M/s. ARTEMIS BIO TECH LTD., (A Division of Themis Medicare Ltd.,) PLOT NO. 1 & 5, Phase I, IDA, JEEDIMETLA, QUTUBULLAPUR MANDAL, RANGAREDDY DISTRICT, TELANGANA PRE FEASIBILITY REPORT Artemis Bio tech Ltd., Plot No. 1 & 5, Phase I, IDA, Jeedimetla, Rangareddy 500 054. Phone: 040 23095293/94 Mobile: +91 9392494945 E mail: damodar.reddy@themismedicare.com ablra@themismedicare.com SUBMITTED TO STATE LEVEL ENVIRONMENT IMPACT ASSESSMENT AUTHORITY, TELANGANA, GOVERNMENT OF INDIA
Pre Feasibility Report M/s. Artemis Bio-tech Ltd., (A Division of Themis MedicareLtd.,) Plot No. 1 & 5, Phase I IDA, Jeedimetla, Rangareddy 500 054,Telangana, India 1. Executive Summary M/s. Artemis Bio-tech Ltd., propose to expand its existing Bulk Drugs and intermediate manufacturing facility from 0.84 TPM to 15.2 TPM at existing site area of 4.06 acres located at Plot No. 1 and 5, Phase I, IDA Jeedimetla, Quthbullapur Mandal, Rangareddy District in Telangana. The site is having a longitude 78 0 22 42.90 (E) and latitude 17 0 31 27.93 (N). The site is surrounded by Gimmi steels in south direction, Open plot in west direction and approach roads in north and east directions. The nearest human settlement from the site is Chintal located at a distance of 0.5 Km to the industrial estate premises. Dulapalle RF at a distance of 1.5 km in north direction, Gajularamaram RF at a distance of 3.5 km in northwest direction, Pochampalli RF at a distance of 6.5 Km in north direction and Gaudavalli RF at a distance of 6.7 km in north direction respectively. There are no ecologically sensitive areas like national parks, and sanctuaries within 10 km radius of the site. The site is located at a distance of 8.85 Km from the critically polluted area of Patancheru and Bollaram Industrial estates. 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 0.84 TPM to 15.2 TPM at Plot No. 1 and 5, Phase I, IDA Jeedimetla, Quthbullapur Mandal, Rangareddy District in Telangana, in existing area of 4.06 acres. Project Proponent Details Mr. Mohan.S.Divi, Managing Director The project proponent T. Damodhar Reddy (Vice-President) with an extensive operational experience in the area of API s process developments and commercialization. 1 P age
2.2 Brief Description of Nature of the Project: The manufacturing process for both Lovastatin and Fumagillin DCH salt involves biotechnology route of fermentation. Simvastatin is manufactured by organic synthesis using Lovastatin as raw material. Batch fermentation processes involve three basic steps: inoculum and seed preparation, fermentation, and product recovery or isolation. Inoculum preparation begins with a spore sample from a microbial strain. The strain is selectively cultured, purified and grown using a battery of microbiological techniques to produce the desired product. Chemical synthesis produces Simvastatin using Lovastatin as raw material. The manufacture involves methylation, and hydrolysis reactions. 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 2.4 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 manufacturing unit from 0.84 TPM to 15.2 TPM at Plot No. 2 P age
1 and 5, Phase I, IDA Jeedimetla, Quthbullapur Mandal, Rangareddy District in Telangana, in existing area of 4.06 acres. 3.2 Size or magnitude of operation: List of products and manufacturing capacity Manufacturing Capacity S.No Name of the Product Capacity (TPM) Permitted* After Expansion** 1 Dimethyl Chloro Tetra Cycline 0.84 -- 2 Simvastatin 0.1 10 3 Fumagillin DCH Salt 0.04 0.2 4 Lovastatin VSP 0.2 5 Total 1.18 15.2 * Only one product will be manufactured at any point of time on campaign basis ** All three products will be manufactured. 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 Water is required for process, scrubbers, washing, cooling tower makeup, steam generation and domestic purposes. The required water shall be drawn from TSIIC (industry supply) in addition to reuse of treated wastewater. The total water requirement after expansion is in the order of 121 KLD consisting of 73 KLD fresh water and the remaining of 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 Effluent Process 18 18.5* Washings 5 5 Scrubber 2 2 Boiler Feed 20 17 3 RO/DM Rejects 5 5 Cooling Tower 15 48 51 12 Domestic 6 1 5 Gardening 2 2 Gross Total 73.0 48 71.0 50.51 Total 121.0 121.51 * Process effluents contain soluble raw materials, byproducts, solvents etc. 3.5.1 Electricity: The requirement of power will be 2000 KVA 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 (Tentative) Description Quantity (KLD) Mode of Treatment Permitted After Expansion HTDS Effluents (TDS & COD> 15000 mg/l) Process 3 18.5 Sent to Stripper followed by MEE and Washings 5 ATFD. Scrubber Effluent 2 Stripper Condensate sent to Cement Plants RO/DM Rejects 5 for Co-Incineration. MEE and ATFD Condensate sent to Biological treatment plant followed by RO. RO rejects sent to MEE and permeate is reused in cooling towers make-up. Total (I) - HTDS 3 30.5 LTDS Effluents (TDS & COD< 15000 mg/l) Process & Washings 14.5 Sent to Biological Treatment System DM Wash Water 2.5 followed by RO. RO permeate reused for Boiler Blow downs 3 3 cooling tower makeup. RO rejects sent to Cooling Tower Blow 12 MEE downs Domestic 5 5 Total (II) - LTDS 25 20 Grand Total (I+II) 28 50.5 4 P age
Solid Wastes and Disposal (Tentative) S.No Description Units Quantity After Expansion Mode of Treatment/Disposal 1 Ash from Boiler TPD 12 Sold to Brick manufactures 2 Solvent residue TPD 0.12 Sent to TDSF/Cement Plants for Coincineration 3 Process Organic residue TPD 0.18 Sent to TDSF/Cement Plants for Coincineration 5 Filter Aid TPD 0.24 Recovered within the plant premises and resued. 6 Spent Carbon Kg/day 30 Sent to TDSF/Cement Plants for Coincineration 7 Spent Solvents KLD 10 Recovered within the plant premises. 8 Mixed Solvents KLD 4.2 Sent to authorized recovery units/cement plants for co-incineration 9 Stripper Distillate KLD 0.3 Sent to Cement Industries for Coincineration. 10 Evaporation salts TPD 0.4 Sent to TSDF 11 ETP Sludge TPD 0.14 Sent to TSDF 12 Detoxified containers No.s/Yr 70 Sold to authorized vendors 13 Waste oil LPM 50 Sent to Authorized Recyclers 14 Used batteries No.s/Yr 10 Sent to Authorized Recyclers 4. Site Analysis 4.1 Plant Location M/s. Artemis Bio-tech Ltd., propose to expand its existing Bulk Drugs and intermediate manufacturing facility from 0.84 TPM to 15.2 TPM at existing site area of 4.06 acres located at Plot No. 1 and 5, Phase I, IDA Jeedimetla, Quthbullapur Mandal, Rangareddy District in Telangana. The site is having a longitude 78 0 22 42.90 (E) and latitude 17 0 31 27.93 (N). The site is surrounded by Gimmi steels in south direction, Open plot in west direction and approach roads in north and east directions. The nearest human settlement from the site is Chintal located at a distance of 0.5 Km to the industrial estate premises. Dulapalle RF at a distance of 1.5 km in north direction, Gajularamaram RF at a distance of 3.5 km in northwest direction, Pochampalli RF at a distance of 6.5 Km in north direction and Gaudavalli RF at a distance of 6.7 km in north direction respectively. There are no ecologically sensitive areas like national parks, and sanctuaries within 10 km radius of the site. The site is located at a distance of 8.85 Km from the critically polluted area of Patancheru and Bollaram Industrial estates. 5 P age
5. Planning Brief: The project is envisages to be completed by December 2016, 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 Total Power requirement shall be 2000 KVA same shall be drawn from TSSPDCL. DG set of 1000 KVA proposed in addition to existing 2 x 500 KVA shall be used during load shut down period. 6.2 Utilities List of Utilities S.No Description Capacity Existing Proposed Total after Expansion 1 Coal Fired Boiler 2 x 2.5 TPH 1 x 2.5 TPH 3 x 2.5 TPH 3 DG Set* 2 x 500 KVA 1 x 1000 KVA 1 x 1000 KVA 2 x 500 KVA * DG set will be used during load shut down. 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 from the plant are from proposed 2.5 TPH coal fired boiler and existing 2 x 2.5 TPH coal fired Boiler, and DG set of 2 x 500KVA existing and proposed 1000 KVA capacity. The proposed air pollution control equipment for coal fired boiler is multi cyclone separators. DG sets shall be provided with effective stack height. DG sets shall be provided with stack heights based on the CPCB formula for 6 P age
effective stack height. Carbondioxide shall be released from process and same shall be let out into atmosphere safely through standard operating procedure. Solid waste Solid wastes are generated from process, solvent distillation, stripper, ATFD, ETP (primary & secondary), and DG sets. The stripper distillate, process residue and solvent residue are sent to cement plants for co-incineration. The evaporation salts are sent to TSDF. Filter media like activated carbon and hy-flow are sent to TSDF. Waste oil and used batteries from the DG sets are sent to authorize recyclers. The sludge from effluent treatment plant is sent to TSDF. Ash generated from coal fired boilers sent 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 authorized buyers after detoxification. 7. Rehabilitation and Resettlement (R&R) Plan Not applicable as the land area is only 4.06 acres and the same is already acquired. 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 016 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. 350 Lakhs. Project Cost Rs. Lakhs Land & development 8 Plant& machinery 195 Civil buildings 32 TP Plant & other environmental infrastructure 32 Total - I 267 Pipe lines & insulation 20% on plant & machinery 38 Electricals & instrumentation 10% on plant & machinery 20 Erection & commissioning & painting 10 Safety equipment 15 Total - II 83 Project Cost (I+II) 350 7 P age
M/s. ARTEMIS BIO TECH LTD., (A Division of Themis Medicare Ltd.,) PLOT NO. 1 & 5, Phase I, IDA, JEEDIMETLA, QUTUBULLAPUR MANDAL, RANGAREDDY DISTRICT, TELANGANA STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants QCI: MoE&F OM, List A 1, S.No.25. (An ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007 Certified Organization) B 115, Annapurna Block, Aditya Enclave Ameerpet, Hyderabad 500 038. Phone: 040 23748 555/616, Telefax: 040 23748666 Email: teamlabs@gmail.com