or btaining or xpansion of api & … report for obtaining tor “for expansion of api &...

PRE-FEASIBILITY REPORTFOR OBTAINING TOR “FOR EXPANSION OF API & INTERMEDIATE

MANUFACTURING FACILITY” OF SUN PHARMACEUTICAL

INDUSTRIES LIMITED AT GHIRONGI INDUSTRIAL AREA, MALANPUR,

BHIND-DISTRICT, MADHYA PRADESH

PROJECT PROPNENTM/S SUN PHARMACEUTICAL INDUSTRIES LIMITED

GHIRONGI INDUSTRIAL AREA, MALANPUR, BHIND-DISTRICT,

MADHYA PRADESH

ENVIRONMENT CONSULTANTENVIROTECH EAST PVT. LTD.

KOLKATA

MAY-2017

PRE-FEASIBILITY REPORT FFoorr OObbttaaiinniinngg TTOORR ““FFoorr EExxppaannssiioonn ooff AAPPII && IInntteerrmmeeddiiaattee MMaannuuffaaccttuurriinngg FFaacciilliittyy””ooff SSuunn PPhhaarrmmaacceeuuttiiccaall IInndduussttrriieess LLiimmiitteedd aatt GGhhiirroonnggii IInndduussttrriiaall AArreeaa,, MMaallaannppuurr,, BBhhiinndd DDiissttrriicctt,, MM..PP..

TOC

PROJECT PROPONENT Page I

ENVIRONMENT CONSULTANT Sun Pharmaceutical Industries Ltd.

(SPIL) Envirotech East Pvt. Ltd.

(EEPL)

TABLE OF CONTENT CONTENT OF CHAPTERS

Section Page No. 1. Executive Summary 1-3 1.1 Introduction 1 1.2 Project History 1 1.3 Project Location & Connectivity 2 1.4 Project Details 2 2. Introduction 4-6 2.1 Identification of Project & Project proponent 4 2.2 Brief description of nature of project 4 2.3 Need for the project & its importance to the country 5 2.4 Demand-Supply Gap 5 2.5 Imports V/s indigenous production 5 2.6 Export Possibility 6 2.7 Domestic/Export Markets 6 2.8 Employment generation 6 3. Project Description 7-35 3.1 Type of Project Including Inter-Linked or Interdependent Project 7 3.2 Project Location 7 3.3 Details of alternative sites considered 8 3.4 Size & Magnitude of Operation 8 3.5 Project Description with Process Details 8 3.5.1 Proposed Production Capacity 8 3.5.2 Detailed Manufacturing Processes, Chemical/Molecular Balances, Process Flow-Charts 8 4. Site Analysis 36-41 4.1 Connectivity 36 4.2 Land Form, land-use & ownership 36 4.3 Topography 36 4.4 Existing Land-use pattern 36 4.5 Existing Infrastructure 37 4.6 Soil classification 38 4.7 Climatic Data from Secondary Sources 38 4.8 Social Infrastructure Available 41 5. Planning Brief 42 5.1 Planning Concept 42 5.2 Population projection 42 5.3 Land-use planning 42 5.4 Amenities/Facilities 42 6. Proposed Infrastructure 43-51 6.1 Industrial Area. 43 6.2 Residential Area 44 6.3 Plantation and Greenbelt 44 6.4 Social Infrastructure 45

PRE-FEASIBILITY REPORT FFoorr OObbttaaiinniinngg TTOORR ““FFoorr EExxppaannssiioonn ooff AAPPII && IInntteerrmmeeddiiaattee MMaannuuffaaccttuurriinngg FFaacciilliittyy””ooff SSuunn PPhhaarrmmaacceeuuttiiccaall IInndduussttrriieess LLiimmiitteedd aatt GGhhiirroonnggii IInndduussttrriiaall AArreeaa,, MMaallaannppuurr,, BBhhiinndd DDiissttrriicctt,, MM..PP..

TOC

PROJECT PROPONENT Page II

ENVIRONMENT CONSULTANT Sun Pharmaceutical Industries Ltd.

(SPIL) Envirotech East Pvt. Ltd.

(EEPL)

6.5 Connectivity 45 6.6 Drinking Water Management 45 6.7 Details of ETP 45 6.8 Zero discharge 47 6.8 Industrial Waste Management 48 6.9 Waste Water Generation 49 6.10 Requirement & Supply/ Source 51 7. Rehabilitation & Resettlement Plan 52

8. Project Schedule & Cost Estimate 53

9. Analysis of Proposal 54

CONTENT OF TABLES

Table 3.1: Locational Details 7 Table 3.2: Production Capacity 8 Table 3.3: Water Consumption 30 Table 3.4: Waste Water Generation Detail 30 Table 3.5: Fuel Consumption 32 Table 3.6: Hazardous Waste Generation 33 Table 3.7: Stack Detail 33 Table 3.8: Process Vent Detail 34 Table 4.1: Connectivity of particulars from the Sun Pharmaceutical Industries Ltd 36 Table 4.2: Present Land use Pattern of Lease Area 37 Table 4.3: Predominant Wind Direction 38 Table 4.4: Climatic Data of IMD-Malanpur (Distt-Bhind) (1971-2000) 39 Table 6.1: Equipment’s & Machinery Details 43 Table 6.2: Connectivity of particulars from the Sun Pharmaceutical Industries Ltd 45 Table 6.3: Hazardous Wastes Generated and their Disposal Methods 48 Table 6.4: Sources of Air Pollution 49 Table 6.5: R.O. Plant Parameter Details 50

CONTENT OF FIGURES

Figure 3.1: Flow Diagram of Alpha Keto Ester 9 Figure 3.2: Flow Diagram of Bicyclo Ketone 13 Figure 3.3: Flow Diagram of Doripenem 18 Figure 3.4: Flow Diagram of Erta Penem 20 Figure 3.5: Flow Diagram of Enol Phosphate 23 Figure 3.6: Flow Diagram of Effluent Treatment Plant 31 Figure 4.1: Layout of plant 37 Figure 4.2: Windrose(Summer season)-Gwalior, IMD 41 Figure 6.1: Flow Diagram of Effluent Treatment Plant 47 Figure 6.2: Zero Discharge Faculty 47 Figure 6.3: P&ID of R.O. Plant 50

CHAPTER 1

EXECUTIVE SUMMARY

PRE-FEASIBILITY REPORT FFoorr OObbttaaiinniinngg TTOORR ““FFoorr EExxppaannssiioonn ooff AAPPII && IInntteerrmmeeddiiaattee MMaannuuffaaccttuurriinngg

FFaacciilliittyy””ooff SSuunn PPhhaarrmmaacceeuuttiiccaall IInndduussttrriieess LLiimmiitteedd aatt GGhhiirroonnggii IInndduussttrriiaall

AArreeaa,, MMaallaannppuurr,, BBhhiinndd DDiissttrriicctt,, MM..PP..

1

PROJECT PROPONENT Page-

1

ENVIRONMENT CONSULTANT

M/s Sun Pharmaceutical Industries Ltd.

(SPIL)

Envirotech East Pvt. Ltd.

(EEPL)

1. EXECUTIVE SUMMARY

1.1 INTRODUCTION

Sun Pharmaceutical Industries Limited is an Indian multinational pharmaceutical company

headquartered in Mumbai, Maharashtra that manufactures and sells pharmaceutical formulations and

active pharmaceutical ingredients (APIs) primarily in India and the United States. The company offers

formulations in various therapeutic areas, such as cardiology, psychiatry, neurology, gastroenterology

and diabetology. It also provides APIs such as warfarin, carbamazepine, etodolac, and clorazepate, as

well as anticancers, steroids, peptides, sex hormones, and controlled substances.

Sun Pharmaceutical Industries Limited, India's largest pharmaceutical company, is an integrated,

research based, multinational pharmaceutical company producing a wide range of quality, affordable

generic medicines, trusted by healthcare professionals and patients across geographies. Sun Pharma’s

continued focus on R&D has resulted in several approvals, in developed and emerging markets many of

which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its

own labs. The company has further strengthened its focus on generics research and is increasingly

working on more complex and specialty areas.

This Malanpur unit engaged in the manufacture of Active Pharmaceutical Ingredients (APIs) &

Intermediates. It is a multi-product manufacturing site engaged in manufacturing of new generation

antibiotics. These products are manufactured in campaigns through multi-step organic synthesis using

batch processes. The product portfolio is a mix of high volume, low value and low volume, high value

products.

The site has modern state-of–the-art plants facilitating minimal manual intervention and consistent

reproduction of processes, on an ongoing basis, and these are built to GMP standards.

The Land is taken on lease by M/s Sun Pharmaceuticals Industries Limited from the Govt. of Madhya

Pradesh – Industrial Infrastructure Development Corporation.

1.2 PROJECT HISTORY

The Plant had started its operations since 1995 with name M/s Cardinal Drugs Ltd with valid EC and at

a later stage M/s Ranbaxy took over the plant in the year 2006. In the year 2008 the M/s Ranbaxy

applies to the CTO & receives the CTO with specific condition in which it mentioned to install the Multi

Effect Evaporator (MEE), to upgrade the pollution control facility & to ensure the solvent recovery not

less then 95%.

MPPCB asked the Site to obtain EC in 2013 with present ownership name. Accordingly, an application

for EC was filed with the name of M/s Ranbaxy Ltd. on 2013 & 2014, CTO for air and water were

rejected by MPPCB stating that Environmental Clearance has not been obtained.




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M/s Cardinal Drugs Ltd. Started operations for production of bulk drugs with valid EC (EC no-

1101/53/95-IA.II(I)) dated 9th Nov 1995 with the production capacity approval of 71.4 TPA, As the

company took over by M/s Ranbaxy limited in year 2006 and later at 2015 M/s Ranbaxy Limited

amalgamated with M/s Sun Pharmaceuticals Industries Limited. So now M/s Sun Pharmaceuticals

Industries Limited applying for the grant of EC with the present ownership name along with proposed

expansion for production capacity of 110 TPA.

The company has taken the ‘Consent to Operate’ for Air and Water from Madhya Pradesh Pollution

Control Board with consent no. AW-45775, with validity up to 31/08/2017 along with the consent for the

Hazardous Waste (Management, Handling & Transboundary Movement) Rules, 2008, with consent no.

H-45451, Valid till 30/06/2021. The company is also having the TSDF membership for the disposal of

hazardous waste valid till 31.03.18.

The project is located under the Notified Ghirongi Industrial Area of Malanpur, District-Bhind, Madhya

Pradesh, thus the project falls under the schedule 5(f) “Synthetic organic Chemical Industry’ with

category ‘B’ as per S.O. 1533 (E) the EIA notification dated 14th Sep 2006 as amended on 25th June

2014. The present proposal is for receiving TOR from SEIAA. So M/s Sun Pharmaceuticals Industries

Limited applying for the grant of EC with the present ownership name along with proposed expansion

for production capacity of 110 TPA for API & Intermediate.

1.3 PROJECT LOCATION & CONNECTIVITY

The project is located over the land which comes under the notified industrial area of Ghirongi, Malanpur

and lies between latitude 26° 21' 43.88" N to 26° 21' 52.52" N and longitude 78° 16' 48.32" E to 78° 16'

58.90" E. having elevation of 567 meters above sea level. The project is located in plot no. K-5, 6, 7 &

10 Ghirongi Industrial Area, Malanpur, Taluka Gohad, District Bhind. The site is well connected with NH-

92 which is about 1.1 km from the project site. The nearest railway station is Malanpur Railway Station

which is 3.7 km from the site in W direction. Nearest Airport –Gwalior; (Rajmata Vijayraje Scindia

Airport) About 7.7 km in S direction.

The site is already under possession of M/s Sun Pharmaceutical Industries Limited and comes under

the notified industrial area of Ghirongi, Malanpur, Taluka Gohad, District Bhind. The distance of Mowai

Dam is about 3 km in SSW direction and Kotiwal Reservoir is about 19.8 km in NW direction. The

famous Bala Ji Temple (Baretha)- Temple-About 5.5 km in S direction & Sun Temple about 15.3 km in

SW direction.

1.4 PROJECT DETAILS

The project occupies Total Plot Area of 10.928 Acres/ 4.4225 ha / (44225 m2) and involve in business of

manufacturing of Intermediate & APIs-Penems, having a capacity of manufacturing of 110 MT after

proposed expansion for production of APIs (Penems) and it’s Intermediates, with annual turnover of




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Malanpur unit approx. Rs. 50.29.2 Cr. Per Year as per March 2016. The total fixed cost of the project is

INR 57.6 Cr. as per the company gross book value as on 22/02/2017.

The major facilities involved area Boiler, MEE, ATFD, Solvent recovery Plant, Solvent storage area,

reactors, Cooling towers, Effluent treatment plant (ETP), and R.O Plant Facilities like administrative

office, parking and greenbelt/plantation also developed as per plan/requirement.

The total water requirement for the project after the proposed expansion will be approx. 160 KLD which

will be sourced from surface water supplied by IIDC-Gwalior and from bore well. The company is

authorized to use 100 KLD of surface water supplied by IIDC and 20 KLD from bore well thus the

company is authorized to use 120 KLD water. M/s Sun Pharmaceutical Industries Limited already

applied to IIDC for the grant of extra 33% of water. The entire wastewater shall be treated in the 100

KLD capacity ETP and the treated water will be used for cooling towers, floor washing and

gardening/green belt.

Solid waste generated during the manufacturing process and wastewater treatment process is mainly

sludge and will be disposed at authorized TSDF facility, as per Hazardous and Other Waste

(Management & Transboundary Movement) Rules, 2008 (Amendment 2016). M/s SUN Pharmaceutical

Industries Ltd has taken the authorization Under Hazardous Waste (Management, Handling &

Transboundary Movement), Rules, 2008 from MP PCB (valid till 30/06/2021). Company is also having

the membership of authorized TSDF facility for the disposal of hazardous waste (valid till 31/03/18)

Power requirement will be sourced from existing line of ‘Madhya Pradesh Madhya Kshetra Vidyut

Vitaran Company’. The company is already authorized to use power load of 900KVA & no additional

power load will be required for proposed expansion as the company is running under load. In case of

power failure, D.G. set will be used as a backup power source.

The M/s Sun Pharmaceutical Industries Ltd hired a total manpower of 250 who will be from, Gwalior and

nearby villages/area and therefore no residential planning has been incorporated.

CHAPTER 2

INTRODUCTION




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2. INTRODUCTION

2.1 IDENTIFICATION OF PROJECT & PROJECT PROPONENT

Sun Pharmaceutical was established by Mr. Dilip Shanghvi in 1983 in Vapi with five products to treat

psychiatry ailments. Cardiology products were introduced in 1987 followed by gastroenterology products

in 1989. Today it is the largest chronic prescription company in India and a market leader in psychiatry,

neurology, cardiology, orthopedics, ophthalmology, gastroenterology and nephrology.

The 2015 acquisition of Ranbaxy has made the company the largest pharmaceutical company in India,

the largest Indian pharmaceutical company in the US, and the 6th largest specialty generic company

globally.

The Malanpur site has modern state-of–the-art plants facilitating minimal manual intervention and

consistent reproduction of processes, on an ongoing basis, and these are built to GMP standards. The

project is located in plot no. K-5, 6, 7 &10 Ghirongi Industrial Area, Malanpur, District-Bhind.

2.2 BRIEF DESCRIPTION OF NATURE OF PROJECT

M/s Cardinal Drugs Ltd. Started operations for production of bulk drugs with valid EC for the production

capacity approval of 71.4 TPA, As the company took over by M/s Ranbaxy limited in year 2006 & later

at 2015 by M/s Sun Pharmaceuticals Industries Limited. So M/s Sun Pharmaceuticals Industries Limited

applying for the grant of EC with the present ownership name along with proposed expansion for

production capacity of 110 TPA for API & Intermediates. No additional land will be required for the

proposed expansion & no additional power load will be required as presently we are having the

permission to withdraw 900KVA & the plant is running under capacity. The company has already

applied to the IIDC for the grant of approval for additional water requirement considering the expansion.

As per EIA Notification dated 14th September, 2006, as amended on 25 June 2014, the project is

located under the Notified Ghirongi Industrial area of Malanpur, District-Bhind (M.P.) So the project falls

under activity ‘5(f)’ of schedule ‘B’ (i.e. for Synthetic Organic Chemicals). The company has taken the

‘Consent to Operate’ for Air and Water from Madhya Pradesh Pollution Control Board with consent no.

AW-45775, with validity upto 31/08/2017. The company has also taken the Authorization under the

Hazardous Waste (Management. Handling & Transboundary Movement) Rules, 2008 vide Consent no.

H-45451 with validity up to 30/06/2021.

Malanpur unit is having a ETP of capacity 100 KLPD for the treatment of effluents. In addition to the

same, Company is having the membership of TSDF from ‘RAMKY ENVIRO ENGINEERS LTD’ with

membership no- MPWMP-HzW-MLP-427, Valid till 31/03/2018.




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2.3 NEED FOR THE PROJECT & ITS IMPORTANCE TO THE COUNTRY

The Indian pharmaceuticals market is the third largest in terms of volume and thirteenth largest in terms

of value, as per a report by Equity Master. India is the largest provider of generic drugs globally with the

Indian generics accounting for 20 per cent of global exports in terms of volume.

API & Intermediate (Penems) are one of the basic raw materials for pharmaceutical manufacturing

industries. Thus, Company has decided to involve in the manufacturing of API & Intermediates

(Penems) in view of the growing market demand, the present project of the company for the

manufacturing of API & Intermediate (Penems) is surely feasible. Products manufactured at site are

consumed in house at Dewas located plant for, dosage form and APIs. Thus the finished products will

be sold in domestic market as well as exported to overseas countries.

The present project will also contribute to the revenue to the Central & State exchequer by means of

payment of various whatsoever taxes applicable to the similar type of Industries.

Thus, the present project will help the Government, by paying taxes from time to time in the form of

revenue and thus, resulting into a contribution to the growth of our Nation.

2.4 DEMAND-SUPPLY GAP

The Indian pharma industry, which is expected to grow over 15 per cent per annum between 2015 and

2020, will outperform the global pharma industry, which is set to grow at an annual rate of 5 per cent

between the same period. The market is expected to grow to US$ 55 billion by 2020, thereby emerging

as the sixth largest pharmaceutical market globally by absolute size.

Being a multi product facility, products are manufactured at Malanpur unit as per the requirements

raised by Dewas plant and the market has been growing at about 15% per annum in both value and

volumetric terms. Thus resulting into a reasonable gap between demand and supply.

The Company is known for its fair business activities and also for supply of Quality products in the

domestic as well as International market.

2.5 IMPORTS V/S INDIGENOUS PRODUCTION

Company is making API & Intermediate (Penems). So the raw material is procurement from the

domestic market in big quantities more than as compared to its Import Purchases.

Since Company is also doing Exports and hence its majority of Export supplies are against the schemes

and benefits allowed /extended by the Hon’ble Ministry of Commerce / Hon’ble Ministry of Finance of

Government of India, to the Exporters. So as to promote the Export business in India.

Thus, Company in this manner and under statutory provisions and rules, is also utilizing the Import

benefit policies allowed/ extended by the Govt. of India to the Exporters.




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2.6 EXPORT POSSIBILITY

As a running business, Company will continue the supplies of its API & Intermediates (Penems) to

domestic market as well as International market. Product demand is always available in both the

markets. Both the Domestic & Export supplies of the company will indirectly contribute to the growth of

our nation.

2.7 DOMESTIC/EXPORT MARKETS

API & Intermediates (Penems) are majorly used in the manufacturing of pharmaceutical drugs and the

market has been growing in domestic sector. The Export market is also increasing for pharmaceutical

industry due to the availability in India at a reasonable price.

2.8 EMPLOYMENT GENERATION

As the company is under operation the total manpower required is 250 nos. including all the levels

(Plant Manager, Shift Incharges, Operators, Drivers, Security guards, Helpers & general workers.

Indirectly many other peoples will also get the business opportunities such as hired vehicles for the

transportation of finished products.

CHAPTER 3

PROJECT DESCRIPTION


FFaacciilliittyy””ooff SSuunn PPhhaarrmmaacceeuuttiiccaall IInndduussttrriieess LLiimmiitteedd aatt GGhhiirroonnggii IInndduussttrriiaall AArreeaa,,

MMaallaannppuurr,, BBhhiinndd DDiissttrriicctt,, MM..PP..

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3. PROJECT DESCRIPTION

3.1 TYPE OF PROJECT INCLUDING INTERLIKED OR INTERDEPENDENT PROJECT

The project is for the expansion of API & Intermediate (Penem) manufacturing facilities situated at the Notified

Ghirongi Industrial area of Malanpur, District Bhind, Madhya Pradesh. As per EIA Notification dated 14th

September, 2006, as amended on 25 June 2014, as the land is located under the notified Industrial area, so the

project falls under activity 5 (f), “Synthetic Organic Chemical Industry” in Schedule ‘B’ as per S.O.1533 (E) EIA

Notification dated 14th Sep 2006 issued by MoEF&CC.

The project involves the production of various types of API & Intermediates of Penem with proposed capacity of

110 TPA after expansion, The Manufacturing area involves reactors, Centrifuges, Dryer and PP area, Boiler,

MEE, ATFD, Solvent recovery Plant, Solvent storage area, reactors, Cooling towers, Effluent treatment plant

(ETP), and R.O Plant Facilities like administrative office, parking and greenbelt/plantation also developed as

per plan.

3.2 PROJECT LOCATION

The project is located in plot no. K-5, 6, 7 & 10 of Ghirongi Industrial Area, Malanpur, District Bhind, M.P. The

site is well connected with NH-92 which is about 1.1 km from the project site. The nearest railway station is

Malanpur Railway Station which is 3.7 km from the site in W direction. Nearest Airport –Gwalior; Rajmata

Vijayraje Scindia Airport about 7.7 km in S direction. Mowai Dam is about 3 km in SSW direction and Kotiwal

Reservoir is about 19.8 km in NW direction. The famous Bala Ji Temple (Baretha) is about 5.5 km in S direction

& Sun Temple is about 15.3 km in SW direction. The locational details of the project are given in Table 3.1.

Table 3-1: Locational Details

Description Details

Location Plot no. K-5, 6, 7 & 10 of Ghirongi Industrial Area, Malanpur, District Bhind, M.P.

Co-ordinates Points Latitude Longitude

A 26° 21' 52.24" N 78° 16' 55.45" E

B 26° 21' 50.45" N 78° 16' 59.35" E

C 26° 21' 43.69" N 78° 16' 55.86" E

D 26° 21' 46.83" N 78° 16' 48.15" E

E 26° 21' 50.79" N 78° 16' 50.27" E

F 26° 21' 49.31" N 78° 16' 53.79" E

Village & plot no. Plot no. K-5, 6, 7 & 10 of Ghirongi Industrial Area, Malanpur, District Bhind, M.P.

Total Area 10.928 Acres/ 4.4225 ha / (44225 m2)

Access road NH-92

District headquarters Gwalior, 12.5 km in SW direction

Nearest Settlement/village Ghirongi about 1 km in W direction

Nearest railway station Malanpur Railway Station, about 3.7 km in W direction.

Nearest airport Gwalior-Rajmata Vijayraje Scindia Airport about 7.7 km in S direction

Source: Google Earth & M/s Sun Pharmaceutical Industries Ltd.




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3.3 DETAILS OF ALTERNATIVE SITES CONSIDERED

As it is an existing project, no alternative sites have been explored.

3.4 SIZE & MAGNITUDE OF OPERATION

The project occupies total area of 10.928 Acres/ 4.4225 ha / (44225 m2) and will be used for manufacturing of

various types of API & Intermediate with proposed expansion in production capacity of 110 TPA. The total cost

of the project is total fixed cost of 57.63 Cr as per the company gross book value as on 22/02/2017.

3.5 PROJECT DESCRIPTION WITH PROCESS DETAILS

3.5.1 Proposed Production Capacity

Proposed expansion in production capacity for various API & Intermediate are mentioned in Table-3.2

Table 3-2: Production Capacity

Product Name Proposed Capacity in TPA

Intermediates

Alpha Keto Easter 5

Bi Cyclo Ketone 40

Enol Phosphate 20

Sub Total 65

API (Penems)

Imipenem 5

Doripenem 5

Ertapenem 15

Maropenem, Feropenem and other carbapenem 20

Sub Total 45

Total 110

Source: M/s Sun Pharmaceutical Industries Limited

3.5.2 Detailed Manufacturing Processes, Chemical/Molecular Balances, Process Flow-Charts

FORMATION OF ALPHA KETO ESTER

1-Bromo-5-Chloropentane reacts with Ethyl acetoacetate in presence of Potassium Carbonate & Hexanes by

maintaining reflux for ~20 Hrs for reaction, after reaction cool and add Toluene for extract product Oxoethyl

Ester (JAP-2-1) it is in Liquid form.

Charge Nitric acid & Acetic acid and purge anhydrous Sulphur dioxide gas at 0 to 5°C, till solid material

precipitate out, filter and wash it with Acetic acid & Methylene Chloride. Unloaded wet material dissolve in 80%

Sulphuric Acid, this is NitrosylSulphuric Acid (JAP-2-2A).




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Charge Oxoethyl Ester (JAP-2-1) cool up to 0 to -10°C and add NitrosylSulphuric Acid (JAP-2-2A) slowly highly

exothermic reaction. Resulted further reacted with formaldehyde solution.

Product extracted in Toluene and recover Toluene and Hexanes. Charge oily mass in Sodium bisulphate &

Water solution to transfer the product in aqueous layer. Than Extract the product in Toluene from aqueous layer

by using Hydrochloric acid (Conc.) and wash organic layer with process water. Recover Toluene from organic

layer, residual mass is Alpha Keto Ester (JAP-2-3P).

Synthetic Scheme Alpha Keto Ester

Figure- 3.1 Flow Diagram of Alpha Keto Ester





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MATERIAL BALANCE FOR ALPHA KETO ESTER

MASS BALANCE FOR STEP-1: OXYETHYL ESTER

S.

No.

Input/MT of Product

Raw Materials Quantity (MT)

1 1-Bromo-5-chloro pentane 1.613

2 Ethyl acetoacetate 1.355

3 Potassium Carbonate 2.855

4 Hyflo 0.081

5 Toluene 6.976

6 Hexane 0.542

7 Water (for dissolving K salts) 4.839

Total (Ton) 18.261

S.

No.

Output/MT of Product Step-1: Oxyethyl ester

Remark Product

Liquid

Effluent Air Emission

Recovery

/Product

Solid

Waste

1 1.613 7.694 0.038 8.836 0.080 Intermediate-1 product is

formed

Fugitive losses

Total

(Ton) 18.261

MASS BALANCE FOR STEP-2 (NITROSYLSULFURIC ACID)

S.

No.

Input/MT of Product


1 Con. Nitric acid 2.267

2 Glacial acetic acid 1.134

3 Methylene Chloride 0.751

4 Sulphurdioxide 2.267

5 ConcSulfuric acid 2.156

6 Water 0.510

7 NaOH ( for scrubber) 3.237

8 Water (for scrubber) 8.095

Total (Ton) 20.417




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S.

No.

Output/MT of Product Step-2 (Nitrosylsulfuric acid) Remark

Product Liquid

Effluent

Air

Emission

Recovery

/Product Solid Waste

1 4.080 16.333 0.004 - - Intermediate-2 product is

formed

Fugitive losses

Total

(Ton) 20.417

MASS BALANCE FOR STEP-3 (ALPHA KETO ESTER)

S.

No.

Input/MT of Product


1 Inermediate-1 1.613

2 Solvent for solution of Intmdt-1 8.836

3 Toluene 13.813

4 Intermediate-2 4.081

5 Formaldehyde soln (36-41% aq) 2.839

6 Sodium bisulfite 3.710

7 HCl comml 4.033

8 Sodium Hydroxide 0.081

9 Water 27.421

10 NaOH ( for scrubber) 0.807

11 Water ( for scrubber) 8.065

Total (Ton) 75.299

S.

No.

Output/MT of Product Step-3 (Alpha keto ester)

Remark Product

Liquid


Recovery

/Product

Solid

Waste

1 1 53.800 0.113 20.386 - IPR Toluene is formed as

byproduct

Fugitive losses

Total

(Ton) 75.299




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FORMATION OF BICYCLOKETONE

Silylation of PNB-diazoacetoacetate (PNBDAA) with Trimethylchlorosilane in presence of sodium iodide and

Triethylamine results in the formation of silylenol ether of PNBDAA. It is further reacted with 4-Acetoxy

Azetidinone in presence of zinc chloride to produce PNB-silyldiazoazetidinone which on desilylation with

methane sulfonic acid gives PNB- diazoazetidinone (BCK-1).

PNB-diazoazetidinone on cyclization in presence of rhodium octanote dimer and zinc chloride results in the

formation of Bicycloketone.

Synthetic Scheme: Bicycloketone

Chemical Reaction involving in the process




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Figure- 3.2 Flow Diagram of Bicycloketone


MASS BALANCE OF BICYCLOKETONE (INTERMEDIATE 1)

S.

No.

Input/MT of Product


1 4-Acetoxy azetidinone 1.19

2 PNBDAA ( Jap-1-1) 1.41

3 Acetonitrile 0.72

4 Toluene 18.1

5 Sodium Iodide 1.0

6 Triethylamine 0.51

7 Trimethyl Chlorosilane (TMCS) 0.72

8 Zinc Chloride 0.21

9 Methanol 7.1

10 Methane Sulphonic Acid 0.17

11 Hyflosupercel 0.24

Total (Ton) 31.37

S. Output/MT of Product Bicycloketone (Intermediate 1) Remark




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(SPIL)


(EEPL)

No. Product

Liquid


Recovery

/Product

Solid

Waste

1 1.25 5.385 0.06 0.6 4.06

Intermediate 1 (BCK-1)

Product is form

Recovery of Acetonitrile

Fugitive losses

2 17.00 2 Recovery of Toluene

Incinerable waste is

generated

3 1.015 Recovery of Mixed Solvent

Total (Ton) 31.37

MASS BALANCE OF BICYCLOKETONE

S.

No.

Input/MT of Product


1 Para-Nitrobenzyl-2-Diazoazetidinone (BCK-1) 1.25

2 Methylene Chloride (3000038) 19.875

3 Rhodium Octanoate(Dimer) 0.00071

4 Isopropyl Alcohol 10.863

Total (Ton) 31.989

S.

No.

Output/MT of Product Bicycloketone

Remark

Product Liquid


Recovery

/Product

Solid

Waste

1 1 - 0.099 17.89 - Recovery of Methylene

Chloride

Fugitive losses

2 0.725 Recovery of Residue having

rhodium

3 10.36 Recovery of Isopropyl

Alcohol

1.915 Recovery of Mixed solvent

Total (Ton) 31.989

FORMATION OF IMIPENEM TECHNICAL

Bicycloketone reacts with Diphenylchlorophosphate and Diisopropylethylamine in presence of Dimethyl

aminopyridine solution in Methylene Chloride and N-methyl-2-pyrrolidone gives Enol Phosphate Ester.

Enol Phosphate Ester further reacts with Cysteamine Hydrochloride solution in N-methyl-2-pyrrolidone gives

PNB-Thienamycin.




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(EEPL)

PNB-Thienamycin further reacts with Benzylformimidate Hydrochloride in presence of Diisopropylethylamine and

gives PNB-Imipenem.

Cleavage of PNB group from PNB-Imipenem using hydrogenation over 2.5 % Pd/C in presence of N-methyl

Morpholine gives Imipenem Technical.






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(EEPL)

MASS BALANCE OF IMIPENEM (BENZYLFORMIMIDATEHCL (SIDE CHAIN))

S.

No.

Input/MT of Product


1 Benzyl alcohol 1.263

2 Formamide 0.525

3 Benzoyl chloride 1.692

4 Acetic anhydride 0.606

5 THF 11.367

6 Aq. NaOH for neutralization of ML 3.789

Total (Ton) 19.242

S.

No.

Output/MT of Product Imipenem (BenzylformimidateHCl (Side Chain))

Remark

Product Liquid


Recovery

/Product

Solid

Waste

1 1.756 0.057 17.429

Benxylformimidate

HCl is form as

product

Recovery of

Processed ML for

THF

Fugitive losses

Total (Ton) 19.242

MASS BALANCE OF IMIPENEM

S.

No.

Input/MT of Product


1 Bicycloketone 2.632

2 Diisopropylethyl amine 3.848

3 Diphenylchlorophosphate 2.332

4 CysteamineHCl 1.053

5 BenzylformimidateHCl 1.753

6 N-methyl Pyrrolidone 32.468

7 Isopropyl alcohol 10.331


9 N-Methyl Morpholine 0.474

10 Palladium / carbon 1.316

11 Dimethyl amino pyridine 0.017




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(SPIL)


(EEPL)

S.

No.

Input/MT of Product


12 Acetone 89.409

13 Hyflo 1.579

14 Activated Carbon 0.684

15 Hydrogen gas 0.121

16 Acetic acid 0.474

17 Water 38.164

Total (Ton) 347.633

S.

No.

Output/MT of Product Imipenem

Remark

Product Liquid

Effluent

Air

Emission

Recovery

/Product

Solid

Waste

1 1 67.746 1.304 152.929 2.263

Imipenem Crud is form as

product

Recovery of M

Fugitive losses

0.061 1.315 11.325 Palladium/ Carbon Cake is

formed

Incinerable waste

80.468 Recovery of Acetone

29.222 Recovery of N-

methylpyrrolidone

Total

(Ton) 347.633

FORMATION OF OTHER PENEM (DORIPENEM TECHNICAL)

The deacetylation of ATS is carried out by refluxing ATS in Methanol in presence of Acetyl chloride and the

resulting Thiol Side Chain is used for condensation. The Beta –Methyl Enol Phosphate is condensed with the

above thiol side chain in presence of Di-Isopropy Ethyl Amine (DIPEA) in DMF to give the diprotectedDoripenem

which is extracted in Ethyl Acetate layer.

The diprotectedDoripenem is taken for debenzylation by Hydrogenation using 2.5% Pd/C in presence of N-

Methylmorpholine / Acetic Acid buffer to give Technical Doripenem. The reaction mass is filtered through

Sparkler Filter to remove 2.5% Pd/C.

Separate layer Collect bottom aqueous layer and upper Ethyl Acetate layer & degas Ethyl Acetate traces from

aqueous layer by applying vacuum.

The material is crystallized in presence of Methanol then adds seed further cool and crystallizes the material.

The precipitated material is filtered and washed with Methanol + DI water mixture & Acetone.




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(EEPL)

Figure- 3.3 Flow Diagram of Doripenem Technical






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MASS BALANCE OF DORIPENEM

S.

No.

Input/MT of Product


1 Beta-Methyl Enol Phosphate 3.125

2 Acetylthiosulfamide (ATS) 3.500

3 Methanol 12.350

4 Acetyl Chloride 0.538


6 DI Water 129.250

7 Dimethyl Formamide 14.688

8 DI- Isopropylethylamine 0.950

9 ETHYL ACETATE 67.500

10 Sodium chloride (NaCl) 1.100

11 2.5% PDC (REPROCESSED) 4.688

12 N- Methyl Morpholine* 0.533

13 Acetic Acid Glacial* 0.315

14 Acetone 4.938

15 Doripenem (Seed) 0.156

16 Hyflosupercel 1.000

Total (Ton) 279.381

S.

No.

Output/MT of Product Doripenem

Remark

Product Liquid


Recovery

/Product

Solid

Waste

1 1 154.104 0.716 32.650 2.291 Recovery of Methylene

Chloride

Fugitive losses

0.078 19.462 Recovery of Spent Pd/C

Sludge Pladdium (Pd)

64.850 Recovery of Ethyl Acetate

ML

Total (Ton) 279.381




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FORMATION ERTAPENEM

Beta-methyl enol phosphate reacts with side chain of Ertapenem (N-protection) in presence of Diisopropyl ethyl

amine and Potassium carbonate in dimethyl formamide results formation of condensed product which on

hydrogenation in presence of sodium bicarbonate and Pd/C results in Ertapenem Sodium (Technical).

Ertapenem Sodium (Technical) precipitated in presence methanol and n-propanol by seeding of Ertapenem

Sodium. Purification of Ertapenem Sodium (Technical) involves dissolution in aqueous Sodium bicarbonate

solution followed by treatment activated carbon at pH 5.5±0.2. Isolation is carried out in presence of Methanol

and n-propanol mixture at temp. -8 to -12°C.

Figure- 3.4 Flow Diagram of Erta Penem





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(EEPL)

MASS BALANCE OF ERTAPENEM

S.

No.

Input/MT of Product (Product Ertapenem-1)


1 Beta-Methyl Enol Phosphate 3.642

2 Side chain of Ertapenem (N- protection) 2.865

3 Diisopropyl ethyl amine (DIPEA) 1.661

4 Potassium carbonate (Anhydrous) 0.073

5 N- N dimethylformamide (DMF) 18.211

6 DI Water 140.564

7 Ethyl acetate 75.394

8 Conc. Hydrochloric acid 0.830

9 Sodium chloride 0.911

10 Sodium Bicarbonate 2.060

11 Activated carbon 0.728

12 2.5% pd/C ( dry ) 5.463

13 Methanol 76.814

14 N- propanol 97.906

15 Acetone 17.264

16 Glacial Acetic acid 1.264

17 Ertapenem Sodium Technical (Seed) 0.036

Total (Ton) 445.686

S.

No.

Output/MT of Product Ertapenem-1 Remark

Product Liquid

Effluent

Air Emission Recovery

/Product

Solid

Waste

1 1.639 142.3 0.623 299.692 1.432

Total (Ton) 445.686

S.

No.

Input/MT of Product (Product Ertapenem-2)


1 Ertapenem Sodium Technical 1.639

2 DI Water 18.033

3 Sodium bicarbonate 0.305

4 Conc. Hydrochloric acid 0.410

5 Methanol 29.525

6 n-propanol 29.213




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(EEPL)

7 Activated carbon 0.328

8 Ertapenem sodium (seed) 0.016

9 Acetone 11.656

Total (Ton) 91.125

S.

No.

Output/MT of Product Ertapenem-2 Remark

Product Liquid

Effluent

Air Emission Recovery

/Product

Solid

Waste

1 1 0 0.853 89.272 0

Total (Ton) 91.125

FORMATION OF OTHER Β-METHYL ENOL PHOSPHATE

4-Acetoxy Azetidinone is reacted with 4, 4-dimethyl-3-propionyl oxazolodine-2-thione in presence of titanium

tetrachloride and Triethyl amine to give 4,4-dimethyl oxazolodine-2-thione Azetidinone.

4,4-dimethyl oxazolodine-2-thione Azetidinone, reacts with Imidazole in presence of dimethylamino pyridine to

give imidazolyl derivative.

Imidazolyl derivative (in-situ) reacts with magnesium mono PNB-malonate (prepared from mono PNB-Malonate

with magnesium chloride in presence of Triethyl amine) to result Beta-Methyl SilylAzetidinone.

Beta-MethylsilylAzetidinone (in-situ) on reaction with Tosylazide in presence of triethyl amine gives Beta-

MethylsilylDiazoazetidinone.

Beta-MethylsilylDiazoazetidinone (In-situ) on desilylation in presence of methanol and concentrated

Hydrochloric acid results in Beta-Methyl Diazoazetidinone (crude) which is isolated as Imidazole complex by

treating it with the Imidazole in Isopropyl acetate and Hexanes.

Cleavage of Beta-Methyl Diazoazetidinone Imidazole complex with concentrated Hydrochloric acid and water in

Methylene chloride results in Beta-Methyl Diazoazetidinone.

Beta-Methyl Diazoazetidinone is cyclized in presence of Rhodium octonoate dimmer / Zinc Bromide to give

Beta-methyl Bicycloketone which is reacted (In-situ) with Diphenylchlorophosphate in presence of

Diisopropylethylamine and dimethylamino pyridine to results in Beta-Methyl Enol Phosphate.




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(EEPL)

Fig-3.5 Flow Diagram of β-Methyl Enol Phosphate





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(EEPL)

Reaction of BMEP (Step-1)





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(EEPL)


MASS BALANCE OF ENOL PHOSPHATE

MASS BALANCE OF BMEP-1

S.

No.

Input/MT of Product


1 4-Acetoxy azetidinone 1.382


3 Triethyl amine 0.700

4 Titanium tetra chloride 1.400

5 Oxazolidine-2-thione ( MEP-2 ) 1.300

6 DI water 14.500

7 Hexane 11.810

Total (Ton) 53.392

S.

No.

Output/MT of Product BMEP-1

Remark Product

Liquid

Effluent

Air

Emission

Recovery

/Product

Solid

Waste

1 1.437 14.5 0.159 19.178 0.798

Intermediate-1 is form as product

Recovery of IPR DCM

Fugitive losses




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(SPIL)


(EEPL)

Solid waste

2 11.167 6.153 Recovery of Hexane

Incinerable Waste

Total 53.392

MASS BALANCE OF BMEP-2

S.

No.

Input/MT of Product


1 Intermadiate-1 1.437

2 Mono p-NitrobenzylMalonate (MEP-5A) 0.913

3 Magnesium Chloride (Anhydrous) 0.259

4 Triethylamine (TEA) 0.494

5 Methylene Chloride (MDC) 26.190

6 Hydrochloric acid –LR (HCl) 2.919

7 DI water 30.819

8 Sodium Bicarbonate 0.988

9 Sodium Chloride 0.862

10 Methanol 9.082

11 Sodium Nitrite 0.023

12 Sulphuric Acid 0.043

13 Methane sulfonyl chloride (Mesyl chloride) 0.437

14 Sodium Azide 0.273

15 Tetrabutyl ammonium bromide (TBAB) 0.014

16 Imidazole 0.665

17 Hexanes 5.691

18 Toluene 7.792

19 Isopropyl acetate 8.751

Total (Ton) 97.652

S.

No.

Output/MT of Product BMEP-2

Remark Product

Liquid

Effluent

Air

Emission

Recovery

/Product

Solid

Waste

1 0.834 43.299 0.123 22.262 2.835

Intermediate-2 is form as

product

Recovery of Methylene Choride

Fugitive losses

Solid waste

2 7.091 6.397 Recovery of Toluene




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(SPIL)


(EEPL)

Incinerable Waste

3 6.935 Recovery of Hexane

4 7.876 Recovery of Isopropyl Acetate

Total

(Ton) 97.652

MASS BALANCE OF BMEP-3 (ENOL PHOSPHATE)

S.

No.

Input/MT of Product


1 Intermadiate-2 0.834

2 Methylene chloride 11.045

3 Rhodium Octanoate 0.004

4 Zinc Bromide 0.003

5 DiphenylChlorophospahte 0.631

6 Dimethyl amino pyridine 0.005

7 Diisopropyl ethyl amine 0.333

8 DilHCl 4.191

9 Methyl Isobutyl ketone 6.010

10 Water 4.168

11 Hexanes 2.751

Total (Ton) 29.975

S.

No.

Output/MT of Product Enol Phosphate

Remark Product

Liquid

Effluent

Air

Emission

Recovery

/Product

Solid

Waste

1 1 8.336 0.099 9.499 0.458

Recovery of Methylene Choride

Fugitive losses

Solid waste

2 4.507 Recovery of MIBK

3 3.074 Recovery of mixed Solvent (from ML,Sale)

4 2.366 Recovery of Hexane

5 0.636 Recovery of residue having rhodium

Total

(Ton) 29.975




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(SPIL)


(EEPL)

3.6 RAW MATERIALS

Road transport is used to bring raw materials and fuels (furnace oil and HSD) to Sun Pharma, Malanpur plant

as well as to send the products from the plant. Sun Pharma, Malanpur plant has well planned storage facilities

for raw materials, intermediates and finished products as described below:

All the solid raw materials (RM)/packaging materials (PM)/ finished goods (FG) as well as intermediates are

being stored in well designed closed Air conditioned/Non-air conditioned ware houses as per the storage

requirements.

Liquid RMs which are covered under Petroleum Rules (HSD/ furnace oil and flammable solvents) are stored in

above ground storage tanks located in enclosed tank farm areas duly approved by the Chief (CCE). The

solvent storage tanks are provided with nitrogen blanketing and breather valve to reduce fugitive emissions.

Low boiling solvents like Methylene chloride are maintained in cooled/insulated tanks.

All other solvents which are not covered under Petroleum Rules as well as other liquid raw material are stored

in above ground tank farm are a duly covered with dykes of required volume (min 110% of tank capacity) to

contain any accidental spillage/leakage; as well as in drums stored in covered stores (protection from direct sun

and rain) that is ventilated with adequate natural ventilation. Cylinders are stored in a cylinder shed duly

approved by CCE. Hazardous materials are stored separately in a covered building (with natural lighting and

ventilation, and no electrical connection for safety reasons).

Transportation of all RMs within the Sun Pharma-Malanpur plant is through mechanical means to prevent spill/

leakage, if any, on account of manual handling.

3.7 LIST OF RAW MATERIALS ALONG WITH THEIR STORAGE CAPACITY

A). TANK FARM AREA

S. No. Storage Tank Max .Storage (KL) Mode of Storage

1 Di Chloro Methane (MDC) 30 KL Above Ground Tank

2 Acetone 20 KL Above Ground Tank

3 Hexane 20 KL Above Ground Tank

4 Toluene 20 KL Above Ground Tank

5 Iso Propyl Alcohol 20 KL Above Ground Tank

6 Methanol 20 KL Above Ground Tank

7 Denatured Spirit 20 KL Above Ground Tank

8 Absolute Alcohol 20 KL Above Ground Tank

9 Liquid Nitrogen 12 KL Above Ground Tank

10 High Speed Diesel (HSD) 15 KL Above Ground Tank

11 Furnace Oil 25 KL Above Ground Tank

** Maximum storage quantity is the maximum inventory of a particular chemical that can be stored during production.




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B). SOLVENT DRUM STORE

S. No. Storage Tank Max. Storage Qty. Mode of Storage

1 N-Methyl Morpholine 60 kg MS Drums

2 Diphenyl Chlorophosphate 2300 kg MS Drums

3 Benzyl Alcohol 400 kg HDPE drums

C) SPECIAL CHEMICAL STORE

S. No. Storage Tank Max. Storage Quantity Mode of Storage

1 Benzyl Chloride 2000 kg HDPE drums

2 Acetic Anhydride 800 kg HDPE drums

3 Titanium Chloride 3500 kg MS Drums

4 Acetyl Chloride 60 kg HDPE drums

5 Diphenyl Chlorophosphate 2300 kg MS Drums ** Maximum storage quantity is the maximum inventory of a particular chemical that can be stored during production.

D) WAREHOUSE, COLD ROOM & CARBON ROOM

S. No. Storage Tank Max. Storage

Quantity

Mode of Storage

1 Dimethylaminopyridine 600 kg Fiber drums

2 Recovered Rhodium Octanoate(DIMER) 2 kg Plastic Box

3 Zinc Bromide 20 kg Fiber drums

4 Sodium Chloride Technical 150 kg Poly bags

5 Imidazole 1800 kg MS Drums

6 Magnesium Chloride Anhydrous 1500 kg HDPE carboys

7 Sodium Bicarbonate 3000 kg Poly bags

8 Caustic Soda 9000 kg Poly bags

9 Acetyl Thiosulfamide 500 kg HDPE carboys

10 Beta-Methyl Enol Phosphate 400 kg Fiber drums

11 Activated Carbon 700 kg Poly bags

12 Cysteamine Hydrochloride 1400 kg Fiber drums

E) DRUM STORE

S. No. Storage Tank Max. Storage Quantity Mode of Storage

1 Ethyl Acetate 8400 L HDPE drums

2 Acetic Acid Glacial 800 kg HDPE drums

3 2N-Methylpyrrolidone 10000 L MS Drums

4 Formaldehyde Solution 1000 kg HDPE drums

5 Hydrochloric Acid 7000 L HDPE drums

6 Nitric Acid 500 kg HDPE drums

7 Triethylamine 1800 kg MS Drums

8 Isopropylacetate 10000 L MS Drums

9 Tetrahydrofuran 10000 L MS Drums

10 Methylisobutyl ketone 15000 L MS Drums




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3.8 AVAILABILITY OF WATER ITS SOURCE, ENERGY/POWER REQUIREMENT

3.8.1 WATER CONSUMPTION

Water is provided by IIDC (Industrial Infrastructure Development Corporation) and deep bore well present to

support additional water requirement. Total water requirement for the operation phase will be maximum 150

KLD. Water consumption details are given as following

Table 3-3: Water Consumption Details

S. No. Description Water consumption in KLD

As per Consent Max. Consumption

1 Industrial

a Utility (Boiler + Cooling) 68 107

b Process (including washing) 38 38

2 Domestic Water 8 15

Other 5

Total 119 160


3.8.2 WASTE WATER GENERATION DETAILS

The Waste water generation is as follows

Table 3-4: Waste Water Generation Details

S. No.

Description

Wastewater Generation in KLD

Remarks As per

Consent Max.

Generation

1 Industrial

a Utility (Boiler + Cooling) 9 28 Blow downs from cooling towers, boiler, ACF/MGF Cleaning, Softner regeneration, Vacuum pump approx. 28 KL will go to ETP

b Process (including washing)

27 38

15 KLD high COD high TDS wastewater will be sent to MEE.

Remaining 23 KLD will be treated in ETP.

2 Domestic Water 6.5 12 Domestic wastewater is being treated in ETP.

Total 42.5 78


3.9 DETAILS OF ETP

Four types of liquid effluents/wastes are likely to be generated from manufacturing process as indicated

below:

Biodegradable Effluents- low TDS & low COD




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Non Bio degradable- high TDS high COD

Organic Effluents (Mother Liquor/Bottom Cut)

Effluents from Utilities (Sand Filter Backwash, Regeneration Effluents from Water Softening and DI

Plants, Boiler Blow down, Cooling Tower Bleed Stream, etc.)

Broadly, the Biodegradable effluents from manufacturing process are treated along with effluents from utilities

in Effluent Treatment Plant (ETP) consisting of Physico-Chemical, Biological treatment processes and

Reverse Osmosis (RO) Separation, Multiple Effect Thermal Evaporation (METE). Non Bio degradable

effluents from manufacturing process are treated in MEE, ATFD units. Organic effluents (Distillation residues)

which are of hazardous in nature from manufacturing process are sent to TSDF Pithampur for incineration.

The stage wise details areas under:

The effluents generated from the existing operations are treated in an Effluent Treatment Plant (ETP- capacity

100 KL/Day). Presently flow rate is approx 42.5 m3/day. It is proposed to increase the flow rate 78 m3/day. The

treatment scheme broadly involves treatment of process waste water in two phases (see ETP flow chart

below), namely, primary treatment (chemical treatment) followed by biological treatment. The below figures

show the broad schematic flow diagrams of the existing effluent management and ETP.

Figure-3.6 Flow Diagram of Effluent Treatment Plant





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3.10 BRIEF DESCRIPTION OF TREATMENT METHODOLOGY IN THE ETP IS AS FOLLOWS

A). PRIMARY TREATMENT (CHEMICAL)

The entire process effluent, except solvent based & toxic streams, is collected in a sump from where it is first

pumped to equalization where it is mixed & sent to neutralization tank & subsequently neutralized with NaOH /

Lime slurry. The neutralized effluent is subjected to coagulation followed by flocculation in flash mixer and tube

settler respectively where sludge separation takes place. Same then flows to aeration tank, primary clarifier,

reaction tank & secondary clarifier. The sludge is dewatered using decanter. The sludge is filled in polybags

and is stored in an interim sludge storage area prior to its disposal to TSDF at Pithampur (M.P). The liquid

separated from the decanter is recycled back to the equalization tank.

B). SECONDARY TREATMENT (BIOLOGICAL)

Post primary clarifier, the effluent flows to aeration tank where nutrients are added. The same is then pumped

to primary clarifier, reaction tank and secondary clarifiers followed by filtration. The sludge is dewatered using

decanter. The sludge is filled in polybags and is stored in an interim sludge storage area prior to its disposal to

TSDF at Pithampur (M.P). Treated water thus obtained shall be fed to RO.

C). TERTIARY TREATMENT (MEMBRANE SYSTEM)

The final clarified water from clarifier shall passed through a multi-grade sand filter / Activated Carbon filter and

shall be pumped to the Membrane filtration system consisting of Reverse osmosis unit. The permeate of the

RO units shall be used either for cooling tower make-up or for on- land irrigation and reject will go to Multi Effect

thermal Evaporator(MEE) for further recovery of water.

3.11 FUEL CONSUMPTION

Fuel consumption details are given below

Table 3-5: Fuel Consumption Details

S. No Stack Attached to Capacity Stack

Nos. Type of Fuel used Fuel consumption

As per Consent

1 Boiler 2.5 TPH 01 FO 190 Lt/Hr.

2 DG Set 1250 kVA 01 HSD 270 Lt/Hr.

3 DG Set 500 kVA 01 HSD 150 Lt/Hr.

Required to Install

1 Boiler 4 TPH 01 FO 300 Lt/Hr.

*Note: DG Sets will be used only during Power failure

3.12 HAZARDOUS WASTE GENERATION

Hazardous Waste Generation and Disposal details are given in Table-3.6




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Table 3-6: Hazardous Waste Generation & its Disposal

S.NO Hazardous Waste Category

Consented Qty (MT)

Generation at Proposed Capacity

(MT)

Disposal Mode

1 Distillation Residues -20.3 80 80 MP Waste Management Project, Pithampur, Distt. Dhar / Co processing

2 Residues & Other Wastes

I -28.1 5 5 MP Waste Management Project, Pithampur, Distt. Dhar

3 Spent Carbon I -28.2 5 5 MP Waste Management Project, Pithampur, Distt. Dhar

4 Date-Expired, Discarded And Off-Specification Drugs


5 Discarded Containers / Barrels / Liners

I -33.3 4 10 MP Waste Management Project, Pithampur, Distt. Dhar / Sell to authorized dealers

6 Spent ion exchange resin containing toxic chemicals

I -34.2 0.6 1.5 MP Waste Management Project, Pithampur, Distt. Dhar

7 Chemical Sludge From Waste Water Treatment

I -34.3 10 60 MP Waste Management Project, Pithampur, Distt. Dhar / Co processing

8

Filters And Filter Material Which Have Organic Liquids In (MEE, ATFD, Filter pads etc.)


9 Used Spent Oil I -5.1 2 3 Sell to authorized dealer

10 Spent Solvent - - 150 Sell to authorized dealer

11 Off specification Raw material

- - 2 MP Waste Management Project, Pithampur, Distt. Dhar


3.13 STACK DETAILS

Stack Details for the project are mentioned in Table-3.7

Table 3-7: Stack Details

Stack Attached to Sources Capacity Nos. of Stacks Stack Height,

m Stack Top Dia,

inch

As per Consent

Boiler 2.5 TPH 01 30 20

DG Set 1250 kVA 01 30 10

DG Set 500 kVA 01 10 06

Required to Install

Boiler 4 TPH 01 30 30





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3.14 PROCESS VENT DETAILS

Process vents are connected with condensers. However, a scrubber is provided to scrub the acid fumes.

Table 3-8: Process Vent Details

Vent connected to Stack Height, m Stack Top Dia, inch Air Pollution Control

Measures Pollutants

Existing At Site

Reactors 15 4 Caustic Scrubbing

System Acid fumes


3.15 DETAILS OF SOLVENT RECOVERY SYSTEM

All solvent recovery systems have double stage condensers with Cold water/ chilled water & brine as

condensing media to reduce solvent emissions from these systems to minimum. Efforts are made to minimize

the discharge of gaseous emissions from process and solvent recovery systems containing mainly volatile

organic chemicals.

3.16 TRANSPORTATION DETAILS OF RAW MATERIALS

Project is already running. Road transport is used to bring raw materials and fuels (furnace oil and HSD) to

Sun Pharma, Malanpur plant as well as to send the products from the plant. Sun Pharma, Malanpur plant has

well planned storage facilities for raw materials, intermediates and finished products also separate storage

facility for hazardous waste.

3.17 EXISTING INFRASTRUCTURE

Infrastructure is fully and well developed for the existing buildings namely Production area, QC lab

administration block, Occupational Health Center, Utility block, Water treatment plant, Boiler house, Canteen,

Warehouse, Engineering workshop, Electrical substation solvent tank farm, solvent recovery plant, effluent

treatment plant, MEE-ATFD, RO plant, Drum Shed and Hazardous waste storage area, Fire water storage

tanks.

3.18 MEASURES TAKEN FOR ENVIRONMENTAL CARE

The site has following hardware/infrastructure for Environmental Care, including the air pollution control devices

for maintaining shop floor environment as well as to reduce the impact of gaseous emissions from vents and

stacks.

ISO-14001 certification since 17-11-2010.

Scrubber in manufacturing area

Condensers and Heat Exchangers to control solvent emissions/losses from manufacturing processes.

Where practicable, liquids are handled in closed systems to eliminate any chances of fugitive emissions. All

solvents/liquids are charged mechanically in the closed loop to avoid solvent losses thus eliminating

chances of air pollution also due to fugitive emissions.




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Breather Valves on storage tanks and process equipment to arrest fugitive emissions.

The storage tanks of low boiling solvents like Methylene chloride are equipped with chilled water utility to

avoid fugitive losses. Tanks are insulated and vent condensers are provided as enhanced control.

All the solvent recovery systems are attached with double stage chilled water/chilled brine condensers to

control solvent vapour emissions. Additionally, closed loop auto heating cut-off system in solvent recovery

columns to arrest fugitive emissions of solvents.

Where process is under vacuum, traps are provided in the vacuum line.

Stacks of adequate heights have been provided for effective dispersion of the air pollutants in the

atmosphere from emission sources, namely, boilers, and DG sets.

ETP with secondary & state of the art tertiary treatment system comprising of membrane based RO

systems.

Multi Effect thermal Evaporators (MEEs) and Agitated Thin Film Driers (ATFDs) for handling high TDS

effluent streams as well as rejects from membrane system.

HEPA filters in process areas to control dust nuisance/pollution.

Air Handling Units (AHUs) with Pre, Microvee filters for supply of fresh air to process areas.

All bulk liquids handled through closed systems.

Sprinkler system for solvent storage tanks.

Acoustics in DG sets to take care of noise pollution.

3.19 SUPPORT DEPARTMENTS

The support departments to cater to the needs of Manufacturing Unit are as follows:

Canteen

Conference Hall for technical discussions and presentations

Stores for Raw material / Finished Goods & Engineering spares

Engineering Workshop

Safety Health & Environment / Occupational Health Centre

Security

Scrap Yard

Car Parking

3.20 ENGINEERING SUPPORT

Following Engineering support are provided for running the manufacturing unit:

Bore well and water distribution system

Cooling Tower

Water Treatment (ETP)

Electricity supply and distribution system

Compressed air supply and distribution system

CHAPTER 4

SITE ANALYSIS




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4. SITE ANALYSIS

4.1 CONNECTIVITY

The project is well connected by all modes of transportation as the project is located over the land which

is developed Notified under Ghirongi industrial area of Malanpur, District-Bhind. Details of the distance

of particulars are mentioned in Table 4.1.

Table 4-1: Connectivity of particulars from the M/s Sun Pharmaceutical Industries Ltd.

Particulars Direction Distance (km)

Aerial Road

Distance from Gwalior City SW 12.5 15.2

Nearest Builtup Area (Malanpur) E 0.5 1.2

Nearest Tourist Place (Shanichar Temple) WNW 8.3 14.1

Nearest National Highway (NH 92) ESE 1.1 1.1

Nearest Rail Station (Malanpur) W 3.7 4.8

Nearest Airport (Gwalior Air port) S 7.7 13.3

4.2 LAND FORM, LAND-USE & OWNERSHIP

The project site is under the ownership of M/s Sun Pharmaceutical Industries Limited. The total plot

area of the existing unit is 44225m2. As the project is located in notified industrial estate, the landuse of

the project site is industrial. The proposed site falls within the notified industrial area of Bhind and has

been allotted by IIDC for industrial development.

4.3 TOPOGRAPHY

The entire Bhind District lies in the Chambal valley. The Hills are only a few, small and isolated, mostly

in the south west. The only divisions of topography are offered by the network of rivers with deep

channels and steep bank. The topology of Bhind is the topography of the valley plains. The area

surrounding to the proposed project is a plane ground without any ups and downs.

4.4 EXISTING LAND-USE PATTERN

The site is already under possession of M/s Sun Pharmaceutical Industries Limited in notified Industrial

area developed by IIDC. The details of the land use is given in Table 4.2




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Table 4-2: Present Land use Pattern of Lease Area

S.no Area Total Area (Ha)

1 Total Plot Area 10.928 Acres/ 4.4225 ha / (44225 m2 )

2 Total Built up Area 7.103 Acres / 2.874 ha / (28746 m2 )

3 Green Area/Plantation Area 3.824 Acres / 1.5478 ha / (15478 m2 )

4.5 EXISTING INFRASTRUCTURE

Project is already established and plant layout is attached for the complete details of the existing

infrastructure as Fig 4.1

Figure 4.1: Layout of M/s Sun Pharmaceutical Industries Ltd.

Source: M/s Sun Pharmaceutical Industries Ltd.

4.6 EXISTING INFRASTRUCTURE AVAILABLE

Infrastructure is fully and well developed for the existing buildings namely Production area, QC lab

administration block, Occupational Health Center, Utility block, Water treatment plant, Boiler house,

Canteen, Warehouse, Engineering workshop, Electrical substation solvent tank farm, solvent recovery

plant, effluent treatment plant, MEE-ATFD, RO plant, Drum Shed and Hazardous waste storage area,

Fire water storage tanks. New boiler house is to be constructed.




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4.7 SOIL CLASSIFICATION

Alluvial Soil as per CGWB classification. Soil samples will be collected during ONE season to assess

the soil quality by estimating texture, moisture, sand, silt, clay, organic matter, alkalinity, acidity, specific

gravity, bulk density, pH, electrical conductivity, Nitrogen, Phosphorous, Potassium, Ca, Mg, K,

Chloride, Sulphate, Carbon, Fe, Cu, Zn, Mn, and Na.

4.8 CLIMATIC DATA FROM SECONDARY SOURCES

The general agro-climatic zone of the study area is Semi-arid.

Information presented in subsequent paragraphs is from the most recently published Long Term

Climatological Tables for the nearest observatory, Gwalior by the Indian Meteorological Department.

The climate of this region is essentially dry. In the state of Madhya Pradesh also Climate can be termed

as extremes with scorching summer temperatures and chilly winter. The city falls in the rain shadow

zone. In summer the temperature can go as high as 47°C and during the winter season the temperature

can drop up to the 4°C. The period from March to May is recognize as summer season, rainy season is

between July to September during which north east monsoon brings monsoon to the area. The Gwalior

climate can be termed as extremes, both in summer and winter. The summers are usually very hot and

the winters very cold in Gwalior. The rains in Gwalior are, however, restricted only to the monsoon

months. The northwestern wind blows, predominantly, over the city of Gwalior and the wind speed

generally ranges from 8 km per hour in summer to 2 km per hour in winter time.

4.8.1 TEMPERATURE

The period from March to May is one of continuous increase in temperatures. May is generally the

hottest month with a mean daily maximum temperature of about 42.1°C and mean daily minimum of

about 27.2°C. January is generally the coldest month with the mean daily maximum temperature of

about 22.9°C and mean daily minimum of about 7.1°C.

4.8.2 WIND

Table 4-3: Predominant Wind Direction

Predominant First Second Third

Month Morning Evening Morning Evening Morning Evening

January CALM N SE/NW NW S/N NE

February CALM N NW NW SE NE

March CALM NW NW N S NE

April NW NW CALM N W W

May NW NW W W CALM N

June W NW NW W SW/CALM N

July W W SW NW NW/CALM NW

August W W NW NW CALM CALM

September W NW CALM W NW N

October CALM CALM W NW SW N




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Predominant First Second Third

Month Morning Evening Morning Evening Morning Evening

November CALM CALM S NW NW N

December CALM CALM S N NW/SE NE

4.8.3 RAINFALL

The total rainfall in year is observed to be 899.0 mm. Distribution of rainfall by season is 46.1 mm in

winter (January, February, March), 76.8 mm in summer (April, May, June), 855.6 mm in monsoons

(July, August, September) and 399.6 mm in Post monsoon (October, November and December)

4.8.4 CLOUD COVER

The area remains cloudy between July-December, which is the active period of the monsoon season.

Generally cloud cover ranges from 0 to 2.2 Oktas during this Post monsoon season.

4.8.5 HUMIDITY

The humidity remains relatively high all year round generally it remains between 64 – 84 %.

4.8.6 METEOROLOGICAL DATA

Table 4-4: Meteorological Data (as per IMD)

S. No. Parameters Description of the Season

1 Rainfall in

mm

Total Annual average Rainfall is 223.125 mm

Winter (Dec to Feb)

Months Total rainfall (in mm)

December 6.6

January 10.7

February 14.5

Total 31.8

Summer (Mar to May)

March 5.3

April 6.8

May 13.7

Total 25.8

Monsoon (June to Sept)

June 153.2

July 250.7

August 265.0

September 152.1

Total 821.0

Post-Monsoon (Oct to

Dec)

October 35.2

November 8.1

December 6.6

Total 49.9

2 Temperature Winter (Dec to Feb) Months Max Min Avg.




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(Mean Daily Temp. in 0C)

Dec 24.5 7.4 16.0

Jan 22.7 6.9 14.8

Feb 26.0 9.6 17.8

Average 24.4 8.0 16.2

Summer (Mar to May)

Mar 32.2 14.9 23.6

Apr 38.6 21.1 29.9

May 41.8 26.5 34.2

Average 37.5 20.8 29.2


June 40.5 28.4 34.5

Jul 34.6 26.1 30.4

Aug 32.7 25.1 28.9

Sep 33.5 23.8 28.7

Average 35.3 25.9 30.6

Post-Monsoon (Oct to Dec)

Oct 33.8 18.4 26.1

Nov 29.4 12.0 20.7

Dec 24.5 7.4 16.0

Average 29.2 12.6 20.9

3 Relative

Humidity in per cent

Winter (Dec to Feb)

Month 08.30 hrs 17:30 hrs

Dec 71 52

Jan 73 46

Feb 62 34

Average 68.67 44.00

Summer (Mar to May)

Mar 46 23

Apr 32 16

May 32 18

Average 36.67 19.00


Jun 48 35

July 74 65

Aug 81 73

Sep 74 61

Average 69.25 58.5


Oct 61 47

Nov 63 49

December 71 52

Average 65.00 49.33

4 Wind-speed Winter (Dec to Feb)

Month Speed (kmph)

Dec 2.3

Jan 3.2




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Feb 4.1

Average 3.20

Summer (Mar to May)

Mar 4.8

Apr 5.6

May 7.4

Average 5.93


Jun 8.1

July 7

Aug 6

Sep 5.1

Average 6.55


Oct 2.9

Nov 2.2

Dec 2.3

Average 2.47

Source: Climatological Normals, 1971-2000, Gwalior, Madhya Pradesh

Figure 4.2: Wind Rose (Summer Season)-Gwalior, IMD

4.9 SOCIAL INFRASTRUCTURE AVAILABLE

Schools, Colleges, Hospitals & Healthcare Centers, Shops & Bazaars, and Community Centers etc. are

all available in nearby villages and towns.

CHAPTER 5

PLANNING BRIEF




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Greencindia Consulting Ltd.

(GCPL)

5. PLANNING BRIEF

5.1 PLANNING CONCEPT

The Plant had started its operations since 1995 with name “M/s Cardinal Drugs Ltd.” for production of

bulk drugs with valid EC dated 9th Nov 1995, with the production capacity approval of 71.4 TPA and at

a later stage M/s Ranbaxy took over the plant in the year 2006, In the year 2008 the company applies to

the CTO & receives the CTO with specific condition in which it mentioned to install the Multi Effect

Evaporator (MEE), to upgrade the pollution control facility & to ensure the solvent recovery not less than

95%. An amalgamation of Ranbaxy with Sun Pharmaceutical Industries limited held in March 2015.

5.2 POPULATION PROJECTION

The project is already established and only working manpower is required to run the production.

5.3 LAND-USE PLANNING

No additional land will be required for the proposed expansion. The project involves permanent change

in land-use of 10.928 Acres / 4.4225 ha land and presently having the following facilities at site

Production area

QC lab

Administration block

Utility block

Water Treatment Facility (including ETP, R.O etc.)

Boiler house

Warehouse

Engineering workshop

Electrical substation

Solvent tank farm

Solvent Recovery plant, MEE-ATFD

Hazardous waste storage area

Fire water storage tanks

5.4 AMENITIES/FACILITIES

The following amenities/facilities available are

Area for rest & fooding/Canteen

Toilets

Drinking water facilities

First aid facilities/Occupational Health Center

Regular Medical checkup facility for labours & staff

CHAPTER 6

PROPOSED INFRASTRUCTURE




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6. PRESENT INFRASTRUCTURE

6.1 INDUSTRIAL AREA

Total buildup area of M/s Sun Pharmaceutical Industries Ltd, Malanpur unit is about 10.928 Acres/ 4.4225 ha / (44225 m2) Equipment and machinery & other facilities presently available/installed at Malanpur unit are given in Table 6.1

Table 6-1: Equipments & Machinery & Other Facilities available

S.No DESCRIPTION AREA (Sq. M)

1 TEMPLE 18.00

2 SECURITY ROOM 99.00

3 CANTEEN/ HR STORE/GUEST ROOM 243.00

4 LIQUID NITROGEN TANK 187.789

5 ETP OFFICE 30.81

6 SLUDGE TREATMENT SYSTEM AREA 67.48

7 AERATION TANK AREA 154.12

8 BORE WELL

9 DG PAD 9.00

10 SUBSTATION 85.463

11 DG HOUSE/LT ROOM 77.00

12 LT ROOM 42.17

13 RO PLANT 29.00

14 DI WATER PLANT 80.00

15 CHEMICAL STORAGE ROOM OF UTILITY 64.32

16 BOILER HOUSE -1 99.00

17 BOILER HOUSE -2 171.10

18 FO./DIESEL TANK AREA 548.28

19 U.G. WATER TANK 79.28

20 MAINTENANCE WORK SHOP 63.00

21 UTILITY BUILDING-1 354.75

22 HYDROGEN CYLINDER ROOM 17.80

23 UTILITY BLOCK 249.02

24 ENGG. OFFICE 31.65

25 DRYER ROOM 142.50

26 QA/QC BUILDING 312.63

27 ADMIN. BLOCK 312.63

28 PLANT BUILDING -1 613.85

29 DAY TANK-II 161.65

30 RECOVER SOL. TANKS AREA 287.266

31 MDC FRESH TANK 40.33

32 DAY TANK-I 86.99




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33 SOLVENT RECOVERY 72.88

34

OCCUPATION HEALTH CENTRE/EMERGENCY CONTROL

CENTRE 50.00

35 FIRE WATER TANK/PUMP HOUSE 78.125

36 CYLINDER YARD 273.28

37 RM LOT MAKING ROOM 65.12

38 INTERMEDIATE DISPENSING ROOM 47.36

39 CARBON ROOM 30.18

40 WARE HOUSE(FG/RM/ENGG.STORE) 360.00

41 CONTROL TEMP. ROOM/SPECIAL CHEMICAL STORAGE 150.00

42 DRUM STORE-1 150.000

43 TANK FARM AREA 2429.49

44 SECURITY TOWER 5.589

45 NEW SRP AREA 56.000

46 NEW SRP DAY TANK AREA 112.426

47 NEW SRP TANK 138.17

48 FRESH SOLVENT TANK AREA 182.80

49 COOLING TOWER AREA 69.804

50 DRUM YARD AREA 1023.75

51 SCRAP YARD 225.00

52 HIGH TDS STREAM 24.00

53 MCC PANEL ROOM 30.00

54 ATFD 541.125

55 QUALITY BUILDING 121.50

56 DG HOUSE 60.00

57 HAZARDOUS WASTE ROOM 240.00

58 CAR Shed 7.00

59 WEIGH BRIDGE STATION 9.00

60 SPENT SOLVENT COLLECTION TANK 125.55

61 DRUM STORE-2 236.00

62 ETP RO PLANT 61.43

63 UTILITY BUILDING-2 249.01

TOTAL AREA 12788.06


6.2 RESIDENTIAL AREA

The permanent employees stay in Malanpur & in Gwalior city. The contractual employees are hired from

nearby villages. Hence, there is no planning for any residential area in the present project.

6.3 PLANTATION AND GREENBELT

M/s Sun Pharmaceutical Industries Limited is very much concern towards the plantation & Greenbelt

developed. The total area used for the plantation at Malanpur unit is 3.824 Acres / 1.5478 ha / (15478

m2) which is approximately 35% of the total plot area.




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6.4 SOCIAL INFRASTRUCTURE

Schools, Colleges, Hospitals & Healthcare Centers, Shops & Bazaars and Community Centers etc. are

all available in nearby villages and town.

6.5 CONNECTIVITY

The project is well connected by all modes of transportation as the project is located over the land which

is developed within the Notified Industrial Area of Ghirongi, Malanpur, District-Bhind. Details of the

distance of particulars are mentioned in Table 6.2.

Table 6-2: Connectivity of particulars from the M/s Sun Pharmaceutical Industries Ltd.

Particulars Direction Distance (km)

Aerial Road

Distance from Gwalior City SW 12.5 15.2

Nearest Builtup Area (Malanpur) E 0.5 1.2

Nearest Tourist Place (Shanichar Temple) WNW 8.3 14.1

Nearest National Highway (NH 92) ESE 1.1 1.1

Nearest Rail Station (Malanpur) W 3.7 4.8

Nearest Airport (Gwalior Air port) S 7.7 13.3

6.6 DRINKING WATER MANAGEMENT

The total water requirement for the plant will be around 160 KLD, which will be sourced from IIDC

supplied water and bore well. However, the company is having the consent for 119 KLD but considering

the future requirement the company already submitted an application to IIDC for the grant of approval of

extra water requirement.

6.7 DETAILS OF ETP

Four types of liquid effluents/wastes are likely to be generated from manufacturing process as indicated

below:

Biodegradable Effluents low TDS/COD

Non Bio degradable High TDS/COD

Organic Effluents (Mother Liquor/Bottom Cut)

Effluents from Utilities (Sand Filter Backwash, Regeneration Effluents from Water Softening and

DI Plants, Boiler Blow down, Cooling Tower Bleed Stream, etc.)

Broadly, the Biodegradable effluents from manufacturing process are treated along with effluents from

utilities in Effluent Treatment Plant (ETP) consisting of Physico-Chemical, Biological treatment

processes and Reverse Osmosis (RO) Separation, Multiple Effect Thermal Evaporation (METE). High




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inorganic effluents from manufacturing process are treated in a steam stripper to remove maximum

quantity of volatile organic chemicals (mostly solvents) before further treating in MEE, ATFD units.

Organic effluents (Distillation residues) which are of hazardous nature from manufacturing process are

sent to TSDF Pithampur for incineration.

THE STAGE WISE DETAILS

The effluents generated from the existing operations are treated in an Effluent Treatment Plant (ETP-

capacity 100 KL/Day). Presently flow rate is approx 42.5 m3/day. It is proposed to increase the flow rate

78 m3/day. The treatment scheme broadly involves treatment of process waste water in two phases

(see ETP flow chart below), namely, primary treatment (chemical treatment) followed by biological

treatment. The below figures show the broad schematic flow diagrams of the existing effluent

management and ETP.

BRIEF DESCRIPTION OF TREATMENT METHODOLOGY IN THE ETP IS AS FOLLOWS

A). PRIMARY TREATMENT (CHEMICAL)

The entire process effluent, except solvent based & toxic streams, is collected in a sump from where it is

first pumped to equalization where it is mixed & sent to neutralization tank & subsequently neutralized

neutralized with NaOH / Lime slurry. The neutralized effluent is subjected to coagulation followed by

flocculation in flash mixer and tube settler respectively where sludge separation takes place. Same then

flows to aeration tank, primary clarifier, reaction tank & secondary clarifier. The sludge is dewatered

using decanter. The sludge is filled in polybags and is stored in an interim sludge storage area prior to

its disposal to TSDF at Pithampur (M.P). The liquid separated from the decanter is recycled back to the

equalization tank.

B). SECONDARY TREATMENT (BIOLOGICAL)

Post primary clarifier, the effluent flows to aeration tank where nutrients are added. The same is then

pumped to primary clarifier, reaction tank and secondary clarifiers followed by filtration. The sludge is

dewatered using decanter. The sludge is filled in polybags and is stored in an interim sludge storage

area prior to its disposal to TSDF at Pithampur (M.P). Treated water thus obtained shall be fed to RO.

C). TERTIARY TREATMENT (MEMBRANE SYSTEM)

The final clarified water from clarifier shall passed through a multi-grade sand filter / Activated Carbon

filter and shall be pumped to the Membrane filtration system consisting of Reverse osmosis unit. The

permeate of the RO units shall be used either for cooling tower make-up or for on- land irrigation and

reject will go to Multi Effect thermal Evaporator(MEE) for further recovery of water.




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Figure. 6-1.Flow Diagram of Effluent Treatment Plant


6.8 ZERO DISCHARGE

M/s Sun Pharmaceutical Industries Ltd. is having the ETP of capacity of 100 KLD and treats all the

effluent and sewage waste thus making itself as a Zero Discharge facility.

Figure-6-2. Flow Diagram of Zero Discharge Facility





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6.9 INDUSTRIAL WASTE MANAGEMENT

There will be two types of Solid wastes generated from the project.

(a) Non Hazardous Solid waste.

There will be two types of Non hazardous waste generated

(1) Municipal Solid Waste

The Municipal solid waste includes the paper waster from Office as well as other domestic wastes.

Paper wastes would be sold to scrap vendors, while other wastes would be disposed off as per

Municipal Solid Waste Management Rules.

(2) Sludge from Effluent Treatment Plant (ETP) which would Collection, storage and disposed at

CHW-TSDF Site as the company is having the membership under Madhya Pradesh Waste

Management Project (division of RAMKY Enviro Engineers Ltd.) with membership no. MPWMP-HzW-

MLP-27, valid till 31st March 2018

(b) Hazardous Solid waste.

All the hazardous waste generated at the manufacturing facility is to be disposed as per the legal

requirement. For Hazardous Waste, Malanpur unit has taken the authorization under Hazardous Waste

(Management, Handling & Transboundary Movement) Rules, 2008 from MP PCB with consent no. H-

45451, Valid till 30/06/2021

The details different Hazardous wastes generated and its disposal is given in the table below.

Table 6-3: Hazardous Waste Generation & Disposal

S.NO Hazardous Waste Category Consented

Qty. MT

Generation @ proposed capacity 110 MT

Disposal Mode

1 Distillation Residues -20.3 80 80 MP Waste Management Project, Pithampur, Distt. Dhar / Co processing

2 Residues & Other Wastes I -28.1 5 5 MP Waste Management Project, Pithampur, Distt. Dhar

3 Spent Carbon I -28.2 5 5 MP Waste Management Project, Pithampur, Distt. Dhar

4 Date-Expired, Discarded And Off-Specification Drugs/Medicines


5 Discarded Containers / Barrels / Liners

I -33.3 4 10 MP Waste Management Project, Pithampur, Distt. Dhar / Sell to authorized dealers

6 Spent ion exchange resin containing toxic chemicals

I -34.2 0.6 1.5 MP Waste Management Project, Pithampur, Distt. Dhar

7 Chemical Sludge From Waste Water Treatment





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S.NO Hazardous Waste Category Consented

Qty. MT

Generation @ proposed capacity 110 MT

Disposal Mode

8 Filters And Filter Material Which Have Organic Liquids In (MEE,ATFD,Filter pads etc.)


9 Used Spent Oil I -5.1 2 3 Sell to authorized dealer

10 Spent Solvent - - 150 Sell to authorized dealer

11 Off specification Raw material - - 2 MP Waste Management Project, Pithampur, Distt. Dhar

Source: M/S Sun Pharmaceuticals Industries Ltd.

(c) Liquid Effluent

Effluent from existing plant is treated in the existing Effluent Treatment Plant (ETP) having capacity of 100

KLD for primary, secondary & state of the art tertiary treatment. Domestic waste water will also be treated in

existing ETP.

Currently Company has been completely reusing the Treated water in various modes such as in Mfg.

Process, Domestic purposes, gardening etc. to achieve Zero Discharge condition.

(d) Air Pollution

Air pollution sources are mention in Table 6.4

Table 6-4: Air Pollution Sources

S.no. Source Qty. Capacity Fuel Used Fuel

Consumption

Stack

Height

(m)

Stack

Dia

(Inches)

1. Boiler 1 4.0 Ton Furnace Oil (F.O) 300Lit/hr 30 32

2. Boiler 1 2.5 Ton Furnace Oil (F.O) 190Lit/hr 30 20

3. D.G Set 1 1250 KVA Diesel (HSD) 270 Lit/hr 30 10

4. D.G Set 1 500 KVA Diesel (HSD) 150 Lit/hr 10 6

Source: M/S Sun Pharmaceutical Industries Ltd.

6.10 WASTE WATER GENERATION

Water requirement and waste water generation from process at various stages are treated in ETP plant

& R.O plant to achieve the zero discharge condition.




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Figure-6-3 P&ID of R.O. Plant


R.O PLANT PARAMETERS

R.O Plant Parameter Design Values (Inlet)

CAPACITY 150 KLD

MAKE GENESIS

pH 7.78

Color Not Specified

Odour Not Specified

Temp. (deg. C) Ambient

Turbidity (NTU) 5 NTU

B.O.D. (mg/L) 30 - 60

C.O.D. (mg/L) 200 - 250

TSS (mg/L) 100

TDS (mg/L) 7,500

Total Hardness (mg/L) Not Specified





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6.11 REQUIREMENT & SUPPLY/ SOURCE

MAIN POWER SOURCE

Presently Malanpur plant is having the approval to withdraw total power load capacity of 900 KVA on

33KV power from “Madhya Pradesh Madhya Kshetra Vidyut Vitaran Company” as the main power

source.

BACKUP POWER SOURCE

Malanpur plant is having two D.G. set with the capacity of 1250KVA & 500 KVA respectively, which can

be used for backup purposes which runs on diesel fuel.

Backup Energy/Power Source 1:

D.G Set of capacity : 1250 KVA

Fuel Used : High Speed Diesel (HSD)

Fuel consumption : 270 Lit/hr

Backup Energy/Power Source 2:

D.G Set of capacity : 500 KVA

Fuel Used : High Speed Diesel (HSD)

Fuel consumption : 150 Lit/hr

CHAPTER 7

RESETTLEMENT & REHABILITATION

PLAN




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7. REHABILITATION & RESETTLEMENT PLAN

The project is already established on the land within the Notified Industrial Area of Ghirongi, Malanpur,

District-Bhind (M.P). The land is on lease and is already under possession of M/s Sun Pharmaceutical

Industries Limited and no agricultural land and habitation is present in the land and there is no

displacement involved. Hence, no Land Acquisition, Resettlement and Rehabilitation is envisaged for

the proposed project.

CHAPTER 8

SCHEDULE & COST ESTIMATE



AArreeaa,, MMaallaannppuurr,, BBhhiinndd DDiissttrriicctt,, MM..PP.. 8


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8. PROJECT SCHEDULE & COST ESTIMATE

8.1 LIKELY DATE OF START OF CONSTRUCTION AND LIKELY DATA OF

COMPLETION (TIME SCHEDULE FOR THE PROJECT TO BE GIVEN)

As the unit is existing and application has been made for the grant of EC with the present ownership

name along with proposed expansion for production capacity of 110 TPA for API & Intermediates. No

additional land will be required for the proposed expansion & no additional power load will be required

as presently we are having the permission to withdraw 900KVA & the plant is running under capacity.

In the year 2008 the company applies to the CTO & receives the CTO with specific condition in which it

mentioned to install the Multi Effect Evaporator (MEE), to upgrade the pollution control facility & to

ensure the solvent recovery not less then 95%. Which might increase the production load due to

installation of multiple effect evaporator, Solvent recovery system, DG sets etc as per the consent

conditions. Sun Pharma is proposing to install Boiler of 4 TPH. Hence, likely date of construction and

completion is not applicable.

8.2 ESTIMATED PROJECT COST ALONG WITH ANALYSIS IN TERMS OF

ECONOMIC VIABILITY OF THE PROJECT.

As project is already running so fixed capital and turn over for March 2017 is given below:

Fixed Capital : 57.6 Crores (as per company gross book value 22/02/2017)

Turn over : 50.29 Crores (March 2017)

8.3 WORKING CAPITAL

Not Applicable

8.4 REVENUES

Not applicable

8.5 BREAKEVEN POINT

Not applicable

8.6 PROFITABILITY

Not applicable

CHAPTER 9

ANALYSIS OF PROPOSAL




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9. ANALYSIS OF PROPOSAL

Present proposal is for the expansion of production capacity for the manufacturing & production of APIs-

(penems) & Intermediate. The plant is already established and involved in the manufacturing of Life

saving drugs which are consumed by patients are in the form of dosage form. API (Active

Pharmaceutical Ingredients) works as raw material for dosage form. These APIs are manufactured by

chemical synthesis in production plants & “Good Manufacturing Practices are maintained”.

Our Malanpur location is engaged in manufacturing of APIs and Its intermediates, which are for captive

consumption. However, there are possibilities for export of our products. Being a good corporate citizen

and in the business of life saving drugs the operations are conducted in environmental friendly manner.

The project occupies Total Plot Area of 10.928 Acres/ 4.4225 ha / (44225 m2 ) and involve in business of

manufacturing of Intermediate & APIs-(Penems) having a capacity of manufacturing of 110 MT after

proposed expansion, with annual turnover of Malanpur unit approx. Rs. 50.29 Cr. Per Year as on March

2017. The total fixed cost of the project is INR 57.6 Cr. as per the company gross book value as on

22/02/2017.

The major facilities involved area Boiler, MEE, ATFD, Solvent recovery Plant, Solvent storage area,

reactors, Cooling towers, Effluent treatment plant (ETP), and R.O Plant Facilities like administrative

office, parking and greenbelt/plantation also developed as per plan/requirement.

The water requirement for the project will be approx 160 KLD which will be sourced from supplied water

from IIDC and bore well. The company is authorized to use 119 KLD of potable water & company

already applied to IIDC for the grant of extra qty. of water. The entire wastewater shall be treated in the

100 KLD capacity ETP and the treated water will be used for cooling towers, floor washing and

gardening/green belt.

Solid waste generated during the manufacturing process and wastewater treatment process is mainly

sludge and will be disposed at authorized TSDF facility, as per Hazardous and Other Waste

(Management & Transboundary Movement) Rules, 2016. M/s Sun Pharmaceutical Industries Ltd, has

taken the authorization under Hazardous Waste (Management, Handling & Transboundary Movement)

Rules, 2008 from MP PCB.

Power requirement will be sourced from existing line of Madhya Madhya Kshetra Vidyut Vitaran

Company. In case of power failure, D.G. set will be used as a backup power source.

The M/s Sun Pharmaceutical Industries Ltd hired a total manpower of 250 who will be from Gwalior city,

nearby villages/area and therefore no residential planning has been incorporated.

Due to its connectivity with the major infrastructure this location is suitable for the sale of the product in

domestic and export to international market.

or btaining or xpansion of api & … report for obtaining tor “for expansion of api &...

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