DASAMI LAB PVT.LTD. (Formerly Known as Medchem Organics Pvt. Ltd.) SY.NO. 404, 405, 407, 408, 409 & 410, VELIMINEDU VILLAGE, CHITYAL MANDAL, NALGONDA DISTRICT, TELANGANA PRE FEASIBILITY REPORT M/s. Hazelo Lab Pvt. Ltd.. Plot No: 7 2 A2 Hetero Corp, Industrial Estate, Sanathnagar, Hyderabad 500018 Phone: 040 23704923/23704924 E mail: jagadeeshwar.v@heterodrugs.com SUBMITTED TO MINISTRY OF ENVIRONMENT, FORESTS AND CLIMATE CHANGE GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI
Pre Feasibility Report M/s. Dasami Lab Pvt.Ltd., Survey No.404, 405, 407,408, 409 & 410 Veliminedu Village, Chityal Mandal, Nalgonda District, Telangana. 1. Executive Summary M/s. Dasami Lab Pvt. Ltd., (formerly known as Medchem Organics Pvt.Ltd.) proposed to expand its Bulk Drug & Intermediates Manufacturing Unit at Sy.No. 404, 405, 407, 408, 409 & 410, Veliminedu Village, Chityal Mandal, Nalgonda District, Telangana. The total area acquired for proposed expansion in addition to existing areas is 51 acres. The site is having a longitude 79 0 2 45.76 E and latitude 17 0 13 27.56 N. Chinna Vagu is in SW direction at a distance of 7.1 Km from the site. There are two Reserve forests in the study area; Chityala RF at a distance of 6 Km in east direction, Shivanenigudem RF at a distance of 9 Km in NE direction of the site. 2. Introduction of the Project 2.1 Identification of Project and Project Proponent: The objective of this pre-feasibility study is to provide information for proposed expansion of Bulk Drug and Intermediates Manufacturing with Production Capacity from 15 TPM to 421 TPM at Sy.No. 404, 405, 407, 408, 409 & 410, Veliminedu Village, Chityal Mandal, Nalgonda District, Telangana. It is proposed to increase the manufacturing capacity from 15 TPM to 421 TPM by acquiring additional land of 43.875 acres in addition to existing 7.125 acres of land; total land area after expansion is 51 acres. Expansion includes addition of production blocks, facility for utility proposed and enhancement of ZLD system. 2.1 Brief Description of Nature of the Project: The Bulk Drug & Intermediates manufacturing will involve series of chemical reactions to get the final Product. The products of reaction are purified, filtered and dried before packing the final product. The Chemical reactions require various supporting services like Heating, Cooling and Agitation etc. 1 P age
2.2 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 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. 2.3 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. 2.4 Imports Vs. Indigenous Production: The project shall meet the reduce imports in some of the intermediate products and also enhance the foreign exchange reserves in view of the proposed exports of few products. 2.5 Domestic/export Markets: The products shall cater to both domestic and export markets. 2.6 Employment Generation (Direct and Indirect) due to the project: The present project for manufacturing of Bulk Drugs & Intermediates requires substantial handling of raw materials, goods in process and finished goods. It is expected that the following employment will be generated by the project: 3. Project Description 3.1 Type of Project including interlinked and interdependent projects, if any: M/s.Dasami Lab Pvt.Ltd., (formerly known as Medchem Organics Pvt.Ltd.) proposes to expand the Manufacturing capacity from 15 TPM to 421 TPM by addition of production block, additional facility for utility proposed and enhancement of ZLD system at Sy.No. 404, 405, 407, 408, 409 & 410, Veliminedu Village, Chityal Mandal, Nalgonda District, Telangana. 3.2 Size or magnitude of operation: M/s. Dasami Lab Pvt.Ltd., (formerly known as Medchem Organics Pvt.Ltd.) Located at Sy. No. 404, 405, 407, 408, 409 & 410, Veliminedu Village, Chityal Mandal,, Nalgonda District, Telangana. Obtained consent and authorization (CFO) for manufacturing of 15 TPM of Drugs & Intermediates vide Letter No. TSPCB/256/RCP/NLG/HO/CFO/2014-196 dated 22.11.2014. It is proposed to expand the manufacturing capacity from 15 TPM to 421 TPM and expansion of existing 2 P age
land area to 51 acres by addition of production block, additional facility for utility proposed and enhancement of ZLD system. Capacity after proposed expansion is presented in Table A-1. Table A-1 Manufacturing Capacity After Expansion S.No Name of the Product Capacity TPM 1 Amlodipine Besylate 20 2 Aprimilast 3 3 Bocepravir 6 4 Bupropion Hcl 20 5 Carvedilol 30 6 Clopidogrel Hydrogen Bisulfate 10 7 Colisevelam 6 8 Dalfampridine 17 9 Dex lansoprazole 5 10 Divalproex Sodium 15 11 Drotaverine Hcl 3 12 Duloxetine HCL 15 13 Esli Carbazapine 2 14 Fexofenadine Hcl 10 15 Glimepride 3 16 Lansoprazole 8 17 Lomitapide 2 18 Mesalamine 7 19 Nebumitone 10 20 Omeprazole 5 21 Piperquine Phosphate 5 22 posacanazole 7 23 Ramipril 7 24 Ranolazine 10 25 Sevelamir Hcl 29 26 Sparfloxacin 20 27 Telapravir 5 28 Ticagrelor 1 29 Tramadol Hcl 12 30 Valacyclovir 6 31 Valagancyclovir Hcl 2 Oncology 32 Abiraterone Acetate 1 33 Anastrozole 2 34 Bendamustine Hydochloride 2.5 35 Bexarotene 3 36 Bicalutamide 5 37 Bortezomib 0.5 3 P age
38 Carboplatin 5 39 Capecitabine 2 40 Cisplatin 2 41 Cyclophosphamide 2 42 Dasatinib 2 43 Emtricitabine 30 44 Erlotinib HCl 4 45 Gefitinib 2 46 Gemcitabine HCl 1 47 Imatinib Mesylate 16 48 Irinotecan HCl 14 49 Lapatinib Ditosylate Monohydrate 2 50 Letrozole 2.5 51 Nilotinib HCl 2 52 Oxaliplatin 4 53 Pazopanib Hydrchloride 2 54 Pemetrexed Disodium 0.5 55 Sorafenib Tosylate 6 56 Temozolomide 1 57 Sunitinib Malate 6 Total 421 4 P age
3.3 Process Description with process details (a schematic diagram/flow chart) Process description is as in the Form I Annexures. 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 required water shall be drawn from ground water sources in addition to reuse of treated wastewater. The total water requirement after expansion is of 487.2KLD consisting of 292.2KLD fresh water and the remaining of recycled water. Total water balance is presented in Table below. Total Water Balance After Expansion Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water Recycled Water Loss Effluent Process 113.2 118.4 Washings 10 10 Scrubber 5 5 Boiler Feed 95 85 10 Cooling Tower 10 190 164 36 RO/DM Plant 24 24 Domestic 25 5 20 Gardening 15 15 Gross Total 292.2 195 269.0 223.44 Total 487.2 492.4 3.5.1 Electricity: The required energy shall be drawn from TSPDCL. DG set of 3 x 1000 KVA is proposed in addition to existing 380 KVA DG set. 5 P age
3.6 Quantity of wastes to be generated (liquid and solid) and Scheme for their Management/disposal: The sources of effluent generation from the plant are from the process, Floor & reactor washings, Utilities, QC, R&D, Scrubber and plant domestic waste. The Effluent Treatment details and the Solid Waste Management details are listed in the below tables. Quantity of Effluent Generated and Mode of Treatment Description Quantity (KLD) Mode of Treatment Permitted After Expansion HTDS Effluents Process 20.8 118.44 Sent to Stripper. Stripper Washings 3 10 condensate shall dispose to cement Scrubber Effluent 5 industries for co-processing/tsdf. RO/DM Plant Rejects 24 Stripper bottom sent to MEE followed by AFTD. Condensate from MEE shall be sent to biological treatment plant followed by RO. RO rejects sent to MEE and permeate is reused in cooling towers and boiler make-up and scrubbers. Total I 23.8 157.44 LTDS Effluents QC and R&D 1 Boiler Blow downs 3 10 Sent to Biological Treatment Cooling Tower Blow 36 System followed by RO. RO downs Domestic 3 20 permeate reused for cooling tower makeup and Scrubbers. RO rejects sent to MEE. Total II 7 66 Grand Total (I+II) 30.8 223.44 6 P age
Total Solid Waste Generated and Mode of Disposal S.No Description Units Quantity Mode of Permitted After Expansion Treatment/Disposal 1 Ash from Boiler TPH - 1.9 Sold to Brick manufactures and cement plants 2 Organic residue+solvent Residue TPD 1.6 11.5 Sent to TDSF, Dundigal, RR District or Coincineration/Cement Plants for Co-processing 3 Spent Carbon TPD 0.06 0.99 Sent to TSDF/Cement Industries 4 Stripper Distillate KLD 5.6 Sent to TSDF/Cement Industries 5 Inorganic Residue TPD 1.2 6.76 Sent to TDSF, Dundigal, 6 Evaporation salts TPD 9.23 RR District for secured land filling 7 ETP Sludge Kg/day 25 923 Sent to TSDF 8 Detoxified containers & container liners No.s/Mo nth -- 500 Sold to authorized vendors 9 Waste oil KLPA 2 5.28 Sent to Authorized Recyclers 10 Used batteries No.s/Yr 3 10 Sent to Authorized Recyclers 4. Site Analysis 4.1 Plant Location M/s. Dasami Lab Pvt.Ltd., proposed to expand its Bulk Drug & Intermediates Manufacturing Unit at Sy.No. 404, 405, 407, 408, 409 & 410, Veliminedu Village, Chityal Mandal,Nalgonda District, Telangana. The total area acquired for proposed expansion in addition to existing areas is 51acres. The site is having a longitude 79 0 2 45.76 E and latitude 17 0 13 27.56 N. Chinna Vagu is in SW direction at a distance of 7.1 Km from the site. There are two reserve forests in the study area; Chityala RF at a distance of 6 Km in east direction, Shivanenigudem RF at a distance of 9 Km in NE direction of the site. 7 P age
5. Planning Brief: The project is envisages to be completed in Phase wise as it involves installation of higher capacity processing equipment s besides improving of yield 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 The required energy shall be drawn from TSPDCL. The power shall be drawn from existing DG sets during load shut downs. DG set of 3X1000 KVA is proposed in addition to existing 380 KVA DG set. It is proposed to establish 2 x 10 TPH coal fired boiler in addition to existing 5TPH coal fired boiler to meet the steam requirement both for process and ZLD system. 6.2 Utilities List of Utilities S.No Utility Permitted Proposed After Expansion 1 Coal Fired Boilers 5TPH 2 x 10 2 x 10 TPH 1 x 5TPH 2 DG Sets (KVA)* 1x 380 3 x 1000 3 x 1000 1 x 380 * DG set will be used during load shut down. Equipments The basic technology 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. The effluent generated from the domestic sent to 8 P age
biological treatment plant along with LTDS effluents. Treated effluent reused for cooling towers make-up. Air Pollution The sources of air pollution from the plant are from utilities existing and proposed. The emissions from the boilers are passed through bag filters before releasing into atmosphere through a chimney. Coal Ash will be collected in ash silo to dispose in closed condition. The stack heights are provided as per the guidelines of CPCB for effective stack heights. Solid waste Solid wastes are generated from the process, solvent distillation, collection/neutralization tank, waste oil from DG sets, used batteries from DG sets. The ash from boiler is sold to brick manufacturers. The solid wastes; evaporation salts, wastes from the process in inorganic form i.e., process salts and filtration aids shall be disposed to the TSDF, while the hazardous wastes of organic nature i.e., distillation residues shall be disposed to authorized cement units and other wastes like used oil and used batteries shall be sent to authorized recyclers. The other solid wastes expected from the unit are containers, empty drums which will be used for packing product, and or returned to the product seller or sold to authorized buyers after detoxification, while the sludge from treatment plant shall be sent to TSDF. 7. Rehabilitation and Resettlement (R&R) Plan Not applicable as the land area is in the existing plant premises. 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) October 2017 9 P age
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. 45 crores Project Cost Rs. In Crores Plant& machinery 22.0 Civil buildings 5.0 Structures 3.0 Total 30.0 Pipe lines & insulation 20% on plant & machinery 6.0 Electricals & instrumentation 10% on plant & machinery 3.0 Erection & commissioning & painting 8% on plant & machinery 2.4 and structures Land & development 0.4 Material handling equipment charges 0.3 Laboratory equipment 1.0 Safety eqpt 0.4 Furniture, fixtures, computers, lighting 0.4 etc Total 14.3 Contingencies & pre-operative expenses 5% on the above 0.7 Project Cost 45.0 10 P age