PRE – FEASIBILITY REPORTenvironmentclearance.nic.in/writereaddata/Online/TOR/27_Apr_2016... ·...

PRE – FEASIBILITY REPORT

PRE-FEASIBILITY STUDY REPORT

FOR

PROPOSED BULK DRUG MANUFACTURING UNIT

OF

TORRENT PHARMACEUTICALS LTD. (ONCOLOGY)

TO BE SET-UP AT

SURVEY NO. 102/p, 105/p, 106, 119, 120/p, 121, 73, 74, AHMEDABAD–MEHSANA HIGHWAY, VILL.: BILESHWARPURA,

TALUKA: KALOL, DISTRICT: GANDHINAGAR

APRIL 2016

M/s. Torrent Pharmaceuticals Ltd. Pre-Feasibility Report 1 | P a g e

INDEX

Sr. No. Description

1 Executive Summary

2 Introduction of the Project

Identification of the project and Project Proponent

Background and Need of the Project

Industry Overview and Prospects

Importance vs. Indigenous production

Export Possibility

Employment Generation

3 Project Description

Type of the project

Location of project

Site selection

Details of alternative site considered

Size or magnitude of project

Project description with process details

Storage facility for raw materials

Mode of transportation of raw material and products

Recycle/reuse options

Sources of water and electricity

Quantity of waste to be generated along with mode of disposal

Details of Boiler & D. G. Set

Stack & Vents

4 Site Analysis

Connectivity

Land use pattern

Land ownership

Topography

Existing infrastructure

Soil classification

Climatic data from secondary sources

Social infrastructure available

5 Planning Brief


Sr. No. Description

Planning concept

Population projection

Land use planning

Assessment of infrastructure demand (Physical & Social)

Amenities/ facilities

6 Proposed Infrastructure

Industrial area

Residential area

Green belt

Social infrastructure

Connectivity (traffic & transportation road/rail metro/water ways)

Drinking water management (source and supply of water)

Sewerage system

Industrial waste management

Power requirement and supply/source

7 Rehabilitation and Resettlement (R& R) Plan

8 Raw Materials

9 Summary of Production

10 Project Schedule

11 Cost Estimation

12 Market Potential & Prospects


1. EXECUTIVE SUMMARY

Name of the unit : M/s. Torrent Pharmaceuticals Ltd. (Oncology)

Location of the unit : Survey No. 102/p, 105/p, 106, 119, 120/p, 121, 73, 74,

Ahmedabad – Mehsana Highway, Village: Bileshwarpura, Taluka: Kalol, District: Gandhinagar – 382 011, GUJARAT.

Telephone Number : Tel. No. 02764233671 (Ext No. : 396)

Mo. No.: 98791 07959

Contact Information : Mr. Harish Guttikar Vice President – Projects Torrent Pharmaceutical limited Ahmedabad – Mehsana highway Village : Indrad Tal : Kadi Dist. : Mehsana – 382 721.

Category of industry : Category ‘A’

Project Activity No. 5 (f) - Bulk Drugs Products

Cost of the Project : 300 Crore

Land Area : 57,737 m2

Source of water : Sardar Sarovar Narmada Nigam Limited (Through sister

Unit of M/s Torrent Pharmaceuticals Limited, Indrad)


2. INTRODUCTION OF THE PROJECT

Torrent Pharmaceuticals Limited (TPL), the flagship company of the Torrent Group, is planning an ambitious expansion of its manufacturing capacities in the Oncology Segment.

The Bileshwarpura site will be developed as a Greenfield manufacturing facility for Oncology API and Oncology Formulations (OSD and Injectable). The facility is to be designed and constructed as per cGMP norms and would meet the regulatory requirements as per Schedule ‘M’, WHO, USFDA, MHRA, TGA and EU.

Targeted market would be major US, EU and India. API manufacturing shall be carried out in highest safety standards and equipment selected shall be designed with Isolator /Containment for OEL 5 category safety requirements. • Facilities shall be designed to cater US, EU, Brazil, ROW and domestic markets

for : – High Potent API

• Module 1 : 1 MT • Module 2 : 10 MT

– Intermediate Block ( 30 MT ) – Prostaglandin – Hydrogenation & Cryo block

• Initial line capacity will be catering market requirement up to 2025 • Provision for future expansion

(i) Identification of the project and Project Proponent

Bileshwarpura site will be developed as a Greenfield manufacturing facility for Oncology API and Oncology Formulations (OSD and Injectable). The facility is to be designed and constructed as per cGMP norms and would meet the regulatory requirements as per Schedule ‘M’, WHO, USFDA, MHRA, TGA and EU and for this a new project on a land Plot No. 102, 105, 106, 119, 120,121, Plot No. 73, 74 ,Village: Bileshwarpura, Taluka: Kalol, District: Gandhinagar, Gujarat is to be carried out. Promoters

Torrent Pharmaceuticals Ltd. Directors

Sr. No. Name Designation

1 Shri Sudhir Mehta Chairman Emeritus

2 Shri Samir Mehta Executive Chairman

3 Shri Markand Bhatt Director

4 Shri Shailesh Haribhakti Director


5 Shri Haigreve Khaitan Director

6 Shri Pradeep Bhargava Director

7 Shri Bhavna Doshi Director

8 Prof. Ashish Nanda Director

9 Dr. Chaitanya Dutt Director( Research & Development )

(ii) Background and Need of the Project:

Currently there is no facility available for manufacturing high potent oncology at

torrent. To cater new category (Oncology or high potent), new facility is required.

(iii) Industry Overview and Prospects:

Torrent complies with global regulatory norms including that of USFDA, WHO,

cGMP, MHRA and others and has received Health, Safety (ISO-18001-2007),

Environment System( ISO-14001-2004), Quality System Management (ISO 9001-

2008) and Energy Management System (ISO 50001-2011) certifications; adequately

reflecting Torrent’s commitment towards quality and safety. Attainment of such

standards have also opened the key to gaining footholds in regulated, lucrative

markets like the US and EU for Torrent Pharma. Torrent firmly believes that quality cannot be talked into a product, but has to exist

inherently. Its efforts towards realizing world-class manufacturing standards are

reflected in its being awarded the 5 Star rating and Sword of Honor Award by British

Safety Council.

(iv) Imported vs. Indigenous Production:

The products which will be manufactured in said unit will be of international

standards, which will have acceptability in the export as well as domestic market.

(v) Export Possibility

The final output of the API plant will be consumed in further process (Formulation

manufacturing) by torrent.


(vi) Employment Generation

Manpower requirement for operation of M/s. Torrent Pharmaceuticals Ltd.

(Oncology) is foresee as 100 nos. with a broad breakdown as follows:

Sr. No. Category Nos.

1 Senior Management 03

2 Middle Management 07

3 Engineer / Chemist / Officers 10

4 Foremen / Supervisors / Assistant 15

5 Operator / Attendant 25

6 Workmen / Labors 40

Total 100 Man Power

Status Total workers in all shifts

Shift 1 15

Shift 2 15

Shift 3 10

Total 40

3. PROJECT DESCRIPTION

(i) Type of Project :

High potent API

(ii) Location of project:

The proposed project is to be set-up at Survey No. 102/p, 105/p, 106, 119, 120/p,

121, 73, 74, Ahmedabad – Mehsana Highway, Village: Bileshwarpura, Taluka: Kalol,

District: Gandhinagar -382 011, Gujarat. The geographical information of the

proposed project is given as Annexure 1 of Form 1 for map of project location.

(iii) Site selection:

The site selected is located at Village: Bileshwarpura, Taluka: Kalol, District:

Gandhinagar of Gujarat state. Some factor which were considered while finalizing

the location are:


The project site is well connected by road & rail to major cities of Gujarat state.

Transport facilities for all over India are sound at project site.

Trained and qualified manpower is easily available in this area.

All raw material and machinery suppliers of this project are located in India as well

as in Abroad.

(iv) Details of alternative site considered:

No alternative site is examined for the proposed project.

(v) Size or magnitude of project:

The production capacity of the proposed project is given below:

Sr. No.

Name of Product Production Capacity

(Kg/Annum)

1 Lenalidomide (Amorphous) 50

2 Everolimus API 50

3 Sunitinib Maleate 50

4 Paclitaxel 50

5 Carboplatin 60

6 Pemetrexed disodium 60

7 Pazopanib 100

8 Cyclophosphamide monohydrate 180

9 Dasatinib 200

10 Erlotinib 200

11 Exemestene 250

12 Gefitinib 250

13 Methotraxate 250

14 Sorafenib tosylate 450

15 Enzalutamide 500

16 Nilotinib 550

17 Imatinib Mesylate 1,000

18 Bicultamide 1,000

19 Cytarabine 1,000

20 Tamoxifen Citrate 1,000

21 Ibrutinib 1,500


Sr. No.

Name of Product Production Capacity

(Kg/Annum)

22 Abiraterone Acetate 2,000

23 Gemcitabine 2,000

24 Hydroxyurea 4,000

25 Capecitabine 4,500

26 Ulipristal Acetate 5

27 Travoprost 5

28 Bimatoprost 5

29 Bromophenac 5

30 Latanoprost 5

31 Briminodine Tartrate 10

32 Olopatadine Hydrochloride 10

33 Misoprostol 20

34 Brinzolamide 100

TOTAL 21,415

(vi) Project description with process details:

Please see attached FORM 1 (Annexure no. - 6) for the process details.


(vii) Storage Facility

Sr. No.

Name of Raw Material Solid/ Liquid

Quantity Storage No. of Container /Month

Max. Storage Container,

Nos. Kg/Kg Kg/Month Type Size

1. Product: Lenalidomide (Amorphous) (50 Kg/Annum)

1 Methyl 2-(bromomethyl)-3-nitrobenzoate Solid 4.75 19.79 Container 50 kg 1 2

2 3-aminopiperidine-2,6-dione hydrochloride Solid 3.57 14.88 Container 50 kg 1 1

3 Dimethyl formamide Liquid 201.17 838.19 Drum 200 lit 5 13

4 Triethyl amine* Liquid 3.51 14.63 Carboy 50 kg 1 1

5 Water Liquid 267.43 1114.29 -- -- -- --

6 10 % Pd/C Solid 0.285 1.19 Container 10 kg 1 1

7 Ethyl acetate* Liquid 28.5 118.75 Tank 5 Kl 1 1

8 Methanol* Liquid 27.79 115.79 Tank 5 Kl 1 1

2. Product: Everolimus API (50 Kg/Annum)

1 Rapamycin (Sirolimus) Solid 3.32 13.83 Container 50 Kg 1 1

2 2,6-Lutidine Liquid 1.71 7.13 Carboy 25 Kg 1 1

3 2-(t-Butyldimethylsilyl)oxyethyl triflate Solid 2.24 9.33 Container 25 Kg 1 1

4 Toluene* Liquid 18.16 75.67 Tank 5 Kl 1 1

5 Ethyl Acetate* Liquid 4021.42 16755.92 Tank 5 Kl 4 10

6 Sodium bicarbonate Solid 1.45 6.04 Woven bag 50 kg 1 1

7 Sodium chloride Solid 1.08 4.50 Woven bag 50 Kg 1 1

8 Sodium sulphate Solid 1.08 4.50 Woven bag 50 Kg 1 1


Sr. No.





9 Silica gel Solid 10.88 45.33 Container 50 Kg 1 3

10 Hexanes* Liquid 1452.95 6053.96 Tank 5 kl 2 4

11 Purified water Liquid 38.29 159.54 -- -- -- --

12 Methanol* Liquid 7.23 30.13 Tank 5 kl 1 1

13 Hydrochloric acid Liquid 0.72 3.00 Carboy 35 Lit 1 1

3. Product: Sunitinib Maleate (50 Kg/Annum)

1 Ethyl-5-formyl-2,4-dimethyl-1H -pyrrole-3-carboxylate

Solid 1.2 5.00 Container 50 Kg 1 1

2 Potassium hydroxide* Solid 0.82 3.42 Container 50 Kg 1 1

3 Methanol* Liquid 129.58 539.92 Tank 5 kl 1 1

4 Water Liquid 13.52 56.33 -- -- -- --

5 Hydrochloric Acid Liquid 1.27 5.29 Carboy 35 Lit 1 1

6 Dichloromethane Liquid 13.16 54.83 Tank 5 kl 1 1

7 N,N -diethylethane-1,2-diamine Solid 0.97 4.04 Container 50 Kg 1 1

8 1-(3-dimethylaminopropyl- 3-ethylcarbodimide HCl


9 1-hydroxybenzotriazole Solid 1.17 4.88 Container 50 Kg 1 1

10 Triethylamine* Liquid 1.61 6.71 Carboy 50 Lit 1 1

11 Dimethylformamide Liquid 4.81 20.04 Drum 200 Lit 1 1

12 Toluene* Liquid 1.56 6.50 Tank 5 kl 1 1


Sr. No.





13 n-Hexane* Liquid 2.4 10.00 Tank 5 KL 1 1

14 Diethyl ether Liquid 0.8 3.33 Drum 200 Lit 1 1

15 Ethyl acetate* Liquid 0.64 2.67 Tank 5 KL 1 1

16 Sodium chloride Solid 0.32 1.33 Woven bag 50 kg 1 1

17 Sodium bicarbonate Solid 0.19 0.79 Woven bag 50 kg 1 1

18 Sodium hydroxide* Solid 0.08 0.33 Woven bag 50 kg 1 1

19 Pyrrolidine Liquid 0.01 0.04 Carboy 25 Lit 1 1

20 Ethanol* Liquid 12.54 52.25 Drum 200 Lit 1 1

21 L-Malic acid Solid 0.28 1.17 Container 25 Kg 1 1

22 Acetonitrile* Liquid 36.67 152.79 Drum 200 Lit 1 3

4. Product: Paclitaxel (50 Kg/Annum)

1 7-triethylsilylbaccatine III Solid 2.22 9.25 Container 50 Kg 1 1

2 N-benzoyl-O-(1-ethoxy- ethyl)-3-phenylisoserine



4 Di-2-pyridyl carbonate Solid 4.11 17.13 Container 50 Kg 1 1

5 4-dimethylaminopyridine Solid 0.78 3.25 Container 25 Kg 1 1


7 Sodium bicarbonate Solid 2 8.33 Woven bag 50 Kg 1 1

8 Water Liquid 24.5 102.08 -- -- -- --


Sr. No.






10 Sodium sulphate Solid 0.18 0.75 Woven bag 50 Kg 1 1

11 Methylene chloride* Liquid 96.35 401.46 Tank 5 Kl 1 1

12 Ether* Liquid 4.44 18.50 Drum 200 Lit 1 1

13 Hydrochloric Acid Liquid 0.00067 0.00 Carboy 35 Lit 1 1



16 Silica Gel Solid 22.2 92.50 Container 50 Kg 2 6

5. Product: Carboplatin (60 Kg/Annum)

1 Cis-diamminedichloroplatinum(II) Solid 0.98 4.90 Container 25 Kg 1 1

2 Silver sulphate Solid 0.951 4.76 Container 25 Kg 1 1

3 Water Liquid 109.58 547.90 -- -- -- --

4 Barium sulphate Solid 0.96 4.80 Container 25 Kg 1 1

5 Carboxylic acid Liquid 0.5 2.50 Carboy 50 Lit 1 1

6. Product: Pemetrexed disodium (60 Kg/Annum)

1 Dimethyl N-[4-(4-hydroxy-6-pivaloylamino pyrrolo[2,3-d]pyrimidin-3-ylethynyl)benzoyl]-L-glutamate



3 Dichloromethane Liquid 345.00 1725.00 Tank 5 Kl 1 1


Sr. No.





4 3% palladium on carbon Solid 2.21 11.05 Container 10 Kg 2 4

5 Hyflow powder Solid 0.83 4.15 Container 50 Kg 1 1

6 Sodium hydroxide* Solid 1.11 5.55 Woven bag 50 Kg 1 1



9 Acetone* Liquid 79.60 398.00 Tank 5 Kl 1 1

7. Product: Pazopanib (100 Kg/Annum)

1 2,3-dimethyl-2H-indazol-6-amine Solid 1.64 13.67 Container 50 Kg 1 1

2 2,4-dichloropyrimidine Solid 2.04 17.00 Container 50 Kg 1 1


4 Sodium bicarbonate Solid 2.3 19.17 Woven bag 50 Kg 1 2

5 Water Liquid 45.7 380.83 -- -- -- --


7 N-(2-chloropyrimidine-4-yl)-2,3-dimethyl-2H-indazol-6-amine


8 Cesium carbonate Solid 3.39 28.25 Container 50 Kg 1 2

9 Iodomethane Liquid 0.81 6.75 Carboy 52 Lit 1 1

10 Dimethylformamide Liquid 4.06 33.83 Drum 200 Lit 1 1

11 N-(2-chloropyrimidin-4yl)-N2,3-trimethyl-2H-indazol-6-amine



Sr. No.





12 5-amino-2-methylbenzene sulfonamide Solid 0.92 7.67 Container 50 Kg 1 1

13 Iso propyl alcohol* Liquid 14.25 118.75 Tank 5 Kl 1 1

14 4M HCl in IPA Liquid 0.02 0.17 Carboy 35 Lit 1 1

8. Product: Cyclophosphamide monohydrate (180 Kg/Annum)

1 N,N-bis(2-chloroethyl)amine hydrochloride Solid 0.90 13.50 Container 50 Kg 1 1

2 3-amino-1-propanol Liquid 0.38 5.76 Carboy 35 Lit 1 1

3 Phosphoryl chloride Liquid 0.77 11.55 Carboy 35 Lit 1 1


5 Dichoromethane Liquid 10.10 151.50 Carboy 35 Lit 5 13

6 Dilute hydrochloric acid Liquid 0.02 0.30 Carboy 35 Lit 1 1

7 Sodium carbonate Solid 0.05 0.75 Woven bag 50 Kg 1 1

8 Sodium Sulphate Solid 0.04 0.60 Woven bag 50 Kg 1 1

9 Activated Carbon Solid 0.04 0.60 Container 25 Kg 1 1

10 Water Liquid 1.95 29.25 -- -- -- --

11 Diethyl ether Liquid 5.05 75.75 Carboy 35 Lit 3 7

12 Hyflow Solid 0.27 4.05 Container 50 Kg 1 1

13 Ethanol* Liquid 2.00 30.00 Carboy 35 Lit 2 3

9. Product: Dasatinib (200 Kg/Annum)

1 Ethyl 2-amino-1,3-thiazole-5-carboxylate Solid 0.85 14.17 Container 50 Kg 1 1


Sr. No.





2 di-tert-butyl carbonate Liquid 1.2 20.00 Carboy 50 Lit 1 2

3 Catalytic 4-dimethylamino pyridine Solid 0.04 0.67 Container 50 Kg 1 1

4 Tetrahydrofuran* Liquid 33.51 558.50 Drum 200 Lit 3 9


6 Celite Solid 0.17 2.83 Container 50 Kg 1 1




10 MgSO4 Solid 1.02 17.00 Woven bag 50 Kg 1 1

11 Hexanes* Liquid 5.53 92.17 Tank 5 Kl 1 1


13 Sodium Hydroxide* Solid 2.29 38.17 Woven bag 50 Kg 1 3

14 Ether Liquid 6.55 109.17 Tank 5 Kl 1 1

15 Phosphorous Pentoxide* Solid 0.09 1.50 Container 50 Kg 1 1

16 Oxalyl Chloride Liquid 0.6 10.00 Carboy 50 Lit 1 1

17 Dimethyl formamide Liquid 0.01 0.17 Drum 200 Lit 1 1


19 2-chloro-6-methyl aniline Liquid 0.45 7.50 Carboy 50 Lit 1 1

20 Diisopropylethylamine Liquid 4.59 76.50 Drum 200 Lit 1 2


22 2,4-dichloro-2-methyl Pyrimidine Solid 0.57 9.50 Container 50 Kg 1 1


Sr. No.





23 Sodium tert butoxide Solid 0.88 14.67 Container 50 Kg 1 1


25 Hydroxyethylpiperazine Liquid 1.51 25.17 Carboy 50 Lit 1 2

26 N methyl Pyrrolidone Liquid 6.19 103.17 Drum 200 Lit 1 2

10. Product: Erlotinib (200 Kg/Annum)

1 4,5-bis(2-methoxyethoxy)-2-nitrobenzoate Solid 1.72 28.67 Container 50 Kg 1 2


3 Platinum(IV) Oxide Monohydrate Solid 0.02 0.33 Container 50 Kg 1 1

4 Hydrogen* Gas 0.2 3.33 Cylinder -- -- --

5 Formamide Liquid 21.84 364.00 Carboy 50 Lit 8 22


7 Acetonitrile* Liquid 30.15 502.50 Carboy 50 Lit 11 31

8 3-Ethynylaniline Liquid 1.38 23.00 Carboy 50 Lit 1 2


10 Dimethyl Formamide Liquid 0.15 2.50 Drum 200 Lit 1 1

11 POCl3 Liquid 1.23 20.50 Carboy 50 Lit 1 2


13 Water Liquid 3.63 60.50 -- -- -- --

14 Heptane Liquid 9.36 156.00 Drum 200 Lit 1 3



Sr. No.





11. Product: Exemestene (250 Kg/Annum)

1 Boldenone Solid 4.00 83.33 Container 50 Kg 2 5

2 Dimethylamine HCl Gas 15.40 320.83 Cylinder -- -- --

3 Isopentenol Liquid 160.00 3333.33 Drum 200 Lit 17 50

4 Parformaldehyde Solid 4.72 98.33 Container 50 Kg 2 6


6 water Liquid 86.88 1810.00 -- -- -- --

7 Hexane* Liquid 6.40 133.33 Tank 5 Kl 1 1


9 Jones reagent Solid 1.56 32.50 Container 50 Kg 1 2


11 Isopropyl alcohol* Liquid 2.00 41.67 Tank 5 Kl 1 1


12. Product: Gefitinib (250 Kg/Annum)

1 Acetoxy-4-(3'-Chloro-4'-fluoroanilino-7-methoxyquinazoline Hydrochloride


2 Ammonium Hydroxide Solid 0.30 6.19 Container 50 Kg 1 1

3 Water Liquid 0.69 14.38 -- -- -- --



Sr. No.





5 3-morphilinopropyl chloride Liquid 1.04 21.73 Carboy 50 Lit 1 2

6 potassium carbonate Solid 3.62 75.42 Woven bag 50 Kg 2 5




13. Product: Methotraxate (250 Kg/Annum)

1 2,4,5,6-tetraaminopyrimidine dihydrate sulfate


2 Barium Chloride Dihydrate Solid 1.85 38.54 Container 50 Kg 1 3

3 Disodium p-methylaminobenzoylglutamic acid


4 Water Liquid 66.00 1375.00 -- -- -- --

5 Dibromopropionaldehyde Liquid 1.66 34.58 Carboy 50 lit 1 2

6 Acetic acid* Liquid 1.66 34.58 Drum 200 Lit 1 1

7 Iodine* Solid 0.96 20.00 Container 50 Kg 1 2

8 Potassium Iodide Solid 1.92 40.00 Container 50 Kg 1 3


14. Product: Sorafenib tosylate (450 Kg/Annum)

1 (4-(4-Aminophenoxy)-N-methylpyridine-2-carboxamide)



Sr. No.





2 1-Chloro-4-isocyanato-2-(trifluoromethyl) benzene


3 Methylene Chloride* Liquid 2.54 95.25 Tank 5 Kl 1 1

4 p-Tolunesulfonic acid monohydrate Solid 0.41 15.38 Container 50 Kg 1 1


6 Activated charcoal Solid 0.08 3.00 Container 25 Kg 1 1

7 Hyflow Solid 0.16 6.00 Container 50 Kg 1 1

15. Product: Enzalutamide (500 Kg/Annum)

1 4-Amino-2-trifluoromethyl benzonitrile Solid 3.17 132.08 Container 50 Kg 3 8

2 Thiophosgene Liquid 1.42 59.17 Carboy 50 Lit 2 4

3 Water Liquid 1025.04 42710.00 -- -- -- --

4 Chloroform* Liquid 93.97 3915.42 Drum 200 Lit 20 59

5 Magnesium sulphate Solid 3.58 149.17 Woven bag 50 Kg 3 9

6 Methyl-2-fluoro-4-aminobenzamide Solid 1.90 79.17 Container 50 Kg 2 5

7 Acetone cyanohydrins* Liquid 5.94 247.50 Carboy 50 Lit 5 15



10 Silica Solid 19.01 792.08 Container 50 Kg 16 48




Sr. No.





16. Product: Nilotinib (550 Kg/Annum)

1 KSM-I Solid 0.89 40.79 Container 50 Kg 1 3

2 KSM-II Solid 0.70 32.08 Container 50 Kg 1 2

3 Diethyl cyanophosphonate Liquid 0.95 43.54 Carboy 35 Lit 2 4

4 N,N-Dimethylformamide Liquid 25.27 1158.21 Carboy 35 Lit 33 100

5 Triethyl amine* Liquid 0.59 27.04 Carboy 35 Lit 1 3


7 Sodium hydrogen carbonate Solid 0.89 40.79 Woven bag 50 Kg 1 3


9 Water Liquid 26.74 1225.58 -- -- -- --


11 Con.HCl Liquid 0.19 8.71 Carboy 35 Lit 1 1

12 Hyflow Solid 1.02 46.75 Woven bag 50 Kg 1 3

17. Product: Imatinib Mesylate (1000 Kg/Annum)

1 N-(2-methylphenyl)-4-(3-pyridyl)-2-pyrimidine-amine


2 4-(4-methyl-piperazinomethyl)-benzoyl chloride


3 Pyridine* Liquid 160.00 13333.33 Drum 200 Lit 67 200


Sr. No.





4 Water Liquid 100.03 8335.83 -- -- -- --

5 Dichloro Methane Liquid 38.00 3166.67 Tank 5 Kl 1 2



8 Methane Sulfonic Acid Liquid 0.02 1.67 Carboy 35 Lit 1 1

18. Product: Bicultamide (1000 Kg/Annum)

1 N-[4-cyano-3-(trifluoromethyl)phenyl]-2- methyloxirane-2-carboxamide


2 4-fluorobenzenethiol Solid 25.00 2083.33 Container 50 Kg 42 125

3 Tetrahydro furan* Liquid 50.00 4166.67 Drum 200 Lit 21 63

4 Sodium hydride Solid 1.00 83.33 Container 50 Kg 2 5

5 Metachloro perbenzoic acid Solid 2.00 166.67 Container 50 Kg 4 10


7 Water Liquid 10.00 833.33 -- -- -- --


19. Product: Cytarabine (1000 Kg/Annum)

1 1-(p-β-dimethylaminoethoxyphenyl)-1,2-diphenylbutan-1-ol


2 Phosphorus pentasulfide Solid 1.96 163.33 Container 50 Kg 3 10



Sr. No.






5 Chloroform* Liquid 17.70 1475.00 Drum 200 Lit 8 22

6 Sulfuric acid* Liquid 10.92 910.00 Carboy 50 Lit 19 55


8 Sodium sulfate Solid 0.89 74.17 Woven bag 50 Kg 2 5


10 Ammonical methanol Liquid 147.50 12291.67 Drum 200 Lit 62 185

11 Ether Liquid 8.85 737.50 Drum 200 Lit 4 11

20. Product: Tamoxifen Citrate (1000 Kg/Annum)

1 1-(p- β-dimethylaminoethoxyphenyl)-1,2-diphenylbutan-1-ol



3 10N-hydrochloric acid Liquid 1.48 123.33 Carboy 35 Lit 4 11

4 Methylene Chloride* Liquid 20.00 1666.67 Tank 5 Kl 1 1

5 Water Liquid 223.26 18605.00 -- -- -- --

6 Activated charcoal Solid 0.86 71.67 Woven bag 50 Kg 2 5

7 Hyflow Solid 2.58 215.00 Woven bag 50 Kg 5 13



10 Anhydrous Sodium Sulphate Solid 1.72 143.33 Woven bag 50 Kg 3 9


Sr. No.






12 Citric Acid Liquid 4.00 333.33 Woven bag 50 Kg 7 20


21. Product: Ibrutinib (1500 Kg/Annum)

1 3-iodo-1H-pyrazolo[3,4-d]pyimidin-4-amine Solid 6.83 853.75 Container 50 Kg 17 52

2 4-phenoxyphenylboronic acid Solid 6.15 768.75 Container 50 Kg 16 46

3 Palladium tetrakistriphenylphosphine Solid 1.80 225.00 Container 50 Kg 5 14


5 Ethylene glycol dimethyl ether Liquid 137.95 17243.75 Carboy 50 Lit 345 1035



8 Water Liquid 84.92 10615.00 -- -- -- --

9 (S)-1-Boc-3-Hydroxypiperidine Solid 8.26 1032.50 Container 50 Kg 21 62

10 Polymer bound triphenylphosphine Solid 13.64 1705.00 Container 50 Kg 35 103


12 Diisopropyl diazodicarboxylate Liquid 4.21 526.25 Carboy 50 Lit 11 32


14 Acryl chloride Liquid 0.50 62.50 Carboy 50 Lit 2 4

15 Dioxane* Liquid 11.70 1462.50 Drum 200 Lit 8 22

16 Triethyl amine* Liquid 1.36 170.00 Carboy 35 Lit 5 15


Sr. No.





17 Methylene dichloride Liquid 15.06 1882.50 Tank 5 Kl 1 2

18 Citric acid Solid 0.14 17.50 Container 50 Kg 1 2



22. Product: Abiraterone Acetate (2000 Kg/Annum)

1 Dehydroepiandrosterone-3-acetate (KSM ) Solid 1.92 320.00 Container 50 Kg 7 20

2 Trifluoromethane sulphonic anhydride Solid 0.91 151.67 Container 50 Kg 3 10

3 2,6-di-t-butyl-4-methylpyridine Liquid 0.78 130.00 Carboy 50 Lit 3 8


5 Hexane* Liquid 93.21 15535.00 Tank 5 Kl 4 10

6 Water Liquid 7.61 1268.33 -- -- -- --

7 Magnesium Sulphate Solid 0.21 35.00 Woven bag 50 Kg 1 3

8 Tetra hydro furan* Liquid 5.23 871.67 Drum 200 Lit 5 13

9 Diethyl(3-pyridyl)borane Solid 0.27 45.00 Container 50 Kg 1 3

10 Bis(triphenylphosphine)palladium (II) chloride






Sr. No.





23. Product: Gemcitabine (2000 Kg/Annum)

1 3,5-bis(t-butyldimethylailyloxy)-2-desoxy-2,2-difluroribose


2 Anhydrous Dichloromethane Liquid 1067.73 177955.00 Drum 200 Lit 890 2670

3 Tri ethyl amine* Liquid 10.85 1808.33 Carboy 50 Lit 37 109

4 Methyl sulfonyl chloride Liquid 7.02 1170.00 Carboy 50 Lit 24 71


6 Sodium Bicarbonate Solid 43.04 7173.33 Woven bag 50 Kg 144 431


8 Water Liquid 1337.10 222850.00 -- -- -- --

9 Sodium Chloride Solid 27.11 4518.33 Woven bag 50 Kg 91 271


11 bis(Trimethylsilyl)-N-Acetylcytosine Solid 38.22 6370.50 Container 50 Kg 128 382

12 Trifluromethane sulfonyl oxytrimethyl silane Liquid 31.24 5206.67 Carboy 50 Lit 105 312


14 Ammonia* Liquid 144.93 24155.00 Carboy 50 Lit 484 1450

15 Bio Rad Ion exchange resin Solid 79.63 13271.67 Container 50 Kg 266 797

16 Ammonium Hydroxide Solid 39.81 6635.00 Container 50 Kg 133 399

24. Product: Hydroxyurea (4000 Kg/Annum)

1 Hydroxylamine hydrochloride Solid 1.73 576.67 Container 50 Kg 12 35


Sr. No.





2 Sodium cyanate Solid 4.94 1646.67 Container 50 Kg 33 99

3 Water Liquid 916.08 305360.00 -- -- -- --

4 Amberlite Resin Solid 32.95 10983.33 Container 50 Kg 220 659

25. Product: Capecitabine (4500 Kg/Annum)

1 2',3'-di-O-acetyl-5'-fluorocytidine Solid 4.00 1500.00 Container 50 Kg 30 90



4 n-pentyl chloroformate Liquid 1914.00 717750.00 Carboy 50 Lit 14355 43065


6 Sodium Bicarbonate Solid 2.00 750.00 Woven bag 50 Kg 15 45

7 Water Liquid 49.06 18397.50 -- -- -- --

8 Sodium Sulfate Solid 0.30 112.50 Woven bag 50 Kg 3 7





26. Product: Ulipristal Acetate (5 Kg/Annum)

1 3,3,20,20-bis(ethylene-dioxy)-17α-hydroxy-

19-norpregna-5(10),9(11)-diene Solid 2.50 1.04 Container 25 kg 1 1


Sr. No.





2 Dichloromethane Liquid 127.90 53.29 Tank 5 KL 1 1


4 Hexachloroacetone Liquid 0.23 0.09 Container 25 kg 1 1

5 50% Hydrogen peroxide* Liquid 1.81 0.76 Drum 200 Lit 1 1

6 Sodium thiosulfate Solid 6.25 2.60 50 Kg 1 1

7 Sodium Sulfate Solid 4.00 1.67 Woven Bag 50 kg 1 1

8 Water Liquid 251.38 104.74 -- -- -- --

9 Magnesium turnings* Solid 0.92 0.38 Container 25 kg 1 1

10 1,2-Dibromoethane Liquid 0.01 0.01 Drum 200 Lit 1 1


12 4-Bromo-N,N-dimethylaniline Solid 6.93 2.89 Container 25 Kg 1 1

13 Copper(I) chloride Solid 0.16 0.07 Container 25 Kg 1 1

14 Ammonium Chloride Solid 6.72 2.80 Container 25 Kg 1 1

15 Ethyl acetate* Liquid 8.40 3.50 Tank 5KL 1 1

16 Potassium Hydrogen sulfate Solid 1.07 0.45 Container 25 kg 1 1

17 Potassium Hydroxide* Solid 0.17 0.07 Container 50 Kg 1 1


19 Acetic anhydride* Liquid 2.84 1.18 Drum 200 Lit 1 1

20 70% perchloric acid* Liquid 0.42 0.18 Container 25 Kg 1 1

21 Sodium Acetate Solid 0.40 0.17 Bag 50 kg 1 1

22 Isopropanol Liquid 6.00 2.50 Tank 5 KL 1 1


Sr. No.






27. Product: Travoprost (5 Kg/Annum)

1

(3aR,4S,5R,6aS)-4-(hydroxymethyl)-2-oxohexahydro -2H-cyclopenta[b]furan-5-yl -O.O'-biphenyl phosphate


2 Dimethyl {2-oxo-3-[3-(trifluoromethyl) phenoxy]propyl}phosphonate


3 Dimethy ether Liquid 2.80 1.17 Drum 200 Lit 1 1

4 Cesium chloride heptahydrate Solid 9.50 3.96 Container 50 Kg 1 1

5 Methanol* Liquid 15.60 6.50 Tank 5 KL 1 1

6 Sodium borohydride Solid 1.20 0.50 Container 10 Kg 1 1

7 Potassium carbonate Solid 1.20 0.50 Container 50 Kg 1 1

8 Diisobutyl alluminium hydride Solid 0.90 0.38 Container 25 Kg 1 1

9 4-(carboxybutyl)-triphenyl phosphonium bromide


10 Sodium methyl sulfinyl methylide Solid 0.35 0.15 Container 25 Kg 1 1

11 Dimethyl sulphoxide Liquid 2.80 1.17 Drum 200 Lit 1 1

12 1,8-Diazabicyclo[5.4.0]undec-7-ene Liquid 1.40 0.58 Carboy 50 Lit 1 1

13 Acetone* Liquid 6.80 2.83 Tank 5 KL 1 1

14 1-propyl iodide Liquid 1.60 0.67 Carboy 50 Lit 1 1

15 Water Liquid 5.60 2.33 -- -- -- --


Sr. No.





28. Product: Bimatoprost (5 Kg/Annum)

1

Cyclopentane heptenoic acid, 5- cis-2-(3-

αhydroxy-5-phenyl-1-trans-pentenyl)-3, 5

dihydroxy, [1α, 2β, 3α, 5α] Solid 2.64 1.10 Container 25 kg 1 1


3 DBU (1,8 -Diazabicyclo[5.4.0]undec-7-ene) Liquid 0.004 0.002 Container 25 kg 1 1

4 Methyl Iodide Solid 0.002 0.001 Container 25 Kg 1 1

5 Ethyl Acetate* Liquid 10.33 4.30 Tank 5 KL 1 1


7 Dimethylamine* Solid 0.88 0.37 Bag 50 Kg 1 1


29. Product: Bromophenac (5 Kg/Annum)

1 2,3-dihydro-1H-indole Solid 5.00 2.08 Container 25 kg 1 1

2 4-bromobenzonitrile Solid 3.00 1.25 Container 50 kg 1 1

3 Toluene* Liquid 11.50 4.79 Tank 5 KL 1 1

4 BCl3, (Boron trichloride)* Solid 2.80 1.17 Container 25 kg 1 1

5 AlCl3 (Aluminium chloride) Solid 5.50 2.29 Container 25 kg 1 1

6 MnO2 (Manganese Dioxide) Solid 3.00 1.25 Bag 50 Kg 1 1

7 Methylene chloride* Liquid 19.00 7.92 Tank 5 KL 1 1

8 N chlorosuccinimide Solid 1.20 0.50 Container 25 kg 1 1


Sr. No.





9 N bromosuccinimide Solid 0.90 0.38 Container 25 kg 1 1

10 2-Methoxy ethanol* Liquid 6.80 2.83 Container 50 Lit 1 1

11 H3PO4 (Phosphoric acid)* Liquid 2.50 1.04 Container 35 Lit 1 1

12 DME (Dimethyl ether) Liquid 12.00 5.00 Drum 200 Lit 1 1

13 Diisopryl ether Liquid 13.40 5.58 Drum 200 Lit 1 1

14 Water Liquid 10.00 4.17 -- -- -- --

15 Aq. KOH (Potassium hydroxide)* Liquid 12.00 5.00 Drum 200 Lit 1 1

30. Product: Latanoprost (5 Kg/Annum)

1

3,3a, 4,5,6,6a-hexahydro-2-oxo-4-

hydroxymethyl-5-(4'-phenyl benzoyloxy)-

2H-cyclopenta [b]furan Solid 27.00 11.25 Container 50 Kg 1 1


3 Dicyclohexylcarbodiimide Solid 40.50 16.88 Container 50 Kg 1 1

4 Phsophoric acid* Liquid 2.20 0.92 Carboy 35 Lit 1 1

5 Dimethyl sufoxide Liquid 16.00 6.67 Drum 200 Lit 1 1

6 Triphenyl-(4-phenyl-3-

oxobutyl)phosphonium iodide Solid 38.40 16.00 Container 50 Kg 1 1

7 Potassium hydroxide* Solid 5.00 2.08 Container 50 Kg 1 1

8 Methylene chloride* Liquid 285.00 118.75 Tank 5 Kl 1 1

9 Water Liquid 1430.00 595.83 -- -- -- --


Sr. No.





10 Con. Hydrochloric acid Liquid 43.60 18.17 Carboy 35 Lit 1 2

11 Sodium chloride Solid 75.00 31.25 Bag 50 Kg 1 2

12 Sodium sulphate Solid 52.00 21.67 Bag 50 Kg 1 2


14 Sodium borohydride Solid 2.38 0.99 Container 10 Kg 1 1

15 Chloroform* Liquid 310.00 129.17 Carboy 50 Kg 3 8


17 Diisopropyl ether Liquid 1100.00 458.33 Drum 200 Lit 3 7

18 Ab. Ethanol* Liquid 220.00 91.67 Drum 200 Lit 1 2

19 10% Pd/C Solid 1.40 0.58 Container 10 Kg 1 1

20 Sodium nitrite Solid 0.72 0.30 Container 10 Kg 1 1

21 Sodium bicarboante Solid 0.50 0.21 Bag 50 kg 1 1

22 Diisobutylaluminum hydride Liquid 9.10 3.79 Carboy 35 Lit 1 1

23 Sodium hydrogen sulphate Solid 34.00 14.17 Container 50 Kg 1 1


25 Potassium carbonate Solid 2.10 0.88 Container 50 Kg 1 1

26 Hexane* Liquid 12.00 5.00 Tank 5 KL 1 1

27 4-carboxybutyl triphenyl phosphonium

bromide Solid 5.32 2.22 Container 50 Kg 1 1


29 Potassium butoxide Solid 4.49 1.87 Container 25 Kg 1 1


Sr. No.






31 Dimethyl fomamide Liquid 6.00 2.50 Drum 200 Lit 1 1

32 Isopropyl iodide Liquid 2.00 0.83 Carboy 35 Lit 1 1

33 Isopropanol Liquid 17.30 7.21 Drum 200 Lit 1 1

34 Activated carbon Solid 0.11 0.05 Container 10 Kg 1 1

35 Celite Solid 10.00 4.17 Container 50 Kg 1 1

31. Product: Briminodine Tartrate (10 Kg/Annum)

1 6-Amino-5-bromoquinoxaline

hydrobromide Solid 4.00 3.33 Container 25 kg 1 1

2 Thiophosgene Liquid 1.20 1.00 Carboy 25 Lit 1 1

3 Water Liquid 60.00 50.00 -- -- -- --

4 Cyclohexane* Liquid 40.00 33.33 Drum 200 Lit 1 1

5 Ethylene diamine* Liquid 6.00 5.00 Carboy 50 Lit 1 1



8 Hydrogen sulphide* Solid 1.00 0.83 Container 25 kg 1 1

32. Product: Olopatadine Hydrochloride (10 Kg/Annum)

1 (3-dimethylaminopropyl)-triphenyl

phosphonium bromide hydrobromide Solid 29.42 24.52 Container 50 Kg 1 2



Sr. No.





3 1.6N-n-butyl lithium hexane solution Liquid 49.00 40.83 Cylinder 50 Kg 1 3

4 11-oxo-6,11-dihydrodibenz [b,e]oxepin-2-

acetic acid Solid 3.02 2.52 Container 10 Kg 1 1

5 Water Liquid 770.00 641.67 -- -- -- --



8 Sodium hydroxide* Solid 62.00 51.67 Bag 50 kg 2 4


10 Ethyl acetate* Liquid 2022.00 1685.00 Tank 5 KL 1 2

11 Sodium bicarboante Solid 164.10 136.75 Bag 50 kg 3 9

12 Sodium chloride Solid 92.00 76.67 Bag 50 kg 2 5

13 Sodium sulphate Solid 6.13 5.11 Bag 50 kg 1 1


15 Hexanes* Liquid 1840.00 1533.33 Tank 5 KL 1 1

16 Triethyl amine* Liquid 184.00 153.33 Carboy 50 Kg 4 10

17 p-toluene sulfonic acid Solid 24.26 20.22 Container 25 Kg 1 2

18 Isopropyl alcohol (2-Propanol)* Liquid 290.00 241.67 Drum 200 lit 2 4


33. Product: Misoprostol (20 Kg/Annum)

1 (±)4-methyloct-1-yn-4-ol Solid 2.30 3.83 Container 50 Kg 1 1


Sr. No.





2 Triethyl silyl chloride Solid 3.10 5.17 Container 10 Kg 1 2

3 Dimethi Formamide Liquid 5.00 8.33 Drum 200 Lit 1 1

4 Triiethyl amine* Liquid 0.89 1.48 Carboy 50 Lit 1 1

5 20 % Diisobutyl aluminium hydride in

Toluene Liquid 10.00 16.67 Cylinder 50 Lit 1 1

6 Hexane* Liquid 15.60 26.00 Tank 5 KL 1 1



9 Iodine* Solid 0.20 0.33 Container 50 Kg 1 1

10 Copper 1-pentyne Liquid 0.40 0.67 Carboy 25 Lit 1 1

11 n- Butyl Lithium Liquid 2.30 3.83 Cylinder 50 Lit 1 1

12 Bis hexamethyl phosphourous triamide Liquid 1.10 1.83 Carboy 35 Lit 1 1

13 Dihydropyran Liquid 1.08 1.80 Carboy 35 Lit 1 1

14 Para tolunene sulphonic acid Solid 1.20 2.00 Container 50 Kg 1 1

15 Acetic acid* Liquid 1.50 2.50 Carboy 35 Lit 1 1

16 Water Liquid 15.00 25.00 -- -- -- --

34. Product: Brinzolamide (100 Kg/Annum)

1 Thiourea* Solid 1.96 16.33 Bag 50 kg 1 1

2 Benzyl chloride* Liquid 3.11 25.88 Container 50 ltr 1 2

3 Ethanol* Liquid 20.51 170.93 Drum 200 ltr 1 3


Sr. No.





4 3-acetyl-2,5-dichlorothiophene Semi solid

4.56 37.98 Carboy 50 ltr 1 3

5 5.4 M aqueous sodium hydroxide* Liquid 15.19 126.61 Carboy 50 ltr 3 8

6 5.25% sodium hypochlorite Liquid 4.56 37.98 Tank 5 KL 1 1

7 2-propanol * Liquid 9.12 76.00 Tank 5 KL 1 1

8 Water Liquid 173.29 1444.08 -- --

9 3-acetyl-5-chloro-2-(benzylthio) thiophene Liquid 6.38 53.17 Carboy 50 ltr 2 4

10 Ethyl acetate Liquid 277.45 2312.08 Tank 5 KL 1 2

11 Sodium tungstate dihydrate Solid 3.70 30.84 Container 50 kg 1 2

12 30% hydrogen peroxide* Liquid 51.04 425.33 Carboy 50 ltr 9 26

13 Sodium bisulfite Solid 63.80 531.67 Woven Bag 50 kg 11 32

14 Aqueous sodium bicarbonate Solid 63.80 531.67 Woven Bag 50 kg 11 32

15 Saturated aqueous sodium chloride Solid 63.80 531.67 Woven Bag 50 kg 11 32

16 t-butyl methyl ether Liquid 80.44 670.33 Drum 200 ltr 4 10

17 Sodium sulfate Solid 6.38 53.17 Bag 50 kg 2 4

18 3-acetyl-5-chloro-2-thiophenesulfonamide Liquid 3.81 31.75 Carboy 50 ltr 1 2

19 Sodium bicarbonate Solid 1.22 10.18 Woven Bag 50 kg 1 1

20 Magnesium sulphate Solid 2.44 20.36 Woven Bag 50 kg 1 2

21 Methylene chloride* Liquid 12.22 101.81 Tank 5 KL 1 1

22 Acetonitrile* Liquid 16.64 138.64 Drum 200 ltr 1 2

23 Trimethylorthoacetate Liquid 2620.23 21835.23 Carboy 50 ltr 437 1310


Sr. No.





24 Tetrahydrofuran* Liquid 9.15 76.25 Drum 200 ltr 1 2

25 Triethylamine* Liquid 1567.98 13066.48 Carboy 50 ltr 261 784

26 70% aqueous ethylamine* Liquid 12477.27 103977.25 Drum 200 ltr 520 1560

27 Hydrochloric acid Liquid 12477.27 103977.25 Carboy 35 ltr 2971 8912

28 1 M aqueous hydrochloric acid Liquid 831.82 6931.82 Carboy 35 ltr 198 594

29 p-toluenesulfonyl chloride Liquid 1.95 16.29 Carboy 50 ltr 1 1

30 Sodium bicarbonate Solid 4.16 34.66 Woven Bag 50 kg 1 3

Note:

* Hazardous Chemicals as per the Manufacture, Storage & Import of Hazardous Chemicals Rules, 1989, 2000 and subsequent amendments.


(viii) Mode of transportation of raw material and products:

The raw material will be received in bags/drums/carboys/barrels/tankers. All these

raw materials will be stored in appropriate storage area.

(ix) Recycle / reuse options:

Industry will explore the possibility of reuse/recycle of water & solvents.

(x) Sources of water and electricity

(1) Water Source Sardar Sarovar Narmada Nigam Ltd. (Through sister Unit of M/s Torrent Pharmaceuticals Limited, Indrad)

(2) Electricity Source Uttar Gujarat Vij Company Limited

(3) Electricity Requirement 2500 KVA

(4) D.G. Set

2000 KVA x 02 nos. 500 KVA x 02 nos.

No. of D.G. Sets Capacity

(KVA) Remarks

D.G. Set No. 1 2000 --

D.G. Set No. 2 2000

D.G. Set No. 3 500 Standby in case of failure of UGVCL (G.E.B) power supply D.G. Set No. 4 500


(xi) Quantity of waste to be generated along with its mode of disposal:

Sr. No.

Type of Waste Cat. Quantity per Year

Mode of Disposal

1. Used Oil 5.1 1 KL Will be reused within premises OR sold to registered recyclers.

2. a. Incinerable Waste containing activated charcoal etc.

28.1 20 MT Will be sent to approve CHWIF site for incineration or for co-processing.

b. Waste containing Sodium Sulphate/ other salts, Hyflow and Silica Gel

5 MT Will be disposed at secured landfill site.

3. Spent Organic Solvent/ Mother Liquor

28.5 20000 MT Will be sold to an authorized solvent recovery units.

4. Discarded Barrels/ Containers/ Bags/ Liners

33.3 50 MT Will be sold to MoEF authorized recyclers.

5. Resins from DM Plant 34.2 1 MT Will be sold to registered re-processors.

6. ETP Sludge (100% basis) 34.3 50 MT Will be disposed at secured landfill site.

7. Process Waste 28.1 20 MT Will be sent to approve CHWIF site for incineration or for co-processing.

8. Carbon Waste (from ETP) 28.2 20 MT Will be disposed at secured landfill site.

9. Solid waste from MEE 34.3 100 MT Will be disposed at secured landfill site/ CHWIF site.

10. Oil Contaminant Waste 5.2 500 Nos. Will be sent to approve CHWIF site for incineration or for co-processing.

11. Spent Carbon (from boiler) 28.2 50 MT Will be sent to approve CHWIF site for incineration or for co-processing.

12. Spent Catalyst 28.2 500 kg Will be sent to approve CHWIF site for incineration or for co-processing.

13. Distillation Residue 36.4 100 MT Will be sent to approve CHWIF site for incineration or for co-processing.


(xii) Details of Boiler & D. G. Set:

Sr. No. Description Type of Fuel Fuel Consumption

Boiler

1 Steam Boiler - 1

(5 TPH capacity) Natural Gas

OR

Furnace Oil

2,000 scm/day

OR

1800 Liter/day 2 Steam Boiler - 2

(5 TPH capacity – Stand By)

D. G. Set

1 D. G. Set - 1 (2,000 kVA)

HSD 800 Liter/hour 2 D. G. Set - 2 (2,000 kVA)

3 D. G. Set - 3* (500 kVA)

4 D. G. Set - 4* (500 kVA)

* Standby in case of power failure

(xiii) Stack & Vents

Flue Gas Stacks

Sr. No.

Stack attached to Height of Stack from Ground

Level (m)

Diameter of Stack

(m)

Air Pollution Control Unit

1 Steam Boiler - 1 (5 TPH)

30 0.60 Bag Filter Steam Boiler - 2 (5 TPH)

2 D. G. Set - 1 (2,000 kVA) 12 0.10

Not applicable* 3 D. G. Set - 2 (2,000 kVA) 12 0.10

4 D. G. Set - 3 (500 kVA) 12 0.10

5 D. G. Set - 4 (500 kVA) 12 0.10

*It would not be out of place to mention that Diesel is comparatively clean fuel.


Process Gas Emission

Sr. No.

Vent attached to Stack height from G.L.,

meter

Stack dia. at top, meter

Expected Pollutant APCM

1 Process Vent –1

attached to condenser

of reactors.

23 0.1 Process

solvent

vapors

Water Scrubber

2 Process Vent –2


of reactors

23 0.1 HCl Water Scrubber followed by a conventional

Caustic Scrubber

3 Process Vent –3


of reactors.

17 0.1 Process

solvent

vapors

Water Scrubber

4 Process Vent –4


of reactors.

17 0.1 HCl Water Scrubber followed by a conventional

Caustic Scrubber


4. SITE ANALYSIS

Connectivity:

Existing roads and rails will be used for the proposed project. No new roads or rails

are envisaged outside the boundary of the plant.

Land use Pattern:

The proposed plant will be set up on plain open land. The said land is fall in the

Kalol Taluka of Gandhinagar District. The total land in the district is 2,166 sq. km. out

of which 187.4 sq. km. are under cultivation. The total land of the Kalol taluka is

482.23 sq. km. The land classification according to the different uses for the rural

areas of the district is given below on the basis of information collected for the

Village Directory.

Land Classification of Rural Area

Sr. No. Classification Area (in Hectares)

1 Forest 18.8

2 Irrigated 1,115.5

3 Un-Irrigated 520.0

4 Cultivated Waste Land

(Including Gaucher & Groves)

187.4

5 Area not available for cultivation 142.0

Total 1,983.7

Source: Village Directory, 2001 Land Ownership:

Out of the total land, survey nos. 73 & 74 is owned by the company where as

survey nos. 102, 105,106,119, 120 & 121 are on lease.

Topography:

The project is to be developed on plain land fall in Gandhinagar District.

Gandhinagar district forms a part of Gujarat plain and is sub-divided into two

submicro regions namely Sabarmati plain and Khari plain on the basis of

physiography, climate, geology, soils and natural vegetation.


Existing Infrastructure:- Land: The plot area of the proposed plant is 57,737 Sq. Meter. Utilities:

Power requirement of the proposed plant will be met by Uttar Gujarat Vij

Company Limited (UGVCL).

The source of water for entire plant shall be met by Sardar Sarovar Narmada

Nigam Limited (Through sister Unit of M/s Torrent Pharmaceuticals Limited,

Indrad).

Natural Gas or Furnace Oil will be used as fuel in boiler.

Transport:-

Rail: The nearest broad gauge railway station is Pansar & Kalol.

Road: The project site is 20 meter away from the State Highway No. 41 and well

connected by road.

Air: The nearest domestic/International airport available is Ahmedabad, approx. 32

km.

Communication: All modern communication facilities i.e. Telephone, Mobile Phones,

Internet, walky-talky etc. will be provided at the proposed plant site.

Soil Classification:

The characteristic of soil of this district is sandy to sandy loam and of goradu type. It retains moisture to some extent. Climate data from secondary sources: Temperature:

Maximum: 44.7 OC

Minimum: 7.3 OC

Rainfall

Average (Annual): 625.44 mm

Maximum rainfall: 484 mm/month

Minimum rainfall: 12 mm/month

Relative Humidity

Maximum: 88 %

Minimum: 18 %


Wind Speed: Maximum: 61 km/hr

Minimum: 0 km/hr

Social Infrastructure Available

Total No. of Villages in Gandhinagar District: 291 Villages

Total No. of Towns in Gandhinagar District: 10 Towns

Total No. of Villages in Kalol Taluka: 69 Villages

Sr. No. Type of Amenities Available No. of Villages with basic amenities

1 Education 69 Villages

2 Medical 56 Villages

3 Drinking Water 69 Villages

4 Post Office 49 Villages

5 Telephone 69 Villages

6 Transportation & Communication 69 Villages

7 Banks 23 Villages

8 Power Supply 69 Villages

9 Approach to Pucca Road 66 Villages

Source: Gandhinagar District Census Handbook, 2001

5. PLANNING BRIEF :

(i) Planning Concept:

The proposed unit is manufacturing bulk drugs where all types of facilities are

available. Transportation services are nearest to the plant.

(ii) Population Projection:

Population of Kalol Taluka, including Urban & Rural area, is about 3,10,081.

(iii) Land use planning:

As per Annexure 2 of Form 1 (iv) Assessment of Infrastructure Demand:

There is no competitive demand from other industries at present.

(v) Amenities / Facilities:

All type of facilities are available like water, hospitals, schools, transportation etc.


6. PROPOSED INFRASTRUCTURE:

(i) Industrial area: The total plot area is approximately 57,737 Sq. Meter. (ii) Residential area : Not applicable (iii) Green belt : as shown in Annexure – 3 of Form 1 (iv) Social infrastructure : Not Applicable (v) Connectivity: No new road, rail, air/waterborne or other transport

infrastructure including new or altered routes and stations are envisaged for

the proposed plant.

(vi) Drinking water management: Source of water supply is Sardar Sarovar

Narmada Nigam Ltd. (through sister unit of M/s. Torrent Pharmaceuticals Ltd.)

(vii) Sewerage system: Sewerage will be treated into the effluent treatment plant.

(viii) Industrial waste management :

Water pollution: Industrial waste water generated due to various activities

will be treated in the proposed Effluent Treatment Plant

having primary, secondary and tertiary treatment

facilities as well as in Multiple Effect Evaporator. The

treated water from the ETP will be used in toilet flushing

and for gardening purpose.

Air pollution: Bag filter will be provided to stack attached to Boilers and

scrubbers will be provided to stack attached to process

reactors.

(ix) Power requirement and supply/ source:

The power requirement of the proposed plant will be 2500 KVA. It will be

obtained from UGVCL as well as D.G. Sets.

7. REHABILITATION AND RESETTLEMENT (R & R) PLAN :

Not applicable

8. RAW MATERIALS :

Please see attached FORM 1 (Annexure no. 5) for the raw material details.


9. SUMMARY OF PRODUCTION

Please see attached FORM 1 (Annexure no.4) for the product details.

10. PROJECT SCHEDULE:

It has been estimated that completion of the different phases of the project will take

approximately 02 years.

11. SUMMARY OF COST OF PROJECT

Sr. No. Description Cost (Rs.)

1 Land & Land Development 10 Crore

2 Factory Building & Office 30 Crore

3 Plant & Machineries 250 Crore

4 Pre operative Exps. 10 Crore

Total Project Cost 300 Crore

12. MARKET POTENTIAL & PROSPECTS

Turnover

Turnover from the proposed project is expected to be as per detail bellow.

YEAR EXPECTED TURNOVER (Rs.)

2019 – 2020 50 Crore

2020 – 2021 100 Crore

2021 – 2022 200 Crore

2022 – 2023 400 Crore

Financial Assistance

The total outlay for the project is estimated as Rs. 300 Crore.

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