2SO4 2C3H7Br + Na2SO4 + 2H2O

Reactors

Reflux

Cooling & Washing

DEM +

n-PBr +

NaOH

H2O

NaBr

DEDPM

n-Propyl Bromide By Product



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Output Product: 1.0 Ton n-propyl bromide; Output Effluent: 4.3Tons (Na2SO4 in Aqueous

medium)

Figure 2-2 Manufacturing of n-Propyl Bromide

2.2.3. Manufacturing of Gabapentin

1,1Cyclohexane di acetic mono amide reacts with Sodium Hypochlorite in the presence of

sodium hydroxide medium, and Hydrochloric acid to give Gabapentin, and Sodium Chloride

formed during neutralization stage is isolated separately and packed for sales.

C10H17NO3 + NaOCl+ NaOH+ HCl C9H17NO2 + NaCl + CO2 + H2O

N-Propanol +H2SO4

Reflux

Cooling & Layer separation

Na2SO4

NaBr

Water



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Output Product: 1.0 Ton; Output Effluent: 7.8 Tons (NaCl in Aqueous medium)

Figure 2-3 Manufacturing of Gabapentin

2.3. By-Products Generation (Existing Operations)

Besides the production of main products, Sodium Bromide and Sodium Chloride are being

produced as by-products from the processing of main products.

2.4. Electrical Energy Use in the Existing

The existing plant’s connected load is 1302KW (1041KVA) and having a peak load of

379kW (474 KVA).

2.5.Existing Land area

The existing land was leased form SIPCOT. The total land leased is 12acres in which existing

plant is operated and proposed expansion will be carried out within the same land. The land

lease document for 12 acres from SIPOCT is attached as Annexure-1.

Reactor

Neutralization

Cooling & Chilling

Centrifuge

Drying

Amide Sodium Hypo Chloride Sodium Hydroxide,

HCl

Purified Water

NaCl

Gabapentin



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Table 2.2 Details of Land Use Breakup

S.No Land use Area in Acres 1 Built up Area 0.343 2 Vacant Area 8

3 Soild Waste Storage/Disposal area 0.66

4 Green Belt Area 3 Total 12

2.6. Existing Environmental Management Plan & Environmental Clearance and

Compliance

The facility has been adopting a robust environmental management programs and have been

achieving the regulatory compliance in the existing facility. The facility was issued

environmental compliance by MOEF, vide letter no. F.No. J-11011/1057/2007-1A (II), dated

February 27th 2008 and obtained CTE, CTO form the concerned authority TNPCB.

The consent to operate under Air (Prevention) and Control of Pollution Act and Water

(Prevention) and Control of Pollution Act are obtained as per the norms and guidelines of the

Tamil Nadu Pollution Control Board (TNPCB) from time to time.

2.7.Air Quality Management Plan

The major air pollution sources of the existing plant are Boiler, DG set (occasionally) and

fugitive emission from process activities. ADPL have already installed adequate Air Pollution

Control Measures to conform with the norms of National Ambient Air Quality Standards

(NAAQS). The details of the existing air pollution sources with control measures are

presented in Table 2.3



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Table 2.3 Air Pollution Sources & Control Measures in the Existing Facility

S.No Source Air Pollution Control Measure

Height (m) ground level

1 DG set 2x320 KVA Stack 13.5 2 Boiler 3T Stack 30 3. Reactor Falling film venture scrubber

Stack emission monitoring was undertaken by Tamil Nadu Pollution Control Board once in

six months. SPM, SO2 and NOX parameters are monitored by MOEF approved laboratory

and also TNPCB. The test reports of Air Quality Monitoring and stack emission monitoring

undertaken by Tamil Nadu State Pollution Control Board (TNPCB) are presented in

Annexure 5.

2.8. Noise Levels in Existing Facility

The Noise Level Monitoring has been monitored by the TNPCB once in six months. Five

locations were selected to monitor for noise levels in the existing plant. The test reports of

noise monitoring from the TNPCB are given in Annexure 6. Noise levels at the facility are

well within the stipulated levels.

2.9. Water Consumption and Wastewater Generation

Water required for the plant is met through the supplies from SIPCOT. The SIPCOT water

allocation letter is attached as Annexure 7. The existing water consumption is 25.5m3/day

and the details of the same are presented in Table 2.4 and the water balance diagram is

presented in Figure 2.1.

Table 2.4 Water Requirement for the Existing Plant

Unit Water requirement (m3/day)

Reactor 15 Boiler & Cooling Tower make up 8 Domestic & Gardening 2.5

Total 25.5



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Figure 2-4 Water Balance for the Existing Facility

2.10. Wastewater Treatment and Disposal

The existing plant effluent generated is about 12m3/day and is treated in existing ETP having

capacity of 18m3/day and consisting of the following equipments presented in Table 2.5 and

the block diagram of the ETP is presented in Figure 2.2 .

Table 2.5 Existing ETP units

Sl.No Name of the Treatment Unit No of Units

Dimensions (meters)

1. Collection Tank 1 5x5.2x5.75 2. Flash Mixer 1 2.5x2.4x2.5 3. Flocculator 1 2.5x2.4x2.5 4. Primary Settling tank 1 5x5.2x5.75 5. Filter feed tank 1 5x5.2x5.75 6. Pressure sand filter 1 10m3/hr 7. Activated Carbon Filter 1 10m3/hr 8. RO unit 1 6m3/hr 9. Mechanical Evaporator 1 750 l/h

10. Solar Evaporation Pan 12 10.6x7.4x0.3 each

All the Units are in m3/day

Fresh Water 25.5

Reactors Boiler &Cooling

Tower

Domestic & Gardening

ETP

Solar Evaporation

Ponds

15

8

8

4

2.5

12

12



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Figure 2-5 Zero Liquid Discharge System for the Exisitng Facility

The ETP outlet & MEE Reject is collected and tested by TNPCB District Environmental

Laboratory, Ammbattur. The analysis is presented in Table 2.6 and the analysis report is

attached as Annexure 8.

Table 2.6 Characteristics of Treated Effluent

S.NO Parameter Unit Value

ETP outlet

MEE Reject

1 pH - 6.55 6.88 2 TSS mg/l 114 16 3 TDS mg/l 1530 286 4 BOD at 270Cfor 3days mg/l 155 3 5 COD mg/l - 40

2.11. Generation of Solid waste, Treatment & Disposal

ADPL has obtained Hazardous waste authorization letter from the TNPCB which was

obtained on 18/08/2015 and valid for five years. The details of the hazardous and non

Collection Tank

Flash Mixer

Primary

Settling Tank

Activated

Carbon Filter

Pressure

Sand Filter

RO

Flocculator

MEE

SEP



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hazardous waste generated are presented in Table 2.7. The Hazardous waste authorization

letter from TNPCB is attached as Annexure 9.

Table 2.7 Solid & Hazardous Waste Generation & Disposal Methods

S. No. Type of Waste Category Peak

generation Quantities

Current Disposal method

Hazardous

1

Production/formulation of drugs/pharmaceuticals & health care product(Schedule I)

28.1 10 TPA Recover and reuse CPCB authorized recycler

2

Purification and treatment of exhaust water and waste water from the processes in this schedule and CETPs (Schedule I)

34.3 2 TPA Recover and reuse CPCB authorized recycler

Non-hazardous 1 Food waste - 200 Kg/month Piggery yard

2 Plastic waste - 50 Kg/month Sold to the authorized dealers



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3. PROPOSED EXPANSION ACTIVITIES

3.1.Overview

ADPL has proposed to enhance the production of their existing product DEDPM and addition

of three new products (Valproic Acid, Pregabalin and ITO pride HCl) based upon the present

market conditions.

The proposed project is for expansion of production of bulk drugs by the addition of other

three new products is presented in Table 3.1.

Table 3.1 Details of the Existing and Proposed Products

S. No. Name of Products

Production Capacity (Tons/Month)

Existing Additional Quantities (proposed)

Total After Expansion

Products (Tons/Month) 1. n-Propyl Bromide* 100 - 100 2. Di-Ethyl Di-Propyl Malonate 100 - 100 3. Gabapentin 5 45 50 4. Valproic Acid - 100 100 5. Pregabalin - 20 20 6. Ito Pride HCl - 10 10

Total Capacity 205 175 380

*n-propoly Bromide is not manufactured till date due to market conditions although EC is obtained in 2008.

The proposed expansion will be carried out within the existing facility. The existing facility is

located at the plot no. 85 to 88, 105, 106,115 and 116, SIPCOT Export Promotion, Industrial

Park (EPIP), Gummidipoondi, Tiruvallur District. The total land area available at the facility

is 12 acres in which existing facility (built up area) is operated and same land will be utilized

for the proposed expansion. No additional land will be purchased for this expansion.

As with the improvement in the technology and sciences ADPL has modified the existing

process according to the “Green Chemistry”. By adopting to this type of technologies the

solvents used in the processes are eliminated and thereby reducing the emissions from the

process.

Proposed Expansion Proposed Products Legend:



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3.2. Manufacturing Process of Products

3.2.1. Manufacturing of Gabapentin

1,1Cyclohexane di acetic mono amide reacts with Sodium Hypochlorite in the presence of

sodium hydroxide medium, and Hydrochloric acid to give Gabapentin, and Sodium Chloride

formed during neutralization stage is isolated separately and packed for sales.

C10H17NO3 + NaOCl+ NaOH+ HCl C9H17NO2 + NaCl + CO2 +H2O


Output Product: 1.0 Ton; Output Effluent: 7.8 Tons (NaCl in Aqueous medium)

Figure 3-1 Manufacturing Process of Gabapentin

Reactor

Neutralization

Cooling & Chilling

Centrifuge

Drying

Amide Sodium Hypo Chloride Sodium Hydroxide

HCl

NaCl (Isolation)

Gabapentin

Purified Water



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3.2.2. Manufacturing of Valproic Acid

Diethyl Malonate react with n-Propyl Bromide in presence of NaOH to give Diethyl di propyl

malonate. After washing Sodium bromide is isolated and DEDPM is separated and

DEDPM on hydrolysis & decarboxylation using Sodium Hydroxide and HCL,

Valproic Acid is obtained.

By-products: Sodium Bromide formed during the process is isolated separately and packed

for sales as by product (from reaction 1). Ethanol & Sodium Chloride from 2nd reaction as by-

products.

C7H12O4 +2C3H7Br + 2NaOH C13H24O4 + 2 NaBr + H2O

C13H24O4 + 2 NaOH +2 HCl C8H16O2 +2NaCl+2C2H6O +CO2

Figure 3-2 Manufacturing Process of Valproic Acid

DEM + n-PBr + NaOH

Valproic Acid

Reactors

Distillation

Water

Neutralization

Decarboxylation

NaCl

HCl

Washing Water

Reactor

Reflux

Cooling & Washing

DEDPM+ NaOH

NaBr

Reflux



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Outlet Effluent 1.455 (Tons) of sodium bromide in Aqueous Medium & 4.2 Tons

(NaCl in Aqueous medium) & Ethanol (0.8 Tons).

Output Product: 1.0 Ton Valproic Acid

3.2.3. Manufacturing of Pregabalin

Manufacturing of Pregabalin involves two stages

1. Manufacture of 3- Carbomoylmethyl-5-Methyl Hexanoic Acid

2. Manufacture of Pregabalin using 3- Carbomoylmethyl-5-Methyl hexanoic acid as a

raw material.

Carbomoylmethyl-5-Methyl Hexanoic Acid is manufactured by reacting 3-Isobutyl Glutaric

Acid with Diamide followed by heat reflux and addition of sodium hydroxide. The next step

involves neutralization with HCl, Cooling, Centrifuging and drying. 3-Carbamoylmethyl-5-

methyl Hexanoic acid (R-CMH) react with NaOCl in presence of sodium hydroxide medium

& neutralization using HCl, to give Pregabalin & sodium chloride recovered.

1. 3-Iso butyl glutaric acid to 3- Carbamoyl 5-methyl Hexanoic acid

C9H16O4 + CH4N2O+ NaOH+ HCl C9H17NO3 + NaCl + NH3+CO2 + H2O

Process Hrs: 31.0 hrs

Product : 1.0 Ton, Effluent : 2.014 Ton (NaCl in Aqueous medium)

2. 3-Carbamoyl 5- methyl hexanoic acid to Pregabalin

C9H17NO3 + NaOCl + HCl + NaOH C8H17NO2 +2 NaCl + CO2 + H2O


Product : 1.0 Ton ; Effluent : 8.232 Tons (NaCl in Aqueous medium)



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Figure 3-3 Manufacturing Process of Pregabalin

Reactors

Lye addition

Heat Reflux

Neutralization

Cooling & Chilling

Centrifuging

Drying

3-Isobutyl Glutaric Acid, Diamide

NaOH

HCl

NaCl

Carbamoylmethyl-5-methyl Hexonic Acid

Reactors Sodium Hypo Chloride

Hypo chilling

NaCl

Reactor NaoH

Neutralization HCl

Centrifuging

Water

Drying

Pregabalin



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3.2.4. Manufacturing of ITO Pride HCl

(2-[4 - aminomethyl) phenoxy] N,N-dimethyl Ethan amine) is reacted with Veratroyl

Chloride in presence of anhydrous sodium hydroxide medium. Neutralization using HCl, the

product is isolated and removal of the sodium chloride salt solution. formation of the

ItoPride HCl.

C11H18N2O + C9H9ClO3 + NaOH + HCl

Ito amine Veratroyl Chloride

C20H26N2O4 .HCl + NaCl + H2O

Ito Pride Hydrochloride


Out Put Product : 1.0 Ton; Out Put Effluent : 1.8 Tons (NaCl in Aqueous medium )

Figure 3-4 Manufacturing Process of ITO Pride

Reactors

Heat Reflux

NaCl

Dissolution

Neutralization

Cooling & Chilling

Centrifuging

Drying

ITO Pride

ITO Amine (2-[4 - aminomethyl phenoxy] N,N-

dimethyl ethanamine ) &

Vertroyl Chloride (3 ,4 -d imethoxy benzoyl chloride)

NaOH

HCl



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3.3.Augmentation of Existing Plant and Machinery

The proposed project involves expansion of bulk drugs in their existing facility. Hence

naturally no alternative sites are considered. The details of the land break up are as shown in

the Table 3.2. Locations of the proposed facilities to be installed within the existing facility

in the Master Layout are given as Annexure 10.

Table 3.2 Details of Land Use Breakup

S.No Land use Area in Acres 1 Built up Area 0.343 2 Vacant Area 8

3 Solid Waste Storage/Disposal area 0.66

4 Green Belt Area 3 Total 12

3.4.Water Consumption for the Proposed Expansion

At present the total water requirement is 25.5m3/day and after the proposed expansion the

raw water requirement will be increased to 260m3/day which will be sourced from SIPCOT.

In order to maintain environmental friendly operations ADPL has proposed a new quadruple

effect evaporator system with a dedicated 3TPH boiler system. The solids form the ATDF

(Agitated Thin Film Dryer) will be disposed to an authorized vendor.



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Figure 3-5 Water Balance for the Proposed Expansion

3.5.Wastewater Generation for the Proposed Expansion

After expansion wastewater generated will be 90m3/day out of which 70m3/day of treated

water will be recycled back to the process in the form of condensate. Before going to the

process the condensate is sent to the condensate polishing unit where the losses in this

process will be approximately 20 to 30m3/day and remaining 40m3/day to 50m3/day will be

utilized in the boiler as feed water.

In order to maintain environmental friendly operations ADPL has proposed a new quadruple

effect evaporator system with a dedicated 3TPH boiler system. The solids form the ATDF

(Agitated Thin Film Dryer) will be disposed to an authorized vendor. Wastewater generation

details are presented in Table 3.3.

All the Units are in m3/day

Fresh Water (260m3/day)

Reactors Boiler Cooling Tower Domestic Usage

Gardening

ETP

Quadruple Effect

Evaporator

ATDF

130

50

70

30

25

10

15

15

20

90

90 70

Recycled to Boiler

STP

Solids for disposal Proposed

Units



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Table 3.3 Wastewater Generation Details for Existing and Proposed

Equipment

Existing Wastewater generation (m3/day)

Proposed Wastewater Generation

(m3/day)

Reactor 8 55 Boiler 2 25 Cooling Tower 2 10

Total 12 90

3.6.Solid Waste Generation and Disposal

The details of solid waste (both hazardous & non-hazardous) generated for existing and post

project scenarios of the plant are given in Table 3.4 along with quantity and disposal

methods. For the new and increased quantity, application will be made to TNPCB for

authorization after getting prior environmental clearance.

Table 3.4 Solid Hazardous Waste for Existing and Proposed

S. No. Type of Waste Category

Existing Peak


Proposed Peak


Current Disposal method

Hazardous

1

Production/formulation of drugs/pharmaceuticals & health care product(Schedule I)

28.1 10 TPA

50 TPA

Recover and reuse CPCB authorized recycler

2

Purification and treatment of exhaust water and waste water from the processes in this schedule and CETPs (Schedule I)

34.3 2 TPA 25 TPA

Recover and reuse CPCB authorized recycler

Non-hazardous

1 Food waste - 200 Kg/month 1000 Kg/month

Piggery yard

2 Plastic waste - 50 Kg/month 500 kg/month

Sold to the authorized dealers

3.7.Steam Demand and Fuel Requirements

At present the existing facility is having 3TPH boiler with a steam demand of 0.35TPH. After

the expansion additional 3x2TPH boilers will be installed to fulfill the steam demand for



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process as well as quadruple effect evaporator system. The steam requirement for quadruple

effect evaporator system will be in the range of 0.24 TPH and for process will be to the tune

of 0.64 which will be provided by another boiler.

At present furnace oil of 20KL/month is used as fuel to the existing boiler. Fuel requirement

will be increased to 80KL/Month due to installation of 3x2 TPH Boilers.

Table 3.5 Steam Demand and Fuel Requirement for Existing & Proposed

Particulars Units Existing Additional Proposed Steam Demand TPH 0.35 0.59 0.88

Furnace Oil KL/Month 20 60 80

3.8.Additional Man Power Required

The unit is operated round the clock in three shifts. For the expansion project, additional man

power of 90 Nos. will be deployed. Total number of employees (including contract workers)

after expansion will be 50 nos.

3.9.Power Requirement

The peak demand in the existing plant is about 474 KVA which is being sourced from Tamil

Nadu Generation and Distribution Corporation Limited (TANGEDCO). After the proposed

expansion an additional power of 400 KVA will be required which will also sourced from

TANGEDCO. Total requirement power will be decreased after expansion as the process

technology is going to be changed.

As back-up power 2 no’s of DG sets having capacity of 325 KVA is available in the existing

plant



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4. PROPOSED ENVIRONMENTAL MANAGEMENT PLAN AND

CLEARANCES REQUIRED

4.1.Control of Air Emissions

The main source of emissions from the existing plant is 325KVA DG set and 3TPH boiler.

After expansion the only source for additional increase of emission will be 3TPH boiler. The

details of the existing and proposed emissions and control measures are given in Table4.1.

Table 4.1 Existing and Proposed Emission Sources

Point Emission Sources

Air Pollution Control Measures

Stack Height (m)

DG set 325 KVA Stack 13.5 3 TPH Boiler Stack 26 2x3TPH Boiler (Proposed) Stack (Proposed) --

Fugitive Emission Sources Control Measure

Reactor Falling Film venture scrubber with water media

4.2.Noise Control Measures

Construction Phase

Structural work, deployment of machinery, approach road construction will result in

noise and vehicular traffic. Material handling and transportation would also lead to

significant noise pollution. Continuous exposure of workers to high sound levels may

result in annoyance, fatigue etc. The acceptable limit for each shift being of 8-hour

duration, the equivalent noise level exposure during the shift is 90 dB(A). Hence noise

generation due to excavation may affect workers, if equivalent 8 hours exposure is more than

the safety limit. The workers in general are likely to be exposed to an equipment noise level

of 80-90 dB (A) in an 8 hour shift for which all statutory precautions as per laws will

be taken into consideration. Thus the negative impact will be short-term and reversible

(limited to the duration of the road construction works) and is not considered to be a

significant threat to the health or well being of humans.



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Mitigation Measures

Construction activities generating disturbing sounds will be restricted to normal working

hours

Workers operating equipment which generates noise will be equipped with noise

protective gear. Workers experiencing prolonged noise levels of 70 – 80 dBA should

wear earplugs

Construction activities will be restricted to daytime and no construction will be

practiced during night

To reduce the impact of air and noise pollution and to provide a clean, healthy

environment, a greenbelt area is maintained within the project site and along the

roadsides.

Operation Phase

No significant increase in the noise levels due to the operation of the proposed production

activities is expected. The additional proposed utilities having potential to generate noise are

DG set, Air Compressor, cooling tower and chiller. Noise levels at 1m distance from the

source will be maintained less than 85 dB(A).

4.3.Additional Safety Measures Needed

The safety measures adopted at the existing facility such as fire fighting system, personal

protective equipment are in line with the proposed project expansion. Additional safety

measures for the proposed tank farm will be developed as per the applicable guidelines.

4.4.Hazardous Substances and Occupational Health Program

Chemicals in any form are to be stored, handled and used by thoroughly understanding

their physical, chemical and hazardous properties and necessary precautions will be taken

to avoid any potential hazards. Chemicals will be stored in standard containers like MS,

HDPE, GI Drums, PVC Carboys, etc. All the chemicals will be arranged and stored in

accordance with their compatibility, dry, well ventilated, with flame proof electrical

equipment’s and lighting. All the chemicals will be provided with identification labels.



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Chemical Safety Data Sheets and handling procedure will be prepared and displayed for

information and safety of the working personnel.

As per the guidelines of MoEF, EHS Management Group is formed by ADPL. The

commitment and policy of the company includes the implementation of the Environmental

Management Plan that incorporates all issues related to environmental and social components

and will comply with the suggestions given by the Ministry of Environment and Forests

(MoEF).



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5. Project Cost and Implementation

5.1.Project Cost

The estimated project cost for the proposed expansion project is about Rs.32 Crores. out of

which about Rs.7Cr will be spent towards Environmental Protection and management

programs under the expansion program.

5.2.Project Timeline

The bar chart showing the project implementation is given in Table 5.1. The project will be

completed within 9 months form date of obtaining all the required statutory and regulatory

permissions.

Table 5.1 Bar Chart showing the Project Implementation

Sl. No. Description No. of Months

1 2 3 4 5 6 7 8 9

1 Procurement of Equipment

2 Civil & Structural Work

3 Equipment Erection

4 Electricals & Auto machines

5 Tests and Trial Runs

6 EB Yard and related work

7 Commissioning and Trial Production.

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