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
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.
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-
2
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
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-
3
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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.
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..
2
PROJECT PROPONENT Page-
4
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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.
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..
2
PROJECT PROPONENT Page-
5
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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.
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..
2
PROJECT PROPONENT Page-
6
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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.
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..
3
PROJECT PROPONENT Page-
7
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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.
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..
3
PROJECT PROPONENT Page-
8
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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).
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..
3
PROJECT PROPONENT Page-
9
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
Source: M/s Sun Pharmaceutical Industries Limited
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..
3
PROJECT PROPONENT Page-
10
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
Raw Materials Quantity (MT)
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
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..
3
PROJECT PROPONENT Page-
11
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
Raw Materials Quantity (MT)
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
Effluent Air Emission
Recovery
/Product
Solid
Waste
1 1 53.800 0.113 20.386 - IPR Toluene is formed as
byproduct
Fugitive losses
Total
(Ton) 75.299
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..
3
PROJECT PROPONENT Page-
12
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
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..
3
PROJECT PROPONENT Page-
13
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
Figure- 3.2 Flow Diagram of Bicycloketone
Source: M/s Sun Pharmaceutical Industries Limited
MASS BALANCE OF BICYCLOKETONE (INTERMEDIATE 1)
S.
No.
Input/MT of Product
Raw Materials Quantity (MT)
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
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..
3
PROJECT PROPONENT Page-
14
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
No. Product
Liquid
Effluent Air Emission
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
Raw Materials Quantity (MT)
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
Effluent Air Emission
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.
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..
3
PROJECT PROPONENT Page-
15
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(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.
Chemical Reaction involving in the process
Source: M/s Sun Pharmaceutical Industries Limited
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..
3
PROJECT PROPONENT Page-
16
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
MASS BALANCE OF IMIPENEM (BENZYLFORMIMIDATEHCL (SIDE CHAIN))
S.
No.
Input/MT of Product
Raw Materials Quantity (MT)
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
Effluent Air Emission
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
Raw Materials Quantity (MT)
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
8 Methylene Chloride 160.978
9 N-Methyl Morpholine 0.474
10 Palladium / carbon 1.316
11 Dimethyl amino pyridine 0.017
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..
3
PROJECT PROPONENT Page-
17
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
S.
No.
Input/MT of Product
Raw Materials Quantity (MT)
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.
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..
3
PROJECT PROPONENT Page-
18
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
Figure- 3.3 Flow Diagram of Doripenem Technical
Source: M/s Sun Pharmaceutical Industries Limited
Chemical Reaction involving in the process
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..
3
PROJECT PROPONENT Page-
19
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
MASS BALANCE OF DORIPENEM
S.
No.
Input/MT of Product
Raw Materials Quantity (MT)
1 Beta-Methyl Enol Phosphate 3.125
2 Acetylthiosulfamide (ATS) 3.500
3 Methanol 12.350
4 Acetyl Chloride 0.538
5 Methylene Chloride 34.750
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
Effluent Air Emission
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
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..
3
PROJECT PROPONENT Page-
20
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
Source: M/s Sun Pharmaceutical Industries Limited
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..
3
PROJECT PROPONENT Page-
21
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
MASS BALANCE OF ERTAPENEM
S.
No.
Input/MT of Product (Product Ertapenem-1)
Raw Materials Quantity (MT)
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)
Raw Materials Quantity (MT)
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
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..
3
PROJECT PROPONENT Page-
22
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(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.
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..
3
PROJECT PROPONENT Page-
23
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
Fig-3.5 Flow Diagram of β-Methyl Enol Phosphate
Source: M/s Sun Pharmaceutical Industries Limited
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..
3
PROJECT PROPONENT Page-
24
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
Reaction of BMEP (Step-1)
Reaction of BMEP (Step-2)
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..
3
PROJECT PROPONENT Page-
25
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
Reaction of BMEP (Step-3)
MASS BALANCE OF ENOL PHOSPHATE
MASS BALANCE OF BMEP-1
S.
No.
Input/MT of Product
Raw Materials Quantity (MT)
1 4-Acetoxy azetidinone 1.382
2 Methylene Chloride 22.300
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
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..
3
PROJECT PROPONENT Page-
26
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(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
Raw Materials Quantity (MT)
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
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..
3
PROJECT PROPONENT Page-
27
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(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
Raw Materials Quantity (MT)
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
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..
3
PROJECT PROPONENT Page-
28
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(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.
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..
3
PROJECT PROPONENT Page-
29
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
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..
3
PROJECT PROPONENT Page-
30
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
Source: M/s Sun Pharmaceutical Industries Limited
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
Source: M/s Sun Pharmaceutical Industries Limited
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
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..
3
PROJECT PROPONENT Page-
31
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
Source: M/s Sun Pharmaceutical Industries Limited
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..
3
PROJECT PROPONENT Page-
32
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
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..
3
PROJECT PROPONENT Page-
33
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
I -28.4 2 2 MP Waste Management Project, Pithampur, Distt. Dhar
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.)
I -35.1 44 220 MP Waste Management Project, Pithampur, Distt. Dhar / Co processing
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 Pharmaceutical Industries Limited
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
Source: M/s Sun Pharmaceutical Industries Limited
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..
3
PROJECT PROPONENT Page-
34
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
Source: M/s Sun Pharmaceutical Industries Limited
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.
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..
3
PROJECT PROPONENT Page-
35
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
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..
4
PROJECT PROPONENT Page-
36
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
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..
4
PROJECT PROPONENT Page-
37
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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.
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..
4
PROJECT PROPONENT Page-
38
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
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..
4
PROJECT PROPONENT Page-
39
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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.
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..
4
PROJECT PROPONENT Page-
40
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
S. No. Parameters Description of the Season
(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
Monsoon (June to Sept)
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
Monsoon (June to Sept)
Jun 48 35
July 74 65
Aug 81 73
Sep 74 61
Average 69.25 58.5
Post-Monsoon (Oct to Dec)
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
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..
4
PROJECT PROPONENT Page-
41
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
S. No. Parameters Description of the Season
Feb 4.1
Average 3.20
Summer (Mar to May)
Mar 4.8
Apr 5.6
May 7.4
Average 5.93
Monsoon (June to Sept)
Jun 8.1
July 7
Aug 6
Sep 5.1
Average 6.55
Post-Monsoon (Oct to Dec)
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.
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..
5
PROJECT PROPONENT Page-
42
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
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
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..
6
PROJECT PROPONENT Page-
43
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
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..
6
PROJECT PROPONENT Page-
44
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
Source: M/s Sun Pharmaceutical Industries Limited
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.
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..
6
PROJECT PROPONENT Page-
45
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
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..
6
PROJECT PROPONENT Page-
46
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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.
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..
6
PROJECT PROPONENT Page-
47
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
Figure. 6-1.Flow Diagram of Effluent Treatment Plant
Source: M/s Sun Pharmaceutical Industries Limited
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
Source: M/s Sun Pharmaceutical Industries Limited
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..
6
PROJECT PROPONENT Page-
48
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
I -28.4 2 2 MP Waste Management Project, Pithampur, Distt. Dhar
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
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..
6
PROJECT PROPONENT Page-
49
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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.)
I -35.1 44 220 MP Waste Management Project, Pithampur, Distt. Dhar / Co processing
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.
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..
6
PROJECT PROPONENT Page-
50
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
Figure-6-3 P&ID of R.O. Plant
Source: M/S Sun Pharmaceutical Industries Ltd.
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
Source: M/S Sun Pharmaceutical Industries Ltd.
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..
6
PROJECT PROPONENT Page-
51
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
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..
7
PROJECT PROPONENT Page-
52
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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.
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.. 8
PROJECT PROPONENT Page-
53
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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
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..
9
PROJECT PROPONENT Page-
54
ENVIRONMENT CONSULTANT
M/s Sun Pharmaceutical Industries Ltd.
(SPIL)
Envirotech East Pvt. Ltd.
(EEPL)
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.