ASTRIX LABORATORIES LIMITED SY. NO. 10 & 42, IDA, GADDAPOTHARAM VILLAGE, JINNARAM MANDAL, MEDAK DISTRICT, ANDHRA PRADESH PRE FEASIBILITY REPORT Sy. No. 10 & 42, IDA, Gaddapotharam (V), Jinnaram (M), Medak (Dist.) 502 319 Phone: +91 040 3049 3876, 8008001511 E mail ID: srinivas.gangavarapu@mylan.in SUBMITTED TO MINISTRY OF ENVIRONMENT AND FORESTS, GOVERNMENT OF INDIA PARYAVARAN BHAVAN, LODHI ROAD, NEW DELHI
Pre Feasibility Report M/s., Survey No. 10 & 42, IDA, Gaddapotharam Village, Jinnaram Mandal, Medak District, AndhraPradesh 502 319 1. Executive Summary M/s., propose to expand its existing Bulk Drugs and intermediate manufacturing facility from 38.2 TPM to 70 TPM with addition of Co- Generation Power Plant of 5 MW Capacity located at Sy.No. 10 & 42, IDA, Gaddapotharam (Village), Jinnaram (Mandal), Medak (District), in Andhra Pradesh. The unit has about 28.5 acres of land. The site is having a longitude 78 0 23 02 (E) and latitude 17 0 35 53 (N). The plant is surrounded by AET Laboratories in north, IDA road followed by TSDF in south, open land followed by Unisocks in east and IDA road followed by TPS Laboratories, open land in west directions. The nearest human settlement from the site is Sambhupur village located at distance of 0.95 km from the site. There are no ecologically sensitive areas like national parks, sanctuaries within 10 km radius of the site. 2. Introduction of the Project / Background Information: 2.1 Identification of Project and Project Proponent: The objective of this pre-feasibility study is to provide information for the expansion of Synthetic Organic Chemicals manufacturing unit from 38.2TPM to 70TPM and 5MW cogeneration power plant at Sy.No. 10 & 42, IDA, Gaddapotharam (Village), Jinnaram (Mandal), Medak (District), in Andhra Pradesh, in existing area of 28.5 acres. 2.2 Brief Description of Nature of the Project: The synthetic organic chemicals manufacturing will involve series of chemical reactions to get the final Product. The products of reaction are purified, filtered and dried before packing as the final product. The Chemical reactions require various supporting services like Heating, Cooling and Agitation etc. 1 P age
2.3 Need for the project and its importance to the country and or region: World population is growing at an alarming rate. In the Indian sub continent also, population growth is more than that of developed countries. To meet the needs and comforts of ever-growing population, industrialization became inevitable. For the growing population the needs of health care substitutes are also increasing. The proposed expansion caters the Medical needs of the population s2.4 Demands-Supply Gap: The project is envisaged to meet the demand supply gap in both domestic market and export market, as API demand is increasing day by day. 2.5 Imports Vs. Indigenous Production: The project shall enhance the foreign exchange reserves in view of the proposed products. 2.6 Domestic/export Markets: The products shall cater to both domestic and export markets. 2.7 Employment Generation (Direct and Indirect) due to the project: The present project for manufacturing of Synthetic Organic Chemicals requires substantial handling of raw materials, goods in process and finished goods. The proposed expansion shall increase the employment potential. 3. Project Description 3.1 Type of Project including interlinked and interdependent projects, if any: The objective of this pre-feasibility study is to provide information for the expansion of Synthetic Organic Chemicals from 38.2TPM to 70TPM and 5MW co-generation power plant at Sy.No. 10 & 42, IDA, Gaddapotharam (Village), Jinnaram (Mandal), Medak (District), in Andhra Pradesh, in existing area of 28.5 acres. 2 P age
3.2 Size or magnitude of operation: List of products and manufacturing capacity Manufacturing Capacity After Expansion S.No Name of the Product Quantity TPM Kg/day 1 Nevirapine 15 500 2 Lamivudine 30 1000 3 Emtricitabine 15 500 4 Zidovudine 5 166.67 5 Efavirenz 0.8 26.67 6 Stavudine 0.7 23.33 7 Lopinavir 0.5 16.67 8 Ritanovir 0.5 16.67 9 Didanosin 1 33.33 10 Clopidogrel Bisulphate 0.5 16.67 11 Atomoxatine HCl 0.1 3.33 12 Fluindione 0.4 13.33 13 Validation products 0.5 16.67 Total 70 2333.3 Co-Generation Power Plant 5 MW 3.3 Process Description with process details (a schematic diagram/flow chart) Typical process description with process details is presented in Annexure I of FORM I Application. 3.4 Raw material required along with estimated quantity likely source, marketing area of final product/s, mode of transport of raw material and finished product. All the raw materials required for manufacturing mostly available in India or from abroad. There are no banned chemicals or products which are proposed to be used. It is proposed to enter into long term arrangements with some of the raw material suppliers both in India and overseas to avoid shortages at any time. 3.5 Availability of water its source, energy/power requirement and source should be given The total water requirement shall increased from 164.01 KLD to 916.5 after expansion out of which 666 KLD shall be drawn from HMWS (Industrial Supply) and balance shall be recycled water.. The total water balance is presented table below. 3 P age
Total Water requirement After Expansion (Tentative) Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water Recycled Water Loss Wastewater Process & Washings 53 53.5* Scrubber 5 5 Solvent recovery plant 2 2 Boiler 216 196 20 Process & Utility RO rejects to Cooling 144.04** 250.5 420.54 80 tower make-up Cooling Tower 106 DM Plant, Softener & Purified water system 35 35 Detoxification 5 5 ZLD Washings 10 10 Water for gardening 50 50 Domestic 40 40 Gross Total 666 250.5 666.5 250.5 Total 916.5 917 * Process effluents contain soluble raw materials, byproducts, solvents etc. **144.04 KLD generated from process & Utility RO is being recycled into Cooling Tower for make up. 3.5.1 Electricity: The requirement of power will be 5 MW. Further, due to the nature of the reactions and requirement of continuous power, the management proposes to put in place 100% self generation of power by DG sets of 8085 KVA total capacity. Therefore no delay or difficulty is foreseen on the power front. Surplus power if any generated from the 5 MW Captive power generation plant will be utilized in Mylan Laboratories Limited, Unit 1, which is adjacent to our plant and also part of Mylan Group of industries. 4 P age
3.6 Quantity of wastes to be generated (liquid and solid) and Scheme for their Management/disposal Quantity of Effluent Generated and Mode of Treatment After Expansion (Tentative) Description of Effluent Quantity (KLD) Mode of Final Disposal Permitted After Expansion HTDS Effluents Process 23.9 51.5 Treated in effluent treatment plant consist of Stripper, MEE, ATFD and Biological treatment followed by RO. RO Permeate reused for cooling tower makeup and RO rejects sent to MEE. Total HTDS 23.9 51.5 LTDS Effluents Washings Effluent 2 Sent to Biological Treatment System Scrubber Effluent 5 Solvent recovery plant 2 Boiler 8 20 Cooling Tower 5 80 DM Plant, Softener & Purified 7 35 water system Detoxification 5 ZLD Washings 10 Domestic 14 40 followed by RO. RO permeate reused for cooling tower makeup. RO rejects sent to MEE. Total LTDS 34 199 Grand Total (HTDS+LTDS) 57.9 250.5 5 P age
Solid Wastes and Disposal After Expansion (Tentative) S.No Description of waste UOM Permitted After Expansion Disposal method 1.Hazardous Waste with Disposal Option: 1 Forced Evaporation Salts Kg/day 430 3125.6 TSDF 2 ETP Sludge Kg/day 100 2000 TSDF 3 Process Inorganics Salts Kg/day 787.33 1078.47 TSDF 4 Mixed Spent Solvents KL/day 16.7 25 TSDF / Cement Industry 5 Spent Carbon Kg/day 283.3 1587.9 TSDF / Cement Industry 6 Distillation bottom residue Kg/day 645.7 1501.1 TSDF / Cement Industry (including process organics) 7 Thermocol Kg/day 50 TSDF 8 Insulation Waste Kg/day 50 TSDF 9 Glass wool Kg/day 50 TSDF 10 Softener / DM Plant Resins Kg/day 35 TSDF 11 Off specifications, rejected & Kg/day 25 TSDF / Cement Industry Discarded Raw materials, lab chemicals & products etc 12 Stripper Distillate ( VOC) KL/Day 2 TSDF / Cement Industry 13 Used Filters (HEPA filters Oil Nos / 20 TSDF for Incineration Filters etc) Month 14 Discarded PPE Kgs / day 30 TSDF for Incineration 2.Hazardous Waste with Recycling Option : 15 Discarded Container & liners Dispose off to outside a HDPE containers No's/ M 300 500 agencies after b Glass Bottles No's/ M 250 300 detoxification c Plastic Containers No's/ M 250 300 d Liners & bags Kg/day 500 1000 16 Used Oil LPM 200 500 Authorized recyclers 17 Distilled Industrial waste solvent after recovery (colorless ) KL/day 10 Sale to authorized recyclers 18 Spent Solvents KL/day 24.266 25 Recovered within the premises / Sale to authorized recyclers 19 Lead acid batteries No's/Year 50 Authorized recyclers 20 E- Waste Kg/day 50 E waste Disposal facility 3. Non Hazardous Waste : 21 Paper, cotton waste & Packing materials i.e.wood, carton, ropes 22 Ply wood containers/ broken glass etc 23 Metal scrap ( MS, SS, GI,Aluminum) TPM 25 Sale to out side agencies/ recyclers TPM 10 Sale to out side agencies/ recyclers TPM 25 Sale to out side agencies/ recyclers 24 Coal Ash / Fly Ash TPM 1000 TSDF to use as a stabilizing agent / Brick manufactures 6 P age
4. Site Analysis 4.1 Plant Location M/s., proposed to expand its existing Bulk Drugs and intermediate manufacturing facility from 38.2 TPM to 70 TPM with addition of Co- Generation Power Plant of 5 MW Capacity located at Sy.No. 10 & 42, IDA, Gaddapotharam (Village), Jinnaram (Mandal), Medak (District), in Andhra Pradesh. The company has about 28.5 acres of land. The site is having a longitude 78 0 23 02 (E) and latitude 17 0 35 53 (N). The plant is surrounded by AET Laboratories in north, IDA road followed by TSDF in south, open land followed by Unisocks in east and IDA road followed by TPS Laboratories, open land in west directions. The nearest human settlement from the site is Sambhupur village located at distance of 0.95 km from the site. There are no ecologically sensitive areas like national parks, sanctuaries within 10 km radius of the site. 5. Planning Brief: The project is envisages to be completed by December 2015, and the production shall be initiated thereon. Consultants are identified for preparing the detailed project report. 6. Proposed Infrastructure: 6.1 Power Requirement and Supply/Source Existing connected power load from AP Transco is 4686 HP and proposed connected power load is 7500 HP. 6.2 Utilities List of Utilities S.No Description Capacity Existing Proposed Total after Expansion 1 Coal Fired Boiler 1 x 8 TPH 1 x 30 TPH 1 x 30 TPH 1 x 8 TPH 2 Furnace Oil Fired 1 x 4 TPH -- 1 x 4 TPH Boiler 3 DG Set* 2 x 380 KVA 2 x 1025 KVA 2 x 380 KVA 1 x 500 KVA 2 x 1500 KVA 1 x 500 KVA 1 x 750 KVA 1 x 750 KVA 1 x 1025 KVA 3 x 1025 KVA 2 x 1500 KVA * DG set will be used during load shut down. 7 P age
Equipments The basic equipment involved in the manufacturing of Bulk drugs is the process Kettles, Heat Exchangers, Centrifuges, and Storage Tanks. To support the process equipment Boilers, Chilling plants, Cooling Towers Etc. are required. All the above equipment can be sourced indigenously and the lead time to supply the equipment will not exceed 20 weeks. 6.3 Waste management Liquid Effluents The main sources of effluent generation from the plant are process, washings, Scrubber, blow downs from utilities like cooling tower, boiler & domestic effluents. The process effluents are segregated on the basis on TDS and COD loads and treated in Effluent treatment system. Air Pollution The sources of air pollution in the plant are from the existing 1x8 TPH Coal fired boiler, 1x4 TPH FO fired boiler and proposed 30 TPH coal fired to meet the steam requirement both for co-generation and process and existing backup DG sets of 2x380, 1x500, 1x1025 and 1x750 KVA and proposed 2x1025 and 2x1500 KVA, to cater to energy requirement during load shut downs. The proposed air pollution control equipment for coal fired boiler is bag filter. DG sets shall be provided with stack heights based on the CPCB formula for effective stack height. Solid waste Solid wastes are generated from the process, solvent distillation, distillate from stripper, salts from ATFD, sledges from ETP (primary & secondary), waste oil from DG sets, used batteries from DG sets. The stripper distillate, process organic residue and solvent residue are sent to TSDF/cement plants for co-incineration. The evaporation salts are sent to TSDF. Filter media like spent carbon; catalyst and hyflow are sent to TSDF/authorized recyclers. Waste oil and used batteries from the DG sets are sent to authorized recyclers. The sludge from effluent treatment plant is considered hazardous and the same is sent to TSDF. The ash from boiler is sold to brick manufacturers. The other solid wastes expected from the unit are containers, empty drums which are returned to the product seller or sold to authorize buyers after detoxification. 7. Rehabilitation and Resettlement (R&R) Plan Not applicable as the land area is only 28.5 acres already acquired. 8 P age
8. Project Schedule & Cost Estimates 8.1 Likely date of start of construction and likely date of completion (Time schedule for the project to be given) December 2015 8.2 Estimated project cost along with analysis in terms of economic viability of the project The estimated cost of the project is approximately Rs.60 Crores. Project Cost Rs. In Crores Plant& machinery 39.75 Civil buildings 0.83 Structures 0.75 Total 41.33 Pipe lines & insulation 20% on plant & machinery 8.27 Electricals & instrumentation 10% on plant & machinery 4.14 Erection & commissioning & painting 8% on plant & machinery and 3.30 structures Land & development 0.08 Furniture, fixtures, computers, lighting etc 0.05 Total 57.15 Contingencies & pre-operative expenses 5% on the above 2.9 Project Cost 60 9 P age