Pre-Feasibility Report

of

Concord Biotech Ltd (Unit III) Survey No. 84, 94/A, 94/B, 119, 120, 126, 135, 136 of Village: Ranasar and Survey No.666, 667, 668 of Village: Malawada, Dist.: Kheda, Gujarat

Project Activity: 5(f), Category: A

Applicant Concord Biotech Ltd. Plot no. 1482-1486, Trasad Road, Taluka: Dholka, Dist. Ahmedabad, Gujarat.

1. Introduction

Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. M/s. Concord Biotech Limited (Unit-III) is an upcoming unit located at Survey No. 84, 94/A, 94/B, 119, 120, 126, 135, 136 of Village: Ranasar and Survey No. 666, 667, 668 of Village: Malawada, Dist.: Kheda, Gujarat. 2. Cost of Project:

Costs of project will be 150 Crores. Out of which 10 Crores will be used for Environment Management System as capital cost and 2 Crores for annual operating cost. 3. Production Capacity Production capacity is prescribe below:

List of Products Capacity, Capacity, Sr.No Products KgPM MTPA (A) Antibiotic 1 Vancomycin 835 10 2 Teicoplanin 170 2 3 Daptomycin 170 2 4 Fidaxomycin 85 1 5 Mupirocin & salts 1250 15 6 Fosfomycin 420 5 7 Dalbavancin 45 0.5 8 Telavancin 45 0.5 9 Capreomycin 10 0.1 10 Tobramycin sulphate 210 2.5 11 Oritavancin 45 0.5 12 Polymyxin Salts 420 5 13 Bacitracin 420 5 14 Fusidic Acid 6670 80 15 Colistin Salts 85 1 Sub Total 10880 130.1 (B) Antibiotic, Antiparasitic

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16 Milbemycin oxime 1670 20 Sub Total 1670 20 (C) Antifungal 17 Caspofungin 20 0.2 18 Micafungin 80 0.93 19 Anidulafungin 55 0.65 Sub Total 155 1.78 (D) Immunosuppressant 20 Tacrolimus 85 1 21 Cyclosporine 4170 50 22 Rapamycin 45 0.5 23 Mycophenolate Mofetill & Mycophenolate sodium 12500 150 24 Zotarolimus 10 0.1 25 Fingolimod 5 0.05 Sub Total 16815 201.65 (E) Oncology 26 Everolimus 85 1 27 Pimecrolimus 250 3 28 Ixabepilone 10 0.1 29 Romidepsin 10 0.1 30 Temsirolimus 4.5 0.05 31 Ridaforolimus 4.5 0.05 32 Doxorubicin 75 0.85 33 Epirubicin 20 0.2 34 Idarubicin 10 0.1 35 Bleomycin 10 0.1 36 Geldanamycin 10 0.1 37 Mitomycin 10 0.1 38 Dactinomycin 10 0.1 39 Trabectedin 10 0.1 Sub Total 519 5.95 (F) Statins 40 Pravastatin 45 0.5 Sub Total 45 0.5 (G) R & D Products 170 2 Total (A+B+C+D+E+F+G) 30254 361.98

List of Raw Materials

Sr Name of product Name of Raw Material Quantity No. (MTPM) (A) Antibiotic 1. Vancomycin Dextrose 0.07 Dextrine 4.20 Potato Protein 1.01

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Sr Name of product Name of Raw Material Quantity No. (MTPM)

CaCO3 0.06 Soya flour 1.01 Salt minerals 0.07 Ethanol 0.11 IPA 0.11 2. Teicoplanin Dextrose 2.48 Dextrine 8.10 Cotton seed flour 3.79

CaCO3 0.30 Soya flour 3.79 Salt minerals 0.60 Ethanol 0.24 3. Daptomycin Dextrose 0.61 Dextrine 4.17

CaCO3 0.05 Soya flour 0.10 Salt minerals 0.05 IPA 0.14 4. Fidaxomycin Dextrose 0.20 Tapioca Starch 0.60 Soybean flour 0.22 Veg Peptone 0.12 Yeast Extract 0.17 Minerals 0.06 Ethyl acetate 0.03 Isopropyl alcohol 0.02 Methanol 0.09 5. Mupirocin & salts Wheat Gluten meal 1.01 Corn Syrup powder 0.95 Salt & minerals 0.42 Antifoam (Silicon) 0.06 Ethyl acetate 0.02 Sulphuric acid 0.14 Sodium bicarbonate 0.60 n-heptane 0.06 6. Fosfomycin Fosfomycin phenylethyl amine 0.67 25 % sodium hydroxide solution 0.52 MIBK - Methyl isobutyl ketone 0.21 Activated carbon 0.02 Hyflow 0.02 7. Dalbavancin Beaf Extract 0.14 Yeast autolysate 0.14 Peptone 0.14

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Sr Name of product Name of Raw Material Quantity No. (MTPM) Dextrose Monohydrate 0.14 Sodium chloride 0.04 Calcium carbonate 0.06 n-Butanol 0.08 Ethyl acetate 0.07 8. Telavancin – Soya flour 0.21 Potato protein 0.21 Calcium Chloride 0.21 Sodium Chloride 0.13 Maltodextrin 0.08 Mineral salts 0.13 Isobutyl acetate 0.13 9. Capreomycin – Bacto Peptone 0.03 Casamino acid 0.02 Cerelose 0.10 Magnesium sulphate 0.02 Calcium Chloride 0.002 Ethyl acetate 0.24 n-Heptane 0.01 10. Tobramycin Starch 0.68 sulphate Soya peptone 1.74

Dextrose 1.95 Corn Gluten 1.16 Soya flour 1.64 Soyabean Oil 0.19 Calcium Carbonate 0.09 Magnesium Sulphate 0.02 Ammonium Chloride 0.02 Zinc Sulphate 0.005 Ethyl acetate 0.58 11. Oritavancin – Dextrose 0.63 Soyabean Flour 0.38 Potato Protin 0.75

CaCO3 0.06 Corn Steep Liquid 0.08 PPG 2000 0.08 Soya Peptone 0.13 Antifoam 0.05 Methanol 0.25 Isopropyl alcohol 0.004 Chlorobiphenyl Carboxaldehyde 0.08 12. Polymyxin Salts Wheat Flour 20.83 Yeast Extract 1.25

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Sr Name of product Name of Raw Material Quantity No. (MTPM) Ammonium Sulfate 0.83 Calcium Carbonate 1.25

H2SO4 41.67 Acetone 1.67 13. Bacitracin Dextose 16.67 Soy Flavor 4.17 Gluten 4.17 Ammonium Sulfate 0.17 Butanol 0.67 14. Fusidic Acid Sucrose 47.62 CSL 9.52 KH2PO4 2.38 MgSO4 2.38 Sheftone C 0.95 Antifoam 0.24 Toluene 0.01 Methanol 0.01 Acetone 0.003 15. Colistin Salts NaOH 0.31 Sodium Bisulfite 0.31 Formaldehyde 0.06 (B) Antiparasitic 16. Milbemycin oxime – Sucrose 16.67 Yeast extract 11.67 Soya flour 8.33 Magnesium sulphate 1.67 Di-potassium hydrogen 0.50 phosphate Calcium carbonate 3.33 Ferrous sulphate 0.05 Ethyl acetate 37.50 Isopropyl alcohol 2.92 (C) Antifungal 17. Caspofungin PnBo 0.03 DMF 0.03 CyCl2 0.01 Ammonium acetate 0.02 Catalyst 0.003 Acetonitrile 1.83 18. Micafungin – FR 901379 Nucleus 0.62 Side Chain 0.47 DMAP 0.50 DMF 0.04 Ethyl acetate 0.02

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Sr Name of product Name of Raw Material Quantity No. (MTPM) 19. Anidulafungin Echinocandin Nucleus 0.08 Side Chain (TOBt) 0.04

KH2PO4 0.01 Acetone 0.08 (D) Immunosuppressant 20. Tacrolimus Dextrose 11.96 Dextrin 19.10 Milk 0.03

CaCO3 0.20 Soya Peptone 1.30 Yeast extract 0.87 Proteose peptone 0.03 Sodium acetate 0.99 PEG 400 0.49 Citric acid 2.01 Salt & minerals 0.35 Toluene 17.36 Acetone 0.17 Ethyl acetate 0.17 21. Cyclosporine Dextrose 2.38 Fructose 285.71 Soyaflour 2.38 L-valine 29.76 L-leucine 23.81 Corn steep liquor 0.42 Salt & minerals 17.86 Toluene 95.24 Acetone 1.19 Methanol 1.19 Cyclohexane 1.19 22. Rapamycin Dextrose 1.04 Dextrin 58.33 Soyaflour 33.85

CaCO3 0.78 Soyapeptone 3.91 Yeast Extract 0.10 Proteose peptone 0.10 NaCl 3.13 Citric acid 2.60 PEG 400 2.08 Salts minerals 1.04 Toluene 41.67 Acetone 0.52 Ethyl acetate 0.52 23. Mycophenolate IBA 13.33 Xylene 10.00

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Sr Name of product Name of Raw Material Quantity No. (MTPM) Mofetill & Di-pyridyl carbonate 1.67 Mycophenolate Sodium bicarbonate 5 %sol 1.08 sodium Acetone 2.50 Activated Carbon 0.83 Acetone 5.79 Sodium 2 Ethyl Hexanoic acid 6.94 24. Zotarolimus Sirolimus 0.03 Di-chloro methane 0.003 Toluene 0.01 IPA 0.01 1 H tetrazole 0.06 Di isopropyle ethyle amine 0.19 2,6 Lutidine 0.08 N-hapthane 0.01 MTBE 0.002 25. Fingolimod Dietyl-2 acetamido- 0.02 (octyphenyl)ethyl malonate Pyridine 0.01 Acetic anhydride 0.01 LiAlH4 0.01 Ethyle Acetate 0.02 Methanol 0.01 Ethanol 0.01

ET2O 0.06 (E) Oncology 26. Everolimus Sirolimus 0.10 Toluene 0.05 2-(t-butyldimethylsilyl) oxyethyl 0.07 triflate) 2,6-lutidine 0.04 Methanol 0.01 Formic acid 0.01 Dichloromethane 0.03 n-Heptane 0.03 27. Pimecrolimus Ascomycin 0.38 Toluene 0.50 Acetonitrile 0.34 Trifloromethane sulfonic 0.16 anhydride Ethyldiisopropylamine 0.13 Benzenetriethylammonim 0.50 chloride Acetone 0.34 28. Ixabepilone Epothilone B 0.02

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Sr Name of product Name of Raw Material Quantity No. (MTPM) Tetrabis (TPP)Palladium 0.0001 Sodium azide 0.003 Triphenyl phosphine 0.01 Di-phenyl phosphoryl azide 0.003 Ethyl acetate 0.04 29. Romidepsin Dextrose 0.08 Glycerol 0.01 Yeast extract 0.02 Corn starch 0.02 Ammonium Sulphate 0.001 Magnesium sulphate 0.0004 Potassium Di Hydrogen 0.003 phosphate Sodium Chloride 0.004 Isobutyl acetate 0.02 30. Temsirolimus Sirolimus 0.005 Dichloromethane 0.005 Mix anhydride (side chain) 0.007 DMAP 0.002 Hydrochloric acid 0.001 Tetrahydro furan 0.002 n-Heptane 0.002 31. Ridaforolimus Sirolimus 0.005 Dimethyl phosphonic Chloride 0.002 Pyridine 0.000 Dichloromethane 0.005 N-Hexane 0.003 Sodium bicarbonate 0.002 32. Doxorubicin Bromodunarubicin 0.09 Acetone 0.07 Dichromethane 0.06 Hydrobromic acid 0.01 33. Epirubicin Epi-TFA daunorubicin 0.03 Sodium hydroxide 0.003 Dichloromethane 0.17 n-Hexane 0.02 34. Idarubicin Corn Gluten 0.06 Cotton seed meal 0.04 Glucose 0.06 Glycerol 0.06 Yeast Extract 0.04

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Sr Name of product Name of Raw Material Quantity No. (MTPM) Calcium Carbonate 0.02 MIBK - Methyl isobutyl ketone 0.06 Actonitrile 0.01 35. Bleomycin Starch 0.10 Glucose 0.07 Soyameal 0.10 Di potassium hydrogen 0.01 phosphate Zinc Sulphate 0.01 Copper sulphate 0.01 Corn steep liquor 0.04 Ethyl acetate 0.17 36. Geldanamycin Starch 0.14 Cotton seed meal 0.03 Glucose 0.03 Corn steep liquor 0.07 Yeast Extract 0.03 Calcium Carbonate 0.01 MIBK 0.02 Ethyl acetate 0.01 37. Mitomycin Dextrose 0.08 Starch 0.19 Soyabean Flour 0.11 Dry Yeast 0.02

CaCO3 0.06 Corn Steep Liquid 0.04 Yeast Extarct 0.02

K2HPO4 0.08

MgSO4.7H2O 0.001 Antifoam 0.001 Phosphoric acid 0.001 Ethyl acetate 0.03 methanol 0.05 38. Dactinomycin Dextrose 0.08 Starch 0.15 Soyabean Powder 0.08 Dry Yeast 0.04

CaCO3 0.02

(NH4)2SO4 0.02 Yeast Extarct 0.02

K2HPO4 0.004 Antifoam 0.004 Toluene 0.03 Acetone 0.003

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Sr Name of product Name of Raw Material Quantity No. (MTPM) Di isopropyl ether 0.001 39. Trabectedin Dextrose 0.10 Manitol 0.20 Yeast Extract 0.10

(NH4)2SO4 0.05

K2HPO4 0.02 KCl 0.04

FeCl3 0.0001 L-Glycine 0.01

CaCO3 0.04 PPG 2000 0.003 Antifoam 0.01 Sodium Hydroxide 0.001 Ethyl acetate 0.03 Methanol 0.003 Acetonitrile 0.001 Silver Nitrate 0.01 (F) Statins 40. Pravastatin Dextrose 0.32 Cotton seed meal 0.03 NaCl 0.07

CaCO3 0.03 Soyabean flour 0.33 Corn steep liquor 0.07 Salt & minerals 0.02 IBA 0.71 IPA 0.02 Acetonitrile 0.03 Activated Carbon 0.004

4. Manufacturing Process Please refer Annexure-II of Form-1 for process description and process flow diagram. 5. Manpower Requirements Total manpower requirement will be 500. 6. Energy & Fuel Requirements  Energy requirement for the proposed project will be 4000 kVA.  FO requirement will be 1600 liter/hour/boiler (2 boilers of 10 TPH each).  Diesel requirement will be 130 Liter per hour (4 D.G. set of 1010 kVA each).

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7. Water Consumption & Waste Water Generation

Water Consumption 980 KLD (820 KLD Fresh Water +160 KLD Recycle)

Domestic Industrial 35 785

220 Water treatment 160 Water treatment (1st stage RO) 730 (DM/softener) 55 50 5

Product water Reject 60 st 110 510 (2 stage RO) 165

Process Boiler Washing Reject Permeate 270 +140 240 60 65 100

Direct steam inject 140 MVR/MEE Condensate Cooling 65 60 60+100+50 Indirect = 210 heating Salt 0.8 Loss 4.2 Bleed 30 300 45 Blow down 60 70 off

ETP 30+300+45+60+70 = 505

Greenbelt

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8. Source of Pollution and Mitigation Measures A. Air Pollution The main source of air pollution will be from stack attached to Boiler and D. G. Sets. No process gas emission at any stage of manufacturing

process. Most probable pollutants will be SPM, SO2, and NOx. Adequate stack height will be provided to control & disperse the air pollutants within the satisfactory levels. Furthermore, facility for sampling such as ladder and sampling point will be provided as per the GPCB guidelines. The details of stacks with their APC measures & height are given in below. Sr. Stack Fuel Stack APC Probable No. attached to Type Height measures emission

Flue Gas Stack 1. Boiler FO-1600 45 --- PM<150 mg/Nm3 (2 Nos.) liter/hour/ meter SO2<100 ppm boiler NOX<50 ppm (10 TPH each) 2. DG Set Diesel-130 30 --- lit/hr each meter (4 Nos.) (1010 KVA each) Process Gas Stack No Process Emission

B. Water Pollution Source of waste water generation is mainly from process, washing & utility. Waste water generated from process, washing & utility is directly sent to ETP. Domestic effluent is also sent to ETP along with industrial waste water. Reject from RO1 will be used for washing and balance will be further treated in RO2. Reject of RO2 will be sent to MVR/MEE. Condensate of MVR/MEE & permeate of both RO will be utilized for Cooling. Entire quantity of treated water from ETP will be utilized for greenbelt development.

C. Hazardous wastes Pollution Entire quantity of hazardous waste will be handled & disposed as per Hazardous & Other waste (Management & Transboundary Movement)

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Rules, 2016. The unit will provided isolated area with impervious flooring & roof cover for the storage of hazardous waste. Summary of waste and ultimate disposal are summarized below:

Sr. Type of As per Quantity Disposal method No. Solid Waste HWM (MTPM) Rules, 2016 1 ETP Sludge & 35.3 150 Collection, Storage, decontamination, Transportation, Disposal at Approved MEE salt 20 TSDF site. 2 Distillation 20.3 35 Collection, Storage, decontamination, residue Transportation, Disposal by Incineration at Approved CHWIF or Co- processing in cement plant. 3 Spent Carbon 28.3 15 Collection, Storage, decontamination, Transportation, Disposal by Incineration at Approved CHWIF or Co- processing in cement plant. 4 Discarded 33.1 6000 Collection, Storage, decontamination, Container Nos./ month Transportation, Disposal by selling to authorized recycler or reuse. 5 Used oil 5.0 10.00 MT/yr. Collection, storage, transportation, disposal by selling registered recycler. 6 Off 28.4 Whatever Collection, Storage, decontamination, specification & generated Transportation, Disposal by Product & 28.5 Incineration at Approved CHWIF or Co- date expire processing in cement plant. product 7 Spent 28.6 30 Approved Reprocesses or Co- Solvent processing in cement plant.

9. Funds for pollution control measures The management is quite conscious of its responsibility for maintaining clear environment adequate funds can be provided for the pollution control measures. Necessary provision for Environmental management system will be in practice.

10. Monitoring facilities Company is ready to carry out monitoring proposed by pollution control board from time to time through outside agency.

11. Green Belt Development The unit proposes to earmarked space for development of green belt to arrest noise pollution and fugitive emissions as well as to improve aesthetics.

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12. Conclusion On the basis of information presented in the pre-feasibility report on pollution control measures and after its implementation, there will be no discharge of effluent and air emission from the plant beyond the norms specified by the Board as per the provisions of Air (Prevention and Control of Pollution) Act, 1981 and Water (Prevention and Control of Pollution) Act, 1974.

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