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Pre Feasibility Report for Manufacturing of Apis

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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 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 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 3 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. 4 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. 5 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. 6 ii. Location (map showing general location, specific location, and project boundary & project site layout) with Coordinates: Location Map 7 Most Recent Satellite Image of the Project area 8 Topographical Base Map (Ref: Survey of India Toposheet No.46 N10) 9 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. 10 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 11 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 12 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 13 4. Beclomethasone Dipropionate Anhydrous Batch Input Qty 25 Kg Methylene Dichloride 166 Kg β- Methyl Epoxide 25 Kg Hydrochloric Acid 141 Kg
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