Pre Feasibility Report for Manufacturing of Apis

Pre Feasibility Report

For

Manufacturing of APIs

Cipla Limited Plot No. M12 & M14, Misc. Zone, Phase II, Sector III, Indore SEZ, Pithampur, District Dhar (M.P). - 454775

1. IDENTIFICATION OF PROJECT AND PROJECT PROPONENT:

CIPLA Ltd is established in the year 1935 as a listed Public Limited Company. CIPLA is engaged in manufacturing of Bulk Drugs and Formulations of wide range of products in the form of tablets, injections, inhalers, capsules, ointment, powder, topical preparations, liquid, syrup drops, sprays, gels, suppositories etc. The company is having its registered office at Mumbai Central, Mumbai – 400 008.

80 years later, the company has become a front runner in the pharmaceutical industry, wielding the latest technology to combat disease and suffering in many ways, touching the lives of thousands the world over.The company’s products are manufactured in 25 state-of- art units. The company is having its manufacturing facilities at following locations:

Locations Product Category Vikhroli- Mumbai R&D Virgonagar (Bangalore) Bulk Drugs and Formulations Bommasandra (Bangalore) Bulk Drug Patalganga Bulk Drugs and Formulations Kurkumbh Bulk Drugs and Formulations Goa Formulations Baddi Formulations Sikkim Formulations Indore Formulations The company is having well defined board of directors followed by managerial and technical team looking after entire operation. Management Council- 1. Mr. Umang Vohra - Managing Director and Global Chief Executive Officer 2. Mr. PrabirJha - Global Chief People Officer 3. Mr. KedarUpadhye - Global Chief Financial Officer 4. Dr. Ranjana Pathak - Global Head – Quality 5. Geena Malhotra - Global Head - Integrated Product Development 6. Mr. Raju Subramanyam – Global Head - Operations

List of Key Executives- 1. Mr. KuberJagdale- Sr. Vice President – API Operations 2. Mr. Harish Verma – Vice President - EHS 3. Mr. Sanjay Gorana – Sr. Vice President – Formulations Operations 4. Mr. Prashant Bhalve – Vice President – Engineering 5. Mr. Sachin Nemade – Associate Director – API Projects

2. BRIEF DESCRIPTION OF NATURE OF THE PROJECT: The company is putting up a project into its existing manufacturing facility to produce Active Pharmaceutical Ingredients (API) along with its intermediates. The site has existing build up area of 1030 sq meter which includes Production block, Utility, RM & FG Stores and Office block. This facility earlier was used to manufacture Formulation products with the valid consents. A small portion of existing shed will be demolished and construction will be done for building the new production blocks after grant of EC & CTE.

It is proposed to build a API manufacturing plant and related infrastructure. In Phase -1 One multiproduct API plant with multiple streams and in house clean room facility to produce finished products. Phase-2 would include similar Plant.

The plant design shall be in line with current good manufacturing practices(cGMP) and EHS requirements in accordance with current regulations/internal standards. 3. PRODUCTS & PRODUCTION CAPACITY:

List of Products & Capacity (TPA) Proposed Qty. to be Sr. No. Product Name manufactured (TPA) 1 Fluticasone Propionate 1.5

2 Fluticasone Propionate (MDI) 0.1

3 Fluticasone Propionate (DPI) 0.1

4 Beclomethasone Dipropionate Anhydrous 0.7 5 Budesonide 1.5 6 Mometasone Furoate 0.2 7 Fluticasone Furoate 0.02 8 Loteprednol Etabonate 0.1 9 MometasoneFuroate Monohydrate 0.4 10 Beclomethasone Dipropionate Monohydrate 0.05 11 Ciclesonide 0.1 12 FAP Complex 3 13 Fluticasone Stage III 2 14 R&D products 0.2 TOTAL 10

4. SALIENT FEATURE OF THE PROJECT(Phase-1):

 Product : Active Pharmaceutical Ingredients

 Category : Project Category B, 5(f), Synthetic Organic Chemical  Number of Working Days : 365 per annum

 Plant Working Hours : 24 hrs. x 7 days a week

 Nominal Reactor Capacity : ~30 KL (Metallic and Glass lined)

 HVAC : Intermediate area, forced ventilation crystallizer area, forced ventilation with F9 filters Powder processing area, ISO 8 area classification

 Electrical : 33 KV incoming Power supply

 Fuel : Primary Fuel (Gas), Back up fuel (FO/LDO/HSD)

 Backup for Grid Power : 100% power back-up with Power Generator (1500 KVA, DG)

 Fire Hazard of Plant : Classified as Zone-1 / Zone-2.

 Water : Available from AKVN Water source

 Safety : Fire Hydrant, Local extinguishers, Smoke Detectors, Safety Showers, CCTV, PAS, Foam Sprinkler etc.  Utility : All Utilities will be generated in house (Steam, Chilled Brine, Chilled Water, Cooling Water, Hot Water, Hot Oil etc.)  Instrumentation : Central DCS/PLC system considered for Manufacturing block.Utility systems shall be with dedicated controllers BMS shall be controlled from plant DCS

 Effluent : Effluent shall be segregated at source as High COD-High TDS (Strong Stream), Low COD-Low TDS (Weak Stream), and Organic collected separately in tanks, where it will be detoxified before overhead pumping to ETP for furthertreatment.

 Effluent Treatment Plant : Zero Liquid Discharge System with CEMS.

5. PROJECT DETAIL: Site Address Plot No. M12 & M14, Misc. Zone, Phase II, Sector III, Indore SEZ, Pithampur, District Dhar (M.P). – 454775 Production Capacity 10 TPA Cost of Project ~185 Crores Boiler capacity 2 MT Power Requirement 1500 KVA Alternative Source of Power DG Land Available 16 Acres

6. NEED FOR THE PROJECT AND ITS IMPORTANCE TO THE COUNTRY AND OR REGION:  Import substitution and saving of foreign exchange  Export of finished product (API)  Enhancing earning of foreign exchange national ex-chequer.  Possible reduction in the price of contrast media formulation required by general population  Generation of revenue by employing most cost efficient process for the state.  Generation of local employement  Due to patentable technology developed the project will conserve the raw materials by maximising the yield.  The proposed project may contribute to narrow the gap of demand/ supply of APIs. As project, will base on modern technology it will have an edge over other competitors within & outside the state.  Local supplier & vendor business promotion  Socio economic upliftment of neighbouring community.

7. EXPORT POSSIBILITY: There is export possibility of material basis on customer requirement. Transportation shall be through air and ships.

8. DOMESTIC/EXPORT MARKETS: Cipla Limited will manufacture API & its intermediates which in turn make formulations and to be supplied to domestic and export markets.

9. EMPLOYMENT GENERATION (DIRECT AND INDIRECT) DUE TO THE PROJECT: Proposed Direct Employment : ~ 250 Nos. Proposed Indirect Employment : ~ 200 Nos

10. PROJECT DESCRIPTION:

i. Type of the project including interlinked and interdependent project, if any No interlinked and interdependent project with the proposed plant.

ii. Location (map showing general location, specific location, and project boundary & project site layout) with Coordinates:

Location Map

Most Recent Satellite Image of the Project area

Topographical Base Map (Ref: Survey of India Toposheet No.46 N10)

iii. Details of Alternate Site:

Not applicable iv. Size or magnitude of Operation:

Proposed manufacturing capacity is 10 TPA. The site shall be with zero liquid discharge design.

v. Project Description with Process Details:

Details of product, Aq. effluent from process, Solid waste, Emissions & process flow diagram is as per below file:

Aq. Effluents (TPA) Organic Solid Atmospheric Qty Low COD- High COD – Product Effluent Waste Discharge TPA Low TDS High TDS (TPA) (TPA) (TPA) (Weak (Strong Stream) Stream) FAP Complex 3 161 0 77 0.00 2.38

Fluticasone Stage III 2 176 0 73 0.00 2.25

Fluticasone Propionate 1.5 128 0 83 0.05 2.77

Fluticasone Propionate 0.1 0 10 0 0.00 0.00 MDI

Fluticasone Propionate DPI 0.1 0 11 0 0.00 0.00

Ciclesonide 0.1 0 14 16 0.21 0.49

Loteprednol Etabonate 0.1 25 0 13 0.00 0.81

Fluticasone Furoate 0.02 12 0 3 0.01 0.08

Beclomethasone 0.7 72 44 22 0.02 0.68 Dipropionate Anhydrous Beclomethasone 0.05 1 0 0 0.00 0.00 Dipropionate Monohydrate Mometasone Furoate 0.2 0 24 27 0.31 0.84 Anhydrous Mometasone Furoate 0.4 119 0 0 0.00 0.00 Monohydrate Budesonide 1.5 30 99 76 0.00 2.34

Total Effluent (TPA) 10 724 203 390 0.59 12.65

vi. Manufacturing Process 1. Fluticasone Propionate

Batch Input Qty 20 Kg

Dimethyl Formamide 94 Kg Fluticasone Stage III 20 Kg Sodium bicarbonate 4 Kg Reaction CO2 1.88 Kg Bromofluoro Methane 5.4 Kg Purified Water 1000 Kg

Methanol 79 Kg MLR 1183 Kg Filtration, Slurry & Drying Wet Cake 25 Kg

Dry Material 20 Kg

Distilled Activated Charcoal 0.5 Kg 533 Kg Acetone Acetone 596 Kg Distilled Ethyl Material 20 Kg 50 Kg Purification & Isolation Acetate Ethyl Acetate 54 Kg

MLR 10 Kg

Filtration & Drying Wet Cake 17 Kg

Dry Material 15 Kg

Sifting, Micronization & Blending (Powder Processing Operation) Material 14 Kg

Fluticasone Propionate 14 Kg

2. Fluticasone Propionate MDI

Batch Input Qty 6 Kg

Acetone 94 Kg Fluticasone Propionate 6 Kg Purified Water 440 Kg Polysorbate 80 (Tween Purification 0.06 Kg 80)

MLR 534 Kg

Filtration & Drying Wet Cake 8.4 Kg

Dry Cake 5.6 Kg

Sifting & Micronization (Powder Processing Operation) Material 5.4 Kg

Fluticasone Propionate MDI 5.4 Kg

3. Fluticasone Propionate DPI

Batch Input Qty 5 Kg

Acetone 78 Kg Fluticasone Propionate 5 Kg Purified Water 440 Kg Purification

MLR 518 Kg

Filtration & Drying Wet Cake 7 Kg

Dry Cake 4.7 Kg

Sifting & Micronization (Powder Processing Operation) Material 4.5 Kg

Fluticasone Propionate DPI 4.50 Kg

4. Beclomethasone Dipropionate Anhydrous

Batch Input Qty 25 Kg

Methylene Dichloride 166 Kg β- Methyl Epoxide 25 Kg Hydrochloric Acid 141 Kg Purified Water 125 Kg Reaction

Purified Water 1430 Kg MLR 1864 Kg Sodium Bicarbonate 3 Kg Filtration, Slurry & Wet Cake 63 Kg Drying Dry Material 25 Kg

Methylene Dichloride 398 Kg Material 25 Kg Triethyl Ortho Propionate 28 Kg Pyridium P-Toluene Distill Methanol 1 Kg 522 Kg Sulfonate Reaction + MDC Purified Water 625 Kg Sodium Acetate 6.25 Kg Methanol 238 Kg Acetic Acid 50 Kg

MLR 1060 Kg Purified Water 350 Kg Material 33 Kg Filtration, Slurry & Drying Wet Cake 33 Kg

Dry Material 28 Kg

Pyridine 74 Kg Material 28 Kg Propionic Anhydride 20 Kg Reaction Purified Water 950 Kg Hydrochloric Acid 141 Kg

MLR 1813 Kg Purified Water 600 Kg Material 45 Kg Filtration & Slurry Wet Cake 45 Kg Hydrochloric Acid 28 Kg

SPDS 241 Kg Material 45 Kg Activated Charcoal 0.5 Kg Purified Water 400 Kg Purification & Isolation Hydrochloric Acid 1 Kg Isopropyl Alcohol 59 Kg

MLR 700 Kg

Filtration & Drying Wet Cake 32 Kg

Dry Material 29 Kg

Sifting, Micronization & Blending (Powder Processing Operation) Material 28 Kg

Beclometasone Dipropionate ANH 28 Kg

5. Budesonide

Batch Input Qty 25 Kg

Hydrobromic Acid 224 Kg (Aqs. 47%) Butyraldehyde 8 Kg 16α-Hydroxy Predisolone 25 Kg Reaction Purified Water 1020 Kg

Purified Water 700 Kg MLR 1944 Kg

Filtration & Slurry Wet Cake 37 Kg

Methanol 297 Kg Material 37 Kg Purified Water 750 Kg Acetonitrile 0.5 Kg Purification & Isolation Ethyl Acetate 32 Kg Methylene Dichloride 0.7 Kg

MLR 1080 Kg

Filtration & Drying Wet Cake 27 Kg

Dry Material 22.50 Kg

Sifting, Micronization & Blending (Powder Processing Operation) Material 22.50 Kg

Budesonide 22.50 Kg

6. Mometasone Furoate

Batch Input Qty 20 Kg

Pyridine 79 Kg 16α-Methyl Epoxide 20 Kg Para toluene Sulphonyl 22 Kg Chloride Reaction Lithium Chloride 8 Kg Ethyl Acetate 540 Kg Purified Water 100 Kg

Purified Water 900 Kg Aqueous Layer 1258 Kg Hydrochloric Acid 120 Kg Work Up / Layer Sodium Chloride 40 Kg Separation and Organic layer 590 Kg Sodium Bicarbonate 12 Kg Concentration Distil Ethyl Sodium Sulphate ANH 8 Kg 520 Kg Acetate

MLR 14 Kg Diisopropyl Ether 22 Kg Filtration Wet Cake 18 Kg

Methylene Chloride 364 Kg Material 18 Kg Activated Charcoal 1 Kg Reaction Triethyl Amine 32 Kg Furoyl Chloride 16 Kg Purified Water 80 Kg

Hydrochloride Acid 32 Kg Aqueous Layer 124 Kg Methylene Chloride 179 Kg Work Up / Layer Sodium Bicarbonate 8 Kg Separation and Organic layer 66 Kg Sodium Sulphate 4 Kg Concentration Distil MDC 530 Kg

Acetone 666 Kg Distil Acetone 603 Kg Material 20 Kg Distil Ethyl Activated Charcoal 4 Kg Concentration & 72 Kg Isolation Acetate Ethyl Acetate 80 Kg

Distilled Ethyl Acetate 36 Kg 160 Kg Solvent Acetone 157 Kg Material 19 Kg Purification

MLR 16 Kg Methanol 16 Kg Slurry, Filtration & Material 18 Kg Drying Wet Cake 18 Kg

Dry Material 16 Kg

Sifting Material 16 Kg

Mometasone Furoate 16 Kg

7. Fluticasone Furoate

Batch Input Qty 5 Kg

Acetone 39 Kg Fluticasone Stage I 5 Kg Triethyl Amine 4 Kg 2-Furoyl Chloride 5 Kg Condensation Reaction Diethyl Amine 4 Kg Hydrochloric Acid 3 Kg Purified Water 280 Kg

MLR 330 Kg

Filtration & Drying Wet Cake 10 Kg

Dry Material 6 Kg

Tetra Hydro Furan 22 Kg Material 6 Kg Triethyl Amine 2 Kg N, N-Dimethyl Thio 3 Kg Carbamoyl Chloride Reaction Tetrabutyl Ammonium 0.05 Kg Bromide Dimethyl Acetamide 12 Kg Purified Water 250 Kg

MLR 286 Kg

Filtration & Drying Wet Cake 8 Kg

Dry Material 7 Kg

Methanol 56 Kg Material 7 Kg Pottasium Carbonate 4.25 Kg Reaction Purified Water 91 Kg Hydrochloric Acid 7 Kg

MLR 159 Kg

Filtration & Drying Wet Cake 11 Kg

Dry Material 6 Kg

Dimethyl Formamide 28 Kg Material 6 Kg Sodiun Bicarbonate 1.25 Kg Reaction Bromofluoro Methane 1.75 Kg Purified Water 180 Kg

MLR 211 Kg

Filtration Wet Cake 6 Kg

Purified Water 420 Kg Material 6 Kg Acetone 39 Kg Sodium Bicarbonate 1 Kg Purification & Isolation Toluene 35 Kg Methyl Ethyl Ketone 36 Kg

MLR 531 Kg

Filtration & Drying Wet Cake 3.5 Kg

Dry Material 3 Kg

Sifting & Micronization (Powder Processing Operation) Material 2.5 Kg

Fluticasone Furoate 2.5 Kg

8. Loteprednol Etabonate

Batch Input Qty 20 Kg

Purified Water 380 Kg Sodium Metaperiodate 124 Kg Distilled Tetra Hydro Furan 107 Kg Reaction Methanol + 120 kg THF Prednisolone 20 Kg Methanol 32 Kg

MLR 510 Kg

Filtration & Drying Wet Cake 22 Kg

Dry Material 20 Kg

Methylene Dichloride 258 Kg Material 20 Kg Triethyl Amine 15 Kg Reaction Ethyl Chloroformate 15 Kg Purified Water 340 Kg Hydrochloric Acid 2 Kg

Work Up / Layer Aqueous Layer 372 Kg Separation and Concentration Organic Layer 146 Kg Distilled MDC 132 Kg

n-Heptane 308 Kg Distilled 14 Kg Stripping Heptane

Tetra Hydro Furan 89 Kg Material 25 Kg Ethanol 32 Kg Reaction Sodium hydroxide 2.8 Kg

MLR 123 Kg

Filtration & Drying Wet Cake 16 Kg

Dry Material 14 Kg

Hexamethyl Phosporamide 103 Kg Material 14 Kg Iodochloromethane 12 Kg Condensation Purified Water 600 Kg

MLR 710 Kg Filtration & Drying Wet Cake 18 Kg

Distilled Ethyl Acetate 41 Kg 157 Kg Acetone Material 18 Kg Acetone 180 Kg Purification & Isolation

MLR 10 Kg

Filtration & Drying Wet Cake 14 Kg

Dry Material 10 Kg

Sifting & Micronization (Powder Processing Operation) Material 8 Kg

Loteprednol Etabonate 8 Kg

9. Mometasone Furoate Monohydrate

Batch Input Qty 5 Kg

SPDS 474 Kg Distillation Distilled SPDS 435 Kg

SPDS 435 Kg Mometasone Furoate 5 Kg Dissolution & Water Purified Water 1050 Kg Addition

MLR 1485 Kg

Filtration & Drying Wet Cake 5.5 Kg

Dry Material 5 Kg

Sifting & Micronization (Powder Processing Operation) Material 4.75 Kg

Mometasone Furoate Monohydrate 4.75 Kg

10. Beclomethasone Dipropionate Monohydrate

Batch Input Qty 10 Kg

SPDS 79 Kg Distillation Distilled SPDS 63 Kg

SPDS 55 Kg Beclomethasone 10 Kg Dipropionate Dissolution Purified Water 20 Kg

MLR 75 Kg

Filtration & Drying Wet Cake 10 Kg

Dry Material 9 Kg

Sifting & Micronization (Powder Processing Operation) Material 9 Kg

Beclomethasone Dipropionate Monohydrate 9 Kg

11. Ciclesonide

Batch Input Qty 15 Kg

Methylene Dichloride 437 Kg Perchloric Acid 42 Kg 16α-Hydroxy Predisolone 15 Kg Cyclohexane Reaction 5 Kg Carboxaldehyde Sodium Bicarbonate 60 Kg Purified Water 1100 Kg

Work Up / Layer Aqueous Layer 1160 Kg Separation and Organic Layer 499 Kg Concentration Distilled MDC 398 Kg

Methanol 356 Kg Distilled Material 22 Kg Stripping 341 Kg Methanol

MLR 5 Kg

Filtration & Drying Wet Cake 18 Kg

Dry Material 15 Kg

Methylene Dichloride 265 Kg Material 15 Kg TriEthyl Amine 6 Kg Distilled MDC 199 Kg Purified Water 150 Kg Reaction & Distilled Sodium Hydroxide 3 Kg 119 Kg Concentration Methanol Sodium Sulphate 6 Kg Methanol 127 Kg Activated Charcoal 1.5 Kg

Distilled Methanol 110 Kg 119 Kg Solvent Material 15 Kg Ethanol 134 Kg Purification & Isolation

MLR 20 Kg

Filtration & Drying Wet Cake 14 Kg

Dry Material 10 Kg

Sifting & Micronization (Powder Processing Operation) Material 9 Kg

Ciclesonide 9 Kg

12. FAP Complex

Batch Input Qty 25 Kg

Propionic Anhydride 12 Kg Acetone 78 Kg Fluticasone Stage I 25 Kg Pyridine 25 Kg Reaction Purified Water 500 Kg Concentrated Sulphuric Acid 17 Kg

MLR 1370 Kg Purified Water 750 Kg Filtration, Slurry & Wet Cake 40 kg Drying Dry Material 27 Kg

N, N-Dimethyl 15 Kg Thiocarbamoyl Chloride Tetrahydrofuran 111 Kg FAP Compound 27 Kg Reaction Triethylamine 20 Kg Purified Water 450 Kg Dimethyl Acetamide 118 Kg

MLR 852 Kg Methanol 95 Kg Filtration, Slurry & Drying Wet Cake 45 Kg Dry Material 32.50 Kg

FAP Complex 32.50 Kg

13. Fluticasone Stage III

Batch Input Qty 25 Kg

Methanol 198 Kg FAP Complex 25 Kg Pottassium Carbonate 15 Kg Reaction Purified Water 260 Kg Toluene 87 Kg

Hydrochloric Acid 25 Kg Aqueous Layer 530 Kg Potable Water 75 Kg Work Up / Layer Separation and Organic layer 87 Kg Filtration Wet Cake 37.5 Kg

Distilled Ethyl Ethyl Acetate 369 Kg 342 Kg Acetate

Material 37.5 Kg Purification & Isolation

MLR 16 Kg

Filtration & Drying Wet Cake 25 Kg

Dry Material 20 Kg

Fluticasone Stage III 20 Kg

vii. Estimated Quantity of Raw Materials Required;

Estimated Qty S. No RM's/Chemicals Source (Kg/annum)

1 16- ALPHA HYDROXY PREDNESOLONE 1200 Local & Import

2 16 ALPHA METHYL EPOXIDE 400 Import 3 ACETIC ACID – GLACIAL 2800 Local & Import 4 ACETONE 116314 Local 5 ACETONITRILE 18 Local & Import 6 ACTIVATED CHARCOAL AR GRADE 150 Local 7 ACTIVATED CHARCOAL SX ULTRA 7.5 Import 8 BETA METHYL EPOXIDE 1000 Local & Import 9 BROMOFLUORO METHANE 326 Import 10 BUTYRALDEHYDE 450 Local & Import 11 CYCLOHEXANE CARBOXALDEHYDE 30 Import 12 DI ISO PROPYL ETHER 600 Local & Import 13 DIETHYL AMINE 5 Local 14 DIMETHYL ACETAMIDE 4728 Local 15 DIMETHYL FORMAMIDE 6270 Local & Import 16 ETHYL ALCOHOL AR 850 Import 17 ETHYL ACETATE 51154 Local 18 ETHYL CHLORO FORMATE 26 Local 19 FAP COMPLEX 1500 Local (In house) 20 FLUTICASONE STAGE I (IMP) 1005 Import

21 FLUTICASONE STAGE III (COMPLEX ROUTE) 1200 Local (In house)

22 FUROYL CHLORIDE 244 Local 23 HEXAMETHYL PHOSPHORAMIDE 280 Import 24 HYDROBROMIC ACID (AQUEOUS 47%) 6975 Local 25 HYDROCHLORIC ACID – CP 11522 Local 26 HYDROCHLORIC ACID AR GRADE 7350 Local 27 HYFLO SUPERCEL 1 Local & Import 28 IODOCHLORO METHANE 24 Local & Import 29 ISOBUTYRYL CHLORIDE 30 Local 30 ISOPROPYL ALCOHOL 4710 Local & Import 31 LITHIUM CHLORIDE 160 Local 32 METHANOL 51870 Local & Import 33 METHYL ETHYL KETONE 80 Import 34 METHYLENE CHLORIDE 41952 Local & Import

Estimated Qty S. No RM's/Chemicals Source (Kg/annum)

35 N N DIMETHYL THIO CABOMYL CHLORIDE 603 Local & Import

36 N-HEPTANE (COMMERCIAL) 40 Local & Import

37 PARA TOLUENE SULPHONYL CHLORIDE 440 Local

38 PERCHLORIC ACID 70% GR GRADE 125 Local 39 POTABLE WATER 90000 Local 40 POTASSIUM CARBONATE POWDER 904 Local 41 PREDNISOLONE 40 Import 42 PROPIONIC ANHYDRIDE 1560 Import 43 PURIFIED WATER (DM WATER) IP 587900 Local 44 PYRIDINE 5498 Local & Import

45 PYRIDINIUM PARA TOLUENE SULFONATE 40 Local

46 SILICA GEL 60-120 MESH 160 Local 47 SODIUM ACETATE ANHYDROUS 250 Local 48 SODIUM BICARBONATE 1212 Local & Import 49 SODIUM CHLORIDE 800 Local & Import 50 SODIUM HYDROXIDE FLAKES 21 Local 51 SODIUM METAPERIODATE 64 Local 52 SODIUM SULPHATE ANHYDROUS 270 Local

53 SPECIAL DENATURED SPIRIT WITH TOLUENE. 34020 Local

54 SULPHURIC ACID COMMERCIAL 680 Local 55 TETRA HYDRO FURAN (THF) 5455 Import 56 TETRABUTYLAMMONIUM BROMIDE 0.05 Local 57 TOLUENE 20844 Local & Import 58 TRIETHYL ORTHO PROPIONATE 1480 Import 59 TRIETHYLAMINE 1550 Local

viii. Resource optimization/ recycling and reuse

As mentioned in salient features.

ix. Availability of Water its source, energy / power requirement and source: a) Water Source: AKVN b) Quantity of water: 170KLD c) Alternate source of water: No alternate source d) Power requirement: 1500KVA

x. Power Requirement: a) Construction Phase – 500 KVA b) Power source – Grid c) One DG set of 1500 KVA shall be kept as standby arrangement xi. Quantity of wastes to be generated (liquid and solid) and Scheme for their management/ disposal For Liquid Waste

 Zero Liquid discharge system is considered for the plot consisting of Primary, Secondary consisting of Biological & followed by RO, stripper, MEE and ATFD, CEMS will be installed in-line with regulatory requirements.

 Hazardous solid waste storage area having 90days’ storage capacity shall be provided in ETP area.

 Polyhouse is considered for drying of ETP sludge.

. ETP will be in modular design with gravity flow.

 All effluent transfer from manufacturing block to ETP shall be above ground through pipelines.

A. Air Pollution: -

 All Process vents containing Hazardous, Toxic, Solvent/Organic vapors etc shall be routed through vent scrubbers.

 Solvent tanks will be provided with either vent condensers and/or Nitrogen blanketing & breather valve to reduce the emissions due to evaporation of solvents.

 LEL sensors are considered on Process vent condenser outlet interlocked with heating source.

 BIBO units are considered in HVAC exhaust units to trap particulate from exhaust duct. 26

B. Liquid waste: -

 Aqueous Process effluents streams shall be detoxified at source (inside manufacturing plant) before pumping to ETP.

 Sewage and detoxified Process effluents will be routed through closed pipelines from each manufacturing buildings and Utility to the Zero Discharge Effluent Treatment facility located inside plot.

 Solvents & Mother liquor sent for recovery shall be detoxified inside manufacturing area before removing in drums.

 All effluent lines shall be above ground.

C. Hazardous solid waste: -

 Hazardous solid waste shall be sent to Third party for disposal.

 Waste packing materials, Drums, Bins shall be detoxified in plant area before taken for disposal.

D. Green Belt

 Green belt (~33%) around plot is considered with three rows of tree.

E. Energy conservation

 CFC-Free Equipment shall be considered.

 Energy efficient electrical components considered for the plant.

 Designed buildings to maximize day-lighting.

 HVAC heating units considered with cooling water return as a heating source to save energy.

 Power generation with renewable energy like Solar is proposed for street lighting, General block lighting.

 Auto switchover lighting system is proposed for minimum manned area like warehouse.

 Utility block in close proximity of all the manufacturing blocks to reduce pumping energy.

F. Rain Water Harvesting:

 Storm Water drain lines will be connected to Rain Water Harvesting Pits for ground water recharge located at regular intervals within individual plots. 27

ETP Scheme: -

Hazardous Waste Management:

Type Of Waste Quantity Storage Utilization/ Disposal Used oil 1 TPA Covered shed on Given to re-cycler authorized by concrete floor MPPCB/MoEF Oil soaked waste 0.2 TPA Covered shed on Given to re-cycler authorized by concrete floor MPPCB/MoEF / TSDF site Discarded container 5 TPA Covered shed on Given to re-cycler authorized by concrete floor MPPCB/MoEF / TSDF site Chemical sludge 2 TPA HDPE drums in TSDF site covered shed Spent ion Resin 0.5 TPA Covered shed on Given to re-cycler authorized by concrete floor MPPCB/MoEF Spent solvents 400 TPA Covered shed on Given to re-cycler authorized by concrete floor MPPCB/MoEF Process residues & waste 1 TPA Covered shed on Given to re-cycler authorized by concrete floor MPPCB/MoEF Spent catalyst/carbon 3TPA Covered shed on Given to re-cycler authorized by concrete floor MPPCB/MoEF

11. SITE ANALYSIS: i. Connectivity Location Plot No. M12 & M14, Misc. Zone, Phase II, Sector III, Indore SEZ, Pithampur, District Dhar (M.P).- 454775

Place/ District Tehsil-Dhar/ Dist - Dhar

S. Particulars Details No. 1. 22°37'22.03"N 75°37'53.95"E 2. 22°37'25.13"N 75°37'47.86"E 3. 22°37'24.43"N 75°37'55.32"E 4. 22°37'22.99"N 75°37'59.63"E 1 Co-ordinate 5. 22°37'27.41"N 75°38'0.20"E 6. 22°37'29.74"N 75°37'57.56"E 7. 22°37'28.90"N 75°37'57.05"E 8. 22°37'32.23"N 75°37'51.14"E Town – Pithampur – Distance – 5 KM

2 Nearest Town City – Indore – Distance – 36 KM

District Head quarter – Dhar – Distance - 25 KM Nearest Railway Rau Railway Station approx. – 20 KM 3 Station/Town

4 Nearest Airport Indore Domestic Airport approx. - 30 KM 5 Nearest Highway/Road Mhow- Ghatabillod 6 Hills/Valley Narmada Valley 7 Ecological Sensitive Zone None 8 Reserve Forest None 9 Nearest Village Pithampur OdhallNalla 10 Nearest River/ Nalla Choral River Narmada River Lupin Limited ACG Associates Capsules Other industries in 5 km 11 Cipla radius IPCA Glenmark North :OpenLand South :Road 12 Surrounding Features East :Lupin Limited West :Open Land

ii. Land Form, Land use and Land Ownership Project Proponent is having 66958square meter of land which is possession and diverted for industrial purposes. iii. Topography Topography of the area is almost plain. Map is attached. iv. Existing Land use pattern The land use of the project area is pertaining to industrial activity only owned by AKVN. One manufacturing facility of 1030sq meters available currently. This facility earlier was used to manufacture Formulation products. This facility will be converted in Utility block, along with Engineering Store and offices for Engineering and EHS.

v. Land Use Breakup

Total Area Sr.No. Particulars proposed – % use of Land (Sq. Mt.) 1 Total Land Area 66958 100%

2 Built up area 13668 20.4%

2.1 Production blocks 6300 9.4%

Utility (Cooling tower, Panel board, Boiler, 2.2 1770 2.64% Chilling plant, storage tanks)

2.3 R/M and F/G Stores 1200 1.79%

2.4 Office Block including QA and QC 2590 3.86%

2.5 ETP & ZLD 990 1.47%

3 Green belt 22117 33.03%

4 Open Area 31173 46.55%

vi. Soil Classification

The soil in the area is generally of black cotton type soil in some areas. The soil has been classified as ustocherpts/ ustorthents / rhodustalfs / haplustalfs / haplusterts as per pedological taxonomy.

vii. Climate data from Secondary Source:

Tem. Wind Date Tem. (Min) Humidity Wind Speed (Max) Direction 01-May 41 °C 39 °C 18% 32 km/h W 02-May 42 °C 41 °C 16% 19 km/h W 03-May 41 °C 40 °C 12% 23 km/h SW 04-May 41 °C 39 °C 18% 20 km/h W 05-May 40 °C 39 °C 21% 17 km/h W 06-May 41 °C 41 °C 8% 103 km/h W 07-May 39 °C 38 °C 16% 27 km/h WNW 08-May 38 °C 38 °C 18% 21 km/h WNW 09-May 39 °C 39 °C 23% 19 km/h W 10-May 40 °C 40 °C 20% 19 km/h NW 11-May 42 °C 40 °C 18% 17 km/h WNW 12-May 42 °C 41 °C 14% 23 km/h W 13-May 35 °C 32 °C 28% 13 km/h WNW 14-May 39 °C 39 °C 24% 15 km/h WE 15-May 40 °C 40 °C 23% 18 km/h WNW

viii. Social Infrastructure available Social infrastructure like community center, hospital and electricity is available in Pithampur

12. PLANNING BRIEF: i. Planning Concept: The plant shall be installed after receiving environment clearance and consent to establish under air and water act from the MPPCB. ii. Population Projection: The project is small in magnitude. No influx of population is expected as labour shall be deployed from the local villages.

iii Land use planning Land use planning will be as explained under Section 11 of this PFR.

Amenities / facilities

 First aid facility OHCshall be provided at site.  The area shall not being used at all by general public.  A rest shelter shall be provided for workers.  Guards during day & night shall be deputed at site to prevent unauthorized entry.  In case of natural hazards such as earthquake we will take assistance from the local competent authority of Govt.

13. PROPOSED INFRASTRUCTURE

The major plant & machinery required for the proposed project is as given under. Sr. No. Equipment Nos. 1 Reactor 31 2 Agitated Nutsche Filter Dryer 13 3 Agitated Vessel 6 4 AOD Pump 18 5 Blender 3 6 Cold Room 1 7 Heat Exchanger 94 8 Drum Containment System 6 9 Powder Transfer System 16 10 Hot Water System 20 11 Isolator 26 12 Jet Mill 3 13 Centrifugal Pump 16 14 Purified Water System 1 15 Scrubber 2 16 Sifter 3 17 Candle Filter 2 18 Tanks 54 19 Vacuum Pump 25 20 Brine Chiller 2 21 Cooling Tower 2 22 Water Chiller 3 23 Air Compressor 5 24 Nitrogen Generation Unit 1 25 Boiler 1

i. General Description & Type of Boiler Type: Fire Tube Boiler (Gas Fired Boiler with FO Provision) of 2 TPH capacity.

ii. Residential area (Non-Processing area) As the local people from nearby villages shall be engaged in project activity. Therefore, no housing / building are proposed.

iii. Greenbelt Out of 66958 Sq. Mtr area; 22117 sq meter (33%) area will be covered with the good green belt.

iv. Connectivity Site is well connected with by State Highway 52 & 47.

v. Drinking water management Drinking water will be supplied through AKVN with proper RO system.

vi. Sewerage System

The domestic waste shall be taken to ETP.

vii. Industrial waste management As described earlier.

viii. Power Requirement And Supply / Source As described earlier.

14. REHABILITATION & RESETTLEMENT PLAN No R & R plan is required.

15. PROJECT SCHEDULE AND COST ESTIMATE Schedule of Implementation

a. Commencement & Completion - one to one half year from the date of commencement b. Civil Work - One year from the date of commencement of civil work c. Plant & Machinery - 6 months from the date of releasing purchase order and payment d. Erection - 3- 6 months after receiving the equipment e. Commissioning - 3 months – 6 months f. Trial Run - 3 months for dummy trials and Process trials as per R&Dschedule g. Commercial Production- 1 to 3 months from the date of trial batches

Water Consumption Waste water Generation Sr.No. Heads (KLD) (KLD) 1 Manufacturing Process 3.0 3.0

2 Domestic 5.8 5.8 Industrial Equipment 3 6.3 6.3 Washing/ Cleaning 4 Facility Cleaning 14.9 14.9

5 Gardening 15.5 -

6 Boiler 40.3 4.5

7 Cooling 70.0 12.1

TOTAL 155.8@ 170 KLD 46.6

Estimated project cost

Total SR. NO. DESCRIPTION INR IN LACS 1 Civil 5,365 2 Process Equipment’s 4,651 3 Mechanical 3,354 4 Electrical 1,292 5 Instrumentation & Automation 613 6 EHS 491 7 ETP 300 8 Quality Control & Stores 1,525 9 Others 880 Total 18,471

16. ANALYSIS OF PROPOSAL (FINAL RECOMMENDATION)

Financial and social benefits with special emphasis on the benefit to the local people including tribal population, if any, in the area.

From the foregoing analysis, it is observed that proposal is environmental compatible and will help to people improving their financial status, performance and repayment capability. This also helps the company in venturing into production of APIs which will eventually elevate their profits and also their ranking in the industry. CSRprogram shallbe executed through the group discussionand need base program will be proposed for the area, bywhich people of the area will be benefitted.