0 0 11 Feb 2016 1310476131PreFeasibilityReportOrygamusLaboratories PDF

Contents
S. Page No.
Description
No.
1.0 Executive Summary 1
1.1 Salient Features of the Project 1
2.0 Introduction 2
2.1 Identification of the Project and project proponent 2
2.2 Brief description of Nature of the Project 3
2.3 Need for the Project and its importance to the country 4
and or region
2.4 Demand and Supply Gap 4
2.5 Imports Vs. Indigenous production, Export Possibility, 4
Domestic/Export Markets
2.6 Employment Generation due to the proposed project 5
3.0 Project Description 5

3.1 Type of the project 5
3.2 Location 5
3.3 Alternate sites 6
3.4 Size or magnitude of operation 6
3.5 Project description with Process details 8
3.6 Raw materials 8
3.7 Resources optimization / recycling and reuse 8
3.8 Availability of water and Energy 9
3.9 Quantity of Wastes Generated and their Management / 9
Disposal
3.9.1 Water requirement and Wastewater generation and their 9
Management / Disposal
3.9.2 Hazardous/ Solid Waste Generation, Handling and their 11
Disposal
3.10 Schematic flow sheet for EIA procedure 12
4.0 Site Analysis 12
4.1 Connectivity 12
4.2 Land Form, Land use and Land ownership 12
4.3 Topography 13
4.4 Existing Land use pattern 13
4.5 Existing Infrastructure 13
4.6 Soil Classification 13
4.7 Climate data from Secondary sources 13
i
S. Page No.
Description
No.
4.8 Social Infrastructure 14
5.0 Planning 14
5.1 Planning Concept 14
5.2 Population Projection 14
5.3 Land use planning 14
5.4 Assessment of Infrastructure Demand 15
5.5 Amenities/Facilities 15
6.0 Proposed Infrastructure 15
6.1 Industrial Area 15
6.2 Residential Area 15
6.3 Green Belt 15
6.4 Social Infrastructure 16
6.5 Connectivity 16
6.6 Drinking Water management 16
6.7 Sewerage System 16
6.8 Industrial Waste Management 16
6.9 Hazardous/ Solid Waste Management 18
6.10 Power Requirement & Supply / Source 18
7.0 Rehabilitation and Resettlement (R&R) Plan 18
8.0 Project Schedule & Cost Estimates 19
8.1 Time Schedule for the project construction 19
8.2 Estimated project cost 19
9.0 Analysis of proposal (Final Recommendations) 19
9.1 Budgetary allocation for Pollution Control Measures 19
ii
List of Tables
Table Title Page
1 Proposed Products, their Capacity and Therapeutic Category 6
Proposed Water Balance and segregation and Treatment

2 10
Method
3 Effluent Treatment Flow as per segregation 10
4 Solid Waste Generation from the Proposed Products 11
Environmental Components Shortest distance from Project

5 13
Periphery
6 Breakup of proposed landuse Pattern 15
7 Maximum Quantity of Process emissions for Proposed Products 16
8 Stack Emission Details 17
9 Budgetary allocation for pollution Control Measures 20
iii
LIST of Annexures
Annexure
Title Page
No.
I Certificate of Incorporation 21
II General location of the Proposed Project 22
III Specific Location of the Proposed Project 23
IV Google map showing the coordinates 24
V Proposed Plant Layout 25
VI Typical process description & Flowchart for proposed products 26-74
VII Raw Materials required for the manufacture of Proposed products 75-98
VIII Hazardous chemicals list 99
IX Water analysis report 100
X Proposed Effluent Treatment Plant Flow Diagram 101
XI Schematic Flow Sheet for EIA Procedure 102-103
XII Topomap of 10 km Radius of Proposed Project 104
XIII Soil Analysis Report 105
Other Annexures
XIV Agreement of Sale 106-109
iv
M/s. Orygamus Laboratories Pvt. Ltd. Pre-Feasibility Report
Pre-Feasibility Report for Proposed APIs, API Intermediates

Manufacturing and R&D Facility
1.0 Executive Summary
M/s. Orygamus Laboratories Pvt. Ltd., proposes its Active Pharmaceutical Ingredients
(APIs) and API Intermediates manufacturing with R&D facility at Sy. 208/17 & 208/18 at
Ramalingampally (V), Bommalaramaram (M), Nalgonda District, Telangana State with a total
investment of Rs. 45 crores.
The proposed project falls under the Category ‘A’ project or activity 5(f) according to the
EIA Notification 2006.
1.1 Salient Features of the Project:
• Proposed project is in land of 5.45 Ha (13.48 Acres).

• The proposed project is to manufacture 38 APIs and API intermediates with a production
capacity of 453.6 TPA on campaign basis i.e., any 5 products & R&D activity at a time.
• Total Greenbelt area is 1.91 Ha (35 %).
• This proposed project site is located at an aerial distance of
i. 0.5 km (E) from Rangapuram village, 1.3 km (NW) from Ramalingampally and 2 km
(W) from Ankireddipalli village.
ii. 0.1 km (E) to the village road connecting Ramalingampally to Keesara.
iii. Hyderabad ORR at 8 km (SW)
iv. Shamshabad Airport, Hyderabad at 46 km (SW).
v. Nalgonda at 79 km (SE)
vi. Bommalaramaram at 3.1 km (E).
vii. Keesaraguta at 3.5 km (SSW).
• Total cost of the proposed project is Rs. 45 crores. Total capital cost allocated towards
environmental pollution control measures is Rs. 9.2 crores. Recurring cost will be about Rs. 7
crores per annum.
• Total water requirement will be about 462 KLD of which fresh water requirement will be
328KLD and balance 134 KLD will be recycled water from ETP-ZLD. Fresh water will be met
from Groundwater from Bore well / from private tankers.
• The proposed power requirement of the plant would be 1000 KVA. DG sets are used as
standby during power failure.
• Total 300 employees will be benefitted due to the proposed project. Out of which direct 200
and indirect 100 employees.
• Coal of about 64 TPD will be used in the proposed boilers for 12 and 4 TPH.
1
• Diesel of about 320 lit / hr will be used in the proposed 1000 & 500 KVA D.G. Sets and 2 lak
K.cal/hr Thermic Fluid Heater.
• Industry will provide dual scrubbers based on the characteristics of process emissions.
Economizer, multi-cyclone separator & bag filter for Boiler emissions will be provided to
reduce the particulate emissions into atmosphere.
• The wastewater generated from the plant will be about 152 KLD from process, washing,
utilities, DM regeneration, Scrubber, Q.C, R&D and domestic wastewater.
• The effluent will be pumped to the above ground level R.C.C lined tanks for storage and
neutralization then sent to proposed ETP-ZLD of 200 KLD capacity within the premises.
• Domestic wastewater will be sent to septic tank and the overflow to ETP - ZLD.
• Hazardous waste will be segregated and collected in the HDPE drums / bags as appropriate
and will be stored in the covered and raised platform with provision of leachate collection
system.
• Solid waste like boiler ash will be sent to cement brick manufacturers.
• Compressors, Boilers and DG sets will be the major noise generating units in the plant. Out
of these, the generator will be functioning at the time of power failure. D.G. sets will be built-
in acoustic enclosures to minimize the noise levels. However the workers in this area will be
provided with ear muffs.
Industry has uploaded Form-I along with draft Terms of Reference (ToR) in MoEF&CC
website, in the process of obtaining ToR for preparation of EIA, in line with issue of Environmental
Clearance. Hence, a technical pre-feasibility report highlighting the proposed project and the
various operations including waste generation and mitigation measures are prepared & submitted
to the Environmental Appraisal Committee (EAC) for issuing ToR.
2.0 Introduction
2.1 Identification of the Project and Project Proponent
M/s. Orygamus Laboratories Pvt. Ltd., proposed greenfield project of manufacturing Active
Pharmaceuticals Ingredients (APIs) and API Intermediates manufacturing with R&D facility in an
area of 5.45 Ha located at Ramalingampally Village, Bommalaramaram Mandal, Nalgonda District,
Telangana State. A copy of the Certificate of the Incorporation from Registrar of Companies is
enclosed as Annexure-I. The proposal is to obtain Environmental Clearance from the Ministry of
Environment, Forests and Climate Change (MoEF&CC) and Consent for Establishment from
TSPCB.
• Total investment for the proposed project is about Rs. 45 Crores.
• Total production capacity is 453.6 TPA from proposed 38 APIs and API intermediates on
campaign basis i.e., any 5 products at a time with R&D will be manufactured.
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Project Proponent:
• Dr. D. Srinivasa Reddy is the founder and Managing Director of Orygamus Laboratories Pvt.
Ltd., (Optimus Group), a global player in Specialty API and API Intermediates in API industry.
His vision has been to leverage technological advancements in drug development and
manufacturing towards realizing quicker cycles, cost-effective drugs and affordable healthcare.
He started Optimus (formerly Suryakiran) in 2004 with the intention to realize this goal. He
started his career by technical consulting assignments for other pharmaceutical companies in
India and abroad came to be recognized for expertise in developing and manufacturing new
molecules.
• Mr. V V Srinivasa Rao has 25 years of experience with leading pharmaceutical organizations
where he spearheaded innovative and advance research in Organic Chemistry. Mr. Rao has a
Master’s degree in Chemistry. He has been associated with Optimus group since 2005. His
efforts are very significant in the Company's growth in last 10 years. He is part of the Executive
Board since 2008.
• Mr. S. Bajeesaida Director and is responsible for the Technical activity of the company. He
holds a graduation in Engineering and has over 28 years of experience in Engineering and
Projects functions with some of the top Pharma companies in India. He is overall responsible
for achieving the company’s goals and objectives in terms of planning, strategies, reach and
regulatory milestones.
2.2 Brief Description of Nature of the Project
The project proponent proposed its API manufacturing unit. As per EIA Notification 2006,
the project is 5 (f) Synthetic Organic Chemical Industry (Bulk Drug (API) & Intermediates). The
products manufactured are used in API formulation industry and the therapeutic category of the
products is Antivertigo, Anti-Alzheimer's, Antithyroid, Antiasthmatic, Analgesic, Antidepressant,
Antiglaucoma, Antidyskinetic, Anti-viral, Anti-inflammatory, Antifibrotic, Antineoplastic,
Antiangiogenic, Antiglaucoma, Anticholinergic, Antiepileptic, Antibiotic, Antihyperlipidemic,
Anticonvulsant, Analgesic, Antidepressant, Antiasthmatic, Anti-multiple sclerosis agent,
Anticoagulant etc., which are applicable for human consumption around the world after formulation
activity.
The manufacturing process of APIs consists of chemical synthesis and multiple stage of
processing extending to maximum of 13 stages involving different types of chemical reactions. The
entire process operations are operated by various technical, skilled and unskilled persons with due
care to be met various standards prescribed by authorities.
Technology for manufacturing the products listed under proposed project is available from
in-house R&D & private consultants and proposes to adopt new technologies and techniques that
are continuously refined in every stage of manufacturing to meet global standards. Industry will
3
implement the proven technologies in the R&D for the cost effective & environment friendly
practices.
2.3 Need for the Project and its Importance to the Country and or Region
 India has achieved an eminent global position in pharma sector. The Indian
pharmaceuticals market is third largest in terms of volume and thirteen largest in terms of
value, as per a pharmaceuticals sector analysis report by equity master.
 The market is dominated majorly by branded generics which constitute nearly 70% to 80%
of the market. The Indian pharmaceutical industry is estimated to grow at 20 per cent
compound annual growth rate (CAGR) over the next five years, as per India Ratings. The
domestic pharma growth rate was 11.9 per cent in October 2014.
 The Government of India has unveiled 'Pharma Vision 2020' aimed at making India a
global leader in end-to-end drug manufacture.
 Telangana has proposed to set up India's largest integrated pharmaceutical city spread
over 11,000 acres near Hyderabad, complete with effluent treatment plants and a township
for employees, in a bid to attract investment of Rs 30,000 crore (US$ 4.85 billion) in
phases.
 Hyderabad, which is known as the bulk drug capital of India, accounts for nearly a fifth of
India's exports of drugs, which stood at Rs 90,000 crore (US$ 14.56 billion) in 2013-14.
2.4 Demand and Supply Gap
The products manufacture by the proponent has demand from China, Japan, Middle East,
Latin American countries and other Asian countries etc. In addition, the products are consumed in
domestic market by Dr. Reddy labs, NATCO, Pfizer, Cipla, Mylan, Novartis etc. It is reported that
there is increase in the consumption of these products by about 5-6% every year. As Indian
industries are importing from neighbouring countries and western countries, indicates the gap in
the demand and supply of the products in the domestic markets.
2.5 Imports vs. Indigenous production, Export Possibility, Domestic/Export Markets
Presently China is dominating in the API (bulk drug) market the world over. India is
importing all major intermediate chemicals required for manufacturing lifesaving drugs i.e., Anti-
Cancer Drugs, Anti ulcerative, etc. We are importing from China – the Third generation Antibiotics
mainly Cephalosporin intermediates that are of very high value. Most of our imports are from
Chinese companies and thus we are losing our valuable foreign reserves to China. As mentioned
above the imports have gone up from $ 2.9 billion in 2011 to about $ 4.6 billion in 2012 on account
of APIs, Pharmaceuticals and fine chemicals. During the same period the imports of formulations
has also doubled. The Chinese, American and European markets play a very vital role in the
supply of these products to our country. This clearly indicates that there is tremendous scope for
4
developing the indigenous products by reducing the imports and thus saving the foreign exchange
reserves of the country. This potential can be utilized to the fullest extent possible by increasing
the production capacity of the existing industries or by establishing new industries to meet the
market demand of the products.
As it is a well-known fact that Indian products are well accepted abroad for its quality and
marketing flexibility. The exports from the Indian companies to other foreign countries such as
Europe, America, Japan and other African countries has been increasing from Rs.8007 in 2005 to
Rs.16565 Crores in 2009. This shows the acceptability of the products produced in India. The
formulations market has shown a tremendous increase in the exports from about Rs.9500 to
Rs.23700 Crores during the same period. However, the basic raw material for formulations is
APIs. Hence, this sector has a tremendous potential of indigenous market as well as export market
and the promotion of such projects will not only help by way of generation of employment but also
by generation of foreign currency reserves for the country. The figures mentioned above are
sourced from BDMA.
2.6 Employment Generation due to the Proposed Project

This proposed project will give direct employment to local people based on qualification
and requirement. In addition to direct employment, indirect employment shall generate ancillary
business to some extent for the local population. Total employment from the proposed project will
be about 300 nos. out of which 200 will be direct and 100 will be indirect thereby there will be
increase the employment potential.
3.0 Project Description
3.1 Type of the project

Proposed project of APIs & API intermediates falls under category ‘A’ as per EIA Notification
2006 under the item No. 5 (f). There are no interlinked projects.
3.2 Location
The unit is located at Sy. 208/17 & 208/18, Ramalingampally (V), Bommalaramaram (M),
Nalgonda District, Telangana State. The proposed site is located in an intersection of Latitude
17°33'48"N & Longitude 78°42'23"E. The study area represents Rural Environment.
The map showing general location, specific location, Google map showing the Coordinates
and plant layout of the Project is enclosed at Annexures II, III, IV, and V respectively.
3.3 Alternate sites
This proposed project is in the area of 5.45 Ha at Sy. Nos. 208/17 & 208/18,
Ramalingampally (V), Bommalaramaram (M), Nalgonda District, Telangana State. Considering
other acceptable sites, Proponent has chosen this project site because the site is barren rocky
land and surrounded by chemical and stone crusher industries.
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Environmental considerations of this proposed project site.

 Site is barren rocky land and 0.5 km away from human habitation.
 0.7 km (E) away from pond near Rangapuram and 1.35 km (NW) away from pond near
Ramalingampally,
 3.6 km (NE) away from Shamirpet vagu,
 There are around five reserve forests in 10 km study area.
• Parvatapuram Forest Block – 0.8 km (SW)
• Kisaragutta R.F. (Dense Scrub) – 2.4 km (SW)
• Keshavpur R.F. (Open scrub) - 2.5 km (NW)
• R.F. (Open scrub) near Yadagiripalli- 4.5 km (WSW)
• Ponnal R.F. (Open Scrub) – 7 km (NW)
 Exist Transportation and Communication network
 There are no rare or endangered or endemic or threatened (REET) species of animals or birds.
 Availability of infrastructure facilities
3.4 Size or magnitude of operation
Project Area: 5.45 Ha.
Production Capacity: 453.6 TPA from 38 APIs & API intermediates and R&D activity
(5 products will be manufactured at a time).
Products: The proposed products and by-products along with its production capacities are
presented in Table 1.
Table 1: Proposed Products, their Capacity and Therapeutic Category

Therapeutic Category
SI. Quantity Quantity
Product / Intermediate to the
No. (kg/day) (TPA)
product
APIs – Campaign Products
1 Betahistine 166.67 60 Antivertigo Drug
2 Rivastigmine 250 90 Anti-Alzheimer's drug
3 L-Thyroxine 83.33 30 Antithyroid Agent
4 Fenoterol Hydrobromide 166.67 60 Antiasthmatic
5 Xylazine Hydrochloride 250 90 Analgesic
6 Duloxetine Hydrochloride 125 45 Antidepressant
7 Dorzolamide Hydrochloride 83.33 30 Antiglaucoma
8 Biperiden Hydrochloride 250 90 Antidyskinetic
9 Modafinil 250 90 Analeptic
10 Ledipasvir 66.67 24 Antiviral
Anti-inflammatory,
11 Pirfenidone 83.33 30
Antifibrotic
12 Darunavir Ethanolate 166.67 60 Antiviral
13 Sofosbuvir 250 90 Antiviral
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Therapeutic Category
SI. Quantity Quantity
Product / Intermediate to the
No. (kg/day) (TPA)
product
14 Imatinib Mesylate 41.67 15 Antineoplastic
15 Gefitinib 33.33 12 Antineoplastic
16. Erlotinib 50 18 Antineoplastic
17 Dasatinib 16.67 6 Antineoplastic
18 Atazanavir Sulfate 166.67 60 Antiviral
19 Pomalidomide 8.33 3 Antineoplastic
20 Lenalidomide 16.67 6 Antiangiogenic
21 Latanoprost 20.83 7.5 Antiglaucoma
22 Solifenacin Succinate 41.67 15 Anticholinergic
23 Cabazitaxel 8.33 3 Antineoplastic
24 Entecavir 41.67 15 Antiviral
25 Perampanel 8.33 3 Antiepileptic
1-((2R,3R,4R,5R)-3-fluoro-4-
hydroxy-5-(hydroxymethyl)-3- Sofosbuvir
26 23.33 8.4
methyl tetrahydrofuran-2- Intermediate
yl)pyrimidine-2,4(1H,3H)-dione
(S)-Isopropyl-2-(((R)-(perfluoro
Sofosbuvir
27 phenoxy)(phenoxy) phosphoryl) 41.67 15
Intermediate
amino) propanoate
28 Daclatasvir Dihydrochloride 41.67 15 Antiviral
29 Rifaximin 125 45 Antibiotic
30 Linezolid 250 90 Antibiotic
31 Rosuvastatin Calcium 116.67 42 Antihyperlipidemic
32 Pregabalin 83.33 30 Anticonvulsant
33 Flurbiprofen 108.33 39 Analgesic
34 Vilazodone Hydrochloride 37.5 13.5 Antidepressant
35 Montelukast Sodium 166.67 60 Antiasthmatic
Anti-multiple sclerosis
36 Teriflunomide 41.67 15
agent
37 Abiraterone Acetate 125 45 Antineoplastic
38 Dabigatran Etexilate Mesylate 166.67 60 Anticoagulant
Total Production Capacity
1250 450
(Maximum 5 products at a time).
R&D activity 10 3.6
Total Production Capacity
(Maximum 5 products at a time and 1260 453.6
R&D activity)
List of By-Products
SI. Quantity Quantity Generated from the
By-product
No. (kg/day) (TPA) product
1 Selenium 159 57 TPA Fenoterol
2 Aluminium Hydroxide sol. (8%) 681 245 TPA Hydrobromide
Scrubbing liquid from
3 Dil. HCl 20% 2029 730 TPA
process emissions
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3.5 Project Description with Process Details
The manufacturing process of APIs consists of chemical synthesis extending to maximum

of 13 stages of processing involving different types of chemical reactions. Typical process
description with process details is enclosed at Annexure - VI. These drugs are mainly used for
human Medication after Formulation activity for various diseases. Industry will implement the
proven technologies in the R&D for the cost effective & environment friendly practices. The plant
layout showing proposed components of the project is enclosed at Annexure-VI.
3.6 Raw Materials
The raw materials required for the manufacture of proposed products are the chemicals
and the fuel.
• The APIs & API Intermediates manufacturing involve the use of various chemicals and
organic solvents either directly as reactant or for extraction of a product of interest from the
reaction mixture.
• Coal consumption will be 64 TPD for the proposed 12 and 4 TPH coal fired boilers
• About 320 lit/hr diesel will be used at full operation load in the proposed 1000 & 500 KVA
DG sets and 2 lac.Kcal/hr TFH.
• The total power requirement of the proposed plant is 1000 KVA. DG sets are used as
standby during power failure.
• Mode of transportation of all raw materials and finished products from the project site is by
road to local markets and by road / rail / sea if exported / imported.
The chemicals (raw materials) required for the manufacture of proposed products is
presented at Annexure – VII and Hazardous chemicals list is presented at Annexure – VIII.
3.7 Resources Optimization / Recycling and Reuse

R&D facility in the unit will take all efforts to recycle the wastes / reuse wherever possible.
Following are some of the recycle options proposed by the industry.
 Industry is proposing for Zero liquid discharge plant to reuse all treated effluents as makeup
water for Cooling Tower. This will reduce the fresh water consumption.
 Industry is proposing dedicated reactors for few products there by reducing the reactor
washing.
 All solvents are recovered to the extent possible and reused in the process.
 Organic residue and spent carbon will be sent to Authorized Cement industries to burn in
Cement Kiln as an alternate fuel.
 Boiler ash will be sent to Cement Brick manufacturing units.
 Waste / Used oil will be sent to Authorized Waste / Used oil Reprocessing units.
 Waste Lead acid batteries will be sent back to suppliers on buy back basis.
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 Optimum utilization of solar energy.

Recycling and reuse of by-products, solvents generated during the process will also be
planned properly thereby implementing the clean manufacturing techniques.
3.8 Availability of Water and Energy
The total fresh water requirement is about 328 KLD which will be met from Groundwater
through from Bore well/ tankers. The proposal is to minimize the effect on the level of water table
by practicing reuse / recycling of the treated water wherever possible thereby reducing the fresh
water requirement. Water analysis report of the raw water at project is enclosed as Annexure–IX.
The total power requirement will be met from Telangana State Southern Power Distribution
Committee (TSSPDC) limited. Coal and Diesel will be procured from the distribution sources
closer to the project.
3.9 Quantity of Wastes to be Generated and their Management / Disposal
3.9.1 Water requirement and Wastewater Generation and their Management / Disposal
The proposed water requirement and wastewater generation and its proposed treatment is
presented in Table 2. The sources of wastewater generation are from the process, floor & reactor
washes, utilities, Q.C, R&D, scrubber and plant domestic waste. Total proposed wastewater will be
152 KLD, which will be segregated into HTDS/HCOD & LTDS/LCOD and collected by gravity into
a collection tank separately. This individual effluent will be pumped to the above ground level
R.C.C lined tanks for storage and neutralization then sent to ETP-ZLD. The effluents segregated
quantity, characteristics and treatment flow is briefly presented in Table 3.
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Table 2: Proposed Water Balance, Segregation and Treatment Method

Input (KLD) Output (KLD)
Description Evaporation Segregation type of
Fresh Recycled Total
/ Handling Wastewater
Water Water Wastewater
Loss
55
Process 53 -2 HTDS/HCOD
(58.9)
Washings
(reactor,
20 20 LTDS/LCOD
containers,
floor, etc.,)
91 0 64 13
(Blow down)
Boiler
(12 & 4TPH) 14 Utilities
(24% (LTDS/LCOD)
(MEE steam
make up) condensate)
Cooling Tower 20
106 134 220
4000 TR (Bleed)
DM
5 5 HTDS / LCOD
Regeneration
Scrubber
8 8 HTDS / LCOD
(4 Nos.)
Q.C and R&D 5 5 LTDS/LCOD
Domestic (300
15 3 12 LTDS/LCOD
nos @50 lpcd)
Greenbelt
25 - 25 - --
(5 acres)
Reuse:
328 134 310 152 Stripper Condensate : 1 KLD
Moisture in Salt and ETP
Total Sludge : 2 KLD
Water loss in ETP 15 KLD
462 462 (Total water loss is 18 KLD =
12 %)
Note: 55 KLD is 58.9 Tons consists of 55.3 KLD effluent and 3.6 Tons of salts (Max. on various
combinations) as per material balance.
Table 3: Effluent Treatment Flow for as per Segregation

Effluent Quantity
Treatment Flow
Characteristics (KLD)
Collection Equalization  Neutralization  Settling
Process, Scrubber &  Holding tank  Steam stripper  MEE along with
D.M Regeneration Scrubber & DM effluent  MEE Condensate to ETP
HTDS/HCOD &  MEE Concentrate to ATFD  ATFD Condensate
68
HTDS / LCOD to ETP.
HTDS > 5000 mg/l Salts to TSDF.
HCOD > 5000 mg/l Stripped solvents to SPCB authorized cement
industries
Boiler, Cooling tower, Collection Equalization  Neutralization  Settling
72
Q.C. and R&D  Holding tank  Biological treatment along with
10
LTDS / LCOD Domestic (overflow from septic tank) Dual Sand

LTDS < 5000 mg/l filter  Activated carbon filter  R.O. system
LCOD < 5000 mg/l Permeate to Utilities.
R.O rejects Forced evaporation condensate to
utilities.
Salts to TSDF.
Septic tank  overflow sent to ETP along with LTDS
Domestic 12
/ LCOD Effluent
Proposed ETP facility is enclosed as Annexure-X. All the treatment tanks etc., will be
constructed / installed above the ground with water proof lining. This individual effluent will be
pumped to the above ground level R.C.C lined tanks for storage and neutralization then sent to
proposed ETP-ZLD of 200 KLD capacity within the premises.
ETP – ZLD facility with primary (equalization and neutralization), secondary (stripper with
MEE, ATFD & biological) and tertiary treatment (PSF, ACF & R.O) will be provided. Domestic
wastewater will be sent to septic tank and the overflow to ETP (biological treatment). Concentrate
from MEE system will be sent to ATFD and the salts from the evaporation system will be collected
and sent to TSDF, Dundigal for safe disposal.
3.9.2 Hazardous/Solid Waste Generation, Handling and their Disposal
Solid waste will be segregated, detoxified and collected in the HDPE Drums / Bags and will
be stored in the extended covered and raised platform with Leachate collection system. The
proposed solid waste and other waste generated, handling and disposal method from the various
stages of APIs & API intermediates manufacturing plant is presented in the Table 4. Spillages
such as wastewater / solid wastes / raw material are possible and the risk of this would be limited
to within the premises of the manufacturing facility. A precautionary measure like spillage control
management is practiced in the industry.
Table 4: Solid Waste Generation from the Proposed Products

Proposed
Sl. Handling
Source Quantity Disposal
No. Method
(TPD)
1. Organic residue 3
2. Spent Carbon 0.04 Sent to TSPCB
HDPE Authorized Cement
Distillation Bottom Drums industries / TSDF
3. Residue 0.8 based on the
(1% of spent solvents) characteristics of waste
Inorganic & Evaporation
4. 3.8
salt (Process)
Evaporation salt HDPE Bags
5. 0.5
(Non-Process)
6. ETP Sludge 0.2
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Proposed
Sl. Handling
Source Quantity Disposal
No. Method
(TPD)
Stored in Sold to Cement Brick
7. Boiler Ash 25.6 covered Manufacturers
area
Other Hazardous Waste generation from the Plant
Detoxified Container / Disposed to TSPCB
500 Nos / Designated
8. Liners drums / HDPE Authorized agencies
month covered
Carboys / Fiber Drums after complete
area
9. PP Bags 200 Kg/ month detoxification
Spent solvents Stored in Sent to Inhouse
10. (with moisture) 80 KLD Drums / Solvent Recovery
(Solvents 77 + water 3) Tanks System
Recovered Solvents Tanks/ Reuse in process /
11. 74 KLD
from spent solvents Drums Authorized Recyclers
Spent Mixed solvents Stored in Sent to TSPCB
12. (from SRS + ETP) 4 KLD Drums / Authorized Recyclers /
(3 + 1) Tanks Cement industries
Sent to TSPCB
Stored in Authorized agencies
13. Waste oils & Grease 2 KL/A
Drums for reprocessing /
recycling.
Designated
Used Lead acid 100 Nos. / Sent to suppliers on
14. covered
Batteries annum buy-back basis.
area
Misc. Waste Stored in
15. 45 TPA TSDF
(spill control waste) Drums
Sent to suppliers on
16. Spent catalyst 150 TPA
Stored in buy back basis
Drums Used in ETP for
17. Spent Hydrochloric Acid 68 TPA
Neutralization
* Solid waste quantities maximum on various combinations i.e., maximum 5 campaign products at
a point of time with R&D activity.
3.10 Schematic Flow Sheet for EIA Procedure
The schematic flow sheet for EIA procedure is depicted as Annexure -XI.
3.0 Site Analysis

3.1 Connectivity
The proposed project site is about 0.5 km (E) from Rangapuram village, 1.3 km (NW) from
Ramalingampally; 8 km (SW) from Hyderabad ORR; 3.1 km (E) from Bommalaramaram; 3.5 km
(SSW) from Keesaraguta; 46 km (SW) from Shamshabad Airport, Hyderabad; 79 km (SE) from
direction Nalgonda;
4.2 Land Form, Land use and Land Ownership
Total land is 5.45 Ha. Industry has entered agreement with land owner and will be in
possession by February 2016.
12
4.3 Topography
The Topography map with a 10 km radius is enclosed as Annexure-XII.
4.4 Existing Land Use Pattern
The proposed land use pattern of project area (core area) 5.45 Ha. Industrial land and
shortest distance of environmental components in buffer area from the project periphery is given in
Table 5.
Table 5: Environmental Components Shortest distance from Project Periphery

S.No. Particulars Details (Distance & Direction)
1. Water bodies 0.7 km (E) away from pond near Rangapuram
1.35 km (NW) away from pond near Ramalingampally,
3.6 km (NE) away from Shamirpet vagu,
2. Reserve Forests There are around five reserve forests in 10 km study area.
• Parvatapuram Forest Block – 0.8 km (SW)
• Kisaragutta R.F. (Dense Scrub) – 2.4 km (SW)
• Keshavpur R.F. (Open scrub) - 2.5 km (NW)
• R.F. (Open scrub) near Yadagiripalli- 4.5 km (WSW)
• Ponnal R.F. (Open Scrub) – 7 km (NW)
3. National Parks/ Wild Life Nil
Sanctuaries/ Eco
sensitive areas
4. Agricultural land Nil
5. Non-Agricultural land Adjacent
6. Habitation Rangapuram – 0.5 km (E)
4.5 Existing Infrastructure

Village road connecting Ramalingampally to Keesara, Transportation facilities, power
supply, Telecommunication facility etc., are available near to site.
4.6 Soil Classification
The soil in the project site is Red and in the study area is mostly red in colour, containing
46.86% sand, 38.22% silt and 14.92% clay. The soil analysis report of the project site is enclosed
at Annexure-XIII.
4.7 Climate Data from Secondary Sources

The project area comes under the Deccan Plateau of vast triangular platform of peninsular
shield, which is the most distinctive physiographic unit of India. The area is represented by
undulating topography marked by scattered hillocks, domes, ridges, Irregularities of land are also
operations to assess the environmental quality frequently observed.
13
The area enjoys pleasant, warm and dry climate. The coldest season is during December
and January, where the temperature touch a minimum of 12-16°C and warmest period is during
the month of April to May when the Mercury shoots up to 43 - 46 °C.
The area experiences the maximum rainfall during the months of June to September and a
little rainfall during October and November due to North-East monsoon. Apart from these,
occasional rainfall is obtained from cyclonic storms and depression originating in the Bay of
Bengal. The average annual rainfall of the area is 786 mm. The rainfall is erratic and long period of
dry spells leading to drought conditions are frequent and periodic. The relative humidity ranges
between 75-95% during monsoon and 35-40% in summer afternoon.
4.8 Social Infrastructure

Village road which connects Ramalingampally to Keesara / Bommalaramaram, road
network, transportation facilities, power supply and other basic amenities such as
telecommunication facility, education centre, hospitals, fire station community halls are available at
Mandal Headquarters Bommalaramaram at 3 km distance. Hyderabad ORR is at 8 km.
5.0 Planning
5.1 Planning Concept
Type of Industry: The proposed project is of APIs & API Intermediates manufacturing industry
with R&D facility.
Facilities: Facilities required for the project will be provided as per requirement.
Transportation: Transportation of raw material and final products is done via roads as the
proposed project is well connected with roads, rail and airways.
Town and Country Planning Classification: This industry land is private land and will be
converted to industrial use.
5.2 Population Projection

There is a marginal scope for increase in the population from the proposed project.
Preference will be given for local villagers for Skilled / unskilled. Non local Skilled workers prefer to
stay in the nearby locations to avoid travelling from long distances. Local / Non local educated
youth will be employed as semi-skilled workers and training will be provided. Local Non-technical
villagers will be preferred for the unskilled jobs such as gardening, movement of materials, etc.
Hence, on the whole there is a possibility of little increase in population of the area.
5.3 Land use Planning
The unit has been proposed in the total area of 5.45 Ha. Land use pattern of the Project
area is given in Table 6.
14
Table 6 : Break up of proposed land use pattern
S. Proposed Per cent

Description
No. (sq.m) (%)
1. Built up (Plinth) area 9880 18.14
2. Roads 8536 15.67
3. ETP Area 800 1.47
4. Open area 16182.48 29.72
5. Greenbelt 19060.72 35.00
Total 54459.2 100.00
5.4 Assessment of Infrastructure Demand
There is no much demand for infrastructure for the proposed project as all infrastructure is
available near the project site.
5.5 Amenities/Facilities
Industry will provide the following amenities / facilities in the proposed project.
• Canteen
• Potable drinking water
• Training block
• Laying of Black top / Concrete internal roads
• Fire hydrant facility
• Eye/body wash showers
• First Aid kits at all prominent places.
• Head nurse for emergency medication.
• Rest Room for employees
• Seating facilities for those employees who do their work standing and ergonomically
designed sitting facilities for those who do their work sitting
• Pre-employment and routine medical examinations and the necessary follow up actions
• Communication systems like Phone, Internet with safety measures, etc.
• Security system at the entrance etc.
6.0 Proposed Infrastructure

6.1 Industrial Area
Production blocks, Ware house, utility area, ETP area, administration facilities are been
proposed in the area.
6.2 Residential Area

There will be no residential area within the project site.
6.3 Greenbelt
The unit has been proposed in the area of about 5.45 Ha i.e., 54459.2 sq.m. Out of which
about 19060.72 sq.m for Greenbelt area which is equivalent to 35 % of the total area.
15
6.4 Social Infrastructure

As a Corporate / Entrepreneur Social Responsibility (ESR), Industry will contribute for
development of village social infrastructure.
6.5 Connectivity
There is no change in connectivity compare to current facility.
6.6 Drinking Water Management
Potable drinking water will be provided to all employees. The source of drinking water is
Groundwater.
6.7 Sewerage System

Sewage will be generated from the Canteen and Toilets, which will be collected into
sewage collection tank through pipelines and septic tank respectively. Overflow of these tanks will
be sent to ETP – ZLD system.
6.8 Industrial Waste Management
Storage system needs to meet the project demand. The management of these wastes is to
be handled very sensitively and by adopting proper segregation techniques.
Liquid Waste Management: The liquid wastes from the various industrial activities will be
segregated and send to ETP-ZLD.
Process Emissions Management:
Manufacturing of APIs and API intermediates will result in gaseous emissions. Maximum
Process emissions from proposed products on campaign basis are given in Table 7. Proposed
gaseous emissions will be scrubbed in two stage scrubber with water or other liquid based on the
characteristics of gases. Dil HCl (20%) will be sold as by-product.
Table 7: Maximum Quantity of Process Emissions from Proposed Products
Maximum Quantity on
Sl. Process
various combinations Treatment Method
No. Emission
(kg/day)
1. HCl 405.83 • Scrubbed with water
2. SO2 120.83 • Scrubbed with caustic sol.
3. Methyl Chloride 182.58 • Scrubbed using caustic sol
4. CO2 388.63 • Dispersed into atmosphere
5. H2 23.17 • Diffused with flame arrestor
Fugitive emissions Management:

 Solvents used in the APIs & API intermediates manufacturing process will be stored in
drums and bulk quantities will be stored in above storage tanks.
 Solvents are handled in closed conditions thereby reducing the losses in the form of
evaporation.
16
 Proper earthing will be provided to all the electrical equipment and the joints / connections
wherever solvent handling is done.
 Reactor and solvent handling pump will have mechanical seals to prevent leakage.
 The industry will take measures for reduction of fugitive emissions and further reduction
industry will provided vent condensers to the tanks.
 Chilled brine circulation will be carried out to condensate the solvent vapor and to the
receivers of the solvent vapors which ensures the maximum recovery.
 Solvent vapours from the Centrifuge and Catch pots will connect to vent condensers.
 The height of the solvent receiver tank vent is above production block roof level and the
diameter is 20 mm.
 Flame proof fitting / equipments / pumps / lighting will be used wherever solvents are used.
The solvent storage tanks will be provided with breather valve to prevent losses.
Solvent Solvent Loss in Solvent Loss in Solvent Loss Solvent Solvent

Input Effluent Org. residue (Handling) Recovery Recovery
(KLD) (KLD) (KLD) (KLD) (KLD) (%)
81.42 0.51 0.85 3.37 76.6 94.08
Emissions from Utilities Management:
Boilers and DG sets are the two main sources contributing to emissions from the plant. The
proposed 12 & 4 TPH coal fired boilers and 2 lak Kcal/hr TFH will be which will be used for steam
requirements. Proposed 1000 KVA and 500 KVA DG Sets will be used as standby power during
power failures. The emissions from the boiler are given in Table 8.
Table 8: Stack Emission Details

Flue PM SO2 NOx
Exit
Stack Gas
Diameter Temperature Gas
Source Height Flow
(m) ( oC) Velocity kg/hr
(m) rate
(m/sec)
(m3/hr)
Coal Fired Boilers
12 TPH 40 0.9 150 26615 11.6 1.6 17 9.7
4 TPH 30 0.6 150 10645 10.5 0.5 5.7 3.2
Thermic Fluid Heater (HSD)
2 lak
30 0.3 150 868 4.0 0.004 0.088 0.094
Kcal/hr
DG Sets
1000 KVA 11 0.4 150 5650 12.5 0.063 1.25 1.34
500 KVA 9 0.3 150 2820 11.1 0.032 0.63 0.67
The various measures proposed to minimize the pollution from the boiler are as follows:
17
 Multi-cyclone separator followed by Bag filter will be installed to control the particulate (PM)
emissions within statutory limit of 115 mg/Nm3. To facilitate wider dispersion of pollutants,
40m & 30m height stack each will be installed.
 The NOx emissions from the boilers will be controlled by controlling combustion measures,
which will be approached by way of low NOx burners or by air stagging in boiler. The NOx
emissions will be restricted to below 500 mg/Nm3.
 Stacks will be provided to proposed 2 lak.cal/hr TFH, 500 & 1000 KVA D.G sets as per
CPCB / SPCB Guidelines.
 Fugitive dust will be controlled by adopting dust extraction and dust suppression measures
and development of greenbelt along the periphery of the proposed Boiler area.
Noise Management:
• Compressors, Boilers and DG sets will be the major noise generating units in the plant.
• The noise levels of the DG sets will be well within the limits as these will be installed with
acoustic enclosures. Workers will always be provided with ear muffs.
• All the equipment in the plant would be designed to have a total noise level not exceeding
85-90 dB(A) as per the requirement of OSHA (Occupational Safety and Health
Administration) standards.
6.9 Hazardous/ Solid Waste Management
• Solid waste mainly segregated into process organic residues, inorganic salts, boiler ash
spent mixed unrecoverable solvents and spent carbon.
• The organic residues, Spent carbon & Spent mixed unrecoverable solvents can be
disposed off to Cement plants as recommended by CPCB for use as alternate fuels either
in the solid or liquid form.
• Boiler ash will be sold to cement brick manufacturers.
• Inorganic salts are to be sent for landfill at HWMP – TSDF.
6.10 Power Requirement & Supply / Source

Power supply of 1000 KVA will be drawn from the nearby sub-station of TSSPDCL.
Proposed 1000 KVA and 500 KVA DG sets will be used as alternate arrangement in case of failure
in power supply.
7.0 Rehabilitation and Resettlement (R&R) Plan

The proposed land is plain barren rocky land. Therefore Rehabilitation and Resettlement
plan is not applicable to this project site.
18
8.0 Project Schedule & Cost Estimates
8.1 Time Schedule for the project construction
The timelines for commencement of proposed construction activity will be from April 2017
as it is expected that the proposed project will be in a position to obtain Environmental Clearance
& Consent for Establishment for the project. In 2017-18 the commercial production is expected to
be commenced.
8.2 Estimated project cost
Overall estimated cost involved in the total project like land, building, plant & machinery is
Rs. 45 Crores. Total capital cost allocated towards environmental pollution control measures is
Rs. 9.2 Crores and the Recurring cost will be about Rs.7 Crores per annum.
9.0 Analysis of proposal (Final Recommendations)
• The proposed project will result in growth of surrounding area by generating direct and
indirect employment to local people. Around 300 members will be benefitted due to the
proposed project.
• Under the Corporate Social Responsibility the Industry will develop a policy of developing the
villages in the vicinity by identifying the requirements.
• No adverse effect on environment is envisaged as proper mitigation measures will be taken

up.
• Industry will provide the Safety, Health & Environment Department and also engage
recognized laboratories to carry out all necessary monitoring parameters for its activities.
• The segregated (HTDS / LTDS) wastewater will regularly analyzed before and after
treatment in ETP-ZLD.
• Qualified staff will be appointed for the purpose of Operation and Maintenance of the
pollution control facilities.
• Stand-by facilities will be provided to all the pumps so as to ensure fail proof treatment,
handling and disposal.
9.1 Budgetary allocation for Pollution Control Measures
The management will set aside adequate funds in its budget to fully meet the stated
objectives of the environmental policy. The proposed capital equipment for environmental
management include effluent treatment plants, pipelines and channels for wastewater discharge,
air pollution control, solid/hazardous waste storage facilities, Noise attenuation, Occupation health
19
/ safety, greenbelt development and the environment laboratory. The break-up of budgetary
allocation for various control measures is presented in Table 9.
Table 9: Budgetary allocation for Pollution Control Measures
S. Description Proposed cost

No. (in lakhs)
Capital *Recurring
Air Pollution Control
1. Multicyclone & Bag filter with Stacks 70
2. Scrubbers 50 10
3. Vent condensers 50
Water Pollution Control
ETP Civil works, Steam stripper, MEE,
450 400
3. ATFD, R.O. and mechanical equipment
Noise Pollution Control
4. Silencers / acoustic enclosures 10 5
Solid Waste Management
Covered Platform with leachate collection
20 200
5. system
6. Greenbelt Development 10 5
7. Occupation Health and Safety 20 20
8. Fire Management 60 5
9. Dyke walls and Storm water drains 30 5
10. Environmental Laboratory 100 10
11. Misc. 50 40
Total 920 700
* Recurring cost includes manpower, consumables, maintenance, energy charges per annum
20
ANNEXURES
ANNEXURE - I
21
General Location Map ANNEXURE - II
Telangana state
Project Site
(1)Bommalaramaram (M), Nalgonda District.22
ANNEXURE - III
Specific Location (Route map)
M/s Orygamus Laboratories Pvt. Limited
M/s. Orygamus Laboratories Pvt. Ltd.

23
Village
ANNEXURE - IV
Google Image with Coordinates – Orygamus Laboratories Pvt. Ltd.
24
ANNEXURE - V
NORTH
W E
S.NO. DESCRIPTION LENGTH WIDTH

S
1 SECURITY ROOM 12.0 10.0 GREEN BELT
2 VEHICLE PARKING 30.0 10.0 FIRE HYDRANT

10 X 10 M
3 FIRE HYDRENT 10.0 10.0

VEHICLE PARKING
30 X 10 M
4 CANTEEN 30.0 17.0
6 M WIDE ROAD
5 WAREHOUSE 40.0 20.0 SECURITY
12 X 10 M
6 UTILITY 20.0 15.0
7 PRODUCTION BLOCK - 1 70.0 20.0 CANTEEN

30 X 17 M
LAWN
8 PRODUCTION BLOCK - 2 70.0 20.0
9 PRODUCTION BLOCK - 3 70.0 20.0

WAREHOUSE 6 M WIDE ROAD
10 PRODUCTION BLOCK - 4 70.0 20.0 40 X 20 M
8 M WIDE ROAD
11 TANK FORM 30.0 15.0
PRODUCTION BLOCK-1 GREEN BELT
12 ETP 40.0 20.0 70 X 20 M
LAWN
13 DISTILLATION COLUMN 20.0 20.0
6 M WIDE ROAD
14 BOILER 20.0 15.0

UTILITY
15 TRANSFORM YARD 15.0 15.0 20 X 15 M PRODUCTION BLOCK-2
70 X 20 M
6 M WIDE ROAD
6 M WIDE ROAD
PRODUCTION BLOCK-3
70 X 20 M
LAWN
TANK FORM
30 X 15 M
GREEN BELT
6 M WIDE ROAD
GREEN BELT
6 M WIDE ROAD
LAWN/OPEN AREA
ETP
20 X 40 M 90X40M
GREEN BELT
6 M WIDE ROAD 6 M WIDE ROAD

LAWN/OPEN AREA
DISTILLATION COLUMN PRODUCTION BLOCK-4

6 M WIDE ROAD
100X30M
20 X 20 M
70 X 20 M
6 M WIDE ROAD
LAWN/OPEN AREA
86X30M
BOILER
20 X 15M
LAWN/OPEN AREA TRANSFORM YARD

15 X 15M
86X30M
S.NO. DESCRIPTION TOTAL AREA PER. CENT GREEN BELT
(Sq.M) (%) AREA:53366.74 SQM

GREEN BELT
13.48 Acres
1 Built Up (Plinth) Area 9880.00 18.14 Survey No.:208/17&18 RAMLINGAMPALLY(V),BOMMALARAMARAM(M),NALGONDA DIST
ALL DIMENSIONS ARE METERS ONLY

2 Roads 8536.00 15.67
M/s. Orygamus Laboratories
M/S.ORYGAMUS Pvt. Ltd.
LABS PRIVATE LIMITED
3 ETP Area 800.00 1.47
4 Open Area 16182.48

15090.02 29.72 Title SITE LAYOUT
5 Greenbelt 19060.72 35.00 Drawing No. Effective Date
Total 54459.2
53366.74 100.00 Revision History First Issue
Prepared By Checked By Approved BY
25
ANNEXURE - VI
PRODUCT : Betahistine
Description :
Stage-1 : 2-Hydroxy-1-pyridinyl-3-trichloro propane is heated with concentrated Sulfuric Acid in presence of

Methanol (90%) solvent media to get 3-Pyridin-2-yl acrylic acid.
Stage-2 : 3-Pyridin-2-yl acrylic acid is reduced with Hydrogen on Palladium Carbon and treated with Ammonium
Hydroxide in presence of Methanol solvent media to get 3-Pyridin-2-yl propionamide.
Stage-3 : 3-Pyridin-2-yl propionamide is reacted with Bromine and Sodium Methoxide in presence of Methanol
solvent media to get (2-Pyridin-2-yl ethyl) carbamic acid methyl ester.
Stage-4 : (2-Pyridin-2-yl ethyl) carbamic acid methyl ester is heated with Potassium Hydroxide to get 2-Pyridin-2-
yl ethylamine.
Stage-5 : 2-Pyridin-2-yl ethylamine reacted with Methyl Iodide in presence of Sodium Carbonate in Toluene
solvent media to get Betahistine.
Flow Chart
2-Hydroxy-1-Pyridinyl-3- Sol.Recovery
trichloro Propane Evaporation Loss
Methanol (90%) Stage I Organic Residue
Sulfuric Acid Inorgainc Solid Waste
Process Emissions
Stage-1 Sol.Recovery
Hydrogen Evaporation Loss
Palladium Carbon Stage II Effluent
Ammonium Hydroxide (28%) Organic Residue
Methanol Process Emissions
Stage-2
Bromine Sol.Recovery
Sodium Methoxide Stage III Evaporation Loss
Methanol Effluent
Water
Stage-3
Potassium Hydroxide Stage IV Effluent
DM Water
Stage-4
Toluene Sol.Recovery
Sodium Carbonate Stage V Evaporation Loss
Methyl Iodide Effluent
DM Water
Betahistine
26
ANNEXURE - VI
PRODUCT : Rivastigmine
Description :
Stage-1 : a-m-Hydroxy phenyl ethyl dimethylamine in dry Acetonitrile reacted with n-Ethyl methyl carbomyl
chloride in presence of Sodium Hydride and Diethylether to get Rivastigmine.
Flow Chart
a-m-Hydroxy phenyl ethyl
dimethy amine
Acetonitrile Sol.Recovery
N-Ethyl methyl Carbomyl Evaporation Loss
chloride Stage I
Effluent
Diethyl ether Organic Residue
Sodium Hydride (60%) Process Emissions
Water
Rivastigmine
27
ANNEXURE - VI
PRODUCT : L-Thyroxine
Description :
Stage-1 : 2-Acetylamino-3-(4-hydroxy-3,5-diiodo phenyl) propionic acid ethyl ester under goes digestive
coupling reaction it was suspended in Boric acid and Ethanol and digested with Sodium Hydroxide to get
2-Acetylamino-3-[4-(4-hydroxy-3,5-diiodo phenoxy)-3,5-diiodo phenyl] propionic acid ethyl ester.
Stage-2 : 2-Acetylamino-3-[4-(4-hydroxy-3,5-diiodo phenoxy)-3,5-diiodo phenyl] propionic acid ethyl ester is

refluxed in Glacial Acetic acid and Hydrochloric acid to get L-Thyroxine.
Flow Chart
2-Acetylamino-3-(4-hydroxy-
3,5-diiodo phenyl) propionic
acid ethyl ester Sol.Recovery
Boric Acid Stage I Evaporation Loss
Ethanol Effluent
Sodium Hydroxide Organic Residue
Water
Stage-1
Acetic Acid
Stage II Effluent
Hydrochloric Acid (36%)
Water
L-Thyroxine
28
ANNEXURE - VI
PRODUCT : Fenoterol Hydrobromide
Description :
Stage-1 : 3,5-Dibenzyloxy Acetophenone is reacted with Selenium Dioxide in presence of 1,4-Dioxane to get (3,5-
Bis benzyloxy phenyl) oxo acetaldehyde.
Stage-2 : (3,5-Bis benzyloxy phenyl) oxo acetaldehyde is reacted with 4-Methoxy phenyl-2-aminopropane in
presence of Methanol to get amine compound and it is reduced with Sodium Borohydride in presence of
Hydrochloric acid to get 1-(3,5-Bis benzyloxy phenyl)-2-[2-(4-methoxy phenyl)-1-methyl ethylamino] ethanol.
Stage-3 : 1-(3,5-Bis benzyloxy phenyl)-2-[2-(4-methoxy phenyl)-1-methyl ethylamino] ethanol is treated with
Aluminum Chloride in presence of Toluene to get 4-{2-[2-(3,5-Bis benzyloxy phenyl)-2-hydroxy ethylamino] propyl}
phenol.
Stage-4 : 4-{2-[2-(3,5-Bis benzyloxy phenyl)-2-hydroxy ethylamino] propyl} phenol is treated with Maleic Acid in
presence of Ethyl Acetate to form Maleate Salt then basified with Sodium Bicarbonate to get 4-{2-[2-(3,5-Bis
benzyloxy phenyl)-2-hydroxy ethylamino] propyl} phenol.
Stage-5 : 4-{2-[2-(3,5-Bis benzyloxy phenyl)-2-hydroxy ethylamino] propyl} phenol is debenzylated with Hydrogen on
Palldium Carbon in presence of Ethyl Acetate to get Fenoterol.
Stage-6 : Fenoterol is treated with Hydrogen Bromide in Acetic Acid (33%) in presence of Isopropyl Alcohol to get
Fenoterol Hydrobromide.
29
ANNEXURE - VI
Flow Chart
3,5-Dibenzyloxy Acetophenone By-Product
Selenium Dioxide Sol.Recovery
Stage I
1,4-Dioxane Evaporation Loss
Organic Residue
Stage-1
4-Methoxy phenyl-2-
aminopropane Sol.Recovery
Methanol Stage II Evaporation Loss
Sodium Borohydride Effluent
Hydrochloric Acid (36%) Organic Residue
Water
Aluminum Chloride Evaporation Loss
Toluene Stage III Aqueous Send to Auth. Party
Water Organic Residue
Process Emissions
Maleic Acid Evaporation Loss
Ethyl Acetate Stage IV Effluent
Sodium Bicarbonate Organic Residue
DM Water Process Emissions
Hydrogen Evaporation Loss
Stage V
Palladium Carbon Organic Residue
Ethyl Acetate Process Emissions
Fenoterol
Hydrogen Bromide in Acetic Sol.Recovery
Stage VI
Acid (33%) Evaporation Loss
Isopropyl Alcohol Organic Residue
Fenoterol Hydrobromide
30
ANNEXURE - VI
PRODUCT : Xylazine Hydrochloride
Description :
Stage-1 : 2,6-Dimethyl Aniline react with Thiophosgene in presence of Sodium Carbonate in Chloroform solvent
media to get 2,6-Dimethyl phenyl isothiocyanate.
Stage-2 : 2,6-Dimethyl phenyl isothiocyanate is reacted with 3-Amino propanol in presence of Toluene we get
Phenyl thiourea compound and reacted with concentrated Sulfuric acid and Sodium Carbonate to get Xylazine
Base.
Stage-3 : Xylazine Base purified in Isopropyl Alcohol and react with Hydrogen Chloride in Isopropyl Alcohol
(20%) to get Xylazine Hydrochloride.
Flow Chart
2,6-Dimethyl Aniline Sol.Recovery
Thiophosgene Evaporation Loss
Chloroform Stage I Effluent
Sodium Carbonate (10%) Organic Residue
Stage-1
3-Amino Propanol Sol.Recovery
Sufluric Acid Evaporation Loss
Toluene Stage II Effluent
DM Water Spent Carbon
Carbon Process Emissions
Xylazine Sol.Recovery
Isopropyl Alcohol Evaporation Loss
Hydrochloride (20%) Stage III
Organic Residue
Isopropyl Alcohol Process Emissions
Xylazine Hydrochloride
31
ANNEXURE - VI
PRODUCT : Duloxetine Hydrochloride
Description :
Stage-1 : 2-Acetyl Thiophene is reacted with Paraformaldehyde and Dimethylamine Hydrochloride in presence of
Acetone and Hydrochloric acid to get 3-Dimethylamino-1-thiophen-2-yl propan-1-one Hydrochloride.
Stage-2 : 3-Dimethylamino-1-thiophen-2-yl propan-1-one Hydrochloride is reacted with Sodium Hydroxide in

presence of Methanol to get 3-Dimethylamino-1-thiophen-2-yl propan-1-one and this under goes reduction with
Sodium Borohydride in presence of Methylene Dichloride and n-Hexane solvent media at 0-10oC to get 3-
Dimethylamino-1-thiophen-2-yl propan-1-ol.
Stage-3 : 3-Dimethylamino-1-thiophen-2-yl propan-1-ol is reacted with 1-Fluoro naphthalene in presence
Potassium Hydroxide base and Dimethyl Sulfoxide solvent media to get Dimethyl-[3-(naphthalen-1-yloxy)-3-
thiophen-2-yl propyl]amine further treated with Oxalic Acid and Sodium Hydroxide in presence of Toluene and
Ethyl Acetate solvent media to get pure Dimethyl-[3-(naphthalen-1-yloxy)-3-thiophen-2-yl propyl]amine.
Stage-4 : Dimethyl-[3-(naphthalen-1-yloxy)-3-thiophen-2-yl propyl]amine is reacted with Phenyl chloroformate in
presence of Diisopropylether and Toluene to get Carbamate and it is treated with Potassium Hydroxide in
Dimethyl Sulfoxide and Ethyl Acetate to get R,S-Duloxetine.
Stage-5 : R,S-Duloxetine resoluted with Di-P-Tolyl-L-Tartaric Acid in presence of Methanol and Acetone to get S-
Duloxetine DPTTA Salt.
Stage-6 : S-Duloxetine DPTTA Salt Resolution with Sodium Hydroxide in presence of Methylene Dichloride to get
S-Duloxetine this is further treated with Isopropyl Alcohol Hydrochloride (20%) in presence of Acetone to get
Duloxetine Hydrochloride.
32
ANNEXURE - VI
Flow Chart
2-Acetyl Thiophene
Acetone Sol.Recovery
Dimethylamine Hydrochloride Stage I Evaporation Loss
Paraformaldehyde Aqueous Send to Auth. Party
Stage-1
Methanol
Sodium Hydroxide Sol.Recovery
Sodium Borohydride Stage II Evaporation Loss
Methylene Dichloride Effluent
n-Hexane Organic Residue
DM Water
Stage-2
Dimethyl Sulfoxide
Potassium Hydroxide
18-Crown-6 Sol.Recovery
1-Fluoro naphthalene Evaporation Loss
Stage III
Toluene Effluent
Oxalic Acid Organic Residue
Sodium Hydroxide
Ethyl Acetate
DM Water
Stage-3
Diisopropyl ether
Toluene
Phenyl Chloroformate Sol.Recovery
Hydrochloric Acid (10%) Evaporation Loss
Stage IV
Sodium Bicarbonate (50%) Effluent
Potassium Hydroxide Organic Residue
Dimethyl Sulfoxide Process Emissions
Ethyl Acetate
Water
33
ANNEXURE - VI
Flow Chart
R,S-Duloxetine
Di-P-Tolyl-L-Tartaric Acid Sol.Recovery
Stage V
Methanol Evaporation Loss
Acetone Organic Residue
S-Duloxetine DPTTA Salt

Methylene Dichloride Evaporation Loss
Water Effluent
Stage VI
Isopropyl Alcohol Spent Carbon
Hydrochloride (20%) Process Emissions
Carbon
Duloxetine Hydrochloride
34
ANNEXURE - VI
PRODUCT : Dorzolamide Hydrochloride
Description :
Stage-1 : Methyl(R)-3-hydroxy butyrate is treated with p-Toluene sulfonyl chloride in presence of Pyridine
solvent media to get 3-(Toluene-4-sulfonyloxy) butyric acid methyl ester.
Stage-2 : 3-(Toluene-4-sulfonyloxy) butyric acid methyl ester is made to react with 2-Thiophene thiolithium in
presence of Tetrahydrofuran to get 3-(Thiophen-2-ylsulfanyl) butyric acid methyl ester.
Stage-3 : 3-(Thiophen-2-ylsulfanyl) butyric acid methyl ester is heated with Hydrochloric acid in presence of
Toluene solvent media to get 3-(Thiophen-2-ylsulfanyl) butyric acid.
Stage-4 : 3-(Thiophen-2-ylsulfanyl) butyric acid made to react with Trifluoro Acetic Anhydride in presence of
Toluene solvent media to get 6-Methyl-5,6-dihydro thieno[2,3-b]thiopyran-4-one.
Stage-5 : 6-Methyl-5,6-dihydro thieno[2,3-b]thiopyran-4-one is reduced with Lithium Aluminum Hydride in

Tetrahydrofuran (60%) at 0-5oC in presence of Toluene solvent media to get 6-Methyl-5,6-dihydro-4H-
thieno[2,3-b]thiopyran-4-ol.
Stage-6 : 6-Methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-4-ol is quinch in Sulfuric acid at 0-5oC to get 6-Methyl-

5,6-dihydro-4H-thieno[2,3-b]thiopyran-4-ol.
Stage-7 : 6-Methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-4-ol was treated with Hydrogen Peroxide in presence

of Catalyst in Ethyl Acetate solvent media to get 6-Methyl-7,7-dioxo-4,5,6,7-tetrahydro-7l*6*-thieno[2,3-
b]thiopyran-4-ol.
Stage-8 : 6-Methyl-7,7-dioxo-4,5,6,7-tetrahydro-7l*6*-thieno[2,3-b]thiopyran-4-ol is treated with Acetic
Anhydride and Acetonitrile in presence of Pyridine and Tetrahydrofuran to get N-(6-Methyl-7,7-dioxo-4,5,6,7-
tetrahydro-7l*6*-thieno[2,3-b]thiopyran-4-yl) acetamide.
Stage-9 : N-(6-Methyl-7,7-dioxo-4,5,6,7-tetrahydro-7l*6*-thieno[2,3-b]thiopyran-4-yl) acetamide is treated with
Chlorosulfonic acid at 0oC and added Thionyl Chloride in presence of Ethylene Dichloride solvent media to get
4-Acetylamino-6-methyl-7,7-dioxo-4,5,6,7-tetrahydro-7l*6*-thieno[2,3-b]thiopyran-2-sulfonyl chloride.
Stage-10 : 4-Acetylamino-6-methyl-7,7-dioxo-4,5,6,7-tetrahydro-7l*6*-thieno[2,3-b]thiopyran-2-sulfonyl chloride
is treated with Ammonim Hydroxide in presence of Tetrahydrofuran solvent media to get N-(6-Methyl-7,7-dioxo-
2-sulfamoyl-4,5,6,7-tetrahydro-7l*6*-thieno[2,3-b]thiopyran-4-yl) acetamide.
Stage-11 : N-(6-Methyl-7,7-dioxo-2-sulfamoyl-4,5,6,7-tetrahydro-7l*6*-thieno[2,3-b]thiopyran-4-yl) acetamide is

react with Borane Dimethylsulfate in presence of Sodium Hydroxide in Tetrahydrofuran solvent media to get
Dorzolamide Base.
Stage-12 : Dorzolamide Base was treated with Maleic acid in presence of Acetone solvent media to get
Dorzolamide Maleate.
Stage-13 : Dorzolamide Maleate is treated with Sodium Bicarbonate in presence of Ethyl Acetate solvent
media to get pure Dorzolamide this is further treated with Isopropyl Alcohol Hydrochloride (20%) to get
Dorzolamide Hydrochloride.
35
ANNEXURE - VI
Flow Chart
P-Toluene Sulfonyl Chloride Sol.Recovery
Evaporation Loss
Methyl ( R )-3-hydroxy butyrate
Stage I Effluent
Pyridine Organic Residue
Water Process Emissions
Stage-1
2-Thiophene thiolithium Sol.Recovery
Sodium Chloride Stage II Evaporation Loss
Tetrahydrofuran Effluent
Toluene Evaporation Loss
Hydrochloric Acid (36%) Stage III Effluent
Process Emissions
Trifluoro Acetic Anhydride Evaporation Loss
Stage IV
Toluene Effluent
Stage-4
Lithium Aluminum Hydride in Sol.Recovery
Tetrahydrofuran (60%) Stage V Evaporation Loss
Toluene Effluent
36
ANNEXURE - VI
Flow Chart
Stage-5
Sulfuric Acid Stage VI Effluent
Water
Stage-6
Hydrogen Peroxide (50%) Sol.Recovery
Ethyl Acetate Stage VII Evaporation Loss
Catalyst Effluent
Stage-7
Acetic Anhydride
Pyridine Sol.Recovery
Acetonitrile StageVIII Evaporation Loss
Sulfuric Acid Organic Residue
Water
Chlorosulfonic Acid Evaporation Loss
Stage IX
Thionyl Chloride Organic Residue
Ethylene Dichloride Process Emissions
Ammonium Hydroxide (26%) Evaporation Loss
Stage X
37
ANNEXURE - VI
Flow Chart
Borane Dimethyl Sulfide Evaporation Loss
Tetrahydrofuran Stage XI Effluent
Dorzolamide Sol.Recovery
Maleic Acid Stage XII Evaporation Loss
Dorzolamide Maleate
Ethyl Acetate Sol.Recovery
Sodium Bicarbonate Evaporation Loss
DM water StageXIII Effluent
Sodium Sulfate
Dorzolamide Hydrochloride
38
ANNEXURE - VI
PRODUCT : Biperiden Hydrochloride
Description :
Stage-1 : Cyclopentadiene is reacted with Methyl vinyl ketone in presence of Sodium Methoxide in Methanol
solvent media to get 1-Bicyclo[2.2.1]hept-5-en-2-yl ethanone.
Stage-2 : 1-Bicyclo[2.2.1]hept-5-en-2-yl ethanone is react with Piperidine Hydrochloride and Paraformaldehyde
in presence of Sodium Hydroxide in Isopropyl Alcohol solvent media to get 1-Bicyclo[2.2.1]hept-5-en-2-yl-3-
piperidin-1-yl-propan-1-one.
Stage-3 : 1-Bicyclo[2.2.1]hept-5-en-2-yl-3-piperidin-1-yl-propan-1-one is treated with Phenyl Magnesiumchloride
in presence of Tetrahdyrofuran and 1,4-Dioxane solvent media to get Biperiden.
Stage-4 : Biperiden is treated with Hydrochloric acid in presence of Isopropyl Alcohol solvent media to get
Biperiden Hydrochloride.
Flow Chart
Cyclopentadiene
Methyl vinyl ketone Sol.Recovery
Stage I
Sodium Methoxide Evaporation Loss
Methanol Organic Residue
Stage-1
Piperidine Hydrochloride Sol.Recovery
Sodium Hydroxide Evaporation Loss
Stage II
Paraformaldehyde Effluent
Water
Stage-2
Phenyl maganesium chloride Sol.Recovery
1,4-Dioxane Evaporation Loss
Stage III
Water
Biperiden Sol.Recovery
Isopropyl Alcohol Stage IV
Organic Residue
Biperiden Hydrochloride
39
ANNEXURE - VI
PRODUCT : Modafinil
Description :
Stage-1 : Thiourea dissolve in 48% Hydrobromic acid and reacted with Benzhydrol and Chloroacetic acid in
presence of Sodium Hydroxide in Ethylene Dichloride solvent media to get Benzhydrylsulfanyl acetic acid.
Stage-2 : Benzhydrylsulfanyl acetic acid treated with Thionyl Chloride in presence of Toluene solvent media to
get Benzhydrylsulfanyl acetyl chloride.
Stage-3 : Benzhydrylsulfanyl acetyl chloride treated with Ammonium Hydroxide to get 2-Benzhydrylsulfanyl
acetamide.
Stage-4 : 2-Benzhydrylsulfanyl acetamide treated with Hydrogen Peroxide in presence of Acetic acid solvent
media to get Modafinil.
Flow Chart
Benzhydrol
Thio Urea
Hydrobromic Acid (48%) Sol.Recovery
Ethylene Dichloride Stage I Evaporation Loss
Sodium Hydroxide Effluent
Chloroacetic Acid Organic Residue
Water
Thionyl Chloride Evaporation Loss
Stage II
Toluene Organic Residue
Process Emissions
Stage-2
Ammonium Hydroxide (26%) Stage III Effluent
Water
Stage-3
Hydrogen Peroxide (50%) Sol.Recovery
Stage IV
Acetic Acid Evaporation Loss
Water Effluent
Modafinil
40
ANNEXURE - VI
PRODUCT : Ledipasvir
Description :
Stage-1 : Led (1R,3S,4S)-3-(6-Bromo-1H-benzimidazol-2-yl)-2-azabicyclo [2.2.1]heptane-2-carboxylic acid-1,1-

dimethylethyl ester on reaction with Bis(pinacolato)diboron, Potassium Propionate and Dichlorobis(di-tert-butylphenyl
phosphine)palladium(II) were charged into reactor and the reaction was charged with Isopropyl Acetate, the reaction
mass was heated to 75°C and agitated for 3-4 hours, after completion of reaction, the reaction mass was cooled to
ambient temperature, 6-{5-(7-Bromo-9,9-difluoro-9H-fluoren-2-yl)-1H-imidazol-2-yl]-5-aza-spiro[2,4]heptane-5-carboxylic
acid tert-butyl ester was charged into reaction mass, Tripotassium Phosphate solution was charged and heated to 70-
80°C, and maintained for 1 hour, cooled the reaction mass to 35-40°C, charged N-Acetyl-L-cystine and stirred for 15
hours at 35-45°C, after completion of reaction the reaction mass was cooled to 20-25°C, separated layers, N-Acetyl-L-
cystine was charged to organic layer and heated to 40-45°c and maintained for 2 hours. The reaction mass was cooled
to 20-25°C, and washed with Sodium Hydroxide, Oxalic acid solution was added to reaction mass and stirred to form
slurry compound, the resulting solid was filtered, dried to Stage-1 Compound.
Stage-2 : To a solution of Stage-1 Compound in Acetonitrile at 65°C, charged Hydrochloric acid solution, the reaction
mixture was stirred for 2 hours at 65°C, reaction completion was monitored, after reaction completion, cooled to 40-
45°C, Acetonitrile was added, the resulting slurry was cooled to ambient temperature and filtered, dried to get Stage-2
Intermediate.
Stage-3 : Stage-2 Intermediate reacted with 2-((Methoxy carbonyl) amino)-3-methyl butanoic acid in presence of 1-Ethyl-
3-(3-dimethylaminopropyl)carbodiimide,Diisopropylethylamine and Sodium Bicarbonate using Butyl Alcohol,
Dimethylformamide and Ethyl Acetate as solvent media to obtain Ledipasvir.
41
ANNEXURE - VI
Flow Chart
(1R,3S,4S)-3-(6-Bromo-1H-
benzimidazol-2-yl)-2-azabicyclo
[2.2.1]heptane-2-carboxylic acid-1,1-
dimethylethyl ester
6-{5-(7-Bromo-9,9-difluoro-9H-
fluoren-2-yl)-1H-imidazol-2-yl]-5-aza-
spiro[2,4]heptane-5-carboxylic acid
tert-butyl ester Sol.Recovery
Potassium Propionate Evaporation Loss
Hydrogen Stage I Effluent
Bis(pinacolato)diboron Organic Residue
Dichlorobis(di-tert-butylphenyl Process Emissions
phosphine)palladium(II)
Isopropyl Acetate
N-Acetyl-L-cystine
Tripotassium Phosphate (20%)
Oxalic acid
Sodium Hydroxide
Water
Acetonitrile Evaporation Loss
Stage II
Hydrochloric acid (4%) Effluent
Process Emissions
Stage-2
Dimethylformamide
1-Ethyl-3-(3-dimethylaminopropyl)
carbodiimide
Butyl Alcohol Sol.Recovery
2-((Methoxy carbonyl) amino)-3- Evaporation Loss
methyl butanoic acid Stage III
Effluent
Diisopropylethylamine Organic Residue
Ethyl Acetate Inorgainc Solid Waste
Sodium Bicarbonate
Hyflo
Water
Ledipasvir
42
ANNEXURE - VI
PRODUCT : Pirfenidone
Description :
Stage-1 : Bromobenzene on reaction with 5-Methyl-1H-pyridin-2-one in presence of Potassium Carbonate and

Copper Oxide in Dimethylformamide solvent medium at elevated temperature. After completion of the reaction,
the reaction mass was cooled and extracted the compound in Toluene, Toluene layer was washed with purified
water, the solvent was evaporated to get crude material, and the crude material was isolated by using Hexane.
The solid was treated with aueous Hydrochloric acid and isolated by adjusting pH to basic using Sodium
Hydroxide to get solid. The solid was filtered and dried to obtain pure Pirfenidone.
Flow Chart
Bromobenzene
5-Methyl-1H-pyridin-2-one
Potassium Carbonate Sol.Recovery
Copper Oxide Evaporation Loss
Dimethylformamide Effluent
Stage I
Hexane Inorgainc Solid Waste
Sodium Hydroxide Process Emissions
Hydrochloric acid (35%)
Water
Pirfenidone
43
ANNEXURE - VI
PRODUCT : Darunavir Ethanolate
Description :
Stage-1 : 4-Amino-N-((2S,3S)-3-amino-2-hydroxy-4-phenylbutyl)-N-isobutylbenzenesulfonamide reacts with

(3R,3aS,6aR)-Hexahydrofuro [2,3-b]furan-3-yl (4-nitrophenyl) carbonate in presence of Ethanol, N-Methyl-2-
Pyrrolidinone, Sodium Carbonate and Sodium Chloride. After completion of reaction Ethyl Acetate and purified
water were added to the reaction mass, organic layer was filtered and purified by using Ethanol to form the
Darunavir Ethanolate.
Flow Chart
4-Amino-N-((2S,3S)-3-amino-2-
hydroxy-4-phenylbutyl)-N-
isobutylbenzenesulfonamide
(3R,3aS,6aR)-Hexahydrofuro
[2,3-b]furan-3-yl (4-nitrophenyl) Sol.Recovery
carbonate Evaporation Loss
Stage I
N-Methyl-2-Pyrrolidinone Effluent
Sodium Carbonate Organic Residue
Sodium Chloride
Ethyl Acetate
Ethanol
Water
Darunavir Ethanolate
44
ANNEXURE - VI
PRODUCT : Sofosbuvir
Description :
Stage-1 : 2'-Deoxy-2'-fluoro-2'-C-methyluridine on reaction with Propan-2-yl(2S)-2-{[(pentafluoro phenoxy)

(phenoxy)phosphoryl] amino}propanoate in presence of tert-Butylmagnesium Chloride in Tetrahydrofuran. After
completion of the reaction solvent was evaporated. The product was extracted in Methylene Dichloride and
washed with water and Sodium Bicarbonate in presence of Hydrochloric acid, distilled out and isolated the solid
to get Sofosbuvir.
Flow Chart
2'-Deoxy-2'-fluoro-2'-C-
methyluridine
Propan-2-yl(2S)-2-{[(pentafluoro
phenoxy)(phenoxy)phosphoryl]
amino}propanoate Sol.Recovery
Tetrahydrofuran Evaporation Loss
Sodium Bicarbonate Stage I Effluent
Methylene Dichloride Organic Residue
Hydrochloric acid (35%) Inorgainc Solid Waste
tert-Butylmagnesium Chloride Process Emissions
(20%) in Tetrahydrofuran
Hyflo
Water
Sofosbuvir
45
ANNEXURE - VI
PRODUCT : Imatinib Mesylate
Description :
Stage-1 : 6-Methyl-N1-(4-(pyridin-3-yl) pyrimidin-2-yl)benzene-1,3-diamine reacts with 4-((4-Methyl piperazin-

1-yl) methyl) benzoyl chloride Dihydrochloride in presence of N-Methyl Morpholine and Methylene Dichloride.
After completion of the reaction the resulting reaction mass was basified, extracted using Methylene
Dichlorideand layers were separated. Dimethylformamide and Acetonitrile were charged to the aqueous layer
and basify with Sodium Hydroxide. The resulting reaction mass filtered and washed by using purified water
and Acetonitrile to get Imatinib.
Stage-2 : Imatinib reacts with Methanesulfonic acid in presence of Acetone, after completion of the reaction,
the resulting product is subjected to filtration and washing using Acetone to form the Imatinib Mesylate as a
white solid.
Flow Chart
6-Methyl-N1-(4-(pyridin-3-yl)
pyrimidin-2-yl)benzene-1,3-
diamine
4-((4-Methylpiperazin-1-yl)
methyl) benzoyl chloride Sol.Recovery
Dihydrochloride Evaporation Loss
Stage I
N-Methylmorpholine Effluent
Dimethylformamide
Acetonitrile
Sodium Hydroxide
Water
Imatinib Sol.Recovery
Methanesulfonic acid Stage II Evaporation Loss
Imatinib Mesylate
46
ANNEXURE - VI
PRODUCT : Gefitinib
Description :
Stage-1 : Dimethylformamide, 4-Chloro-6-(3-chloropropoxy)-7-methoxyquinazoline and Morpholine were heated to

70-750C for -6-8 hrs. The reaction mass was cooled to room temperature, and Methylene Dichloride and water was
charged. The layers separated and the aqueous layer extracted with Methylene Dichloride twice. The combined
Methylene Dichloride layer was washed with water, dried over Sodium Sulfate and concentrated completely at 35-
400C to yield Stage-1 Compound.
Stage-2 : Methanol and Stsge-1 Compound were stirredfor 15 minutes at 25-300C, then a solution of -Chloro-4-
fluoroaniline in Methanol was charged and refluxed for 6 hrs. The reaction mass was cooled to 15-200
Hydrochloric acid was added drop wise, and stirred at 5-100C for 30 minutes. The solid filtered and washed with
chilled Methanol to form Gefitinib.
Flow Chart
4-Chloro-6-(3-chloropropoxy)-7-
methoxyquinazoline Sol.Recovery
Morpholine Evaporation Loss
Dimethylformamide Stage I Effluent
Sodium Sulfate Inorgainc Solid Waste
Water
3-Chloro-4-fluoroaniline Evaporation Loss
Methanol Stage II Effluent
Hydrochloric acid (35%) Organic Residue
Process Emissions
Gefitinib
47
ANNEXURE - VI
PRODUCT : Erlotinib
Description :
Stage-1 : 6,7-Bis(2-methoxy ethoxy) quinazoline, Methylene Dichloride and Dimethylformamide are taken in
0
round bottom flask and start stirring, to the content added Oxalyl Chloride at 25-30 C slowly for 30 minutes,
heated to reflux temperature for 1 hour 30 minutes and cooled to room temperature then washed with 8%
Sodium Bicarbonate solution and the resulting organic layer is washed with water and dried the organic layer
using Sodium Sulfate and distilled the solvent under vacuum at 55-600C. To the residue added n-Heptane and
stirred for 1 hour at 25-300C, filtered the material and washed with n-Heptane to get Stage-1 Compound.
Stage-2 : Stage-1 Compound and Isopropyl Alcohol are added to 3-Ethynylaniline at 25-300C. Under stirring,
the contents are heated to reflux and then refluxed for 1 hour 30 minutes to 2 hours. The reaction mass is
cooled to 25-300C and stirred for 30 minutes. Filtered the material, washed with chilled Isopropyl Alcohol
followed by n-heptane and dried the material at 50-600C to form Erlotinib.
Flow Chart
6,7-Bis(2-methoxy ethoxy)
quinazoline
Oxalyl Chloride Sol.Recovery
Dimethylformamide Evaporation Loss
Methylene Dichloride Stage I Effluent
Sodium Sulfate Organic Residue
Sodium Carbonate Inorgainc Solid Waste
n-Heptane Process Emissions
Water
Stage-1
3-Ethynylaniline Sol.Recovery
Stage II
n-Heptane Organic Residue
Erlotinib
48
ANNEXURE - VI
PRODUCT : Dasatinib
Description :
Stage-1 : Charge Acetonitrile, 2-((6-Chloro-2-methylpyrimidin-4-yl)amino)-N-(2-chloro-6-methyl phenyl) thiazole-5-

carboxamide and 1-(-2-Hydroxyethyl) piperazine in presence of Triethylamine and Tetrabutylammonium Bromide. Stir
0 0
the reaction mass for 10-15 minutes at 30-35 C. Heat the reaction mixture to 75-80 C and stir for 20-24 hrs. Charge
0 0
water slowly and stir the reaction mass for 30-45 minutes at 75 C. Cool the reaction mass to 30-35 C and stir for 2-3
hrs. Filter the reaction mass and wash with Acetonitrile and water to obtain Dasatinib.
Flow Chart
2-((6-Chloro-2-methylpyrimidin-4-
yl)amino)-N-(2-chloro-6-methyl
phenyl)thiazole-5-carboxamide Sol.Recovery
1-(-2-Hydroxyethyl) piperazine Evaporation Loss
Stage I
Triethylamine Effluent
Tetrabutylammonium Bromide Organic Residue
Acetonitrile
Water
Dasatinib
49
ANNEXURE - VI
PRODUCT : Atazanavir Sulfate
Description :
Stage-1 : The tert-Butyl-2-((2S,3R)-3-((tert-Butoxycarbonyl)amino)-2-hydroxy-4-phenylbutyl)-2-(4-(pyridin-2-
yl)benzyl)hydrazine carboxylate is suspended in Methylene Dichloride. Concentrated Hydrochloric acid is added at a
0
sufficiently slow rate to maintain the temperature of the reaction below 30 C. The resulting biphasic mixture is
0
heated at 30-40 C until the two BOC groups have been cleaved. The aqueous solution of the resulting
trihydrochloride salt is added to a buffered solution of the active esters generated from (R)-2-((Methoxycarbonyl)
amino)-3,3-dimethylbutanoic acid and N-Ethyl-N'-dimethyl aminopropyl carbodiimide in Methylene Dichloride. The
0
mixture is stirred at 30-40 C until the coupling reaction is deemed complete by HPLC. The resulting free base is
washed sequentially with 1M Sodium Dihydrogen Phosphate, 0.5 Dipotassium Phosphate and 10% brine. The
0
resulting solution is polished filtered at 40-50 C. Crystallisation of the bisulfate salt was performed by the addition of
10% of the sulfuric acid charge, seeding followed by the addition of the remainder of the acid charge after according
to five progressively faster flow rates, as calculated by an empirically derived cubic equation over approximately
0
5hrs. The product slurry is cooled to 20-25 C over 1hr and held in this temperature range for at least 1hr. Isolation of
product is carried out on a centrifuge. After Methylene Dichloride wash to remove N-Methyl Pyrrolidone, the product
is dried to get Atazanavir Sulfate.
Flow Chart
tert-Butyl-2-((2S,3R)-3-((tert-
Butoxycarbonyl)amino)-2-
hydroxy-4-phenylbutyl)-2-(4-
(pyridin-2-yl)benzyl)hydrazine
carboxylate
(R)-2-((Methoxycarbonyl)
amino)-3,3-dimethylbutanoic
acid Sol.Recovery
Hydrochloric acid (35%) Evaporation Loss
Dipotassium Phosphate Effluent
Stage I
N-Ethyl-N'-dimethyl amino Inorgainc Solid Waste
propyl carbodiimide Spent Carbon
1-Hydroxybenzotriazole Process Emissions
Sodium Dihydrogen Phosphate
Sodium Hydroxide
Sulfuric acid
N-Methyl Pyrrolidone
Sodium Chloride
Water
Atazanavir Sulfate
50
ANNEXURE - VI
PRODUCT : Pomalidomide
Description :
Stage-1 : Stirred mixture of 3-Nitrobenzene-1,2-dicarboxylic acid with Acetic Anhydride and Acetic acid at
elevated temperature till completion of reaction and reaction mixture cooled to room temperature. Water was
added to isolate the solid. Solid was collected by filtration and dried to obtained the Stage-1 Compound.
Stage-2 : Stage-1 Compound and 3-Aminopiperidine-2,6-dione Hydrochloride was charged to Acetic acid.
Resulting mixture was stirred at elevated temperature till completion of reaction. Cool the reaction mass to room
temperature. Charged Methylene Dichloride and water. The product is extracted in Methylene Dichloride. The
solvent is evaporated and crude product is isolated in water. Further the crude product is purified in Acetone to
obtained the Stage-2 Intermediate.
Stage-3 : Stirred the mixture of Stage-2 Intermediate, Palladium Carbon and Ethyl Acetate till completion of
reaction. Then Palladium Carbon was filtered off and solvent was distilled out to get the crude Pomalidomide
which was purified in Ethanol to gave pure Pomalidomide.
Flow Chart
3-Nitrobenzene-1,2-dicarboxylic
acid Sol.Recovery
Acetic acid Stage I Evaporation Loss
Acetic Anhydride Effluent
Water
Stage-1
3-Aminopiperidine-2,6-dione
Hydrochloride Sol.Recovery
Triethylamine Evaporation Loss
Stage II
Acetic acid Effluent
Acetone
Water
Palladium Carbon Evaporation Loss
Ethyl Acetate Stage III Effluent
Ethanol Organic Residue
Hydrogen Process Emissions
Pomalidomide
51
ANNEXURE - VI
PRODUCT : Lenalidomide
Description :
Stage-1 : 2-(Bromomethyl)-3-nitrobenzoic acid, Aminopiperidine-2,6-dione Hydrochloride and Triethylamine was

charged to Acetic acid. Resulting mixture was stirred at elevated temperature till completion of reaction. Cool
the reaction mass to room temperature. Charged Methylene Dichloride and water. The product is extracted in
Methylene Dichloride. The solvent is evaporated and crude product is isolated in water. Further the crude
product is purified in Acetone to obtained the Stage-1 Compound.
Stage-2 : Stirred the mixture of Stage-1 Compound, Palladium Carbon and Ethyl Acetate in presence of
Hydrogen atmosphere till completion of reaction. Then Palladium Carbon was filtered off and solvent was
distilled out to get the crude Lenalidomide, which was purified in Ethanol obtain Pure Lenalidomide.
Flow Chart
2-(Bromomethyl)-3-nitrobenzoic
acid
Aminopiperidine-2,6-dione
Hydrochloride Sol.Recovery
Triethylamine Stage I Evaporation Loss
Acetic acid Effluent
Acetone
Water
Ethyl Acetate Stage II Effluent
Lenalidomide
52
ANNEXURE - VI
PRODUCT : Latanoprost
Description :
Stage-1 : [(Z)-7-(1R,2R,3R, 5S)-5-Hydroxy-2 [(3R)Trimethyl silyloxy-5-(phenyl-1-pentyl)-3-trimethyl silyloxy]

cyclopentyl-5-hept-enoic acid], Isoproyl Bromide and Cesium Carbonate were charged to Dimethylformamide.
Resulting mixture was stirred at 40-450C till completion of reaction. Cool the reaction mass to room temperature.
Slowly added Ethyl Acetate ans aqueous solution of Potassium Hydrogen Sulfate and the product is extracted in
Ethyl Acetate. The solvent is evaporated completely to obtain Stage-1 Compound as a viscous oil.
Stage-2 : Stirred the mixture of Stage-1 Compound, water and dilute Hydrochloric acid at ambient temperature
till completion of reaction. Slowly added Sodium Bicarbonate solution to adjust pH to 6.5. Charged Ethyl Acetate
and the product is extracted in Ethyl Acetate. Solvent was distilled out completely and crude product was
purified by column cromatography to obtained Latanoprost.
Flow Chart
[(Z)-7-(1R,2R,3R, 5S)-5-
Hydroxy-2 [(3R)Trimethyl
silyloxy-5-(phenyl-1-pentyl)-3-
trimethyl silyloxy] cyclopentyl-5- Sol.Recovery
hept-enoic acid] Evaporation Loss
Isoproyl Bromide Stage I Effluent
Cesium Carbonate Organic Residue
Dimethylformamide Process Emissions
Ethyl Acetate
Potassium Hydrogen Sulfate
Water
Ethyl Acetate Evaporation Loss
Hydrochloric acid (35%) Stage II Effluent
Sodium Bicarbonate Organic Residue
Latanoprost
53
ANNEXURE - VI
PRODUCT : Solifenacin Succinate
Description :
Stage-1 : (1S)-1-Phenyl-1,2,3,4-tetrahydroisoquinoline reacts with Ethyl Chloroformate in presence of Toluene and

Triethylamine. After completion of reaction, separate the layers, wash the organic layer with Hydrochloric acid and
purified with water and the resulting material is distilled to get the Stage-1 Compound.
Stage-2 : Stage-1 Compound reacts with 3-Quinuclidinol in presence of Dimethylformamide and Sodium Hydride.
After completion of reaction, separate the layers and wash the organic layer using Toluene and purified with water,
the resulting in-situ product is treated with Succinic acid and filtered using pre-chilled Ethyl Acetate to get the crude
Solifenacin Succinate. The crude Solifenacin Succinate is purified using Ethyl Acetate and Ethanol to form Pure
Solifenacin Succinate.
Flow Chart
(1S)-1-Phenyl-1,2,3,4-
tetrahydroisoquinoline Sol.Recovery
Ethyl Chloroformate Evaporation Loss
Toluene Stage I Effluent
Triethylamine Organic Residue
Hydrochloric acid (35%) Process Emissions
Water
Stage-1
3-Quinuclidinol
Dimethylformamide
Sodium Hydride (60%) in
Paraffin oil Sol.Recovery
Stage II
Ethyl Acetate Effluent
Succinic acid Process Emissions
Ethanol
Sodium Hydroxide (50%)
Water
Solifenacin Succinate
54
ANNEXURE - VI
PRODUCT : Cabazitaxel
Description :
Stage-1 : (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-acetoxy-9-(((2R,3S)-3-((tert-butoxy carbonyl) amino)-3-

phenyl-2-((triethylsilyl)oxy)propanoyl)oxy)-11-hydroxy-4,6-dimethoxy-4a,8,13,13-tetramethyl-5-oxo-
2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-1H-7,11-methanocyclodeca [3,4]benzo [1,2-b]oxet-12-yl benzoate
reacts with Pyridine, Hydrogen Fluoride and Acetonitrile. After completion of reaction, the resulting reaction mass
was extracted by using Methylene Dichloride and the resulting mass was purified with Methanol to get Pure
Cabazitaxel.
Flow Chart
(2aR,4S,4aS,6R,9S,11S,12S,12
aR,12bS)-12b-acetoxy-9-
(((2R,3S)-3-((tert-butoxy
carbonyl) amino)-3-phenyl-2-
((triethylsilyl)oxy)propanoyl)oxy)-
11-hydroxy-4,6-dimethoxy-
4a,8,13,13-tetramethyl-5-oxo-
2a,3,4,4a,5,6,9,10,11,12,12a,12 Sol.Recovery
b-dodecahydro-1H-7,11- Stage I Evaporation Loss
methanocyclodeca [3,4]benzo Effluent
[1,2-b]oxet-12-yl benzoate Organic Residue
Hydrogen Fluoride
Pyridine
Acetonitrile
Methylene Dichloride
Methanol
Water
Cabazitaxel
55
ANNEXURE - VI
PRODUCT : Entecavir
Description :
Stage-1 : 6-(Benzyloxy)-9-((1S,3R,4S)-4-(benzyloxy)-3-((benzyloxy) methyl)-2-methylenecyclopentyl)-9H-purin-2-

amine on reduction with Hydrogen in presence of Palladium Carbon using Methanol as solvent medium. After
completion of the reaction, resulting material is distilled and resulting solid is purified using Acetone to get the pure
Entecavir.
Flow Chart
6-(Benzyloxy)-9-((1S,3R,4S)-4-
(benzyloxy)-3-((benzyloxy)
methyl)-2-methylenecyclopentyl)- Sol.Recovery
9H-purin-2-amine Evaporation Loss
Stage I
Hydrogen Organic Residue
Palladium Carbon Process Emissions
Methanol
Acetone
Entecavir
56
ANNEXURE - VI
PRODUCT : Perampanel
Description :
Stage-1 : 2,3'-Bipyridin-6'(1'H)-one on reaction with Phenylboronic acid and 2-(1,3,2-Dioxaborolan-2-yl)

benzonitrile in presence of Copper Acetate, N-Bromo Succinimide, Triphenylphosphine, Palladium Acetate and
Copper Iodide in Methylene Dichloride. After reaction completion the inorganic material was filtered and the
filtrate was washed with water and evaporated the solvent, the crude residue was treated with Toluene and
isolated the compound from Toluene to get Perampanel.
Flow Chart
2,3'-Bipyridin-6'(1'H)-one
Phenylboronic acid
2-(1,3,2-Dioxaborolan-2-yl)
benzonitrile Sol.Recovery
Copper Acetate Evaporation Loss
N-Bromo Succinimide Effluent
Stage I
Triphenylphosphine Organic Residue
Palladium Acetate Inorgainc Solid Waste
Copper Iodide Process Emissions
Toluene
Water
Perampanel
57
ANNEXURE - VI
PRODUCT : 1-((2R,3R,4R,5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)-3-
methyltetrahydrofuran-2-yl)pyrimidine-2,4(1H,3H)-dione
Description :
Stage-1 : ((2R,3R,4R)-3-(benzoyloxy)-4-fluoro-4-methyl-5-oxotetrahydrofuran-2-yl)methyl benzoate is treated with
Vitride solution in Toluene in presence of solvent Toluene, after completion of reaction, pH is adjusted to 2.0-3.0
by adding dilute Hydrochloric acid solution in the reaction mass, layer was separated, further water and Sodium
Chloride wash is given to the reaction mass. Distilled out Toluene from the reaction mass below 65°C to get
concentrated syrupy mass is identified as Stage-1 Compound.
Stage-2 : Stage-1 Compound is dissolved in solvent Methylene Dichloride in which Triethylamine is added,
further Sulfuryl Chloride is added at elevated temperature, after completion of reaction, water added in the
reaction mass, layer was separated, further Citric acid solution andPotassium Hydroxide solution wash is given to
the reaction mass and layer was separated. Distilled out Methylene Dichloride from the reaction mass below 40°C
to get concentrated syrupy mass is identified as Stage-2 Intermediate.
Stage-3 : N-(2-Oxo-1,2-dihydropyrimidin-4-yl)benzamide, Hexamethyldisilazane and Ammonium Sulfate is reflux
in the presence of solvent Chlorobenzene. After completion of clear solution, distilled out Chlorobenzene under
vacuum below 120°C, further cool the reaction mass and dissolve the concentrated syrupy mass in the solvent
Methylene Dichloride. In this solution Stage-2 Intermediate is added at 25-35°C, after completion of addition, Tin
Chloride is added further reaction is reflux at 60-70°C for 12 hrs, cool the reaction mass to 25-35°C. Dilute the
reaction mass with Methylene Dichloride and charge NaHCO3 solution and hyflow filter the reaction mass. Again
and charge Sodium Bicarbonate solution and separate the layer. Distilled out Methylene Dichloride from the
reaction mass below 40°C to get concentrated syrupy mass and product was isolated in Isopropyl Alcohol to give
Stage-3 Compound.
Stage-4 : Stage-3 Compound is hydrolysed with water in acidic medium by using Acetic acid at the elevated
temperature 100-105°C for 3-4 hrs, which is further diluted by adding water at ambient temperature and filter the
product which is identified as Stage-4 Intermediate.
Stage-5 : Stage-4 Intermediate is treated with Ammonia in the presence of solvent Methanol at elevated
temperature 10-20°C, after completion of reaction, on filtration Methanol is distilled out under vacuum below 60-
65°C to get concentrate mass. In this mass Ethyl Acetate added and distilled out to remove traces of Methanol
and Ethyl Acetate and the product was isolated in Ethyl Acetate to obtain 1-((2R,3R,4R,5R)-3-fluoro-4-hydroxy-5-
(hydroxymethyl)-3-methyltetrahydrofuran-2-yl) pyrimidine-2,4(1H,3H)-dione.
58
ANNEXURE - VI
PRODUCT : 1-((2R,3R,4R,5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)-3-
methyltetrahydrofuran-2-yl)pyrimidine-2,4(1H,3H)-dione
Flow Chart
((2R,3R,4R)-3-(Benzoyloxy)-4-
fluoro-4-methyl-5-oxotetra
hydrofuran-2-yl)methyl Sol.Recovery
benzoate Evaporation Loss
Vitride (70%) in Toluene Stage I Effluent
Sodium Chloride Process Emissions
Water
Stage-1
Sulfuryl Chloride Sol.Recovery
Stage II
Methylene Dichloride Effluent
Citric acid (15%) Organic Residue
Potassium Hydroxide (7%)
Stage-2
N-(2-Oxo-1,2-dihydropyrimidin-
4-yl)benzamide
Chlorobenzene Sol.Recovery
Hexamethyldisilazane Evaporation Loss
Stage III
Ammonium Sulfate Effluent
Tin Chloride Organic Residue
Methylene Dichloride Process Emissions
Isopropyl Alcohol
Sodium Bicarbonate (5%)
Acetic acid Stage IV Evaporation Loss
Water Effluent
Stage V
Ammonia (20%) Effluent
Ethyl Acetate Organic Residue
1-((2R,3R,4R,5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)-3-methyltetrahydrofuran-2-yl)pyrimidine-
2,4(1H,3H)-dione
59
ANNEXURE - VI
PRODUCT : (S)-Isopropyl-2-(((R)-(perfluorophenoxy)(phenoxy)
phosphoryl)amino)propanoate
Description :
Stage-1 : Phenyl Phosphorodichloridate is treated with (S)-Isopropyl-2-aminopropanoate Hydrochloride in the
presence of alkaline medium by using Triethylamine in the solvent Methylene Dichloride at the elevated temperature
after completion of reaction, mixture of 2,3,4,5,6-Pentafluorophenol, Triethylamine in Methylene Dichloride is added
at the elevated temperature after completion of reaction, filter the reaction mass to remove Triethylamine salt.
Filtrate is distilled out under vacuum below 35°C further Hexane is added and distilled out to remove traces of
Methylene Dichloride. After completion of distillation, the product was isolated in Hexane and Methyl tert-Butyl ether
and to obtain crude (S)-Isopropyl-2-(((R)-(perfluoro phenoxy)(phenoxy)phosphoryl) amino)propanoate. This Crude is
dissolved in Ethyl Acetate, water and brine wash is given further Ethyl Acetate is distilled out under vacuum below
35°C further Hexane is added and distilled out to remove traces of Ethyl Acetate. After completion of distillation, the
product was isolated in Hexane and Methyl tert-Butyl ether and to obtain pure (S)-Isopropyl-2-(((R)-(perfluoro
phenoxy)(phenoxy)phosphoryl) amino)propanoate.
Flow Chart
Phenyl Phosphodichloridate
(S)-Isopropyl-2-aminopropanoate
Hydrochloride
2,3,4,5,6-Pentafluorophenol
Methylene Dichloride Sol.Recovery
Triethylamine Stage I Evaporation Loss
Hexane Effluent
Methyl tert-Butyl ether Organic Residue
Ethyl Acetate
Sodium Chloride
Water
(S)-Isopropyl-2-(((R)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate
60
ANNEXURE - VI
PRODUCT : Daclatasvir Dihydrochloride
Description :
Stage-1 : 1,1'-([1,1'-Biphenyl]-4,4'-diyl) diethanone on reaction with Bromine in Methylene Dichloride at ambient

temperature, after reaction completion the excess Bromine distilled off under vacuum and filtered to give Stage-1
Compound.
Stage-2 : Stage-1 Compound on reaction with BOC-L-Proline in presence of Diisopropylethylamine in Acetonitrile
solvent at ambient temperature, after reaction completion reaction mass washed with water and solvent was
evaporated, Toluene was charged to resulting crude material and charged Ammonium Acetate, heated to 80-90°C ,
maintained the reaction for 16-20 hours, after reaction completion, product was extracted in to Acetic acid and water,
isolated the solid using Sodium Hydroxide solution, the resulting crude material was purified using N-Methyl
Pyrrolidone and Methanol to give pure Stage-2 Intermediate.
Stage-3 : Stage-2 Intermediate on reaction with Hydrochloric acid solution in Isopropyl Alcohol at ambient
temperature, after reaction completion, the resulting solid was cooled to ambient temperature and filtered, the crude
material was purified in Methanol to give pure Stage-3 Compound.
Stage-4 : Condensation of Stage-3 Compound and N-(Methoxycarbonyl)-L-valine in presence of 1-Ethyl-3-(3-
dimethylaminopropyl) carbodiimide Hydrochloride and Hydroxybenzotriazole and Diisopropylethylamine in Methylene
Dichloride at ambient temperature, after reaction completion, the reaction mass was washed with water, Sodium
Bicarbonate solution, distilled off solvent, to the resulting residue, Ethanol was charged, added Isopropyl Alcohol
Hydrochloride at ambient temperature. The resulting slurry was cooled to room temperature, filtered and purified
using Methanol, Dimethyl Sulfoxide and Isopropyl Alcohol to give pure Daclatasvir Hydrochloride.
61
ANNEXURE - VI
Flow Chart
1,1'-([1,1'-Biphenyl]-4,4'-diyl)
diethanone Sol.Recovery
Bromine Stage I Evaporation Loss
Tetrahydrofuran Process Emissions
Stage-1
BOC-L-Proline
Diisopropylethylamine
Acetonitrile Sol.Recovery
Ammonium Acetate Evaporation Loss
Acetic acid Stage II Effluent
Toluene Process Emissions
Methanol
N-Methyl Pyrrolidone
Water
Isopropyl Alcohol Stage III Effluent
Stage-3
N-(Methoxycarbonyl)-L-valine
Hydroxybenzotriazole
1-Ethyl-3-(3-dimethylaminopropyl)
carbodiimide Hydrochloride
Methylene Dichloride Sol.Recovery
Isopropyl Alcohol Hydrochloride Stage IV Effluent
(15%) Organic Residue
Dimethyl Sulfoxide Process Emissions
Methanol
Sodium Bicarbonate
Ethanol
Isopropyl Alcohol
Water
Daclatasvir Dihydrochloride
62
ANNEXURE - VI
PRODUCT : Rifaximin
Description :
Stage-1 : Rifamycin-O on reaction with 2-Amino-4-methylpyridine in presence of Iodine and Ascorbic acid in
Ethanol and water. After completion of the reaction, the reaction mass was cooled and filtered to get the crude
material. Crude material further purification in Ethanol and water to obtain pure Rifaximin as red colour powder.
Flow Chart
Rifamycin-O
2-Amino-4-methylpyridine
Acetic acid Sol.Recovery
Ascorbic acid Evaporation Loss
Stage I
Iodine Inorgainc Solid Waste
Water
Rifaximin
63
ANNEXURE - VI
PRODUCT : Linezolid
Description :
Stage-1 : Reaction of Methyl-[3-fluoro-4-(morpholin-4-yl)phenyl]carbamate with 2-[(2S)-Oxiran-2-yl-methyl]-1H-

isoindole-1,3(2H)-dione in presence of Triethylamine using Dimethylformamide, after completion of reaction solid
was isolated by using Ethyl Acetate and purified by Methanol to get Stage-1 Compound.
Stage-2 : Reaction of Stage-1 Compound with Monomethylamine in Water and Methanol, after completion of
reaction product was partitioned between water and Methylene Dichloride, washed with Hydrochloric acid. To the
Methylene Dichloride layer Acetic Anhydride was added. After completion of the reaction, reaction mass was
washed with water and solvent was evaporated under reduced pressure to get crude material. Isolation of
Linezolid frm Toluene to form Pure Linezolid.
Flow Chart
2-[(2S)-Oxiran-2-yl-methyl]-1H-
isoindole-1,3(2H)-dione
Methyl-[3-fluoro-4-(morpholin-4-
yl)phenyl]carbamate Sol.Recovery
Stage I
Dimethylformamide Organic Residue
Ethyl Acetate
Methanol
Stage-1
Monomethylamine (40%)
Acetic Anhydride Sol.Recovery
Methylene Dichloride Stage II Evaporation Loss
Ammonia (25%) Organic Residue
Water
Linezolid
64
ANNEXURE - VI
PRODUCT : Rosuvastatin Calcium
Description :
Stage-1 : N-[5-(Bromomethyl)-4-(-4-Fluorophenyl)-6-propan-2-yl) pyrimidin-2-yl]-N-methyl methanesulfonamide

phosphonium salt on reaction with tert-Butyl-[(4R,6S)-6-formyl-2,2-dimethyl-1,3-dioxan-4-yl] acetate in presence
of Potassium Carbonate and Dimethyl Sulfoxide solvent at 800C. After completion of reaction water and Toluene
were added and organic layer was separated. Distillation of Toluene from organic layer and isolation in Methanol
gives Stage-1 Compound.
Stage-2 : Stage-1 Compound is reacted with dilute Hydrochloric acid in presence of Methanol and Toluene. After
completion of reaction, the reaction mass was treated with Sodium Hydroxide solution and washed with Methyl
tert-Butyl ether. Finally the reaction mass is treated with Calcium Acetate to obtain Rosuvastatin Calcium.
Flow Chart
N-[5-(Bromomethyl)-4-(-4-
Fluorophenyl)-6-propan-2-yl)
pyrimidin-2-yl]-N-methyl
methanesulfonamide
phosphonium salt Sol.Recovery
tert-Butyl-[(4R,6S)-6-formyl-2,2- Evaporation Loss
dimethyl-1,3-dioxan-4-yl] Stage I Effluent
acetate Organic Residue
Potassium Carbonate Process Emissions
Dimethyl Sulfoxide
Toluene
Methanol
Water
Stage-1
Methanol
Toluene Sol.Recovery
Stage II
Calcium Acetate Effluent
Methyl tert-Butyl ether Organic Residue
Water
Rosuvastatin Calcium
65
ANNEXURE - VI
PRODUCT : Pregabalin
Description :
Stage-1 : Hydrolysis of Diethyl-(1-cyano-3-methylbutyl) propanedioate with Potassium Hydroxide gives Potassium 3-
Cyano-5-methyl hexanoate, which in-situ reduced by using Raney Nickel as catalyst in presence of Acetic acid in
Methanol solvent medium to give Stage-1 Compound.
Stage-2 : Racemic Stage-1 Compound is then subjected to resolution by using S(+) Mandelic acid as resolving agent
in mixture of Isopropyl Alcohol and Water to form optically pure [S(+)-3-(Amino methyl)-5-methylhexanoic acid
Mandelic acid salt as Stage-2 material.
Stage-3 : Stage-2 material is on basic and acidic treatment with Sodium Hydroxide and Hydrochloric acid gives crude
Pregabalin. It is recrystallised in aqueous medium by conventional manner to obtain Pure Pregabalin.
Flow Chart
Diethyl-(1-cyano-3-methylbutyl)
propanedioate
Potassium Hydroxide Sol.Recovery
Stage I
Raney Nickel Effluent
Hydrogen Organic Residue
Acetic acid Process Emissions
Water
S(+) Mandelic acid Evaporation Loss
Stage II
Isopropyl Alcohol Effluent
Stage-2
Sodium Hydroxide
Stage III Effluent
Water
Pregabalin
66
ANNEXURE - VI
PRODUCT : Flurbiprofen
Description :
Stage-1 : 2,4-Difluoronitrobenzene on reaction with Diethyl methylmalonate in the presence of

Dimethylformamide as a solvent and Sodium Hydroxide as a base, after completion of the reaction product was
extracted with Toluene and washed with water. Toluene layer was concentrated under pressure to give Diethyl-
3-fluoro-(4-nitrophenyl)methyl propanedioate. Resulting Diethyl-3-fluoro-(4-nitrophenyl)methyl propanedioateon
reduction in presence of Palladium Catalyst and Hydrogen gas, Methanol as solvent. After completion of the
reaction catalyst was filtered under nitrogen and Methanol layer was concentrated under reduced pressure to
get Stage-1 Compound.
Stage-2 : Stage-1 Compound on diazotization with Toluene in the presence of Copper powder, Trichloroacetic
acid and Isopropyl Nitrite as a reagent. After completion of the reaction Toluene layer was washed with purified
water and concentrated under reduced pressure. Finally purify the product with the help of Toluene under
reduced pressure to form Stage-2 Intermediate.
Stage-3 : Stage-2 Intermediate on decarboxylation cum hydrolysis in the presence of Sodium Hydroxide and
Acetic acid. After completion of the reaction crude solid was isolated by adding purified water to the reaction
mass. The crude solid was recrystalized in Toluene to obtain Flurbiprofen.
Flow Chart
2,4-Difluoronitrobenzene
Diethyl methylmalonate
Dimethylformamide Evaporation Loss
Methanol Stage I Effluent
Palladium Carbon Process Emissions
Hydrogen
Water
Toluene Evaporation Loss
Copper Powder Effluent
Stage II
Trichloroacetic acid Organic Residue
Isopropyl Nitrite Inorgainc Solid Waste
Acetic acid Stage III Effluent
Flurbiprofen
67
ANNEXURE - VI
PRODUCT : Vilazodone Hydrochloride
Description :
Stage-1 : 1H-Indole-5-carbonitrile on reaction with 4-Chlorobutyryl Chloride in presence of Aluminium Chloride

and Nitromethane in Methylene Dichloride at 0-50C for 2-3 hrs. After completion of reaction the reaction mass was
quenched with aqueous Hydrochloric acid to get precipitated. The precipitated solid was filtered and slurry washed
with purified water, filtered and dried to obtain Stage-1 Compound.
Stage-2 : Reduction of Stage-1 Compound with Sodium Borohydride in presence of Trifluoroacetic acid using
Tetrahydrofuran at 0-50C for 3-4 hrs after completion of reaction, reaction mass was quenched with Sodium
Hydroxide and extracted in Ethyl Acetate, and washed Ethyl Acetate layer with water, distilled out Ethyl Acetate
and isolated the compound in water to get Stage-2 Intermediate.
Stage-3 : Reduction of Ethyl-5-nitro-1-benzofuran-2-carboxylate by using Palladium on Carbon in Ethyl Acetate

solvent under Hydrogen pressure gives Ethyl-5-amino-1-benzofuran-2-carboxylate. After filtration of Palladium
Carbon, reaction mixture pH was adjusted to 2-2.5 with Ethyl Acetate Hydrochloride to give Stage-3 Compound.
Stage-4 : Stage-3 Compound on reaction with Bis(2-chloroethyl)amine Hydrochloride in o -Xylene at reflux

temperature, after completion, solvent was evaporated and crude product was purified by treting with Sodium
Carbonate in presence of Ethyl Acetate, Acetone, Methanol and Carbitol solvent media to form Stage-4
Intermediate.
Stage-5 : Stage-2 Intermediate on condensation with Stage-4 Intermediate in N-Methyl Pyrrolidone medium by
using Sodium Carbonate and Sodium Iodide at 60-650C. After completion of the reaction, reaction material was
cooled and extracted in presence of Hydrochloric acid using Ethyl Acetate, the crude material was purified using
Acetone to get Stage-5 Compound.
Stage-6 : Stage-5 Compound on reaction with Ammonia in Methanol medium under pressure to form Crude
Vilazodone base, further purification using Dimethylformamide and Sodium Hydroxide to give Pure Vilazodone,
which on reaction with Hydrochloric acid to obtain Vilazodone Hydrochloride.
68
ANNEXURE - VI
Flow Chart
1H-Indole-5-carbonitrile
4-Chlorobutyryl Chloride
Aluminium Chloride Sol.Recovery
Stage I
Nitromethane Effluent
Methanol Process Emissions
Water
Stage-1
Sodium Borohydride
Tetrahydrofuran Sol.Recovery
Ethyl Acetate Evaporation Loss
Stage II
Trifluoroacetic acid Effluent
Isopropyl Alcohol Process Emissions
Water
Ethyl-5-nitro-1-benzofuran-2-
carboxylate Sol.Recovery
Ethyl Acetate Hydrochloride Stage III Effluent
(12%) Organic Residue
Ethyl Acetate
Stage-3
Bis(2-chloroethyl)amine
Hydrochloride
o-Xylene Sol.Recovery
Acetone Evaporation Loss
Methanol Stage IV Effluent
2-(2-Ethoxyethoxy)ethanol Organic Residue
(Carbitol) Process Emissions
Ethyl Acetate
Sodium Carbonate
Water
69
ANNEXURE - VI
Flow Chart
Stage-2
Stage-4
Sodium Iodide Sol.Recovery
Sodium Carbonate Evaporation Loss
N-Methyl Pyrrolidone Stage V Effluent
Ethyl Acetate Process Emissions
Acetone
Water
Stage-5
Ammonia (20%)
Methanol Sol.Recovery
Dimethylformamide Stage VI Evaporation Loss
Water
Vilazodone Hydrochloride
70
ANNEXURE - VI
PRODUCT : Montelukast Sodium
Description :
Stage-1 : (S,E)-1-(3-(2-(7-Chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxy propan-2-yl)phenyl)propan-1-ol on reaction

with Methanesulfonyl Chloride in presence of Diisopropylethylamine under Nitrogen atmosphere, after completion of
reaction the in-situ product is reacted with 2-(1-(Mercaptomethyl)cyclopropyl) acetic acid in presence of Sodium
Methoxide, Sodium Hydroxide and Acetic acid using Acetonitrile, Petroleum Ether and Dimethyl Sulfoxide as solvent
media and formation of salt using tert-Butylamine to give tert-Butylamine salt of Montelukast further purified using
Methanol and Toluene to form Pure Stage-1 Compound.
Stage-2 : Stage-1 Compound reacted with Sodium Hydroxide in presence of Methanol and Toluene solvent media, the
resulting solution is subjected to distillation with n-Heptane to obtain Montelukast Sodium.
Flow Chart
(S,E)-1-(3-(2-(7-Chloroquinolin-2-
yl)vinyl)phenyl)-3-(2-(2-hydroxy
propan-2-yl)phenyl)propan-1-ol
Acetonitrile
Toluene
Petroleum Ether
Diisopropylethylamine
Methanesulfonyl Chloride Sol.Recovery
Dimethyl Sulfoxide Stage I Evaporation Loss
Sodium Methoxide (25%) in Effluent
2-(1-(Mercaptomethyl)cyclopropyl)
acetic acid
Sodium Hydroxide
tert-Butylamine
Acetic acid
Water
Stage-1
Methanol Sol.Recovery
Sodium Hydroxide Stage II Evaporation Loss
Toluene Effluent
n-Heptane Organic Residue
Montelukast Sodium
71
ANNEXURE - VI
PRODUCT : Teriflunomide
Description :
Stage-1 : 5-Methyl isoxazole-4-carboxylic acid on reaction with Phosphorous Pentachloride to give acid chloride,
resulting acid chloride on reaction with 4-(Trifluoromethyl)aniline in presence of Potassium Bicarbonate using
Methylene Dichloride and Acetone solvent media to form Stage-1 Compound.
Stage-2 : Stage-1 Compound on hydrolysis in presence of Sodium Hydroxide and Hydrochloric acid using
Methanol and Acetone solvent media to obtain Teriflunomide.
Flow Chart
5-Methyl isoxazole-4-carboxylic
acid
4-(Trifluoromethyl)aniline Sol.Recovery
Stage I
Phosphorous Pentachloride Effluent
Potassium Bicarbonate Process Emissions
Water
Stage-1
Stage II
Methanol Effluent
Water
Teriflunomide
72
ANNEXURE - VI
PRODUCT : Abiraterone Acetate
Description :
Stage-1 : Mixture of 3-Diethylboropyridine, 17-Iodo androsta-5,16-diene-3-β-ol, Bis(Triphenylphosphine)

palladium(II) dichloride and Sodium Carbonate in Tetrahydrofuran is stirred at 800C temperature for 48 hrs (till
completion of reaction). After completion of reaction, mass was cooled to room temperature and organic layer
was separated and solvent was distilled. The residue obtained was crystallized in Toluene to obtain Stage-1
Compound.
Stage-2 : Mixture of Stage-1 Compound, Acetyl Chloride and Triethylamine in Tetrahydrofuran solvent stirred
for 12 hrs at room temperature. White thick precipitation of Triethylammonium Chloride was filtered. Solvent
distillation from filtrate gives residue which was crystallized in Ethanol water mixture to form Abiraterone
Acetate.
Flow Chart
17-Iodo androsta-5,16-diene-3- Sol.Recovery
β-ol Evaporation Loss
3-Diethylboropyridine Effluent
Bis(Triphenylphosphine)
palladium(II) dichloride Stage I
Tetrahydrofuran
Ethyl Acetate
Toluene
Tetrahydrofuran Evaporation Loss
Triethylamine Effluent
Stage II
Acetyl Chloride Organic Residue
Ethanol
Water
Abiraterone Acetate
73
ANNEXURE - VI
PRODUCT : Dabigatran Etexilate Mesylate
Description :
Stage-1 : Ethyl-3-{[3-amino-4-(methylamino) benzoyl](pyridin-2-yl)amino} propanoate reacts with [(4-Cyanophenyl)

amino]acetic acid in presence of Carbonyldiimidazole in Methylene Dichloride at ambient temperature, after reaction
completion, solvent was evaporated and the reaction mass was refluxed in Ethyl Acetate, resulting reaction mass
was washed with water, Ethyl Acetate layer was heated to reflux and cooled to ambient temperature. The resulting
precipitated material was filtered, dried to get Stage-1 Compound.
Stage-2 : Stage-1 Compound and Ammonia were purged with Hydrogen Chloride gas in Ethanol, after purging the
Hydrogen Chloride gas, Nitrogen cylinder was purged and the reaction mass was maintained till reaction completion,
the resulting reaction mixture was cooled and basified the reaction mass with Ammoni solution. The resulting
solution was distilled off and water and Ethanol were charge, the resulting reaction mass was cooled and filtered to
give Stage-2 Intermediate.
Stage-3 : Stage-2 Intermediate on reaction with n-Hexyl Chloroformate in presence of Potassium Carbonate in
Acetone medium, after reaction completion the solvent was evaporated and isolated the solid in Ethyl Acetate to
form Stage-3 Compound as white material.
Stage-4 : Stage-3 Compound was dissolved in Acetone and added Methanesulfonic acid dissolved in Acetone, the
resulting solid was filtered and washed with Acetone to obtain Dabigatran Etexilate Mesylate.
Flow Chart
Ethyl-3-{[3-amino-4-(methylamino)
benzoyl](pyridin-2-yl)amino}
propanoate Sol.Recovery
Carbonyldiimidazole Evaporation Loss
Toluene Stage I Effluent
[(4-Cyanophenyl)amino]acetic acid Organic Residue
Methylene Dichloride Process Emissions
Ethyl Acetate
Water
Stage-1
Ethanol Sol.Recovery
tert-Butanol Stage II Evaporation Loss
Ammonia (20%) Effluent
Hydrogen Chloride Organic Residue
Stage-2
Potassium Carbonate Sol.Recovery
Acetone Evaporation Loss
Stage III
n-Hexyl Chloroformate Effluent
Methanesulfonic acid Stage IV Evaporation Loss
Dabigatran Etexilate Mesylate
74
ANNEXURE - VII
PRODUCT : Betahistine
LIST OF RAW MATERIALS
Consumption of
Daily
Raw Material /
Raw Material Consumption of
Batch of
Raw Material
Product
Kg Kg
2-Hydroxy-1-Pyridinyl-3-trichloro Propane = 3.66 244
Ammonium Hydroxide (28%) = 2 133.33
Bromine = 1.76 117.33
Hydrogen = 0.1 6.67
Methanol = 14.1 940
Methanol (90%) = 18.3 1220
Methyl Iodide = 1.5 100
Palladium Carbon = 0.15 10
Potassium Hydroxide = 1.2 80
Sodium Carbonate = 1.12 74.67
Sodium Methoxide = 1.3 86.67
Sulfuric Acid = 0.715 47.67
Toluene = 5 333.33
PRODUCT : Rivastigmine
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
Acetonitrile = 5 500
α−m-Hydroxy phenyl ethyl dimethy amine = 1 100
Diethyl ether = 1 100
N-Ethyl methyl Carbomyl chloride = 0.736 73.6
Sodium Hydride (60%) = 0.243 24.3
75
ANNEXURE - VII
PRODUCT : L-Thyroxine
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
2-Acetylamino-3-(4-hydroxy-3,5-diiodo phenyl)
= 1.65 55
propionic acid ethyl ester
Acetic Acid = 0.6 20
Boric Acid = 0.465 15.5
Ethanol = 29.7 990
Hydrochloric Acid (36%) = 0.6 20
Sodium Hydroxide = 0.265 8.83

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
1,4-Dioxane = 14.6 973.33
3,5-Dibenzyloxy Acetophenone = 4 266.67
4-Methoxy phenyl-2-aminopropane = 1.67 111.33
Aluminum Chloride = 0.5 33.33
Ethyl Acetate = 30.85 2056.67
Hydrogen = 0.06 4
Hydrogen Bromide in Acetic Acid (33%) = 0.712 47.47
Isopropyl Alcohol = 4.4 293.33
Maleic Acid = 0.85 56.67
Methanol = 58.5 3900
Palladium Carbon = 0.015 1
Selenium Dioxide = 1.337 89.13
Sodium Bicarbonate = 1.3 86.67
Sodium Borohydride = 0.3 20
Toluene = 40.5 2700
76
ANNEXURE - VII
PRODUCT : Xylazine Hydrochloride

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
2,6-Dimethyl Aniline = 0.83 83
3-Amino Propanol = 0.5 50
Carbon = 0.1 10
Chloroform = 4.15 415
Isopropyl Alcohol = 2.5 250
Isopropyl Alcohol Hydrochloride (20%) = 1 100
Sodium Carbonate (10%) = 12.5 1250
Sufluric Acid = 0.2 20
Thiophosgene = 0.79 79
Toluene = 10 1000
77
ANNEXURE - VII

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
18-Crown-6 = 0.11 5.5
1-Fluoro naphthalene = 2 100
2-Acetyl Thiophene = 2 100
Acetone = 66.7 3335
Carbon = 0.1 5
Diisopropyl ether = 1.7 85
Dimethyl Sulfoxide = 26.3 1315
Dimethylamine Hydrochloride = 1.5 75
Di-P-Tolyl-L-Tartaric Acid = 3.405 170.25
Ethyl Acetate = 42.75 2137.5
Hydrochloric Acid (36%) = 1 50
Isopropyl Alcohol Hydrochloride (20%) = 0.9 45
Methanol = 25.84 1292
Methylene Dichloride = 42.45 2122.5
n-Hexane = 4.15 207.5
Oxalic Acid = 1.125 56.25
Paraformaldehyde = 0.5 25
Phenyl Chloroformate = 2 100
Potassium Hydroxide = 2.025 101.25
Sodium Bicarbonate (50%) = 4 200
Sodium Borohydride = 0.5 25
Toluene = 39.45 1972.5
78
ANNEXURE - VII

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
2-Thiophene thiolithium = 1.48 49.33
Acetic Anhydride = 0.65 21.67
Acetone = 8.85 295
Acetonitrile = 0.254 8.47
Ammonium Hydroxide (26%) = 1.65 55
Borane Dimethyl Sulfide = 0.56 18.67
Catalyst = 0.4 13.33
Chlorosulfonic Acid = 0.62 20.67
Ethyl Acetate = 13.5 450
Ethylene Dichloride = 13.5 450
Hydrogen Peroxide (50%) = 1.3 43.33
Isopropyl Alcohol Hydrochloride (20%) = 0.7 23.33
Lithium Aluminum Hydride in Tetrahydrofuran (60%) = 0.3 10
Maleic Acid = 0.45 15
Methyl ( R )-3-hydroxy butyrate = 1.61 53.67
p -Toluenesulfonyl Chloride = 2.86 95.33
Pyridine = 8.725 290.83
Sodium Bicarbonate = 0.6 20
Sodium Chloride = 0.875 29.17
Sodium Sulfate = 0.14 4.67
Sulfuric Acid = 2.8 93.33
Tetrahydrofuran = 42.05 1401.67
Thionyl Chloride = 0.62 20.67
Toluene = 27.45 915
Trifluoro Acetic Anhydride = 2.2 73.33
79
ANNEXURE - VII
PRODUCT : Biperiden Hydrochloride

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
1,4-Dioxane = 4.4 440
Cyclopentadiene = 0.35 35
Hydrochloric Acid (18%) = 1 100
Isopropyl Alcohol = 7.1 710
Isopropyl Alcohol Hydrochloride (20%) = 0.75 75
Methanol = 3.5 350
Methyl vinyl ketone = 0.38 38
Paraformaldehyde = 0.15 15
Phenyl maganesium chloride = 0.6 60
Piperidine Hydrochloride = 0.51 51
Sodium Hydroxide = 0.3 30
Sodium Methoxide = 0.01 1
Tetrahydrofuran = 2.64 264
PRODUCT : Modafinil
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
Acetic Acid = 3.15 315
Ammonium Hydroxide (26%) = 2 200
Benzhydrol = 1.25 125
Chloroacetic Acid = 0.75 75
Ethylene Dichloride = 6.25 625
Hydrobromic Acid (48%) = 5 500
Hydrogen Peroxide (50%) = 0.47 47
Sodium Hydroxide = 0.35 35
Thio Urea = 0.625 62.5
Thionyl Chloride = 0.7 70
Toluene = 7.5 750
80
ANNEXURE - VII
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
(1R,3S,4S)-3-(6-Bromo-1H-benzimidazol-2-yl)-2-
azabicyclo [2.2.1]heptane-2-carboxylic acid-1,1- = 83 22.13
dimethylethyl ester
1-Ethyl-3-(3-dimethylaminopropyl) carbodiimide = 364 97.07
2-((Methoxy carbonyl) amino)-3-methyl butanoic acid = 60 16
6-{5-(7-Bromo-9,9-difluoro-9H-fluoren-2-yl)-1H-
imidazol-2-yl]-5-aza-spiro[2,4]heptane-5-carboxylic = 115 30.67
acid tert-butyl ester
Acetonitrile = 1400 373.33
Bis(pinacolato)diboron = 63 16.80
Butyl Alcohol = 1640 437.33
Dichlorobis(di-tert-butylphenylphosphine)
= 7 1.87
palladium(II)
Diisopropylethylamine = 46 12.27
Dimethylformamide = 730 194.67
Ethyl Acetate = 1370 365.33
Hydrochloric acid (4%) = 2786 742.93
Hydrogen = 1 0.27
Hyflo = 27 7.2
Isopropyl Acetate = 830 221.33
N-Acetyl-L-cystine = 20 5.33
Oxalic acid = 30 8
Potassium Propionate = 70 18.67
Sodium Bicarbonate = 91 24.27
Sodium Hydroxide = 40 10.67
Tripotassium Phosphate (20%) = 166 44.27
81
ANNEXURE - VII
PRODUCT : Pirfenidone
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
5-Methyl-1H-pyridin-2-one = 42 42.04
Bromobenzene = 58 58.06
Copper Oxide = 1 1.00
Hexane = 50 50.05
Potassium Carbonate = 34 34.03
Toluene = 120 120.12
PRODUCT : Darunavir Ethanolate

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
(3R,3aS,6aR)-Hexahydrofuro [2,3-b]furan-3-yl (4-
= 56 55.97
nitrophenyl) carbonate
4-Amino-N-((2S,3S)-3-amino-2-hydroxy-4-
= 73 72.96
phenylbutyl)-N-isobutylbenzenesulfonamide
Ethanol = 220 219.89
N-Methyl-2-Pyrrolidinone = 150 149.93
Sodium Carbonate = 20 19.99
Sodium Chloride = 11 10.99
82
ANNEXURE - VII
PRODUCT : Sofosbuvir
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
2'-Deoxy-2'-fluoro-2'-C-methyluridine = 103 61.68
Hyflo = 9 5.39
Methylene Dichloride = 1030 616.77
Propan-2-yl(2S)-2-{[(pentafluoro phenoxy)
= 216 129.34
(phenoxy)phosphoryl] amino}propanoate
tert-Butylmagnesium Chloride (20%) in
= 1246 746.11
Tetrahydrofuran
PRODUCT : Imatinib Mesylate

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
4-((4-Methylpiperazin-1-yl) methyl) benzoyl chloride
= 21 20.96
Dihydrochloride
6-Methyl-N1-(4-(pyridin-3-yl) pyrimidin-2-yl)benzene-
= 14 13.97
1,3-diamine
Acetone = 170 169.66
Methanesulfonic acid = 4 3.99
N-Methylmorpholine = 38 37.92
83
ANNEXURE - VII
PRODUCT : Gefitinib
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
3-Chloro-4-fluoroaniline = 9 9.02
4-Chloro-6-(3-chloropropoxy)-7-methoxyquinazoline = 14 14.04
Methanol = 110 110.28
Morpholine = 15 15.04
Sodium Sulfate = 6 6.02
PRODUCT : Erlotinib
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
3-Ethynylaniline = 16 16
6,7-Bis(2-methoxy ethoxy) quinazoline = 24 24
Dimethylformamide = 40 40
Isopropyl Alcohol = 200 200
Methylene Dichloride = 290 290
n-Heptane = 210 210
Oxalyl Chloride = 12 12
Sodium Carbonate = 19 19
Sodium Sulfate = 12 12
84
ANNEXURE - VII
PRODUCT : Dasatinib
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
1-(-2-Hydroxyethyl) piperazine = 4 3.98
2-((6-Chloro-2-methylpyrimidin-4-yl)amino)-N-(2-
= 7 6.97
chloro-6-methyl phenyl)thiazole-5-carboxamide
Tetrabutylammonium Bromide = 7 6.97
Triethylamine = 3 2.99
PRODUCT : Atazanavir Sulfate

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
(R)-2-((Methoxycarbonyl) amino)-3,3-
= 55 54.97
dimethylbutanoic acid
1-Hydroxybenzotriazole = 7 7.00
Dipotassium Phosphate = 8 8.00
N-Ethyl-N'-dimethyl amino propyl carbodiimide = 19 18.99
N-Methyl Pyrrolidone = 580 579.71
Sodium Dihydrogen Phosphate = 8 8.00
Sulfuric acid = 15 14.99
tert-Butyl-2-((2S,3R)-3-((tert-Butoxy carbonyl) amino)-
2-hydroxy-4-phenylbutyl)-2-(4-(pyridin-2- = 71 70.96
yl)benzyl)hydrazine carboxylate
85
ANNEXURE - VII
PRODUCT : Pomalidomide
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
3-Aminopiperidine-2,6-dione Hydrochloride = 4 4.00
3-Nitrobenzene-1,2-dicarboxylic acid = 6 6.01
Acetic acid = 6 6.01
Acetic Anhydride = 5 5.01
Acetone = 20 20.02
Ethanol = 30 30.03
Hydrogen = 0.5 0.50
Palladium Carbon = 1 1.00
PRODUCT : Lenalidomide
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
2-(Bromomethyl)-3-nitrobenzoic acid = 11 10.95
Acetone = 70 69.65
Aminopiperidine-2,6-dione Hydrochloride = 8 7.96
Ethanol = 100 99.50
Hydrogen = 1 1.00
86
ANNEXURE - VII
PRODUCT : Latanoprost
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
[(Z)-7-(1R,2R,3R, 5S)-5-Hydroxy-2 [(3R)trimethyl
silyloxy-5-(phenyl-1-pentyl)-3-trimethyl silyloxy] = 19 19.08
cyclopentyl-5-hept-enoic acid]
Cesium Carbonate = 15 15.06
Isoproyl Bromide = 7 7.03
Potassium Hydrogen Sulfate = 7 7.03
PRODUCT : Solifenacin Succinate

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
(1S)-1-Phenyl-1,2,3,4-tetrahydroisoquinoline = 20 19.96
3-Quinuclidinol = 9 8.98
Ethanol = 23 22.95
Ethyl Chloroformate = 11 10.98
Sodium Hydride (60%) in Paraffin oil = 5 4.99
Sodium Hydroxide (50%) = 7 6.99
Succinic acid = 13 12.97
Toluene = 200 199.60
87
ANNEXURE - VII
PRODUCT : Cabazitaxel
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-
acetoxy-9-(((2R,3S)-3-((tert-butoxy carbonyl) amino)-
3-phenyl-2-((triethylsilyl)oxy)propanoyl) oxy)-11-
hydroxy-4,6-dimethoxy-4a,8,13,13-tetramethyl-5-oxo- = 5 5.01
2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-1H-
7,11-methanocyclodeca [3,4]benzo [1,2-b]oxet-12-yl
benzoate
Hydrogen Fluoride = 1 1.00
Methanol = 50 50.05
Pyridine = 5 5.01
88
ANNEXURE - VII
PRODUCT : Entecavir
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
6-(Benzyloxy)-9-((1S,3R,4S)-4-(benzyloxy)-3-
((benzyloxy) methyl)-2-methylenecyclopentyl)-9H- = 37 36.93
purin-2-amine
Acetone = 370 369.26
Hydrogen = 1 1.00
Methanol = 370 369.26
PRODUCT : Perampanel
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
2-(1,3,2-Dioxaborolan-2-yl) benzonitrile = 5 5.01
2,3'-Bipyridin-6'(1'H)-one = 4 4.00
Copper Acetate = 6 6.01
Copper Iodide = 4 4.00
N-Bromo Succinimide = 6 6.01
Palladium Acetate = 1 1.00
Phenylboronic acid = 5 5.01
Toluene = 10 10.01
Triphenylphosphine = 4 4.00
89
ANNEXURE - VII
PRODUCT : 1-((2R,3R,4R,5R)-3-fluoro-4-hydroxy-5-
(hydroxymethyl)-3-methyltetrahydrofuran-2-yl)pyrimidine-
2,4(1H,3H)-dione
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
((2R,3R,4R)-3-(Benzoyloxy)-4-fluoro-4-methyl-5-
= 446 41.63
oxotetra hydrofuran-2-yl)methyl benzoate
Acetic acid = 2100 196
Ammonia (20%) = 78 7.28
Ammonium Sulfate = 10 0.93
Chlorobenzene = 4000 373.33
Citric acid (15%) = 3400 317.33
Hexamethyldisilazane = 1635 152.6
Isopropyl Alcohol = 4200 392
Methanol = 2090 195.07
N-(2-Oxo-1,2-dihydropyrimidin-4-yl)benzamide = 268 25.01
Potassium Hydroxide (7%) = 4000 373.33
Sodium Bicarbonate (5%) = 7808 728.75
Sulfuryl Chloride = 232 21.65
Tin Chloride = 165 15.4
Toluene = 4460 416.27
Vitride (70%) in Toluene = 401 37.43
90
ANNEXURE - VII
PRODUCT : (S)-Isopropyl-2-(((R)-(perfluorophenoxy)
(phenoxy)phosphoryl)amino) propanoate
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
(S)-Isopropyl-2-aminopropanoate Hydrochloride = 56 9.33
2,3,4,5,6-Pentafluorophenol = 60 10
Hexane = 680 113.33
Methyl tert-Butyl ether = 120 20
Phenyl Phosphodichloridate = 67 11.17
91
ANNEXURE - VII

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
1,1'-([1,1'-Biphenyl]-4,4'-diyl) diethanone = 94 15.67
1-Ethyl-3-(3-dimethylaminopropyl) carbodiimide
= 93 15.5
Hydrochloride
Ammonium Acetate = 110 18.33
BOC-L-Proline = 130 21.67
Bromine = 65 10.83
Dimethyl Sulfoxide = 110 18.33
Ethanol = 670 111.67
Ethyl Acetate = 570 95
Hydroxybenzotriazole = 72 12
Isopropyl Alcohol = 2210 368.33
Isopropyl Alcohol Hydrochloride (15%) = 222 37
Methanol = 2430 405
N-(Methoxycarbonyl)-L-valine = 82 13.67
N-Methyl Pyrrolidone = 280 46.67
Sodium Bicarbonate = 78 13
Tetrahydrofuran = 470 78.33
Toluene = 1240 206.67
92
ANNEXURE - VII
PRODUCT : Rifaximin
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
2-Amino-4-methylpyridine = 68 25.56
Ascorbic acid = 4 1.50
Ethanol = 810 304.51
Iodine = 3 1.13
Rifamycin-O = 158 59.40
PRODUCT : Linezolid
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
2-[(2S)-Oxiran-2-yl-methyl]-1H-isoindole-1,3(2H)-
= 210 105
dione
Acetic Anhydride = 83 41.5
Ammonia (25%) = 190 95
Hydrochloric acid (35%) = 220 110
Methanol = 120 60
Methyl-[3-fluoro-4-(morpholin-4-yl)phenyl]carbamate = 265 132.5
Monomethylamine (40%) = 214 107
93
ANNEXURE - VII
PRODUCT : Rosuvastatin Calcium

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
Calcium Acetate = 27 18.81
Methanol = 1510 1051.74
Methyl tert-Butyl ether = 280 195.02
N-[5-(Bromomethyl)-4-(-4-Fluorophenyl)-6-propan-2-
yl) pyrimidin-2-yl]-N-methyl methanesulfonamide = 182 126.77
phosphonium salt
tert-Butyl-[(4R,6S)-6-formyl-2,2-dimethyl-1,3-dioxan-
= 70 48.76
4-yl] acetate
Toluene = 1125 783.58
PRODUCT : Pregabalin
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
Diethyl-(1-cyano-3-methylbutyl) propanedioate = 1130 225.55
Hydrogen = 20 3.99
Methanol = 6500 1297.41
Potassium Hydroxide = 250 49.90
Raney Nickel = 714 142.51
S(+) Mandelic acid = 647 129.14
94
ANNEXURE - VII
PRODUCT : Flurbiprofen
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
2,4-Difluoronitrobenzene = 104 67.26
Copper Powder = 17 11.00
Diethyl methylmalonate = 114 73.73
Hydrogen = 5 3.23
Isopropyl Nitrite = 29 18.76
Methanol = 1040 672.64
Toluene = 1945 1257.96
Trichloroacetic acid = 92 59.50
95
ANNEXURE - VII

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
1H-Indole-5-carbonitrile = 152 22.8
2-(2-Ethoxyethoxy)ethanol (Carbitol) = 240 36
4-Chlorobutyryl Chloride = 226 33.9
Acetone = 1810 271.5
Aluminium Chloride = 110 16.5
Ammonia (20%) = 200 30
Bis(2-chloroethyl)amine Hydrochloride = 193 28.95
Ethyl Acetate Hydrochloride (12%) = 333 49.95
Ethyl-5-nitro-1-benzofuran-2-carboxylate = 254 38.1
Hydrogen = 7 1.05
Methanol = 3560 534
Nitromethane = 300 45
N-Methyl Pyrrolidone 700 105
o -Xylene = 500 75
Sodium Borohydride = 40 6
Sodium Carbonate = 291 43.65
Sodium Iodide = 72 10.8
Tetrahydrofuran = 990 148.5
Trifluoroacetic acid = 590 88.5
96
ANNEXURE - VII
PRODUCT : Montelukast Sodium

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
(S,E)-1-(3-(2-(7-Chloroquinolin-2-yl)vinyl)phenyl)-3-(2-
= 62 61.69
(2-hydroxy propan-2-yl)phenyl)propan-1-ol
2-(1-(Mercaptomethyl)cyclopropyl) acetic acid = 27 26.87
Methanesulfonyl Chloride = 22 21.89
Methanol = 360 358.21
n-Heptane = 400 398.01
Petroleum Ether = 125 124.38
Sodium Methoxide (25%) in Methanol = 74 73.63
tert-Butylamine = 13 12.94
Toluene = 1220 1213.93
PRODUCT : Teriflunomide
Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
4-(Trifluoromethyl)aniline = 7 17.41
5-Methyl isoxazole-4-carboxylic acid = 5 12.44
Acetone = 130 323.38
Methanol = 40 99.50
Phosphorous Pentachloride = 13 32.34
Potassium Bicarbonate = 34 84.58
97
ANNEXURE - VII
PRODUCT : Abiraterone Acetate

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
17-Iodo androsta-5,16-diene-3-β-ol = 49 122.5
3-Diethylboropyridine = 20 50
Acetyl Chloride = 6 15
Bis(Triphenylphosphine) palladium(II) dichloride = 1 2.5
Ethanol = 80 200
Sodium Carbonate (20%) = 200 500
Tetrahydrofuran = 240 600
Toluene = 80 200
Triethylamine = 10 25
PRODUCT : Dabigatran Etexilate Mesylate

Consumption of
Daily
Raw Material /
Batch of
Raw Material
Product
Kg Kg
[(4-Cyanophenyl)amino]acetic acid = 193 42.89
Acetone = 4050 900
Ammonia (20%) = 301 66.89
Carbonyldiimidazole = 178 39.56
Ethanol = 1800 400
Ethyl-3-{[3-amino-4-(methylamino) benzoyl](pyridin-2-
= 251 55.78
yl)amino} propanoate
Hydrogen Chloride = 25 5.56
Methanesulfonic acid = 60 13.33
n-Hexyl Chloroformate = 95 21.11
tert-Butanol = 2260 502.22
Toluene = 1250 277.78
98
ANNEXURE - VIII
LIST OF HAZARDOUS RAW MATERIALS
Raw Material
1,4-Dioxane
2,6-Dimethyl Aniline
Acetic acid
Acetic Anhydride
Acetone
Acetonitrile
Ammonium Hydroxide (28%)
Bromine
Chloroacetic Acid
Chloroform
Chlorosulfonic Acid
Cyclopentadiene
Ethanol
Ethyl Acetate
Ethylene Dichloride
Hydrobromic Acid (48%)
Hydrochloric Acid (36%)
Hydrogen
Isopropyl Alcohol
Methanol
n-Hexane
Pyridine
Sufluric Acid
Tetrahydrofuran
Thio Urea
Thionyl Chloride
Toluene
Butyl Alcohol
Chlorobenzene
Hydrogen Chloride
Hydrogen Fluoride
Methyl vinyl ketone
Monomethylamine (40%)
Morpholine
o -Xylene
Phosphorous Pentachloride
tert-Butylamine
Triethylamine
99
ANNEXURE - IX
Orygamus Laboratories Pvt. Ltd.
100
ANNEXURE - X
Effluent Treatment Flow Scheme
Solvents for Recovery /

PCB Auth. Party
(with moisture)
Condenser
LTDS / LCOD &
HTDS / HCOD Domestic Effluent
Effluent inlet inlet
Condensate
Steam Stripper
Condenser
Pre aeration
tank
Collection cum Neutrali-
MEE System
Pre aeration tank

Equalization zation Holding
Tank Tank
Aeration Storage Dual
Concentrate Tank media
Condensate Tank
filter
Filtrate
Scrubber
ATFD
Effluent inlet
Filtrate
Sludge recycle
Sludge Decanter/
SDBS and dried
sludge to TSDF Sludge Decanter/
ACF
Salts to TSDF
SDBS and dried
sludge to TSDF
Product water to
R.O. System
Storage
Utilities
Rejects RO / Used to Tank
Cooling Tower
Evaporation
Forced
Condensate to
Utilities Salts to TSDF
101
Schematic flow Sheet for EIA Procedure ANNEXURE - XI
Time schedule for obtaining the EC from MOEF
Category A Project
30 days on obtaining
Preparation of FORM I Application & Prefeasibility report information from industry
as per check list
Submission of application by proponent (Form 1, Pre-feasilibility report and Draft Terms of Reference)
Scrutiny 60 days
by EAC
Scoping
Scoping an communication of Terms of Reference for EIA Studies to the Proponent for EIA preparation
120 days minimum other than monsoon

Preparation of Draft EIA report
period of 120 days
Submission of Draft EIA / Summary EIA / Application for Public consultation
Public Consultancy
45 days
Conducting public hearing by SPCB / PCC or any other public Agency / authority engaged by regulatory authority
Submission of proceedings of the public hearing by the SPCB / PCC to EAC

30 days for preparation of Final REIA Maximum
Submission of final EIA by the proponent after improving EIA / EMP
Appraisal
60 days
Appraisal by EAC
45 days
Issuing clearance to project
Decision of
MoEF proponent Decision Making
Specific Concerns
60 days
Reservation on the proposal conveyed to EAC
EAC views on reservations sent to MoEF

30 days
NO Yes
Decision
Rejection of MoEF
102
ANNEXURE - XI
Approach of EIA Study – 4 months other than monsoon period after
obtaining TOR copy from MOEF
Project Features
EIA Team Valued Environment
(Pre-feasibility Report,
Components
Form1)
Identification of Likely Impacts

(Quantitative Significance Analysis
(Ref: Impact Matrix)
Environmental Baseline Monitoring

(To Establish quality of the
Environment)
Application of Impact Prediction Tools

Social Impact (Quantitative Significance Analysis)
Risk Assessment
Assessment
Mitigation Measures
Environmental Management Plan
Reporting
103
ANNEXURE - XII
Topomap of 10km Radius for the Proposed Project – Orygamus Laboratories Pvt. Ltd.
104
ANNEXURE - XIII
Orygamus Laboratories Pvt. Ltd.
105
ANNEXURE -XIV
106
ANNEXURE -XIV
107
ANNEXURE -XIV
108
ANNEXURE -XIV
109

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0 0 11 Feb 2016 1310476131PreFeasibilityReportOrygamusLaboratories PDF

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Contents

3.0 Project Description 5

Table Title Page

1 Proposed Products, their Capacity and Therapeutic Category 6

Proposed Water Balance and segregation and Treatment

3 Effluent Treatment Flow as per segregation 10

4 Solid Waste Generation from the Proposed Products 11

Environmental Components Shortest distance from Project

6 Breakup of proposed landuse Pattern 15

7 Maximum Quantity of Process emissions for Proposed Products 16

8 Stack Emission Details 17

9 Budgetary allocation for pollution Control Measures 20

Pre-Feasibility Report for Proposed APIs, API Intermediates

1.1 Salient Features of the Project:

• Proposed project is in land of 5.45 Ha (13.48 Acres).

• Total investment for the proposed project is about Rs. 45 Crores.

2.2 Brief Description of Nature of the Project

2.4 Demand and Supply Gap

2.5 Imports vs. Indigenous production, Export Possibility, Domestic/Export Markets

2.6 Employment Generation due to the Proposed Project

3.0 Project Description

3.1 Type of the project

3.3 Alternate sites

Environmental considerations of this proposed project site.

3.4 Size or magnitude of operation

Project Area: 5.45 Ha.

Table 1: Proposed Products, their Capacity and Therapeutic Category

3.5 Project Description with Process Details

The manufacturing process of APIs consists of chemical synthesis extending to maximum

3.6 Raw Materials

3.7 Resources Optimization / Recycling and Reuse

 Optimum utilization of solar energy.

3.8 Availability of Water and Energy

3.9 Quantity of Wastes to be Generated and their Management / Disposal

Table 2: Proposed Water Balance, Segregation and Treatment Method

Table 3: Effluent Treatment Flow for as per Segregation

LTDS / LCOD Domestic (overflow from septic tank) Dual Sand

3.9.2 Hazardous/Solid Waste Generation, Handling and their Disposal

Table 4: Solid Waste Generation from the Proposed Products

3.10 Schematic Flow Sheet for EIA Procedure

3.0 Site Analysis

4.2 Land Form, Land use and Land Ownership

The Topography map with a 10 km radius is enclosed as Annexure-XII.

4.4 Existing Land Use Pattern

Table 5: Environmental Components Shortest distance from Project Periphery

4.5 Existing Infrastructure

4.6 Soil Classification

4.7 Climate Data from Secondary Sources

4.8 Social Infrastructure

5.2 Population Projection

5.3 Land use Planning

Table 6 : Break up of proposed land use pattern

S. Proposed Per cent

6.0 Proposed Infrastructure

6.2 Residential Area

6.4 Social Infrastructure

6.7 Sewerage System

6.8 Industrial Waste Management

Process Emissions Management:

Table 7: Maximum Quantity of Process Emissions from Proposed Products

Fugitive emissions Management:

Solvent Solvent Loss in Solvent Loss in Solvent Loss Solvent Solvent

Stage-11 : N-(6-Methyl-7,7-dioxo-2-sulfamoyl-4,5,6,7-tetrahydro-7l6-thieno[2,3-b]thiopyran-4-yl) acetamide is