Pre-Feasibility Report Pyujjfjdlfkgjndghenvironmentclearance.nic.in/writereaddata/FormB/TOR/PFR/22_Jun... · Pre-Feasibility Report Pyujjfjdlfkgjndgh ... Strontium Ranelate, ... of

Pyujjfjdlfkgjndgh Pre-Feasibility Report

Of

Proposed Synthetic Organic Chemical Plant

At

Plot No. D-35, MIDC Kurkumbh

Taluka Daund, District Pune, Maharashtra

By

M/s. Viswa Laboratories Private Limited

EIA Consultant

SMS Envocare Ltd.

301, Pentagon P3, Magarpatta City, Hadapsar, Pune, 411028 MS Phone No.: 020-66801111, Fax No. 020-66801100

Web: www.smsenvocare.co.in

PROPOSED SYNTHETIC ORGANIC CHEMICAL PLANT AT PLOT NO. D-35, MIDC KURKUMBH, TALUKA DAUND, DISTRICT PUNE (MS) BY

M/S. VISWA LABORATORIES PVT. LTD. INDEX

SMS Envocare Ltd. Pune 1

Index

POINT. NO. PARTICULAR PAGE NO. 1 EXECUTIVE SUMMARY………………………………………………………………… 1 1.1 Introduction………………………………………………………………………………… 1

1.2 Promoters & Management……………………………………………………………. 4 1.3 Constitution & Registration Details………………………………………………. 5

2 INTRODUCTION OF THE PROJECT/BACKGROUND INFORMATION… 6 2.1 Identification of Project………………………………………………………………… 6 2.2 Brief description of nature of the project………………………………………. 7 2.3 Need of the project and its importance to the country and region…... 7 2.4 Demand-Supply Gap……………………………………………………………………. 8 2.5 Imports vs. Indigenous production……………………………………………….. 8 2.6 Export possibility…………………………………………………………………………. 8 2.6 Domestic/ export market……………………………………………………………… 9 2.8 Employment Generation (Direct and indirect) due to the project…… 9

3 PROJECT DESCRIPTION……………………………………………………………… 9 3.1 Type of project including interlinked and interdependent projects,

if any……………………………………………………………………………………………. 9

3.2 Location (map showing general location, specific location and project boundary & project site layout) with coordinates………………

10

3.3 Details of alternate sites considered and the basis of selecting the proposed site, particularly the environmental considerations gone into should be highlighted…………………………………………………

14 3.4 Size or magnitude of operation……………………………………………………. 14 3.5 Project description with process details (a schematic diagram/

flow chart showing the project layout, components of the project etc. Should be given)………………………………………………………

14 3.6 Raw material required along with estimated quantity, likely

source, marketing area of final product/s, Mode of transport of raw Material and Finished Product……………………………………………

29 4 SITE ANALYSIS…………………………………………………………………………… 32 5 PLANNING BRIEF…………………………………………………………………………. 38 6 LANDSCAPING AND GREENBELT DEVELOPMENT………………………… 40 7 WATER & WASTE WATER MANAGEMENT……………………………………. 40 8 SOLID & HAZARDOUS WASTE MANAGEMENT……………………………… 41 9 AIR POLLUTION MANAGEMENT…………………………………………………… 41 10 OCCUPATIONAL HEALTH & SAFETY MEASURES…………………………… 41 11 REHABILITATION AND RESETTLEMENT (R&R) PLAN.………………….. 42


M/S. VISWA LABORATORIES PVT. LTD. INDEX


12 PROJECT SCHEDULE & COST ESTIMATES…………………………………….. 42 15 ANALYSIS OF PROPOSAL (FINAL RECOMMENDATIONS)…………... 42

List of Table

TABLE NO. PARTICULAR PAGE NO. 1 Name of fine Chemicals (Existing Products)…………………………………………..6 2 Name of Proposed Products………………………………………………………………….7 3 Water Balance (Existing + Proposed)…………………………………………………….31 4 Waste (Liquid+ Solid) generation and disposal techniques…………………….31 5 Mean Meteorological Data (1995-2004)………………………………………………………38 6 Land Requirement of the Project…………………………………………………………..39 7 Effluent discharge limit as per MPCB norms………………………………………….40 8 Project Cost………………………………………………………………………………………….42 9 EMP Cost……………………………………………………………………………………………..43

List of Figures

FIGURE NO. PARTICULAR PAGE NO. 1 Project Location Map…………………………………………………………………..............10 2 View of Plot…………………………………………………………………………………………11 3 10 Km radius Toposheet Map……………………………………………………………….12 4 Layout Plan………………………………………………………………………………………….13 5 Contour Plan of the Site………………………………………………………………………..34

List of Annexure

ANNEXURE PAGE NO. 1 Process Description of Fine Chemical…………………………………………...............44 2 Membership Certificate With CETP Kurkumbh………………………………………52


M/S. VISWA LABORATORIES PVT. LTD.

PRE-FEASIBILITY REPORT


1. EXECUTIVE SUMMARY

1.1 Introduction M/s. VISWA LABORATORIES PVT LTD was registered in the year 2014 under the

Company’s act. It aims with a focus on partnering with their clients across the entire

chemical industry for Technology development, manufacturing of laboratory reagents

and Fine Chemicals in First phase. Where in the manufacturing processes, only the

purifications, extractions and physical operations are involved like Filtration, distillation,

de-lumping, Milling, Sifting, Pulverization, micronisation and mixing formulations.

After establishment of the Fine chemical business, we propose to undertake the

manufacturing of the molecules by synthetic process with the addition of some new

molecules from the category of bulk drugs and advanced intermediates.

The organization has built up with highly qualified and skilled technocrats having very

vast & rich experience in the same field.

The main objective of the company is to establish the Research & Development Centre

with state of art manufacturing facility in the field of chemicals & pharmaceutical. This

will add the value in the research sector which will create opportunities and provide the

platform to the upcoming scientists in the country. As a result, this will help the chemical

and pharmaceutical industry to breach the gap between the Technology development

and the implementation on the commercial scale which will help to minimize the gap

between the demand & supply. This will also create the employment in the rural areas for

the technically qualified as well as the unskilled people.

To bring our thoughts in reality we acquire the industrial plot of 8115 Sq. m on lease basis

in the Kurkumbh MIDC area. As per the thought process and to bring the thoughts in reality,

we planned to establish the following activities in our registered organization.

Research & Development

Process Development & Scale Up

Manufacturing of Laboratory reagents and Fine Chemicals

Manufacturing of Mixing Formulations and Natural Product

Manufacturing of Bulk drugs and Intermediates





Research & Development Centre: There are very few companies are engaged in the

research and development activities. This area is required more involvement of the

Scientists and companies to add the value to this sector. There are several companies

which need the support of the R&D activities for the development of the new molecules.

There are several virtual biotech companies from abroad are looking for the research and

development facilities to support their research in the Pharmaceutical sector. In several

countries the biotech companies are reliant on the Indian research centers; this is one of

the best opportunities in our country. Opening the Research & Development Centre in the

industrial area will support the research sector and will attract several foreign companies

to extend the business in our country. The Research Centre will create the employment to

the technical people as well as the nontechnical people in the surrounding area.

Process Development And Scale Up: Industrial Technology development area is

another neglected area in the chemical and pharmaceutical sector. Several small scale

industries are struggling for the cost effective technologies due to the non-availability of

infrastructure and not willing to invest on the technology development due to the

uncertainty in the business. Because of the lack of improved cost effectiveness and

environment friendly technologies, several companies have been stopped there

operations and closed down the companies which has created lot of unemployment in the

country. Our main aim is to open the Technology development Centre to support the

companies who requires continues help for the Technology development, this will help

the companies to reduce the manufacturing cost of the products and ultimately will

reduce the cost burden on of common people during end product use. We are focusing

the Technology development of the several pharmaceutical products which will be

helpful to the Industries and common people.

Laboratory Reagents & Fine Chemicals: Manufacturing of Laboratory reagents and fine

chemicals are one of the most important area to support the research organizations in

the Chemical and Pharmaceutical sector. Most of the academic institutes, Government

undertaking research institutes, Pharmaceutical research Companies are continuously in

requirement of the specialty Fine Chemicals. Most of the time the specialty fine chemicals

are not available in our country and due to this most of the institutes and companies

depends on the overseas Fine chemicals companies (e.g Sigma-Aldrich) and purchase

specialty fine chemicals at higher price. Normally from the overseas companies the lead





time to get the chemicals is too long and due this affect the research activities to complete

and conclude. To breach this gap we thought to establish the manufacturing of the

laboratory reagents and fine chemicals, this will create the business to our company as

well as will make available rare and specialty chemicals easily to the research institutes

and organization which will help them to complete and conclude the research on time. As

there is a huge requirement of the Laboratory reagents and Fine chemicals in the market

but the quality suppliers are very limited. This is the best opportunity for us to display

our Chemistry knowledge and implementation skill. Company understood the need of

the sector and decided to establish the manufacturing of the Laboratory Reagents and

Fine Chemicals.

We will covered the Laboratory Reagents, Few Fine Chemicals and few products of the

de-lumping, Pulverization, Micronisation, grinding and mixing formulations, natural

product extraction and distillations. Such as Mesitylene Bis Bromide, Salicylaldehyde

sodium salt, 1-Benzopyrane-2-one, Milrinone, Glimepiride, Tiotropium Bromide,

Strontium Ranelate, Phenylephrine etc. are the name of the products the unit intends to

manufacture under the fine chemical division in the first phase.

Further to a business contingency plan company propose for the backward integration

for some of the products from the above list of fine chemicals like Milrinone, Glimepiride,

Tiotropium Bromide, Strontium Ranelate, Phenylephrine to switch to the synthetic

processes to avoid the dependency to support the business. Apart from this list, we

propose to manufacture some of the more active pharmaceutical ingredients like

Tizanidine Hydrochloride, Theobromine, Trioxalen, Febuxostat , Salbutamol Sulphate,

Lornoxicam and Linezolid etc. These Pharmaceutical products are required by the several

Pharma companies for the formulations in India as well as in the globe. To manufacture

these products, very good and proven Technical Expertise and Experience is required.

Selected products are commonly used as Anti-hypertensive (Cholesterol reducing), Anti

diabetic, Anti asthmatic, Osteoporosis, Anti Histaminic, Antipyretic in clinical application.

A cumulative risk assessment begins with the identification of a group of chemicals, a

common mechanism group (CMG), in selected products all chemicals used is common

chemicals and are easily available in the Indian market as well as foreign market. Selected

products are being used by the common people of all age group. Osteoporosis is





commonly observed in the old age people and in the women after deliveries. Anti-

Histaminic Coughing Pharma products are required in all age group of people, the more

use is in the group below 15 years of age children. Selected products are very useful to

almost all class of peoples, therefore the consumption of these products are very high in

quantities. Due to the high consumption the demand is also very high.

In India there are few Units manufacturing Strontium Ranelate, Phenylephrine,

Theobromine, Domperidone but it is not sufficient to meet the total requirements.

Industries consumptions are quite higher than the supply. Due to the short supply the

unit rates are fluctuating at very high percentage, this gives the impact on the

formulations. Due the high rates of the active Pharma ingredients automatically the cost

of the formulations comes at higher side and the manufactures increases the MRP of the

products which ultimately increase the burden on the common people. Due to high price,

common people suffer and poor cannot afford to take the costly medicines. To overcome

the demand of the active Pharmaceutical ingredient, we want to establish the company at

Kurkumbh MIDC to manufacture all these ingredients at cheaper rates.

The Company consisting of 3 Directors out of these one is technocrat and other two are

from commercial site. This is one of the best combinations in the any industry to set up

the new company with good prospects. The highly qualified and highly experienced

technocrat have come forward for the set up the manufacture of this product and try to

meet the gap between demand and supply in Indian market. After meeting the gap of

demand and supply the rest of material can be exported to the US, Europe, Africa and

other countries which can attract the foreign currency in India.

1.2 Promoters & Management

M/s. VISWA LABORATORIES PVT. LTD. is promoted by technocrats, having vast

experience in chemical and Pharmaceutical field as mentioned below.

1. Dr. VISHNU B. HALNOR, Director and Promoter

He is a M.Sc. Ph.D. in Organic Chemistry from Pune University, having 5 publications in

the national and international journals of heterocyclic chemistry and Heterocyclic

communication. Apart from the publication, he has worked for more than 25 years in the

in the field of Chemicals, Bulk Drugs and Pharmaceuticals in various Companies and hold

higher position. He has got experience of Custom synthesis, Process R&D and API CGMP





Manufacturing. He worked with reputed companies like M/s. Lupin Laboratories

Limited, M/s. SOL Pharmaceuticals Limited, M/s. TASC Pharmaceuticals Limited,

M/s. Glenmark Pharmaceuticals Limited and M/s. Sai Life Sciences limited.

Presently on the Board of M/s. Souvin Pharmaceuticals Private Limited as a Director.

During the service he has handled huge number of APIs of wide range including

Cephalosporin, Penicillin’s, Anti-bacterial, Anti- hypertensive, Anti-Cholesterol, Anti-

diabetic, Anti-dieria, Anti malaria, Anti-Fungal, Anti-Viral, Anti Histaminic, Anti Gout in

the above mentioned pharmaceutical companies.

2. Mr. BALASAHEB P. THORAT

He is graduate and completed material management from Pune University with more

than 18 years of experience in the field. He has to his credit, the supply chain, inventory

management & Taxation. He also worked with reputed Pharmaceuticals Companies ike .

M/s TASC Pharmaceuticals, Veritech Pharma and Gtez Pharmaceuticals.

3. Mrs. MANISHA S. KATKAR

She is commerce graduate from Aurangabad University.

All the Directors have very good experience in the required field apart from the being highly

qualified.. Dr. Vishnu B. Halnor has provided the jobs to the several people from the

Chemistry back ground and Chemical Engineering all over the India in the Chemical and

Pharmaceutical Industries. There are several technical people are willing to work with Dr.

Vishnu B Halnor in the company promoted by him due to his high expertise in the filed

which certainly assures the success in the field. With all their expertise selected products

are having ready demand or say which supply is in short. There is tremendous scope to

minimize the gap between demand and supply.

1.3 Constitution & Registration Details

SR NO PARTICULAR DETAILS

1 Name of the Unit VISWA LABORATORIES PVT. LTD.

2 Registered Office Flat No. F-312, Building–F, Daffodil, Magarpatta

City, Hadapsar, Pune 411 028

3 Proposed Factory Plot No. D-35, M.I.D.C. Area, KURKUMBH

4 Constitution PRIVATE LIMITED COMPANY

5 Registration No U74999PN2014PTC150978





6 Names of Directors Dr. VISHNU BHANUDAS HALNOR

MR.BALASAHEB PARAJI THORAT

Mrs. MANISHA SANJAY KATKAR

7 Proposed Activities The UNIT, ,has planned to set up S.S.I. Unit at

MIDC, Kurkumbh, Dist: Pune, for Manufacturing

of Laboratory reagents, Fine Chemicals,

Intermediates and APIs like Milrinone,

Glimepiride, Strontium Ranelate,

Diphenehydramine Hydrochloride

Phenylephrine, Theobromine, Domperidone

which is used as a basic Raw Material in Drugs

products Pharmaceutical Industries.

2. INTRODUCTION OF THE PROJECT/ BACKGROUND INFORMATION 2.1 Identification of project Proposed Synthetic Organic Chemical Plant is located at Plot No. D-35, MIDC Kurkumbh,

Taluka Daund, District Pune, Maharashtra. Project site is covered under Toposheet No. 47

J/7, 47 J/11. Geographical coordinates of the Project site is Latitude: 180 24’ 01.03” N &

Longitude: 740 31’ 44.73” E. List of the products with monthly and yearly production is

given below:

Table No. 1: Name of fine Chemicals (Existing Products)

Sr. No PROPOSED PRODUCTS UOM

Proposed Qty./

Ton/ Month

Water For Process & Washing Per / Day

Water for Utilities

Per /Day

1 Mesitylene Bis Bromide Kg 0.30 0.00 0.20 2 Salicylaldehyde Sodium Salt Kg 1.50 0.20 0.20 3 1-Benzopyran-2-one Kg 2.00 0.25 0.30 4 Milrinone Kg 0.05 0.00 0.20 5 Glimepiride Kg 0.10 0.00 0.30 6 Tiotropium Bromide Kg 0.05 0.35 0.60 7 Strontium Ranelate Kg 1.00 0.25 0.70 8 Phenylephrine Kg 2.00 0.85 0.40 9 Laboratory Reagents Kg 0.50 0.10 0.10

Total 7.5 2.00 3.00





Above mentioned chemicals are fine products which do not required Environmental

Clearance. Whereas the manufacturing process of Fine Chemicals are enclosed as

Annexure -1

Table No. 2: Name of Proposed Products

SR. NO NAME OF PRODUCT PROPOSED QTY. / MONTH

PROPOSED QTY./ ANNUM UNIT

1 Telmisartan / Losartan 0.50 6.00 MT

2 Tizanidine Hydrochloride 0.10 1.20 MT

3 Adapalene 0.002 0.024 MT

4 Theobromine 1.00 12.0 MT

5 Salbutamol Sulphate 1.00 12.00 MT

6 Trioxalen 0.025 0.30 MT

7 Febuxostat 0.25 3.00 MT

8 Lornoxicam 0.05 0.60 MT

9 Linezolid 0.25 3.00 MT

Total 3.177 38.12 MT

2.2 Brief description of nature of the project

The part of project is for setting up Research & Development, Specialty and Fine

Chemicals, Mixing formulation and Extraction of Natural products, effective utilization of

laboratory set up for custom synthesis. While other Part of Project is for setting up of a

manufacturing plant for producing the above listed Bulk drugs and Intermediates by

synthetic processes.

2.3 Need for the project and its importance to the country and region.

The main objective of the Viswa Laboratories Pvt. Ltd. is to establish the Research &

Development Centre with state of art manufacturing facility in the field of chemicals &

pharmaceutical. This will add the value in the research sector in our country which will

create opportunities and provide the platform to the upcoming scientists in the country.

As a result this will help the chemical and pharmaceutical industry to breach the gap

between the Technology development and the implementation on the commercial scale.

This project will be helpful to reduce the dependency on other countries for the specialty

and fine chemicals as well as will reduce the dependency for the Key Starting Material

(KSM) and advance intermediate. This will save the substantial time for companies





within the country who are importing the advanced intermediates from the countries

mainly China. Timely supply with guaranteed standard quality will help to increase the

productivity of Indian companies.

In the region project will create the employment for the unskilled, skilled and Technical

people directly. This project will provide the business directly or indirectly to the people

who are interested for transportation & logistics, for the small entrepreneur who are

supplying food and beverage. Overall this project will provide the opportunities to the

local people who are interested to do the honest and sincere small business in the region.

2.4 Demands-Supply Gap

As per the study and survey there is huge gap between demand and supply of several

chemicals and advanced intermediates. Our main aim is to minimize this gap by setting

up state of art facility by appointing the required manpower from the regional

universities as well as from the ICT, ISSER, IITs etc.

2.5 Imports vs. Indigenous production

As per the available data, presently Indian companies are importing several chemicals

and advanced intermediates from the overseas countries mainly from china. In India

there are some companies manufacturing the chemicals and advanced Intermediates but

due to the lack of capacities in terms of infrastructure facility as well as technical

strength the production is not sufficient to feed the Indian Pharma companies. Due to the

short supply of raw materials, large scale companies are importing the raw materials

from other countries. This project will be helpful to breach this gap of short supply and

ultimately this will reduce the import of the Chemical raw materials.

2.6 Export possibility

Our project covered Fine Chemicals and advanced Intermediates which has got good

Export potential. There is huge opportunity for the export market for the selected

products. By using our infrastructure and Technical strength we will be able to Export

the Fine Chemicals and advanced Intermediates at very competitive rates. This will

increase the export from India and thereby attracting the foreign currency.





2.7 Domestic / export Markets

As mentioned above there is huge demand for the selected products in domestic as well

as in the overseas. Presently China is ruling the market. This project will reduce the

import and increase the export potential.

2.8 Employment Generation (Direct and Indirect) due to the project

Direct Employment: As mentioned above this project will create substantial direct and

indirect employment in the area / region and in our country for unskilled, skilled and

Technical People. Technical people with the back ground of B.Sc, M.Sc, or Ph.D. In

Organic Chemistry, Drug Chemistry, Medicinal Chemistry, Analytical chemistry,

Microbiology will have good employment opportunities. Apart from this there will be

requirement of few professional from Engineering as well as commerce back ground.

Indirect Employment: Surrounding local people will get the chance to get the business

for food supply, Local Transportation and Logistics, Contracts for the Civil work,

contracts for the Fabrication work, contract for the installation and commissioning of the

equipment. Export will create the business to the forwarding companies. Generate the

revenue to the Corporations like MIDC, MPCB, Factory inspectorate, Labour department,

Food and Drugs department, Excise and sale Tax departments etc. Overall this project

will create the substantial employment directly and indirectly.

3. PROJECT DESCRIPTION 3.1 Type of project including interlinked and interdependent projects, if any.

Proposed project will be located at Plot No. D-35, MIDC Kurkumbh, Taluka Daund,

District Pune (MS).





3.2 Location (map showing general location, specific location, and project boundary & project site layout) with coordinates.

Figure No. 1: Project Location Map





Figure No. 2: View of Plot





Figure No. 3: 10 Km Radius Toposheet Map





Figure No. 4: Layout Plan





3.3 Details of alternate sites considered and the basis of selecting the proposed

site, particularly the environmental considerations gone into should be

highlighted.

No other alternative site identified/considered as proposed site is located in MID Kurkumbh

which is specially developed for such type of industries.

3.4 Size or magnitude of operation

Total capacity of the proposed Synthetic Organic Chemical Plant is 3.177 MT/ month. Total

yearly production will be approximately 38.12 MT/Year

3.5 Project description with process details (a schematic diagram/ flow chart

showing the project layout, components of the project etc. Should be given)

1) TELMISARTAN

Brief Manufacturing Process

Biphenyl derivative is halogenated by using N- bromo succinimide to give bromo

derivative this bromo derivative is condensed with benzimidazole derivative to give

condensed product, which on hydrolysis yields TELMISARTAN.

Flow Chart 4 Methyl Biphenyl CarboxylateN- bromo succinimideDibenzoyl peroxideEDCHexane

Benzimidazole derivativeAcetoneCarbonHyfloPottasium hydroxideMIBKTBABWater

MethanolSodium HydroxideHCITEAMDCAcetic acid

Stage A

Stage-B

Stage-C

Product

Spent Solvent

Solvent Recovery

Spent solvent

Spent solvent

Solvent Recovery

Solvent Recovery

Aq. Layer to ETP

Aq. Layer to ETP





Material Balance

SR.

NO. RAW MATERIAL UOM INPUT OUTPUT

RM

QTY/M

RM

QTY/Y

1 4 Methyl Biphenyl Carboxylate Kg 1.16 0.00 580 6960

2 N- bromo succinimide Kg 1.00 0.8 500 6000

3 Dibenzoyl peroxide Kg 0.0016 0.00 0.8 9.6

4 EDC Kg 0.63 0.57 315 800

5 Hexane Kg 0.58 0.522 290 600

6 Benzimidazole derivative Kg 1.99 0.00 995 11940

7 Acetone Kg 4.0 3.6 2000 4000

8 Carbon Kg 0.10 0.10 50 600

9 Hyflo Kg 0.10 0.10 50 600

10 Pottasium hydroxide Kg 1.28 0.00 640 7680

11 MIBK Kg 0.7 0.63 350 750

12 TBAB Kg 0.14 0.00 70 840

13 Water Kg 4.50 8.63 2250 27000

14 Methanol Kg 2.1 1.89 1050 2200

15 Sodium Hydroxide Kg 0.6 0.00 300 3600

16 HCI Kg 1.6 0.00 800 9600

17 TEA Kg 0.3 0.00 150 1800

18 MDC Kg 0.8 0.72 400 1200

19 Acetic acid Kg 0.2 0.00 100 1200

20 Operational losses Kg 0.0 3.23 0 0

21 Product Kg 0.0 1.0 500 6000

TOTAL 21.79 21.79

Proposed manufacturing 500 kg per month

1) Per kg water consumption will be 4.50 kg. Total Water: 2250 Lit per Month

2) Solid Waste Carbon 50 kg Per Month, will be given to CHWTSDF

3) Solid waste Hyflow- 50 kg Per Month, will be given to CHWTSDF

4) No gasses emission.

5) Spent solvent will be recovered & reused in the process or will be sold to MPCB Approved

vendor Qty. ≃ 4000 Lit





2) TIZANIDINE HYDROCHLORIDE

Brief Manufacturing Process

Ethylene urea will be treated with acetic anhydride using ethyl acetate as solvent to produce

Acetyl Ethylene urea, named as Stage-A. In Stage B, Acetyl Ethylene Urea treated with Chloro

intermediate in Phosphorous oxy chloride and subsequent quenching & workup followed by

hydrolysis to produce a Tizanidine free base. In Stage-C Tizanidine free base is purified by

using Methanol and activated carbon. In final Stage Tizanidine base is taken in Methanol and

hydrochloride salt is produced by using IPA HCl.

Flow Chart

Stage-AReaction

Ethyl acetateEthylene Urea

Stage-BReaction

Drying & Packing

Stage-CPurification

5-Chloro compound

Methanol

WaterPOCl3

Stage-DSalt formation

Sodium Hydroxide

Methanol

IPA HydrochlorideIPA

Spent solvent

Spent solvent

Recovered Solvent

Acetic Anhydride

Spent solvent

Recovered Solvent

Recovered Solvent

Aq.Layer will be sold or Recovered SodiumPhosphate

Material Balance

SR. NO. RAW MATERIAL UOM INPUT OUTPUT RM QTY/M

RM QTY/Y

1 Ethylene Urea Kg 0.77 0.00 77.00 924

2 Ethyl Acetate (R- 97%) Lit 1.54 1.49 154.00 209

3 Acetic Anhydride Kg 1.29 0.71 129.00 1541

6 5- Ehlorocompound Kg 0.77 0.00 77.00 924





7 Pocl3 (R-67%) Kg 5.77 3.87 577.00 2460

8 Caustic flakes Kg 1.39 0.00 139.00 590

9 Water Lit 7.70 10.99 770.00 9500

10 Activated Carbon Kg 0.10 0.20 7.69 92.28

11 Hyflow Kg 0.15 1.00 15.00 180

12 Methanol(R-96.5%) Lit 17.60 16.36 880.00 1200

13 IPA HCl Lit 1.54 1.54 154.00 1850

14 Operational losses Kg 0.00 1.46 - -

15 Product Kg 0.00 1.00 100.00 1200

Total 38.62 38.62


1) Per kg water consumption is 7.70 Lit. Total water – 770 Lit per month.

2) Solid Waste - Carbon- 7.69 kg Per Month, will be given to CHWTSDF

3) Solid Waste - Hyflow- 15.00 kg Per Month, will be given to CHWTSDF

4) Hydrochloric acid generated will scrubbed or quenched in the Scrubber.

5) Spent solvent will be recovered & reused in the process or will sold to MPCB Approved


3) ADAPALENE

Process Description

Adamentanol reacts with 4-bromo phenol in presence of methylene chloride, sulphuric acid

and further undergoes methylation reaction with sodium hydroxide and DMS which gives

methoxy derivative of adamentanol and bromo phenol. Which undergoes Grignard reaction

with magnesium and zinc chloride to give zincate? This will react with bromo nepthol in

presence of Ni catalyst to give adapalene ester which on hydrolysis gives adapalene as a final

product.





Flow Chart 4 -Bromo Phenol1- AdamentanolSulphuric AcidMDCHexaneAq. NaHCO3

Stage A

Stage-B

Spent Solvent

Solvent Recovery

Spent solvent

Solvent Recovery

Aq. Layer to ETP

Aq. Layer to ETP

Sodium HydrideMethyl IodideTHFWater,5% HClEthyl Acetate

Filtration & Drying

Material Balance


RM QTY/Y

1 Bromophenol Kg 1.43 0.00 2.86 34.32

2 1-Adamentol Kg 1.26 0.00 2.52 30.24

3 Sulphuric Acid Kg 0.41 0.00 0.82 9.84

4 Methylene chloride Kg 3.42 3.07 6.84 82.08

5 20 % Na-carbonate Sol. Kg 6.43 0.00 12.86 154.32

6 Hexane Kg 0.143 0.128 0.286 3.43

7 Sodium hydride Kg 0.23 0.00 0.46 5.52

8 Methyl Iodide/DMS Kg 1.00 0.00 2.00 24.00

9 THF Kg 18.8 4.80 37.60 451.20

10 Hydrochloric acid Kg 11.71 0.00 23.42 281.04

11 Ethyl acetate Kg 3.28 2.95 6.56 78.72

12 Magnesium Kg 0.10 0.05 0.20 2.40

13 1,2 Dibromomethane Kg 0.60 0.00 1.20 14.40

14 Zinc chloride Kg 0.38 0.00 0.76 9.12

15 Methyl-6-bromo-2-

Naphthoate Kg 0.80 0.00 1.60 19.20

16 Ni catalyst Kg 0.02 0.00 0.04 0.48

17 THF Kg 1.3 1.17 2.60 31.20





18 Sodium hydroxide Kg 4.30 0.00 8.60 103.20

19 Methanol Kg 2.3 2.07 4.60 55.20

20 Charcoal Kg 1.00 1.50 2.00 24.00

21 Hyflow Kg 3.00 3.50 6.00 72.00

22 Water Kg 48.29 73.46 96.58 1158.96

23 Operational losses Kg 0.00 16.50 0.00 0.00

24 Product Kg 0.00 1.00 2.00 24.00

Total 110.20 110.20

Proposed manufacturing 2.0 kg per month.

1) Per kg water consumption is 48.29 kg. Total Water – 96.58 Lit per month

2) Solid waste will be hyflow-6 kg, Per Month, will be given to CHWTSDF

3) Solid waste Charcoal-2 kg, Per Month, will be given to CHWTSDF




4) THEOBROMINE

Process Description

Monomethyl Urea is reacted with Ethyl cyanoacetate in presence of Sodium ethoxide or

methoxide in alcoholic solvent. First stage product is subjected to nitrosation in water and

sodium nitrite and further reduced by using sodium dithionite. Cyclization is done by using

Formic acid in alcoholic solvent. In final stage Methylation is carried in presence of DMS in

DMF and Theobromine is isolated, dried and packed.





Flow Chart Monomethyl ureaEthyl cyanoacetateSodium ehoxideEthanol or Methanol

WaterAcetic acidSodium nitriteSodium dithionite

Stage A

Stage-B

Stage-C

Spent Solvent

Solvent Recovery

Spent solvent

Spent solvent

Solvent Recovery

Solvent Recovery

WaterPotassium carbonateFormic AcidEthanol or Methanol

DMFDMSWaterCharcoalHyflow

Stage-D

Spent solvent

Solvent Recovery

Aq.MLR To ETP

Aq.MLR To ETP

Aq.MLR To ETP

Filtartion ,Drying & Packing

Material Balance


RM QTY/Y

1 Monomethyl Urea Kg 1.41 0 1410 16920

2 Ethyl cyanoacetate Kg 2.18 0.00 2180 26160

3 Sodium ehoxide Kg 2.58 0.00 2580 30960

4 Ethanol or Methanol Kg 8.46 10.63 2000 3000

5 Water Kg 5.46 8.70 5460 65520

6 Acetic acid Kg 2.31 2.10 2310 5000

7 Sodium nitrite Kg 1.16 0.00 1160 13920

8 Sodium Dithionate Kg 3.47 0.00 3470 41640

9 Water Kg 5.00 7.50 5000 60000

10 Potassium carbonate Kg 2.31 0.00 2310 27720





11 70% Formic Acid Kg 2.90 0.00 2900 34800

13 DMF Kg 7.00 6.65 2000 3000

14 DMS Kg 1.80 0.00 1800 21600

15 Water Kg 5.57 6.72 5570 66840

16 Charcoal Kg 0.10 0.23 100 1440

17 Hyflow Kg 0.05 0.30 50 600


19 Product Kg 0.00 1.00 1000 12000

Total 51.76 51.76


1) Per kg water consumption is 16.03 kg. Total water – 16030 lit per Month

2) Solid waste will be hyflow-50 kg per Month will be given to CHWTSDF

3) Spent Charcoal 100 kg, per month will be given to CHWTSDF



vendor, approx. Qty. – 4000 lit per month

5) SALBUTAMOL SULPHATE

Process Description

In stage first Methyl Salicylate or Salicylaldehyde is acylated to get the Acetyl methyl

salicyalte, which is further reacted with t-Butyl amine to get the adduct and the t-butyl amine

derivative. This product is reduced by using sodium borohydride followed sulphuric acid to

get the Salbutamol sulphate.





Flow Chart

Methyl salicylate OrSalicilaldehydeAluminium chlorideDCMAcetyl Chloride OrChloroacetyl chlorideWater

Stage A

Stage-B

Stage-C

Spent Solvent

Solvent Recovery

Spent solvent

Spent solvent

Solvent Recovery

Solvent RecoveryMethanolWaterSodium BorohydrideHydrochloric AcidSulphuric acid

Aq.MLR To ETP


Aq.MLR To AlCl3Supplier

Iso propanoltert-butyl amineHCl(12M)Water

Aq.MLR To ETP

Material Balance


RM QTY/Y

1 Methyl Salicylate Or

Salicilaldehyde Kg 0.83 0.00 830 9960

2 Aluminium chloride Kg 1.70 0.00 1700 20400

3 DCM Kg 4.15 3.52 1200 3000

4 Acetyl Chloride Or

Chloroacetyl chloride Kg 0.77 0.00 770 9240

5 Sodium hydroxide Kg 2.49 0.00 2490 29880

5 Water Lit 5.80 8.95 5800 69600

6 Isopropanol Kg 4.98 4.48 1800 3000

7 tert-butyl amine Kg 0.71 0.00 710 8520

8 HCl(12M) Kg 0.70 0.00 700 8400





9 Methanol Kg 7.00 6.10 2000 3000

10 Sodium Borohydride Kg 0.62 0.00 620 7440

11 Water Kg 1.24 3.25 1240 14880

13 Sulphuric Acid Kg 0.83 0.00 830 9960


14 Product Kg 0.00 1.00 1000 12000

Total 31.82 31.82


1) Per kg water consumption is 7.04 kg. Total water – 7040 Lit per Month

2) Aqueous mother liquor of Aluminium Hydroxide 5800 Lit be sent back to Aluminium

chloride supplier.

3) Hydrochloric acid generated will scrubbed or quenched in the Scrubber



6) TRIOXALEN

Process Description

The Intermediate Acetic acid-4, 8-dimethyl-2-oxo-6-vinyl-2H-Chromen-7-yl-ester is reacted

with Bromine in presence of Methanol as a solvent to get Dibromo derivative of Chromen.

Further this intermediate is cyclised by using sodium methoxide in methanol to get Trioxalen.

Flow Chart Acetic acid-4,8-dimethyl-2-oxo-6-vinyl-2H-Chromen-7-yl-esterMethanolBromine

Stage AReaction

Stage-BCyclisation

Filtartion,Drying & Packing

Distilled Solvent

Recovered Solvent

Distill solvent

MethanolSodium Methoxide Recovered

Solvent





Material Balance


RM QTY/Y

1

Acetic acid-4,8-dimethyl-2-

oxo-6-vinyl-2H-Chromen-7-yl-

ester

Kg 1.10 0.00 27.50 330

2 Methanol Kg 12.00 11.00 300 400

3 Bromine Kg 0.89 0.00 22.25 267

4 Sodium Methoxide Kg 0.30 0.00 7.50 90

5 Sodium Bromide Kg 0.00 0.97 26.67 0


8 Product Kg 0.00 1.0 25 300

Total 14.29 14.29

Proposed manufacturing 25.0 kg per month

1) Water is not required in the process

2) No Solid waste generation

3) No gasses emission

4) Spent solvent will be recovered & reused in the process or will be sold to MPCB

Approved vendor (300 l)

7) FEBUXOSTAT

Process Description

Intermediate Ethyl 2-(3-Cyano -4-Isobutoxyphenyl) -4-Methyl –Thaizole Carboxylate will be

charged into the reactor along with methanol and barium hydroxide and ester hydrolysis will

be carried out. After the reaction is complete, the solvent is distilled out this recovered

solvent from the reaction will be stored separately for the next batch. After distillation, water

will be charged into the reactor, stirred for some time, pH is adjusted by HCl and filtered the

product. Washed the cake with Methanol and spin-dry the material.

Wet cake will be charged into the reactor plus methanol is added and reaction mass is heated

to get the clear solution. After observing clear solution, filter the reaction mass and feed into

the reactor, distil out 60% methanol, cool the mass and filter the product, dry and pack.





Flow Chart Intermediate- Ethyl Thaiazole carboxylate Barium HydroxideWaterMethanol

Stage AReaction

Stage-BPurification


Distilled Solvent

Recovered Solvent

Distill solventAq.MLR To ETP

MethanolHydrochloric AcidHyflow

Aq. MLR ToETP

RecoveredSolvent

Material Balance


RM QTY/Y

1

ETHYL 2-(3-CYANO-4-

ISOBUTOXYPHENYL) -4-

METHYL-5-

THAIZOLECARBOXYLATE

Kg 1.18 0.00 294 3529

2 Barium Hydroxide Kg 0.65 0.00 161 1941

3 Water Kg 23.59 24.30 6935 83225

4 Methanol Kg 21.88 20.78 1800 3000

5 Hydrochloric Acid Cp

Grade Kg 0.42 0.00 105 1270

6 Hyflow Kg 0.01 0.03 3 36


8 Product Kg 0.00 1.00 250 3000

Total 47.73 47.73



2) Solid waste – Hyflow 3 kg per Month will be given to CHWTSDF





3) No gasses emission

4) Spent solvent will be recovered & reused in the process or will be sold to MPCB Approved


8) LORNOXICAM

Process Description

Ester Intermediate (6-Chloro-4-hydroxy-2-methyl-2H-thieno [2, 3-e]-1, 2-thiazine-3-

carboxylic acid methyl ester 1, 1-dioxide condensed with 2-Aminopyridine in presence of o-

Xylene under inert atmosphere. After reaction completion solvent is recovered and stored

separately for the next batch. Then water added into the reaction mass and filtered. Washed

product with Methanol and taken wet cake for further process. In second stage product is

taken in methanol and potassium carbonate is added to get the clear solution. Added carbon

and filtered the reaction mass through fine filter. Filter collected into the reactor, distilled out

solvent, added water and adjusted pH by using Hydrochloric acid. Stirred reaction mass and

filtered product, dried and packed.

Flow Chart

Ester Intermediate2 Amino PyridineO- XyleneMethanolN2 CylinderWater

Stage A

Stage-B


Distilled Solvent

Recovered Solvent

Distill solventAq.MLR To ETP

K2 CO3MethanolHCl, MDC, Carbon,HyflowN2 CylinderWater

Aq. MLR ToETP

RecoveredSolvent





Material Balance


RM QTY/Y

1

6-Chloro-4-hydroxy-2-

methyl-2H-thieno[2,3-e]-

1,2-thiazine-3-carboxylic

acid methyl ester 1,1-

dioxide

( Ester Intermediate)

Kg 1.27 0.00 63.5 762

2 2 Amino Pyridine Kg 0.50 0.00 25 300

3 O- Xylene Kg 115.00 112.00 1400 2000

5 N2 Cylinder Kg 0.73 0.00 36.5 438

6 Water Lit 12.70 13.60 635 7620

7 K2 CO3 Kg 0.45 0.00 22.5 270

8 Methanol Kg 10.16 9.14 508 6096

9 HCl Kg 0.64 0.00 32 384

10 Carbon Kg 0.09 0.13 4.5 54

11 Hyflow Kg 0.25 0.30 25 150

12 Water Lit 10.16 12.25 508 6096


14 Product Kg 0.00 1.00 50 600

Total 151.95 151.95



2) Solid waste –Carbon 4.5 kg per Month will be given to CHWTSDF

3) Solid waste – Hyflow 25 kg per Month will be given to CHWTSDF



9) LINEZOLID

Process Description

3, 4 Di-fluronitrobenzene is condensed with Morpholine in presence of potassium carbonate

in water. This intermediate subjected to the reduction by Sodium dithionate followed the





reaction with Methyl Chloroformate in THF and water by using phase transfer catalyst TBAB.

After reaction completion, product is isolated and washed with ethyl acetate. Intermediate

obtained from the Stage B is reacted with R-Glycidyl butyrate in presence of Lithium Bromide

and Potassium tertiary butoxide. In stage C the intermediate from Stage-B is condensed with

Methane sulphonyl chloride and carried out azide reaction. In final stage the Thioacetetic acid

is condensed with azide intermediate and final product is isolated.

Flow Chart 3,4DifluronitrobenzeneMorpholineK2CO3Water

Sodium DithionateTBABTHFEthyl AcetateK2CO3Methyl Chloroformate

Stage A

Stage-B

Stage-C

Spent Solvent

Solvent Recovery

Spent solvent

Spent solvent

Solvent Recovery

Solvent Recovery

MethanolActivated CharcoalThioacetic AcidEthyl Acetate

Stage-D

Spent solvent

Solvent Recovery

Aq.MLR To ETP

Aq.MLR To ETP

Aq.MLR To ETP


R GlycidylButyrateLithium BromidePotassiumtetrbutoxideMethane Sulfonyl chlorideAmmonium ChlorideTHF, Methanol,MDC, Water

Aq.MLR To ETP

Material Balance


RM QTY/Y

1 3, 4 Difluronitrobenzene Kg 0.83 0.00 208.33 2500

2 Morpholine Kg 0.55 0.00 138.33 1660

3 K2CO3 Kg 2.85 0.00 712.50 8550





5 Water Kg 6.67 12.5 1666.67 20000

6 Sodium Dithionate Lit 3.21 0.00 802.08 9625

7 TBAB Kg 0.04 0.00 10.42 125

8 THF Kg 5.41 4.87 1500 2500

9 Ethyl Acetate Kg 4.17 3.96 1000 2000

10 Methyl Chloroformate Kg 0.49 0.00 122.92 1475

11 R GlycidylButyrate 0.42 0.00 105.63 1267

12 Lithium Bromide Lit 0.37 0.00 93.13 1117

13 Potassiumtetrbutoxide 0.38 0.00 94.17 1130

14 Methane Sulfonyl chloride 0.66 0.00 164.58 1975

15 Ammonium Chloride 0.50 0.00 125.00 1500

16 Methanol 6.67 6.00 1500 2500

17 MDC 6.67 6.00 1666.67 20000

18 Sodium Azide 0.41 0.00 102.33 1228

19 DMF 3.83 3.63 958.33 11500

20 Water 4.17 7.27 1041.67 12500

21 Charcoal 0.04 0.06 10.42 125

22 Thioacetic Acid 0.62 0.00 154.17 1850


24 Product Kg 0.00 1.00 250 3000

Total 48.96 48.96



2) Solid waste –Carbon 10.42kg per Month will be given to CHWTSDF



Note: Total 9 products are proposed to be manufactured from the unit. Manufacturing

of the products will be based on the orders and demand from the other industries or

on campaign basis.

3.6 Raw material required along with estimated quantity, likely source, marketing

area of final product/s, Mode of transport of raw Material and Finished Product.





Raw material details are already incorporated product wise.

1) Marketing Area- For selected product company has good opportunities in domestic

market in India. We have huge scope for the Export of our listed products in countries

like- Germany, US, Brazil, Egypt, Africa, Bangladesh, and Nepal etc.

2) Mode of Transport- In India it is by Road from Mumbai, Hyderabad, Chennai, Bangalore,

Ahmadabad etc. For export mode of transport will be by Sea or By Air as per the client’s

requirement.

(vii) Resource optimization/ recycling and reuse envisaged in the project, if any,

should be briefly outlined.

Company’s focus will be on maximum utilization of internal resources like:

1) Waste Steam or condensate after circulation to the reactor jackets, will be utilized for

generating hot water which will be useful for the drying of the products. This will reduce

boiler Fuel consumption.

2) Processes are developed in such a way that the maximum solvents are getting distilled

during manufacturing process itself, hence, there is very little requirement to recover it

separately. The solvents recovered shall be used directly in the same process. This will

reduce the operation cost as well solvent procurement cost.

3) Some of the bye products like Sodium Bromide, Aluminum Hydroxide will be sent back

to the respective suppliers to convert back into the Bromine & Aluminum Chloride who will

send us it back. This will reduce the towards raw material as well will protect the

environment from the pollution by reducing the pollution load.

4) Company has the plan of recycling the Aqueous MLR of some products directly for few

cycles. This will reduce the water consumption of the processes.

5) We will plan to collect floor cleaning and condensate water separately so that it can be

used for gardening and to the plants which will reduce the water consumption.

(viii) Availability of water its source, Energy/ power requirement and source should be given.





Water Requirement

Total water requirement for the project shall be 20 CMD (Existing: 10 and Proposed: 10

CMD) which is provided by MIDC Kurkumbh. ETP has been proposed to treat effluent

generated to achieve the standard norms set by the MPCB. Treated effluent shall be used in

the process and excess water if any shall be used for non-potable domestic purpose. Water

Balance of the same is given below:

Table No.3: Water Balance (Existing + Proposed)

SR. NO. PARTICULARS INPUT CMD LOSS CMD LOSS AS EFFLUENT

CMD

1 Domestic 2.00 0.40 0.00 1.6

2 Process & process washings

4.00 0.00 0.00 4.00

3 Cooling tower & Boiler feed 6.00 2.00 Steam

Evaporation 4.00

4 Green Belt 8.00 8.00 Water for plantation 0.00

5 Other 0.00 0.00 0.00 0.00

Total 20 10.40 0.00 9.6 Power Requirement

Total power requirement will be 200 KVA which will be sourced from MSEB. Sanction letter

has already obtained for the same. DG sets of required capacity shall be installed as backup

support in case of power failure.

(ix) Quantity of wastes to be generated (liquid and solid) and scheme for their

Management/ disposal.

Table No. 4: Waste (Liquid +Solid) generation and disposal techniques

SR NO. WASTE GENERATION (DESCRIPTION) UOM EXPECTED

QTY /M DISPOSAL

1 Total Aqueous Effluent Lit 53576 The effluent shall be treated in the ETP and after the treatment it shall be sent to CETP

2 ETP Sludge Kg 100

ETP Sludge shall be sent for scientific disposal at authorized facility such as MEPL (CHWTSDF) Ranjangaon, Pune





(x) Schematic representations of the feasibility drawing which give information of EIA purpose. Plant Layout is already displayed earlier as Figure No. 4 4. SITE ANALYSIS

(i) Connectivity

Proposed project is located at Plot No. D-35, MIDC, Kurkumbh. National Highway no 9 (Pune-

Sholapur Highway) is crossing at about 0.45 km distance from boundary of the project site.

Nearest Railway Station is Daund which is at a distance of about 8.83 km and nearest town is

Daund at a distance of 9 km. There is no Eco-sensitive Zone i.e. National Park / Wildlife

Sanctuary /Reserve Forests/ Biosphere reserve or Archaeological/Religious site present

within the 10 km radius study area.

(ii) Land Form, Land use and Land ownership

MIDC has developed good infrastructure facilities in an area of 473 Hectares to develop a

chemical zone at Kurkumbh in which pharmaceuticals, chemicals and other auxiliary units

3 Total Spent Solvent Lit 29516

The solvents recovered from the processes shall be recycle / reused in the process (90%) for the production of the same products. After in-house use remaining quantity will be sold to MPCB approved vendor

4 Aq. Sodium Bromide Solution

Lit 8026 It will be sent back to the Bromine supplier to manufacture Bromine

5 Aq. Aluminum Hydroxide Solution Lit 5800

It will be sent back to the Aluminum Chloride supplier to manufacture Aluminum Chloride

6 Pd on Carbon Kg 14

This will be sent back to supplier for reactivation and to supply back.

7 Solid Waste – Sodium Sulphate Kg 93

To MEPL (CHWTSDF) Ranjhangaon, Pune

8 Solid Waste – Hyflow Kg 269 To MEPL (CHWSDF) Ranjhangaon, Pune

9 Solid Waste – Activated Charcoal

Kg 276 To MEPL (CHWTSDF) Ranjhangaon, Pune





are in operation since last several years and have contributed for the development of the

area. One of the pioneer companies in the manufacture of antiretroviral drugs is also situated

in this MIDC. Plot no D-35 has been owned by M/s. Viswa Laboratories Pvt. Ltd. where

Synthetic Organic Chemical Plant is proposed. PP has acquired land from MIDC on lease basis.

(iii) Topography

Pune district covers 15,642 square kilometers area. Sahyadri mountain range lies from north

to south in west part in study region and Crestline acts as a main water divide of peninsular

rivers. There are three main mountainous ranges, namely, Harishchandra range, Jeevdhan

range and Dhak-Ahupe range. In south, Saswad plateau lies in between Bhima basin in north

and Neera basin in south and then it extends towards east. South of Harishchandra range, the

Tasubai range lies in south, then Mandavi range and Tamhini range followed by Saswad

plateau indicates two regions of above 900 metres high. One lies in north i.e. Harishchandra

and another is Jeevdhan range. The height in west part in study region is above 1200 metres

and it lowers towards east (450 metres). The central and west parts have elevation from 600

to 1200 metres. The slope is towards southeast in study region. The central and east parts

show elevation between 450 to 600 metres lying from east to west. One zone lies between

Tasubai range and Saswad plateau and east part and south part of Saswad plateau. The

overall slope is 800 metres from northwest to southeast direction in study region. Contour

plan of the project site is given below:





Figure No. 5: Contour Plan of the site

(iv) Existing land use pattern (agriculture, non-agriculture, forest, water bodies

(including area under CRZ)), shortest distances from the periphery of the project

to periphery of the forests, national park, wild life sanctuary, eco sensitive areas,

water bodies (distance from the HFL of the river), CRZ. In case of notified

industrial area, a copy of the Gazette notification should be given.

MIDC has developed good infrastructure facilities in an area of 473 Hectares to develop a

chemical zone at Kurkumbh in which pharmaceuticals, chemicals and other auxiliary units





are in operation since last several years and have contributed for the development of the

area. One of the pioneer companies in the manufacture of antiretroviral drugs is also situated

in this MIDC. Plot no D-35 has been owned by M/s. Viswa Laboratories Pvt. Ltd. where

Synthetic Organic Chemical Plant is proposed. PP has acquired land from MIDC on lease basis.

Existing Infrastructure

MIDC Kurkumbh has well established industrial area having required infrastructure facilities

as under:

1) Common Effluent Treatment Plant (CETP)

2) Waste Water and Sewage Water drains

3) Well Maintained Roads and Street Lights

4) Truck Terminal

5) Well-connected CHWTDSF

6) Sufficient Water Supply

7) Sufficient & uninterrupted MSEB Electricity Supply

Proposed project site is almost plain and do not have any settlement as the plot is situated at

MIDC. The proposed site is acquired from the MIDC on lease basis.

(vi) Soil classification

Soil plays a key role in cultivation and production of crops in study region. It nourishes and

supports growth of plants. The growth of crops depends upon soil structure, colour, thickness

and texture. Organic and inorganic matter, water and air are essential in soil for plant growth.

The development of soil in any region depends mainly upon parent material, climate, living

organism, land utilization and physiography. Deep black, medium deep black lateritic and

coarse shallow soils are observed in study region.

Deep black soil is identified in central and east parts of the region. This soil is mainly found

along Bhima and its tributaries. The colour of this soil varies from brown to dark black. This

soil is well drained, clayey and it appears dark brown to greyish black in colour owing to

excessive predominance of humus content. This soil varies in depth from 5 to 20 feet. The

crop cultivation is supplemented by irrigation. Vegetables, sugarcane, wheat, fodder crops

are grown in this soil. Medium deep black soil is observed in Khed, Shirur, Haveli, Purandar

and Daund talukas.





This soil is deep, well drained and fine textured and it suffers from moderate erosion and has

saline, clayey and calcarious in nature but found comparatively less fertile than deep black

soil. Sugarcane, wheat and vegetables are common crops grown on this soil in study region.

Course shallow soil is hard in nature and locally known as murmad. This soil is semi-fertile

and its water holding capacity is less than black soil. Lateritic coarse shallow soil is reddish

brown in colour. Basaltic soil is turned into laterite soil due to oxidation process which is

caused by heavy rainfall and high temperature. Chemical and mechanical weathering result

laterite soil. This soil contains excessive iron oxide resulting reddish in colour. Laterite coarse

shallow soil is found in north in Junnar, Khed and Shirur, central part in Indapur, Baramati

and Purandar talukas. Coarse shallow high hill soil, which is laterite, found in west part in

study region. This soil is well drained and calcarious in nature. Jowar and bajra crops are well

grown in this soil. Sahyadri and its ranges are covered with shallow laterite soil. Rice is the

main crop in this region.

(vii) Climatic data from secondary sources

Temperature

The winter season starts from November / December and continues till the end of February.

During this season, monthly mean maximum temperature is found to be 32.3C occurring in

the month of February whereas, monthly mean minimum temperature occurs in the month of

December & January as 11.1C. Both the day and night temperatures increase rapidly during

the onset of Pre monsoon season from March to May.

During Pre monsoon the monthly mean maximum temperature found to be 37.8C in the

month of April and monthly mean minimum temperature as 15.6C in the month of March. An

appreciable drop in mean maximum temperature is recorded with the onset of monsoon. The

monthly mean maximum temperature in monsoon season was observed to be 31.7C in the

month of June, while monthly mean minimum temperature was observed to be as 20.9C in

the month of September. By end of September with the onset of post monsoon season

(October & November), day temperature rises slightly with the monthly mean maximum

temperature was observed to be as 31.5C in October and the minimum temperature is

observed as 14.5C in November.





Relative Humidity

During Pre-monsoon period, the monthly mean relative humidity was observed to be in the

range of 48%-61% at 08:30 hrs and at 17:30 hrs it is observed in the range of 21%-39%.

During the monsoon season, relative humidity ranges between 77%-86% at 0830 hrs and

66%-78% at 1730 hrs. In the post-monsoon season the range was observed to be between

78%-81% at 0830 hrs and at 1730 hrs the range of relative humidity occurred between 46%-

56%.

During winter season the range of humidity was observed between 75%-87% at 0830 hrs

and 27%-39% at 1730 hrs. It is observed from the data that the air is dry in pre monsoon and

winter seasons while it is humid during monsoon and post monsoon seasons due to heavy

rains in the region.

Station Level Pressure

In winter season, the mean pressure observed at 0830 hrs was in the range of 951.5 to 953.4

hpa and at 1730 hrs, it is observed in the range of 947.7 to 949.7 hpa with the maximum in

December. In monsoon season, the station level pressure was observed to be in the range of

942.9 to 947.3 hpa at 830 hrs and at 1730 hrs it is ranged between 941.6 to 944.5 hpa.

It can be seen from the data that not much variation is observed in the average atmospheric

pressure levels. The pressure levels are found to be fairly constant over the region.

Rainfall

The average annual rainfall observed based on the 10 years IMD data is 689.7 mm. About

80% of the rainfall is received during the southwest monsoon. Pre monsoon rains are also

observed in the region. Our project area falls under medium rainfall zone, receiving average

annual precipitation of 500 mm.

Wind Speed/Direction

Generally light to moderate winds prevails throughout the year with slightly stronger winds

in the early monsoon period. Winds are light and variable in the post-monsoon and winter

seasons particularly during the morning hours, while during the afternoon hours the winds

are slightly stronger.





The average wind speed in the region is observed to be in the range of 1.9 to 8.5 kmph.

Table No. 5: Mean Meteorological Data (1995-2004) Month Temperature

(oC) Relative

Humidity (%) Station Level

pressure (hpa) Rainfall

(mm) Wind Speed

(kmph) Max Min 0830 Hrs

1730 Hrs

0830 Hrs 1730 Hrs

January 29 11 87 36 952 949 2 2

February 32 13 75 27 952 948 0 3

March 36 16 56 21 950 946 0 4

April 38 20 48 25 948 944 7 5

May 37 23 61 39 947 943 20 8

June 32 23 77 66 944 942 162 8

July 28 23 83 76 943 942 136 9

August 28 22 86 78 945 943 125 7

September 29 21 85 73 947 945 119 5

October 32 19 81 56 950 946 85 3

November 31 15 78 46 952 948 27 2

December 30 11 84 39 953 950 8 2

5. PLANNING BRIEF (i) Planning Concept (type of industries, facilities, transportation etc.), Town and

Country Planning/ Development authority Classification.

Proposed project is being established in a well designated industrial area especially

developed for chemical industries. A plot at MIDC measuring 8115 sq. m. has been acquired

on lease basis to establish proposed synthetic organic chemical unit. The proponent has

planned to set up S.S.I. Unit at this location for Manufacture of Laboratory reagents, Fine

Chemicals, Intermediates and APIs like Milrinone, Glimepiride, Strontium Ranelate,

Diphenehydramine Hydrochloride Phenylephrine, Itroricoxib, Theobromine, Domperidone

which is used as a basic Raw Material in Drugs and Pharmaceutical Industries. Manufacturing

of these products will be based on the orders on hand on campaign basis.

(ii) Population Projection

Total 50 Working persons are required for proposed unit. Local people will be preferred for

jobs based on their educational qualification, experience and capabilities.





(iii) Land use planning (breakup along with green belt etc.)

Total area of plot is 8115 Sq. m is in possession for proposed unit on lease basis. Main unit

area will be about 7303.50 sq. m. about 33% of total plot area shall be reserved for Green belt

development.

Table No. 6. Land Requirement of the Project

Sr. No. Area Statement Area (Sq. M)

A Area of plot as per records 8115.00

B Open Space (10%) on A 811.5

C Balance area (A-B) 7303.50

D Amenity Space (5%) on A 405.75

E Parking Space (12.5%) on A 1014.00

F Net Plot Area 7303.50

G Allowable Built up 100% of (F) 7303.50

H Allowable Ground coverage 50% of (F) 3651.75

I Proposed Ground Floor area 955.39

J Proposed First Floor area 637.49

K Proposed Extra Height Area 99.70

L Total Proposed Area 1690.38

M F.S.I. Consumed 0.208

N Balance F.S.I. 0.792

O Total Ground Coverage 955.39

P Balance Ground Coverage 2696.36

(iv) Assessment of Infrastructure Demand (Physical & Social)

Many large and small scale industrial units have been established in MIDC, which provide

permanent job opportunity to the unemployed youths from Daund, Patas, Varvand and the

other villages in surrounding area of Kurkumbh. MIDC is situated in the command area of

Pandharewadi Grampanchayat. Because of the location of MIDC in this Grampanchayat area,





the local body also gets sizable income by way of taxes. As there is no residential

accommodation available for the work force, the MIDC has developed residential flats on

Kurkumbh Daund Road, in an area of 9 hectors. This facilitates the workers to stay near their

work place. As the local workers have got gainful employment the social impact of it can be

visually seen in the gradual improvement in their lifestyle. Maharashtra State Road Transport

Corporation has made provision of ST Buses to Kurkumbh from Daund and the nearby

villages which facilitate the easy travelling of workers and the staff to MIDC. This MIDC has

given boost to the development of trade at Kurkumbh. Proposed project will also join with

existing CSR activities being conducted in the area to development of the area and society.

6. LANDSCAPING AND GREENBELT DEVELOPMENT Adequate land has earmarked as open spaces and for other non-building purposes. Nearly,

33% of total plot area has proposed for green belt development by planting various types of

trees and ornamental plants. Similarly, considering the requirements of environmental rules

and regulations, suitable local Plant species will be planted with adequate spacing to

maintain or to develop the green zone (buffer zone) in and around the Factory.

7. WATER & WASTE WATER MANAGEMENT The main sources of effluent generation are from the plant / process, washings, blow downs

from utilities like cooling tower, boiler & domestic effluents. The process effluents and

domestic sewage will be treated in Effluent treatment plant. ETP will be provided with

required treatment facilities with the capacities of 10 CMD to treat the generated effluent.

Meanwhile company has made agreement with MIDC Kurkumbh to send the treated effluent

to CETP for dilution purpose. Agreement with Kurkumbh Environment Protection Co-

Operative Society Maryadit (KEPCSM) has already made and copy of the same is enclosed as

Annexure-2. As per the Consent to establish granted by MPCB, effluent discharge shall meet

the following limit:

Table No.7: Effluent discharge limit as per MPCB norms

SR. NO. PARAMETERS Effluent Discharge Standard 1 pH 5.5-9

2 Oil & Grease 10

3 BOD (3 days at 270 C) 30

4 Suspended Solids 100





5 COD 250

6 TDS 2100

7 Sulphates 1000

8 Chlorides 600

8. SOLID & HAZARDOUS WASTE MANAGEMENT Solid wastes are generated from the process mainly Pd on Carbon, Sodium Sulphate, Hyflow,

Activated Charcoal, waste oil and used batteries from DG sets etc. The hazardous waste

generated from different process shall be disposed to the CHWTSDF (MEPL, Rajhangaon),

while the waste oil and used batteries shall be sent to authorize recyclers. The other solid

wastes expected from the unit are containers, empty drums which is used for packing

product, and or returned to the product seller or sold to authorized recyclers. Sludge from

ETP shall be sent to CHWTSDF and Plastic waste will be sold to recycler.

9. AIR POLLUTION MANAGEMENT The main source of air pollution is from boiler and process vent. To control the same,

separate stacks shall be provided which shall be attached with Boiler and process vent.

As per the MPCB concept, emission of Particulate matter shall not exceed the limit of 150

mg/Nm3. Regular water sprinkling shall be ensured in the plant area during construction of

the plant. All internal roads shall be paved of concreted as per requirement to avoid the

dispersion of Particulate matters. Regular maintenance of vehicle with PUC shall be

maintained. Thick green belt shall be developed in about 33% of total plot area which will

help to control the air pollution.

10. OCCUPATIONAL HEALTH & SAFETY MEASURES

The Project design and development has been planned with utmost care and all provisions

have been considered for the safety and security of the plant and personnel. For protection of

the facility against fire, explosion or gas leak, all the blocks and yards will be equipped with

required firefighting arrangement including Fire hydrants, DCP and CO2 Fire extinguishers.

Following safety measures shall be implemented:

Hydrant System

Fire Detection and Alarm System

Different types of Fire Extinguishers (CO2 & DCP)





Fire water storage facilities (Sources of water supply: MIDC)

11. REHABILITATION AND RESETTLEMENT (R & R) PLAN R & R Plan has not been found relevant for the proposed project as there would not be any

land acquisition of local people, property of other assets and liability. The project site is

within the notified Industrial Estate of Kurkumbh MIDC, Maharashtra. Hence, no R & R action

plan has been found relevant.

12. PROJECT SCHEDULE & COST ESTIMATES (i) Likely date of start of construction and date of completion (Time schedule for

the project to be given).

Construction of the project shall be started just after the statutory clearance and consents to

establishment from the concerned authorities. It is expected to complete the Project

construction activities within 6 to 8 months.

(ii) Estimated project cost along with analysis in terms of economic viability

The Capital cost of the Project is estimated at Rs. 583.56 Lakhs

Table No. 8: Project Cost

SR. NO. FIXED ASSETS RS. (LAKHS)

1 Land 28.56

2 Factory Shed 175.00

3 Plant & Machinery 300.00

4 Furniture & Fixture & Office Equipment 5.00

Total Cost of Fixed Assets 508.56

5 Pre-Operative Expenses 25.00

6 Various Government Approvals 50.00

Total Cost of Project 583.56





The estimated capital and recurring cost of Environmental Management Plan will be

around Rs 46.0 Lakhs and Rs. 14.0/year respectively.

Table No. 9: EMP Cost

SR. NO. PARTICULAR AMOUNT (RS. IN LAKHS) Capital Cost

1 Green Belt Development 10.0 2 Solid & Hazardous Waste Management 5.0 3 Water & Waste Water Management 15.0 4 Air Pollution Management including

instrumentation 10 .0

5 Occupational Health & Safety 5.0 6 Miscellaneous Cost 1.0

Total 46.0 Recurring Cost

SR. NO. PARTICULAR AMOUNT (RS. IN LAKHS/year)

1 Green Belt Development 5.0 2 Environmental Monitoring 1.5 3 Solid & Hazardous Waste Management 2.5 4 Water & Waste Water Management 3.5 5 Air Pollution Management 0.5 6 Occupational Health & Safety 1.0 7 Miscellaneous Cost 0.5

Total 14.5

13. ANALYSIS OF PROPOSAL (FINAL RECOMMENDATIONS) Project shall create direct & indirect employment opportunities to the people residing at

surrounding region. Different types of people will be recruited for proposed unit based on the

basic qualification as skilled, unskilled or semiskilled. As the project needs good amount of

workforce of non-technical and technical nature, they are being made available from the

nearby villages. Migration of highly education and skilled experience people will result in

increase of literacy in the surrounding villages. Project will also enhanced the prospects of

employment to the nearby people. Additional government revenues are generated from

taxes, duties and other fees. Additional benefit of the project also includes considerable

growth of the industrial and commercial activities in the region and the state.





Annexure -1 Process description of Fine Chemicals

1-MESITYLENE BIS BROMIDE RAW MATERIAL LIST

Note:- 1) No Use of Water in the process, no effluent generation from the process. 2) Distilled recovered Solvents will be directly sold to the MPCB approved party. 3) Solid Waste generated 15 kg per Month will sent to CHWTSDF Ranjangaon. 4) No gaseous emission 5) Proposed manufacturing 0.3 T per month.

BRIEF PROCESS

In this distillation and isolation process, Mesitylene Bis Bromide 65 % solution in toluene is

charged into the distillation vessel. First distilled out the solvent at atmospheric pressure at

105 to 115oC. Distilled solvent collected in clean and dry drums. Further vacuum is applied to

the Mass and distilled out the product under vacuum. Distillate collected into the clean

drums. After complete distillation the product is unloaded as a molten mass in the trays and

kept in the dryer for cooling. After cooling the material is unloaded into the drums and

analyzed drum wise. Then product packed as per the requirement into the small drums as

per client requirement.

Sr. No Raw Material UOM INPUT OUT PUT RM Per Month

RM Per Annum

1 Mesitylene Bis Bromide Solution in Toluene Kg 1.00 0.00 500.00 6000.00

2 Distilled Solvent Kg 0.00 0.35 291.00 3500.00

3 Product Kg 0.00 0.60 300.00 3600.00

4 Operational Losses Kg 0.00 0.02 17.00 204.00

5 Residue Kg 0.00 0.03 15.00 180.00

Total Kg 1.00 1.00





FLOW CHART

2- SALICYLALDEHYDE SODIUM SALT RAW MATERIAL LIST

Note :-

1) No effluent generation from the process 2) No Solid Waste generation 3) No gaseous emission 4) Proposed manufacturing 1.5 T per month.

BRIEF PROCESS

This is the mixing salt formation process. Charge Salicylaldehyde into the reactor, charge

Sodium Hydroxide Lye solution and heat the mass to 70 to 75 o c, stir, maintain and unload

into the trays for the drying. After drying pack the material into the drumps.

3) FLOW CHART

S. No Raw Material UOM INPUT OUT PUT

RM Per Month

RM Per Annum

1 Salicylaldehyde Kg 1.00 0.00 1500.00 18000.00

2 Sodium Hydroxide Lye solution Kg 0.20 0.00 600.00 7200.00

3 Product Kg 0.00 1.00 1500.00 18000.00 4 Operational Losses Kg 0.00 0.20 600.00 7200.00

Total Kg 1.20 1.20

Distillation

Recovered Distilled Solvents

Filtration Drying & Packing

Tech Mesitylene Bis Bromide Molten Mass

Mixing Vessel Salicylaldehyde Lye Solution

Salt Formulation &

Drying

Product





3- 1-BENZOPYRAN-2-ONE RAW MATERIAL LIST

Note:-

1) No Use of Water in the process, no effluent generation from the process. 2) Recovered Distilled Solvents will be directly sold to the MPCB approved parties or

will be used for the utilities. 3) Solid Waste Residue 55 kg per month. Will be given to CHWTSDF Ranjangaon 4) No gaseous emission 5) Proposed manufacturing 2.0 T per month

BRIEF PROCESS

Mass of 60% solution of 1-Benzopyran-2-One in Methanol where taken into the distillation

vessel and the solvent will be distilled out at atmospheric pressure at 65 to 70oC. Distilled

recover solvent is collected in the clean drums. This solvent will be used for utilities or it will

be sold to the MPCB approved parties in the country. After solvent recovery vacuum applied

to distill out the product and product molten mass is collected in the collection vessel. After

cooling, the material is subjected for multi milling and sifter to make uniform crystals. The

uniform material is analyzed and packed in suitable packing as per the client requirement.

3) FLOW CHART


RM Per Month

RM Per Annum

1 60% Solution of 1-Benzopyran-2-One in Methanol

Kg 1.00 0.00 3636.00 43636.00

2 Product Kg 0.00 0.55 2000.00 36000.00 3 Distilled Solvent Kg 0.00 0.42 1527.00 18325.00 4 Residue Kg 0.00 0.01 55.00 655.00 5 Operational Losses Kg 0.00 0.02 110.00 1310.00

Total Kg 1.00 1.00

Distillation Vessel

60% solution of 1-Benzopyran-2-One in

Methanol

Cooling Milling, sifting

Product

Distilled Solvent





4- MILRINONE RAW MATERIAL LIST

Note:- 1) No Use of Water in the process, no effluent generation from the process.

2) No gasses emission. 3) Proposed manufacturing 0.05 T per month.

BRIEF PROCESS

Hydrated Crystalline Milrinone containing 2 to 3 % moisture subjected to the drying in the

tray dryer. Dry the material for 6 to 8 hours and unload into the drums. Check the moisture

content of the Crystalline Milrinone and it should be around 0.2 to 0.5 %. This material then

passed through multimill and sifter to make it uniform. After sifting the material is subjected

for the micronisation by using Jet mill to get 100 % particle size less that 25 micron. After

micronisation the material is analyzed as per the specifications and packed in the suitable

packing as per the customer requirement.

FLOW CHART


RM Per Month

RM Per Annum

1 Hydrated Crystalline Milrinone Kg 1.00 0.00 51.00 612.00


Total Kg 1.00 1.00

Crystalline Milrinone of 2 to 3

Sifter

Multi Milling

Dryer

Filtration

Jet Mill Micronized Product





5-GLIMEPIRIDE RAW MATERIAL LIST

Note:- 1) No Use of Water in the process, no Aq. effluent generation from the process.

2) No gaseous emission. 3) Proposed manufacturing 0.1 T per month.

BRIEF PROCESS

Lumpy coarse Glimepiride passed through the Pulvariser to get the small crystals. Then the small

crystalline material dried in the dryer at 65 to 70oC for 2 to 3 hours to remove the traces of the

moisture. Check the moisture content of the fine Crystalline product and it should be around 0.05

to 0.1 %. This material then passed through multimill and sifter to make it uniform. After sifting

the material is subjected for the micronisation by using Jet mill to get 100 % particle size less that

10 micron. After micronisation the material is analyzed as per the specifications and packed in

the suitable packing as per the customer requirement.

FLOW CHART


RM Per Month

RM Per Annum

1 Lumpy Glimepiride Kg 1.00 0.00 102.00 1224.00 2 Product Kg 0.00 0.98 100.00 1200.00 3 Operational Losses Kg 0.00 0.02 2.00 24.00 Total Kg 1.00 1.00

Lumpy Coarse Glimepiride

Sifter

Multi Milling

Dryer

Filtration

Jet Mill Micronized Product





6- TIOTROPIUM BROMIDE RAW MATERIAL LIST

Note:- 1) Use of Water in the process for mixing and extraction.

2) No gaseous emission. 3) Solid waste of Fruits and flowers 150 kg will sent to CHWTSDF 4) Proposed manufacturing 0.05 T per month.

BRIEF PROCESS

Flowers and the Fruits of the Dhotra (Thorn Apple) boiled in the vessel at 80 to 85oC in the

water and cooked for 9 to 10 hours. Then the mass is filtered through the nuetch filter to

remove the Fruit cover and the flower un-dissolved parts. After filtration the water is charged

into the vessel and distilled out the total water at 95 to 100oC. After water distillation the

molten mass is unloaded into the trays and kept into the dryer to get the moisture content

upto 0.5 to 1.0 %. Then the material is unloaded into the small drums, analyzed and packed

into the suitable packing as per the client requirement.

FLOW CHART

S. No. Raw Material UOM INPUT OUT PUT

RM Per Month

RM Per Annum

1 Dhotra flowers & Fruits ( Thorn Apple)

Kg 1.00 0.00 200.00 2400.00

2 Water Kg 30.00 30.00 6000.00 72000.00 2 Product Kg 0.00 0.25 50.00 600.00

3 Fruits Covers and Flower un-dissolved part

Kg 0.00 0.75 150.00 1800.00

Total Kg 31.00 31.00

1) Dhotra Flowers and Fruits 2) Water

Mixing Vessel

Nuetch Filter

Distillation vessel

Dryer Products





7-STRONTIUM RANELATE RAW MATERIAL LIST

Note:- 1) Use of Water in the process with solution. Water distilled out from the process

2) No gaseous emission 3) Solid waste Hyflow 250 kg per month, will sent to CHWTSDF 4) Proposed manufacturing 1.0 T per month.

BRIEF PROCESS

Ranelic Acid and the 25% solution of Strontium Hydroxide added into the vessel, heated to 75

to 80oC, stir for 4 to 6 hours. Filtered through the hyflow to remove the dust particles and

extraneous matter. Distilled out the water from the vessel under vacuum at 75 to 80oC.

Cooled the vessel mass to 25 to 35oC and unloaded the molten mass in the trays and loaded

into the air tray dryer and dried the mass at 80 to 85oC till the moisture content up to 0.2 %.

Unload the material, analyze and pack as per the client requirement.

FLOW CHART


RM Per Month

RM Per Annum

1 Ranelic Acid Kg 1.00 0.00 1000.00 12000.00

2 Strontium Hydroxide 25% solution in water Kg 2.50 0.00 2500.00 30000.00

3 Hyflow Kg 0.25 0.25 250.00 3000.00 4 Product Kg 0.00 1.00 1000.00 12000.00 5 Distilled Water Kg 0.00 0.25 2200.00 26400.00 6 Operational Losses Kg 0.00 0.25 250.00 3000.00 Total Kg 1.50 1.50

Ranelic Acid Strontium Hydroxide

Mixing & Distillation Vessel

Drying, Milling & sifting

Products





8-PHENYLEPHRINE RAW MATERIAL LIST

Note:-

1) Use of Water in the process for the fermentation and mixing. Water Filtrate is directly recycled as it contains the enzymes.

2) No gaseous emission. 3) Proposed manufacturing 2.0 T per month.

BRIEF PROCESS Phenylephrine dime taken in the vessel and water added to make the slurry of the material.

Add the enzymes in the mass and stirred for 12 hours at room temperature. Then filtered the

product. Product is dried in the dryer at 50 to 60oC. Filtrate will store in the clean containers

as it contains the enzymes and will be used for the next batch.

FLOW CHART


RM Per Month

RM Per Annum

1 Phenylephrine dimer Kg 1.00 0.00 2000.00 36000.00 2 Enzymes Kg 0.05 0.00 150.00 4000.00 Water Kg 8.00 0.00 0.00 0.00 Water Filtrate Kg 0.00 8.00 16000.00 192000.00


Total Kg 9.05 9.05

Phenylephrine Dimer Water Enzymes

Mixing Vessel

Filtration & Drying

Products





Annexure-2 Membership Certificate with CETP Kurkumbh

Documents

Pre-Feasibility Report Pyujjfjdlfkgjndghenvironmentclearance.nic.in/writereaddata/FormB/TOR/PFR/22_Jun... · Pre-Feasibility Report Pyujjfjdlfkgjndgh ... Strontium Ranelate, ... of