PRE FEASIBILITY REPORT

Transcription

1 Apotex Pharmachem India Pvt Ltd, PLOT NO 1 A, 4 th PHASE, BOMMASANDRA INDUSTRIAL AREA, JIGINI LINK ROAD, ANEKAL TALUK, BANGALORE DISTRICT, KARNATAKA STATE PRE FEASIBILITY REPORT M/s Apotex Pharmachem India PvtLtd Plot No: 1 A,4 th Phase, Bommasandra Industrial Area Anekal Taluk, Bangalore Fax No: E mail: makbarali@apotexcoin SUBMITTED TO MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI

2 Pre Feasibility Report M/s Apotex Pharmachem India PvtLtd Plot No: 1 A,4 th Phase, Bommasandra Industrial Area Anekal Taluk, Bangalore Fax No: yreddy1@apotexcoin 1 Executive Summary M/s Apotex Pharmachem India Pvt Ltd, located at Plot No1 A, 4th Phase, Bommasandra Industrial Area, Jigin Link Road, Anekal Taluk, Bangalore Urban District, Karnataka The unit environmental clearance vide letter no F No J- 1011/181/2006-IA II (I) dt: The unit had renewed consent for operation (CFO) vide Letter No PCB/055/HPI/ /H1189 dated It is proposed to increase the manufacturing capacity from 496 TPA to 5474 TPA within the Existing land of 523 acres Expansion includes enhancement of production block, facility for utility proposed and enhancement of ZLD system Apotex Pharmachem India Pvt Ltd is engaged in research and development, testing and manufacture of Active Pharmaceutical Ingredients (API) and intermediates APIPL has set up state of the art of R&D center along with QC/QA facility located at 1A Bommasandra Jigani link Road, Bangalore The API unit along with R&D facilities is housed in a site of area of 52 acres The site is 27 KM South of Bangalore city railway station To meet the market demand, it is required add new products and remove non feasible products It is proposed to increase the manufacturing capacity from 496 TPA to 5474 TPA within the Existing land of 523 acres Total Capital investment made for proposed expansion is Rs 25 crores 2 Introduction of the Project 21 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 496 TPA to 5474 TPA at Plot No1 A, 4th Phase, Bommasandra Industrial Area, Jigin Link Road, Anekal Taluk, Bangalore Urban District, Karnataka The expansion entails a capital cost of Rs 25 crores towards Extension of production block, utilities and modernization of zero liquid discharge facility, debottlenecking by way of incorporating the advanced technology and state of the art equipment The proposal 1 P age

3 is for expansion of synthetic organic manufacturing unit from within the existing unit of area 523 acres 21 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 22 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 23 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 24 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 25 Domestic/export Markets: The products shall cater to both domestic and export markets 26 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 31 Type of Project including interlinked and interdependent projects, if any: M/s Apotex Pharmachem India Pvt Ltd, located at Plot No1 A, 4th Phase, Bommasandra Industrial Area, Jigin Link Road, Anekal Taluk, Bangalore Urban District, Karnataka The unit environmental clearance vide letter no F No J- 1011/181/2006-IA II (I) dt: The unit had renewed consent for operation 2 P age

4 (CFO) vide Letter No PCB/055/HPI/ /H1189 dated It is proposed to increase the manufacturing capacity from 496 TPA to 5474 TPA within the Existing land of 523 acres Expansion includes enhancement of production block, facility for utility proposed and enhancement of ZLD system 32 Size or magnitude of operation: M/s Apotex Pharmachem India Pvt Ltd, located at Plot No1 A, 4th Phase, Bommasandra Industrial Area, Jigin Link Road, Anekal Taluk, Bangalore Urban District, Karnataka The unit environmental clearance vide letter no F No J- 1011/181/2006-IA II (I) dt: The unit had renewed consent for operation (CFO) vide Letter No PCB/055/HPI/ /H1189 dated It is proposed to increase the manufacturing capacity from 496 TPA to 5474 TPA within the Existing land of 523 acres Expansion includes enhancement of production block, facility for utility proposed and enhancement of ZLD system Capacity before and after expansion is presented in Table A-1 and A-2 Table A-1 Manufacturing Capacity Permitted SNo Name of Product Capacity (TPA) 1 Enalapril Maleate 2 2 Torsemide USP 02 3 Candesartan Cilexetil 02 4 Olmesartan medoxomil 1 5 Perindopril Arginine 02 6 Ramipril 05 7 Perindopril 2 8 Pantoprazole sodium 2 9 Lansoprazole 3 10 Esomeprazole Magnesium Voriconazole Eletriptan HBr Naratriptan Zolmitriptan Rizatriptan Benzoate Almotriptan Malate Finasteride Intermediate Ranolazine 2 19 Tolteridone Trospium Chloride Varenicline Tartrate Fesoterodine fumarate Pramipexol Dolasetron Mesylate Raloxifene 1 3 P age

5 26 Exemestane Letrozole Capecitabine Paliperidone Risperidone Etravirine Raltregravir Valganciclovir 3 34 Entecavir Eszopiclone Gatifloxacine hydrochloride Levothyroxine sodium Mycophenolate Mofetil Tizanidine Rasagiline Mesylate Riluzole Cabergolin Alprazolam Donepezil HCl Linezolid Febuxostat 01 Total P age

6 Table A-2 Manufacturing Capacity After Expansion SlNo Product Capacity (TPA) 1 Alcaftadine Almotriptan Maleate Alprazolam 01 4 Apixaban Atomoxitine Hydrochloride 01 6 Azelastine Cabergoline Canagliflozin 02 9 Candesartan Cilexetil Carvidelol 1 11 Dabigatron Etexilate Mesilate 2 12 Deferasirox Donepezil hydrochloride Dronedarone Hydrochloride 1 15 Eletriptan Hydrobromide Enalapril Maleate Entecavir Esomeprazole Magnesium Eszopiclone Etravirine Exemestane Febuxostat Fesoterodine Fumerate Fingolimod Hydrochloride Gatifloxacin Hemihydrate Ivacaftor Lansoprazole 3 28 Letrozole Levothyroxine Sodium Linagliptin Linezolid 1 32 Liothyronine Sodium Lurasidone Hydrochloride Mycophenolate Mofetil Mycophenolate Sodium 1 36 Naratriptan Hydrochloride Olmesartan Medoxomil 3 38 Olopatadine Hydrochloride Paliperidone Perampanel Perindopril Arginine Perindopril tert Butylamine 15 5 P age

7 43 Pramipexole Dihydrochloride Prasugrel Base Prasugrel Hydrochloride Raloxifene Hydrochloride 2 47 Raltegravir Potassium Ramipril Ranolazine 5 50 Rasagiline Mesylate Riluzole Risperidone Rivaroxaban Rizatriptan Benzoate Saxagliptin Hydrochloride Tetrabenazine Tizanidine Hydrochloride Tolterodine Tartrate Tolvaptan Torsemide Trospium chloride Valgancyclovir Hydrochloride 2 63 Varenicline Tartrate Voriconazole Zolmitriptan Atorvastatin Calcium Dolutegravir 04 Total Process Description with process details (a schematic diagram/flow chart) Process description is as in the Form I Annexures 34 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 35 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 KIADB 6 P age

8 industrial water supply sources in addition to reuse of treated wastewater The total water requirement after expansion is in the order of 285 KLD consisting of 175 KLD 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 8 8 Washings Scrubber 4 4 Boiler Feed Cooling Tower RO/DM Plant 4 4 Domestic Gardening Gross Total Total Electricity: The required energy shall be drawn from BESCOM 36 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 65 8 Sent to Stripper followed by MEE and ATFD Stripper Condensate sent to Cement Plants 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 RO Rejects 4 Sent to MEE followed by ATFD, Biological Treatment plant and RO Total I LTDS Effluents Washings Sent to Biological Treatment System followed by 7 P age

9 Scrubbers -- 4 RO RO permeate reused for cooling tower Boiler Blow downs makeup RO rejects sent to MEE Cooling Tower Blow downs Domestic Sent to Sewage Treatment Plant and treated wastewater reused for green belt development Total II Grand Total (I+II) Total Solid Waste Generated and Mode of Disposal S Description Quantity Unit Method of disposal No Permitted After Expansion 1 Used or Spent Oil 4 10 KL/A Disposed to KSPCB 2 Wastes or residue 01 4 MT/A authorized party for containing Oil Reprocess 3 Process Residue 6 25 MT/A 4 Spent carbon MT/A 5 Off specification 25 MT/A products 6 Date expired products 25 MT/A 7 Spent catalyst 3 MT/A Disposed to KSPCB authorized Party Recycling/Reused 8 Spent Solvents KL/A Disposed to KSPCB authorized party for Reprocess 9 Empty barrels/ containers/ liners contaminated with No s/a Disposed to authorized handler after through washing hazardous chemicals/ wastes 10 Exhaust Air or Gas cleaning residue 3 3 MT/A Disposed to KSPCB authorized party for 11 Chemical sludge from 100 MT/A TSDF waste water treatment 9 12 Evaporation salts MT/A 13 Miscellaneous items (Please specify) Such as used polybags, syringes and needles used PPE, etc) 10 MT/A Disposed to KSPCB authorized Party for Incineration 14 Electronic Waste As Actual generated No s/a Disposed to KSPCB 15 Battery Waste As Actual generated No s/a authorized party for Reprocess 8 P age

10 4 Site Analysis 41 Plant Location M/s Apotex Pharmachem India Pvt Ltd, located at Plot No1 A, 4th Phase, Bommasandra Industrial Area, Jigin Link Road, Anekal Taluk, Bangalore Urban District, Karnataka The unit environmental clearance vide letter no F No J- 1011/181/2006-IA II (I) dt: The unit had renewed consent for operation (CFO) vide Letter No PCB/055/HPI/ /H1189 dated It is proposed to increase the manufacturing capacity from 496 TPA to 5474 TPA within the Existing land of 523 acres Expansion includes enhancement of production block, facility for utility proposed and enhancement of ZLD system Apotex Pharmachem India Pvt Ltd is engaged in research and development, testing and manufacture of Active Pharmaceutical Ingredients (API) and intermediates APIPL has set up state of the art of R&D center along with QC/QA facility located at 1A Bommasandra Jigani link Road, Bangalore The API unit along with R&D facilities is housed in a site of area of 52 acres The site is 27 KM South of Bangalore city railway station To meet the market demand, it is required add new products and remove non feasible products It is proposed to increase the manufacturing capacity from 496 TPA to 5474 TPA within the Existing land of 523 acres Total Capital investment made for proposed expansion is Rs 25 crores 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: 61 Power Requirement and Supply/Source The required energy shall be drawn from BESCOM The power shall be drawn from existing DG sets during load shut downs 9 P age

11 62 Utilities List of Utilities SNo Utility Permitted Proposed After Expansion 1 PNG/Oil Fired Boilers (TPH) 06 TPH 1 x 15 TPH 2 DG Sets (KVA)* 1x500 KVA 1x600 KVA 1x625 KVA 1x1010 KVA 1x500 KVA * DG set will be used during load shut down 1 x 2 TPH 1 x 3 TPH 1 x 2 TPH 1 x 3 TPH -- 1x500 KVA 1x600 KVA 1x625 KVA 1x1010 KVA 1x500 KVA 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 63 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 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 let out into atmosphere through a effective stack height 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 ie, process salts and filtration aids 10 P age

12 shall be disposed to the TSDF, while the hazardous wastes of organic nature ie, 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 81 Likely date of start of construction and likely date of completion (Time schedule for the project to be given) Within three months as it involves installation of higher capacity processing equipment s besides improving of yield and the production shall be initiated there upon 82 Estimated project cost along with analysis in terms of economic viability of the project The estimated cost of the project is approximately Rs 25 crores Project Cost Rs In Crores Plant& machinery 1435 Civil buildings 5 Structures 018 Total - I 195 Pipe lines & insulation 20% on plant & machinery 287 Electricals & instrumentation 10% on plant & machinery 1435 Erection & commissioning & 8% on plant & machinery and 1148 painting structures Total - II 545 Project Cost (Total I + II) P age