Form No-1, Draft TORs. Pre Feasibility Report. Submitted by. Atlas Life Sciences

Transcription

1 Form -1, Draft TORs & Pre Feasibility Report Submitted by Atlas Life Sciences Plot. C-1, 360, 361, GIDC Estate, Odhav, District: Ahmedabad, Gujarat M/s. Atlas Life Sciences 0

2 (a) For item (I) relating to the basic information, the following shall be substituted, namely: (I) Basic Information Sr.. Item Details 1. Name of the Project/s: Atlas Life Sciences (a division of Atlas Dye chem India Pvt. Ltd.) 2. S.. in the schedule Project or Activity -5(f)- Synthetic organic chemicals industry (dyes & dye intermediates; bulk drugs and intermediates excluding drug formulations; synthetic rubbers; basic organic chemicals, other synthetic organic chemicals and chemical intermediates) 3. Proposed capacity/area/length / Proposed Capacity: tonnage to be handled/command area/lease area/ number of wells to be drilled 4. New/ Expansion/ Modernization New As per Annexure-I 5. Existing Capacity/ Area etc. Total Area for project: 1321 sqm 6. Category of Project i.e. 'A' or 'B' Category B 7. Does it attract the general condition? If yes, please specify. 8. Does it attract the specific condition? If yes, please specify. 9. Location Plot/ Survey. Village Tehsil -- District State 10. Nearest railway station/airport along with distance in kms. 11. Nearest Town, City, District Headquarters along with distance in kms. 12. Village Panchayats, zilla Parishad, Municipal Corporation, Local body Plot. C-1, , GIDC Estate Odhav Ahmedabad Gujarat Kalupur Railway station: 6.0 km Air Port: Ahmedabad around 7.0 km District headquarters: Ahmedabad - 5 km Odhav Gram Panchayat M/s. Atlas Life Sciences 1

3 (complete postal address with telephone nos. to be given). 13. Name of the applicant M/s. Atlas Life Sciences (a division of Atlas Dye chem India Pvt. Ltd.) 14. Registered Address 2 nd floor, Shiromani Complex, 15. Address for correspondence As above Name : Designation (Owner/Partner/ CEO): Address: Pin Code: Satellite road, Ahmedabad-15 Mr. Darshan Sheth Executive Director 2 nd floor, Shiromani Complex, Satellite road, Ahmedabad-15 darshan.sheth@atlaslifesciences.com Telephone.: Cell Fax.: Details of Alternative Sites examined, if any. Location of these sites should be shown on a topo sheet. Village- District State proposal for alternative site, Location 17. Interlinked Projects N.A. 18. Whether separate application of interlinked project has been submitted? N.A. 19. If yes, date of submission N.A. 20. If, reason N.A. 21. Whether the proposal involves approval/ clearance under: if yes, details of the same & their status to be given. (a) The forest (Conservation) Act, 1980? (b) The Wildlife (Protection) Act, 1972?, Proposed location is not attracting any of the mention related clearance. M/s. Atlas Life Sciences 2

4 (c) The CRZ tification, 1991? 22. Whether there is any Government Order/Policy relevant/relating to the site? 23. Forest land involved (Hectares) 24. Whether there is any litigation pending against the project and/or land in which the project is propose to be set up? (a) Name of the Court (b) Case. (c) Orders/directions of the t applicable Court, if any & its relevant with the proposed project. M/s. Atlas Life Sciences 3

5 (II) Activity 1. Construction, operation or decommissioning of the Project involving actions, which will cause physical changes in the locality (topography, land use, changes in water bodies, etc.) Sr.. Information/Checklist confirmation 1.1 Permanent or temporary change in land use, land cover or topography including increase in intensity of land use (with respect to local land use plan) 1.2 Clearance of existing land, vegetation and Buildings? Yes/ Yes Details thereof (with approximate quantities /rates, wherever possible) with source of information data The unit will be situated within the designated Industrial area. Hence, the land use pattern will not be changed due to the proposed project Land to be utilized will be a part of designated industrial land and permission is already obtained by developers 1.3 Creation of new land uses? N.A. 1.4 Pre-construction investigations N.A. e.g. bore houses, soil testing? 1.5 Construction works? Yes Construction work will be done as per the requirement of proposed activities. 1.6 Demolition works? demolition work is required to be carried out. 1.7 Temporary sites used for, Housing will not be required. construction works Or housing Workers will be coming from of construction workers? nearby villages. 1.8 Above ground buildings, Yes It will be as per the plant design. structures or earthworks including linear structures, cut and fill or excavations 1.9 Underground works including mining or Tunneling? N.A Reclamation works? reclamation work will be carried out Dredging? N.A Offshore structures? N.A Production and manufacturing processes? 1.14 Facilities for storage of goods or materials? 1.15 Facilities for treatment or disposal of solid waste or liquid effluents? Yes Yes Yes As per Annexure-I & II Unit will create storage facilities of products, raw materials as per the HCSHR and explosive rules. Industrial effluent will be sent to primary effluent treatment plant for treatment, then treated water will be sent to kettle type evaporator. Condensate will be reused for greenbelt development. M/s. Atlas Life Sciences 4

6 Sr.. Information/Checklist confirmation 1.16 Facilities for long term housing of Operational workers? 1.17 New road, rail or sea traffic during construction or operation? 1.18 New road, rail, air waterborne or other transport infrastructure including new or altered routes and stations, ports, airports etc? 1.19 Closure or diversion of existing transport routes or infrastructure leading to changes in traffic movements? 1.20 New or diverted transmission lines or pipelines? 1.21 Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or aquifers? Yes/ 1.22 Stream crossings? t applicable 1.23 Abstraction or transfers of water form ground or surface waters? 1.24 Changes in water bodies or the land surface affecting drainage or run-off? 1.25 Transport of personnel or materials for construction, operation or decommissioning? 1.26 Long-term dismantling or decommissioning or restoration works? 1.27 Ongoing activity during decommissioning which could have an impact on the Environment? 1.28 Influx of people to an area in either temporarily or permanently? Details thereof (with approximate quantities /rates, wherever possible) with source of information data Detail of water balance is given in Annexure-III. Details of hazardous waste are given in Annexure- IV. The workers will be come from nearby local area and hence such facilities will not be required. N.A. new roads and rail are envisaged. closure or diversion of existing routes is required. N.A. any changes to the hydrology of watercourses will be caused. abstraction of water from ground or surface. discharge of wastewater on land hence land surface will not affecting by proposed activities. Raw material & finished product will be transported on existing road. dismantling or decommissioning works are required to carry out. Therefore, land use will not be impacted. N.A. Yes Temporarily during construction phase and permanent during operation phase Introduction of alien species? N.A Loss of native species or genetic diversity? N.A. M/s. Atlas Life Sciences 5

7 Sr.. Information/Checklist confirmation Yes/ Details thereof (with approximate quantities /rates, wherever possible) with source of information data 1.31 Any other actions? additional actions will be implemented 2. Use of Natural resources for construction or operation of the Project (such as land, water, materials or energy, especially any resources which are non-renewable or in short supply): Sr.. Information/Checklist confirmation 2.1 Land especially undeveloped or agricultural land (ha) 2.2 Water (expected source & competing users) unit: KLD Yes/ Yes Details thereof (with approximate quantities /rates, wherever possible) with source of information data The unit will develop within the designated Industrial area developed by GIDC. Yes Sources Water consumption KLD Domestic 6.0 DM plant 1.0 Process 0.5 Cooling 4.0 Boiler 1.5 Gardening 2.0* Total 15.0 ( *) Source of raw water from GIDC water supply 2.3 Minerals (MT) N.A. 2.4 Construction material stone, aggregates, sand/soil (expected source MT) 2.5 Forests and timber (source MT) 2.6 Energy including electricity and fuels (source, competing users) Unit: fuel (MT), energy (MW) 2.7 Any other natural resources (use appropriate standard units) Yes Yes Cement, Stone, Steel etc will be used for construction activities as per the requirements. Quantity is still not worked out. forest products will be used for construction work as well as during the operational phase. Timber will be used for office furniture only. Energy: 65 KVA Source: from Torrent Power Fuel: 3000 SCM/day or 2.5 TPD D.G. set 25 kva HSD 10 ltr/hr other natural resources will be utilized. M/s. Atlas Life Sciences 6

8 3. Use, storage, transport, handling or production of substances or materials, which could be harmful to human health or the environment or raise concerns about actual or perceived risks to human health. S.. Information/Checklist confirmation 3.1 Use of substances or materials, which are hazardous (as per MSIHC rules) to human health or the environment (flora, fauna, and water supplies) 3.2 Changes in occurrence of disease or affect disease vectors (e.g. insect or water borne diseases) 3.3 Affect the welfare of people e.g. by changing living conditions? 3.4 Vulnerable groups of people who could be affected by the project e.g. hospital patients, children, the elderly etc., Yes/ Details thereof (with approximate quantities /rates, wherever possible) with source of information data Yes For storage of hazardous chemicals adequate measures will be taken. It may be noted that as per the Manufacture, Storage and Import of Hazardous Chemical Rules N.A. The living conditions of the people will not be affected as the proposed production activities are going to take place within the notified industrial area. On the other hand this project will create employment for many. N.A. 3.5 Any other causes N.A. 4. Production of solid wastes during construction or operation or decommissioning (MT/month) S. Information/Checklist Yes/ Details thereof (with approximate. confirmation quantities/rates, wherever possible) with source of information data 4.1 Spoil, overburden or mine spoil, overburden or mine wastes wastes will be generated. 4.2 Municipal waste (domestic and or commercial wastes) N.A. 4.3 Hazardous wastes (as per Yes As per Annexure-IV Hazardous Waste Management Rules) 4.4 Other industrial process wastes Yes As per Annexure-IV 4.5 Surplus product N.A. 4.6 Sewage sludge or other sludge from effluent treatment 4.7 Construction or demolition wastes Yes Domestic sewage will be disposed off through a septic tank and soak pit system. Construction wastes will be inert in nature and will be collected and utilized in filling of low-lying areas within the unit. M/s. Atlas Life Sciences 7

9 S. Information/Checklist Yes/ Details thereof (with approximate. confirmation quantities/rates, wherever possible) with source of information data demolition work will be carried out for the proposed manufacturing unit. Therefore, no demolition waste will be generated. 4.8 Redundant machinery or N.A. equipment 4.9 Contaminated soils or other materials N.A Agricultural wastes N.A Other solid wastes Yes Used Lube Oil, Discarded Drums/ containers. 5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr) S. Information/Checklist Yes/ Details thereof (with approximate. confirmation quantities /rates, wherever possible) with source of 5.1 Emissions from combustion of fossil fuels from stationary or mobile sources 5.2 Emissions from production processes 5.3 Emissions from materials handling including storage or transport 5.4 Emissions from construction activities including plant and equipment 5.5 Dust or odours from handling of materials including construction materials, sewage and waste 5.6 Emissions from incineration of waste 5.7 Emissions from burning of waste in open air (e.g. slash materials, construction debris) Yes Yes information data As per Annexure-V As per Annexure-V N.A. Yes There will be generation of SPM/RSPM due to construction activities. However, care will be taken to minimize by proper sprinkling of water. Yes There will be generation of particulate matters due to construction activities. However, care will be taken to make it minimum. N.A. t applicable because of the fact that construction waste/debris will be utilized for filling of low lying areas and other wastes such as earthwork and steel scraps will be transported through trucks to vendors. All the hazardous wastes generated from the proposed unit will be handled and managed as per Hazardous Wastes M/s. Atlas Life Sciences 8

10 S.. Information/Checklist confirmation 5.8 Emissions from any other sources Yes/ Details thereof (with approximate quantities /rates, wherever possible) with source of information data Management and Handling Rules, There will not be any emission from any other sources. 6. Generation of ise and Vibration, and Emissions of Light and Heat: Sr.. Information/Checklist confirmation 6.1 From operation of equipment e.g. engines, ventilation plant, crushers 6.2 From industrial or similar processes Yes/ Yes Details thereof (with approximate quantities /rates, wherever possible) with source of information data There will be generation of noise due to operation of various equipments/machineries. Adequate sound enclosures will be provided to all the equipments and machineries generating high noise & ear protecting devices will be provided to the workers working in such areas where noise levels will be high. Greenbelt development will help to abate noise levels. Yes ise will be generated from industrial process and it will be below the statutory norms. 6.3 From construction or demolition Yes ise Level at different sources is expected to be coming below acceptable limit. 6.4 From blasting or piling N.A. 6.5 From construction or operational traffic Yes There will be momentary increase in the noise level due to traffic during operational phase. N.A. 6.6 From lighting or cooling systems 6.7 From any other sources N.A. 7. Risks of contamination of land or water from releases of pollutants into the Ground or into sewers, surface waters, groundwater, coastal waters or the sea: S.. Information/Checklist confirmation 7.1 From handling, storage, use or spillage of hazardous materials Yes/ Details thereof (with approximate quantities /rates, wherever possible) with source of information data Industry will provide adequate storage area for the safe storage of products, raw materials and hazardous chemicals. Proper care for handling of M/s. Atlas Life Sciences 9

11 S.. Information/Checklist confirmation 7.2 From discharge of sewage or other effluents to water or the land (expected mode and place of discharge) 7.3 By deposition of pollutants emitted to air into the land or into water Yes/ Details thereof (with approximate quantities /rates, wherever possible) with source of information data hazardous material will be taken as per the MSIHC rules & HW management Rules. Sewage will be disposed off into soak pit through septic tank and necessary care will be taken. major impact is anticipated by deposition of pollutants emitted to air, into the land or into water due to all the necessary air pollution control measures to be adopted for controlling the air pollution within the norms specified by Central/State Pollution Control Board. 7.4 From any other sources N.A. 7.5 Is there a risk of long term build up of pollutants in the environment from these sources? major impact is anticipated due to fact that all necessary steps will be provided to control air pollution, water pollution and noise levels within the Central/State Pollution Control Board rms. 8. Risk of accidents during construction or operation of the Project, which could affect human health or the environment Sr. Information/Checklist Yes/ Details thereof (with approximate. confirmation quantities /rates, wherever possible) with source of 8.1 From explosions, spillages, fires etc from storage, handling, use or production of hazardous Substances information data During the construction work no hazardous substances will be used, handled and stored. Therefore, no risk of accidents is anticipated due to hazardous substances. We shall follow the Guidelines of factory act to minimize the accident. 8.2 From any other causes N.A. 8.3 Could the project be affected by natural disasters causing environmental damage (e.g. floods, earthquakes, landslides, cloudburst etc.)? Yes May effect by earthquakes because industry will be located in earth quake zone-iii. M/s. Atlas Life Sciences 10

12 9. Factors which should be considered (such as consequential development) which could lead to environmental effects or the potential for cumulative impacts with other existing or planned activities in the locality. S.. Information/Checklist confirmation 9.1 Lead to development of supporting, facilities, ancillary development or development stimulated by the project which could have impact on the environment e.g.: Supporting infrastructure (roads, power supply, waste or waste water treatment, etc.) housing development extractive industries supply industries other 9.2 Lead to after-use of the site, which could have an impact on the environment 9.3 Set a precedent for later developments 9.4 Have cumulative effects due to proximity to other existing or planned projects with similar effects Yes/ Details thereof (with approximate quantities /rates, wherever possible) with source of information data impact on the surrounding environment is envisaged due to following facts: Existing roads and transportation facilities will be utilized. Power demand will be met through Torrent Power Limited. D.G. set will be installed for supply of electricity during the time of power supply fails. Industrial effluent will be sent to primary effluent treatment plant for treatment, then treated water will be sent to kettle type evaporator. Condensate will be reused for greenbelt development. Proper storage area will be provided having RCC flooring and covered with roof. N.A. N.A. N.A. M/s. Atlas Life Sciences 11

13 (III) Environmental Sensitivity S.. Areas 1 Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value 2 Areas which are important or sensitive for ecological reasons - Wetlands, watercourses or other water bodies, coastal zone, biospheres, mountains, forests 3 Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration 4 Inland, coastal, marine or underground waters Name/ Identity Aerial distance (within 15 km) Proposed project location boundary N.A. N.A. N.A. N.A. 5 State, National boundaries N.A. 6 Routes or facilities used by the public for access to recreation or other tourist, pilgrim areas N.A. 7 Defense installations N.A. 8 Densely populated or built-up area N.A. 9 Areas occupied by sensitive manmade N.A. land uses (hospitals, schools, places of worship, community facilities) 10 Areas containing important, high quality or scarce resources (ground water resources, surface resources, forestry, agriculture, fisheries, tourism, minerals) 11 Areas already subjected to pollution or environmental damage. (those where existing legal environmental standards are exceeded) 12 Areas susceptible to natural hazard which could cause the project to present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions) Yes (IV) Proposed Terms of Reference for EIA studies As per Annexure-VI N.A. N.A. Area fall under the Seismic Zone-III and Design will be prepared with consideration of safety point in respect of seismic zone (As per the IS Code). M/s. Atlas Life Sciences 12

14 (b) The following shall be inserted at the end, namely: ''I hereby given understanding that the data and information given in the application and enclosure are true to the best of my knowledge and belief and I am aware that if any part of the data and information submitted is found to be false or misleading at any stage, the project will be rejected and clearance given, if any to the project will be revoked at our risk and cost. Date: 06/08/2015 Place: Ahmedabad NOTE: Mr. Darshan Sheth (Executive Director) M/s. Atlas Life Sciences (Project Proponent/Authorize Signatory) 1. The projects involving clearance under costal regulation zone notification, 1991 shall submit with the application a C.R.Z may duly demarcated by one of the authorized agencies, showing the project activity, w.r.t. C.R.Z. (at the stage of TOR) and the recommendations of the state costal zone Management Authority (at the stage of EC). Simultaneous action shall also be taken to obtain the requisite clearance under the provision of the C.R.Z notification, 1991 for the activities to be located in the CRZ. 2. The project to be located within 10 km of the national parks, sanctuaries, biosphere reserves, migratory corridors of the wild animals, the project proponent shall submit the map duly authenticated by chief wildlife warden showing these features vis-à-vis the project location and the recommendations or comments of the chief wildlife warden thereon(at the stage of EC)." 3. All correspondence with the ministry of environment and forests including submission of application for TOR/environment clearance, subsequent clarifications, as may be required from time to time, participation in the EAC meeting on behalf of the project proponent shall be made by the authorized signatory only. the authorized signatory should also submit a document in support of his claim of being an authorized signatory for the specific project" M/s. Atlas Life Sciences 13

15 Annexure-I List of Products Sr.. Name of Products Qty. (MT/month) 1. Phenylephrine HCl Pregabalin Levosulpiride Linezolid Olmesartan Medoxomil Gabapentin Levetirecetam Pantoprazole Sodium Monohydride Sucralfate Montelukast sodium Telmisartan Amlodipine Besylate Silodosin Olenzapine Glimepride Chlorthalidone Tapentadol HCl Voricanazole 0.25 Total M/s. Atlas Life Sciences 14

16 List of Raw Materials Sr.. Name of Raw Materials Quantity (MT/Month) Phenylephrine HCl - 4 MTPM 1 L-Phenylephrine base IPA Methanol IPA+HCl Activated charcaol Pregabalin - 6 MTPM 1 Iso Propyl Alcohol 2 2 (s)-(+)-3-aminomethyl-5- Methylhexanoic acid Activated charcoal Levosulpiride - 1 MTPM 1 Methanol N-{[(2S)-1-Ethylpyrrolidine-2- yl]-methyl}-2-methoxy-5- sulfamoyl benzamide Activated Charcoal Linezolid - 2 MTPM 1 n-propanol Linezolid crude Activated Charcoal Olmesartan Medoxomil - 1 MTPM 1 Acetone Olmesartan Medoxomil crude Activated Charcoal Gabapentin - 5 MTPM 1 Methanol Gabapentin crude IPA Activated Charcoal Levetirecetam - 2 MTPM 1 Ethyl acetate Levetirecetam crude Activated Charcoal Pantoprazole Sodium Monohydride - 3 MTPM 1 Pantoprazole Sodium crude Acetone Activated Charcoal Sucralfate - 10 MTPM 1 Sucralfate crude Methanol Activated Charcoal Montelukast sodium 2 MTPM 1 Montelukast crude Toluene N-Haptane Activated Charcoal Telmisartan 2 MTPM 1 Telmisartan Crude M/s. Atlas Life Sciences 15

17 Sr.. Name of Raw Materials Quantity (MT/Month) 2 Methanol Acetic acid Activated carbon Amlodipine besylate 3 MTPM 1 Amlodipine besylate crude Methanol Ethyl acetate Activated carbon Silodosin 0.1 MTPM 1 Silodosin crude Toluene Acetonitriloe Activated carbon Olenzapine 1.0 MTPM 1 Olenzapine Crude MDC Activated carbon Glimepride 2.0 MTPM 1 Glimepride Crude Acetone Activated carbon Chlorthalidone 2 MTPM 1 Chlorthalidone crude Methanol Activated carbon Tapentadol HCl 0.5 MTPM 1 Tapentadol HCL crude IPA Activated carbon Voricanazole 0.25 MTPM 1 Voricanazole crude Acetonitrile Activated carbon M/s. Atlas Life Sciences 16

18 Annexure -II Manufacturing Process 1. Phenylephrine HCl Manufacturing Process Take TPA in RT. Charge L- Phenyleplrine Base & RT. Stir for 10 min. Start addition of IPA + HCL in Reactor at C Adjust ph-0.5 to 1.0 with IPL + HCl. Cross Check ph after 20 mins. Heat the reaction mass up to C & Check clarity of reaction C. IF rxn mass is clear solution then charge Activated charcoal + IPA slurry in C. Maintain the reaction mass 1.0 reflux temperature. Filter the reaction mass and collect clear solution in Pharma reactor. Distilled out IPA under Vacuum approx. half reaction mass volume. After then, cool the reaction mass and chilled the reaction C. Maintain the reaction mass for 1.0 C. CF the reaction mass and wash with chill IPA & centrifuge it. After centrifuge, packed the materials in dedicated HDPE drums. M/s. Atlas Life Sciences 17

19 Chemical reaction Mass Balance M/s. Atlas Life Sciences 18

20 2. Pregabalin Manufacturing Process Take IPA and D.M water in RT. Charge (s0-(+)-3-aminomethyl-5-methyl hexanoic RT. Stir for 10 min. Heat the reaction mass up to C & Check clarity of reaction C. IF rxn mass is clear solution then charge Activated charcoal + IPA slurry in C. Maintain the reaction mass reflux temperature. Filter the reaction mass and collect clear solution in Pharma reactor. After then, cool the reaction mass and chilled the reaction C. Maintain the reaction mass for 1.0 C. CF the reaction mass and wash with chill IPA. Unload the materials and dry C. After drying packed the materials in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 19

21 Flow diagram with Mass Balance M/s. Atlas Life Sciences 20

22 3. Levosulpiride Manufacturing Process Take Methanol in RT. Charge N-{[(2s)-1-Ethylpyrrolidine-2-yl]-Methyl}-2-methoxy-5-sulfamoyl RT. Stir for 10 min. Heat the reaction mass up to reflux temperature & Check clarity of reaction reflux temperature. If rxn mass is clear solution then charge Activated charcoal + slurry in reflux temperature. Maintain the reaction mass reflux temperature. Filter the reaction mass and collect clear solution in Pharma reactor. After then, cool the reaction mass and chilled the reaction C. Maintain the reaction mass for 1.0 C. CF the reaction mass and wash with chill Methanol & centrifuge it. After centrifuge, packed the materials in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 21

23 Mass Balance M/s. Atlas Life Sciences 22

24 4. Linezolid Manufacturing Process Take Propanol in RT. Charge Linezolid RT. Stir for 10 min. Heat the reaction mass up to reflux temperature & Check clarity of reaction reflux temperature. IF rxn mass is clear solution then charge Activated charcoal + propanol slurry in reflux temperature. Maintain the reaction mass reflux temperature. Filter the reaction mass and collect clear solution in Pharma reactor. Distilled out propanol under Vacuum aprrox. Half reaction mass volume. After then, cool the reaction mass and chilled the reaction C. Maintain the reaction mass for 1.0 C. CF the reaction mass and wash with chill propanol & centrifuge it. After centrifuge, packed the materials in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 23

25 Flow diagram & Mass Balance: M/s. Atlas Life Sciences 24

26 5. Olmesartan Medoxomil Process Description Take Acetone and water mixture in RT. Charge Olmesartan medoxomil RT. Stir for 10 min. Heat the reaction mass up to reflux temperature & Check clarity of reaction reflux temperature. IF rxn mass is clear solution then charge Activated charcoal + Water slurry in reflux temperature. Maintain the reaction mass reflux temperature. Filter the reaction mass and collect clear solution in Pharma reactor. After then, Charge D.M. water Lot-1 within a period of 1.0 to 1.5 C temp. Cool the rxn mass 10 C and stirred for 3.0 hrs. Again charge D.M water lot-2@ 10 C. Cool the rxn mass 0 C and stirred for 3.0 hrs. CF the reaction mass and wash with chill D.M water. Unload the materials and dry under vacuum below 50 C. After drying packed the materials in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 25

27 Mass Balance M/s. Atlas Life Sciences 26

28 6. Gabapentin Manufacturing Process: Take Methanol + water in RT. Charge Gabapentin RT. Stir for 10 min. Heat the reaction mass up to reflux temperature & Check clarity of reaction reflux temperature. IF rxn mass is clear solution then charge Activated charcoal of Water slurry in reflux temperature. Maintain the reaction mass reflux temperature. Filter the reaction mass and collect clear solution in Pharma reactor. After then, Added IPA in rxn mass. After then, cool the reaction mass and chilled the reaction C. Maintain the reaction mass for C. After then, raise the temp of rxn mass up to C. Maintain the reaction mass for C. CF the reaction mass and wash with chill IPA. Unload the materials and dry it under C. After drying packed the materials in dedicated HDPE drums. Chemical Reactions: M/s. Atlas Life Sciences 27

29 Flow diagram & Mass Balance: M/s. Atlas Life Sciences 28

30 7. Levetirecetam Manufacturing Process Take Ethyl acetate + water in RT. Charge Levetirecetam RT. Stir for 10 min. Heat the reaction mass up to temp C & Check clarity of reaction C. IF rxn mass is clear solution then charge Activated charcoal of water slurry in C. Maintain the reaction mass reflux temperature. Filter the reaction mass and collect clear solution in Pharma reactor. Distilled out ethyl acetate under Vacuum till reaction mass attained 4-5 volumes. After then, cool the reaction mass and chilled the reaction C. Maintain the reaction mass for C. CF the reaction mass and wash with chill Ethyl acetate. Unload the materials and dry it under C. After drying packed the materials in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 29

31 Flow diagram with Mass Balance M/s. Atlas Life Sciences 30

32 8. Pantoprazole Sodium Monohydride Manufacturing Process Take Acetone + water in RT. Charge Pantoprazole Sodium RT. Stir for 10 min. Heat the reaction mass up to temp C & Check clarity of reaction C. IF rxn mass is clear solution then charge Activated charcoal of water slurry in C. Maintain the reaction mass reflux temperature. Filter the reaction mass and collect clear solution in Pharma reactor. Distilled out ethyl acetate under Vacuum till reaction mass attained 1 volume. After then, cool the reaction mass and chilled the reaction C. Maintain the reaction mass for C. CF the reaction mass and wash with chill Acetone. Unload the materials and dry it under C. After drying packed the materials in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 31

33 Mass Balance M/s. Atlas Life Sciences 32

34 9. Sucralfate Manufacturing process Take Methanol in RT. Charge Sucralfate RT. Raise the 65 C. Charge Activated 65 C. Stir it for 65 C. Filter the reaction mass and collect clear solution in Pharma reactor. Cool the reaction RT. Chill the 05 C. Stir Reaction mass for 1.0 Hrs. Centrifuge the reaction mass and wash with chill Methanol & centrifuge it. After centrifuge, packed the materials in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 33

35 Flow Diagram M/s. Atlas Life Sciences 34

36 10. Montelukast Sodium Manufacturing process Take Toluene in RT. Charge Montelukast sodium RT. Stir it for 15mins. Charge Activated RT Stir it for RT. Filter the reaction mass and collect clear solution in Pharma reactor. Charge N- Hepten in pharma RT. Chill the 15 C. Stir it for C. Centrifuge the reaction mass and wash with chill n-heptane & centrifuge it. After centrifuge, packed the materials in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 35

37 Flow Diagram M/s. Atlas Life Sciences 36

38 11. Telmisartan Manufacturing process Take Methanol in RT Charge Telmisartan RT Stir it for 15 RT Charge Activated RT Stir it for 30 RT Filter the Reaction mass and collect clear solution in pharma reactor. Adjust ph 4.0 With Acetic acid at RT Chill the 20 o c to 25 o c Stir it for 1.0 Hrs@ 20 o c to 25 o c Centrifuge the reaction mass and wash with chill Methanol & centrifuge it. After centrifuge, packed the material in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 37

39 Mass Balance M/s. Atlas Life Sciences 38

40 12. Amlodipine Besylate Manufacturing process Take Methanol in RT Charge Amlodipine Besylate RT Raise the temperature up to 60 o c Charge Activated o c Stir it for o c Filter the Reaction mass and collect clear solution in pharma reactor. Cool the Reaction mass at 30 o c Charge Ethyl acetate in pharma RT Chill the 15 o c Stir it for 15 o c Centrifuge the reaction mass and wash with chill ethyl acetate & centrifuge it. After centrifuge, packed the material in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 39

41 Mass Balance M/s. Atlas Life Sciences 40

42 13. Silodosin Manufacturing process Take Acetonitrile and Toluene in RT Charge Silodosin RT Raise the temperature up to 55 o C Stir it for 15 min. Charge Activated 55 o C Stir it for o C Filter the Reaction mass and collect clear solution in pharma reactor. Chill the 10 o C to 15 o C Stir it for o C to 15 o C Centrifuge the reaction mass and wash with chill Toluene & centrifuge it. After centrifuge, packed the material in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 41

43 Mass Balance M/s. Atlas Life Sciences 42

44 14. Olenzapine Manufacturing process Take MDC in RT Charge Olenzapine RT Raise the temperature up to Reflux Temperature Stir it for 15 min. Charge Activated Reflux Stir it for 30 Reflux Filter the Reaction mass and collect clear solution in pharma reactor. Chill the 0 o c to 5 o c Stir it for o c to 5 o c Centrifuge the reaction mass and wash with chill MDC & centrifuge it. After centrifuge, packed the material in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 43

45 Mass Balance M/s. Atlas Life Sciences 44

46 15. Glimepride Manufacturing process Take Acetone in RT Charge Glimepride RT Raise the temperature up to Reflux Temperature Stir it for 15 min. Charge Activated Reflux Stir it for 30 Reflux Filter the Reaction mass and collect clear solution in pharma reactor. Chill the 0 o c to 5 o c Stir it for o c to 5 o c Centrifuge the reaction mass and wash with chill Acetone & centrifuge. After centrifuge, drying packed the material in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 45

47 Mass Balance M/s. Atlas Life Sciences 46

48 16. Chlorthalidone Manufacturing process Take Methanol in RT Charge Chlorthalidone RT Stir it for 15 min Raise the temperature up to Reflux temperature. Charge Activated Reflux temperature Stir it for 30 Reflux temperature Filter the Reaction mass and collect clear solution in pharma reactor. Chill the 0 o c to 5 o c Stir it for o c to 5 o c Centrifuge the reaction mass and wash with chill Methanol & centrifuge it. After centrifuge, packed the material in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 47

49 Mass Balance M/s. Atlas Life Sciences 48

50 17. Tapentadol HCl Manufacturing process Take Iso propyl alcohol in RT Charge Tapentadol HCL RT Raise the temperature up to 82 o c Charge DM o c Charge Activated o c Stir it for o c Filter the Reaction mass and collect clear solution in pharma reactor. Cool the Reaction RT Chill the 25 o c Stir it for 1.0Hrs Centrifuge the reaction mass and wash with chill Iso propyl alcohol Unload Material and dry 50 o c After drying packed the material in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 49

51 Mass Balance M/s. Atlas Life Sciences 50

52 18. Voricanazole Manufacturing process Take Acetonitrile in RT Charge Voricanazole RT Raise the temperature up to Reflux Temperature Stir it for 15 min at Reflux temperature Charge Activated Reflux temperature Stir it for 30 Reflux temperature Filter the Reaction mass and collect clear solution in pharma reactor. Chill the 15oc Stir it for oc Centrifuge the reaction mass and wash with chill Acetonitrile & centrifuge it. After centrifuge, packed the material in dedicated HDPE drums. Chemical Reaction M/s. Atlas Life Sciences 51

53 Mass Balance M/s. Atlas Life Sciences 52

54 Annexure-III Water consumption & w/w generation Sr. Break up Water w/w. Consumption Generation KL/Day KLD I Domestic II Gardening 2.0* -- III Industrial (a) DM plant (b) Process (c) Cooling (d) Boiler Industrial * Total te: 2.2 KLD industrial waste water will be sent to evaporator & condensate of evaporator will be utilized for greenbelt development. M/s. Atlas Life Sciences 53

55 Water balance diagram All figures are in KLD Water consumption 15.0 KLD (13.0 Fresh + 2.0* recycle) Domestic 6.0 DM plant Utilities 5.5 Green belt 2.0* Soak pit 5.0 Process 0.5 Drying loss 0.35 Boiler 1.5 Cooling 4.0 Retain with product 0.15 Blow down 0.2 Bleed off 1.0 ETP =2.2 Salt 10 kg Evaporator System loss M/s. Atlas Life Sciences 54

56 Annexure IV Details of Hazardous/Solid waste Sr. Type of Category of Quantity Disposal facility. Waste Waste as per HWM in MTPM Rules ETP waste Collection, Storage, Transportation & Disposal at TSDF site approved by GPCB 2. Evaporation salt Collection, Storage, Transportation & Disposal at TSDF site approved by GPCB 3. Distillation residue Collection, Storage, Transportation, Disposal at common Haz. waste Incineration facility (CHWIF) 4. Spent carbon I Collection, Storage, Transportation, Disposal at common Haz. waste Incineration facility (CHWIF). 5. Discarded containers/ drums 33.3 Whichever is generated Collection, Storage and sold to approved recycler or traders. 6. Used oil kl/annum Collection, Storage, Transportation & disposal by selling to Registered Recyclers M/s. Atlas Life Sciences 55

57 Annexure-V Source of Air Emissions Sr.. Stack attached to Flue Gas Stacks 1. Boiler (1.5 T/hr) 2. Thermic Fluid Heater (1 lac Kcal/Hr) 3. D. G. set (25 kva) Fuel Type & rate of consumption Gas-3000 SCM/day or 2.5 TPD HSD 10 lit/hr Stack Height APC measures Probable emission 18 m -- PM<150 mg/nm 3 18 m m -- SO 2 <100 ppm NO x <50 ppm M/s. Atlas Life Sciences 56

58 Annexure-VI Proposed TORs include Industry falls under the category of 5(f) of schedule of EIA tification, 2006 Synthetic Organic chemical Industries and categorized under B because as per the amended EIA tification, 2006; small scale industries of cat. 5(f) may consider B category if unit will fulfill criteria mention in the said notification. We hereby submit following justification for consideration of B category. Sr.. Consideration of Industrial category Remark/Justification 1. Small scale industry i.e. Investment is less than 5 crore Our investment is 4.5 crores. 2. Water consumption <25 m 3 /day Our fresh water consumption will be 13.0 KLD including industrial & domestic. 2.0 KLD recycle water will be used for greenbelt development. 3. Fuel consumption <25 TPD Our fuel consumption will be tune around 2.5 TPD (3000 SCN/day-Natural gas) 4. Consideration of MAH as per MSIHC rules, Our all Haz. chemicals (Raw materials) are not covered under the column-3 of Shedule-2 & 3 of MSIHC rules, 1989 and industrial category are not covered under MAH unit. We further request to consider our case in B2 category by considering following: Location of the industry in the designated industrial area developed by the GIDC. Proposal is for bulk drugs manufacturing with single stage reaction i.e. n- 1 (1 stage ahead of finished product) Generated waste water form process & utility will be treated in primary treatment plant and reuse for greenbelt development, so no discharge from the industry. Eco friendly natural gas will be used as a fuel, so no air pollution control measure will be required. process emission envisages. M/s. Atlas Life Sciences 57

59 Small qty. i.e. 25 kg/month of ETP sludge and 250 kg/month evaporation salt will be sent to approve TSDF site and distillation residue will be sent at CHWIF for final disposal. any adverse Impact envisage due to proposed project. There will be slight positive impact on socio-economic environment due to employment of skilled/unskilled manpower. On the base of above, it can be evaluated that no adverse or negative impact on environment due to proposed project activities. However, there will be slight positive impact on socio-economic environment due to employment of skilled/unskilled persons. Looking to the above, we humbly request you to give us the exemption from EIA study to considering insignificant impact due to proposed activities. M/s. Atlas Life Sciences 58

60 Pre-Feasibility Report M/s. Atlas Life Sciences 59

61 1. Introduction M/s. Atlas Life Sciences is proposes to manufacture Bulk Drugs at Plot. C-1, , GIDC Estate, Odhav, Ahmedabad, Gujarat 2. Cost of Project The estimated cost of the project for the proposed new manufacturing project is estimated around Rs. 4.5 crores. Out of this around Rs. 0.5 crores will be invested for pollution control measures. 3. Production Capacity Production capacity is prescribe below: Sr.. List of Products Name of Products Qty. (MT/month) 1. Phenylephrine HCl Pregabalin Levosulpiride Linezolid Olmesartan Medoxomil Gabapentin Levetirecetam Pantoprazole Sodium Monohydride Sucralfate Montelukast sodium Telmisartan Amlodipine Besylate Silodosin Olenzapine Glimepride Chlorthalidone Tapentadol HCl Voricanazole 0.25 Total M/s. Atlas Life Sciences 60

62 List of Raw Materials Sr.. Name of Raw Materials Quantity (MT/Month) Phenylephrine HCl - 4 MTPM 1 L-Phenylephrine base IPA Methanol IPA+HCl Activated charcaol Pregabalin - 6 MTPM 1 Iso Propyl Alcohol 2 2 (s)-(+)-3-aminomethyl-5- Methylhexanoic acid Activated charcoal Levosulpiride - 1 MTPM 1 Methanol N-{[(2S)-1-Ethylpyrrolidine-2- yl]-methyl}-2-methoxy-5- sulfamoyl benzamide Activated Charcoal Linezolid - 2 MTPM 1 n-propanol Linezolid crude Activated Charcoal Olmesartan Medoxomil - 1 MTPM 1 Acetone Olmesartan Medoxomil crude Activated Charcoal Gabapentin - 5 MTPM 1 Methanol Gabapentin crude IPA Activated Charcoal Levetirecetam - 2 MTPM 1 Ethyl acetate Levetirecetam crude Activated Charcoal Pantoprazole Sodium Monohydride - 3 MTPM 1 Pantoprazole Sodium crude Acetone Activated Charcoal Sucralfate - 10 MTPM 1 Sucralfate crude Methanol Activated Charcoal Montelukast sodium 2 MTPM 1 Montelukast crude Toluene N-Haptane Activated Charcoal Telmisartan 2 MTPM 1 Telmisartan Crude M/s. Atlas Life Sciences 61

63 Sr.. Name of Raw Materials Quantity (MT/Month) 2 Methanol Acetic acid Activated carbon Amlodipine besylate 3 MTPM 1 Amlodipine besylate crude Methanol Ethyl acetate Activated carbon Silodosin 0.1 MTPM 1 Silodosin crude Toluene Acetonitriloe Activated carbon Olenzapine 1.0 MTPM 1 Olenzapine Crude MDC Activated carbon Glimepride 2.0 MTPM 1 Glimepride Crude Acetone Activated carbon Chlorthalidone 2 MTPM 1 Chlorthalidone crude Methanol Activated carbon Tapentadol HCl 0.5 MTPM 1 Tapentadol HCL crude IPA Activated carbon Voricanazole 0.25 MTPM 1 Voricanazole crude Acetonitrile Activated carbon Manufacturing Process Detailed manufacturing process is given in Annexure-II of form-i. 5. Water Balance: The total water requirement will be 15.0 KL/day (13.0 KLD Fresh KLD recycle) which will fulfill by GIDC water supply. The breakup of water consumption is given below: M/s. Atlas Life Sciences 62

64 Sr. Break up Water Consumption w/w Generation. KLD KLD I Domestic II Gardening 2.0* -- III Industrial (a) DM plant (b) Process (c) Cooling (d) Boiler Industrial * Total Water balance diagram All units are in KLD Water consumption 15.0 KLD (13.0 Fresh + 2.0* recycle) Domestic 6.0 DM plant Utilities 5.5 Green belt 2.0* Soak pit 5.0 Process 0.5 Drying loss 0.35 Boiler 1.5 Cooling 4.0 Retain with product 0.15 Blow down 0.2 Bleed off 1.0 ETP =2.2 Salt 10 kg Evaporator System loss M/s. Atlas Life Sciences 63

65 6. Manpower requirements: Total manpower requirement at all level of plant will be Source of Pollution Details of Air Pollution There will be three flue gas stacks, which will the main emission source from the plant under the Air Pollution Control Act, NG will be used as fuel, so APCM will not require. Proper Stack height will be provided in order to achieve norms prescribed by statutory authority. The details of stacks are given below: Sr.. Stack attached to Flue Gas Stacks 1. Boiler (1.5 T/hr) 2. Thermic Fluid Heater (1 lac Kcal/Hr) 3. D. G. set (25 kva) Fuel Type & rate of consumption Gas-3000 SCM/day or 2.5 TPD HSD 10 lit/hr Stack Height APC measures Probable emission 18 m -- PM<150 mg/nm 3 18 m m -- SO 2 <100 ppm NO x <50 ppm Source of Wastewater The main source of the industrial wastewater generation will be from water treatment and utilities. Entire quantity generated wastewater will be treated in ETP, then treated water from ETP will be sent to evaporator & condensate of evaporator will be utilized for greenbelt development. Domestic effluent will be treated into soak pit. Source and disposal of Hazardous wastes There will be six sources of Solid/hazardous waste generation. ETP waste & evaporation salt will be disposed off to approve TSDF site. Distillation residue & spent carbon will be sent to CHWIF approved by GPCB for incineration. Spent oil will be sold to actual users and Drums & liners will be sold to registered recyclers. The details of Solid/hazardous waste are given below: Sr. Type of Category of Quantity Disposal facility. Waste Waste as per HWM in MTPM Rules ETP waste Collection, Storage, Transportation & Disposal at TSDF site approved by M/s. Atlas Life Sciences 64

66 GPCB 2. Evaporation salt Collection, Storage, Transportation & Disposal at TSDF site approved by GPCB 3. Distillation residue Collection, Storage, Transportation, Disposal at common Haz. waste Incineration facility (CHWIF) 4. Spent carbon I Collection, Storage, Transportation, Disposal at common Haz. waste Incineration facility (CHWIF). 5. Discarded 33.3 Whichever Collection, Storage and sold to containers/ is approved recycler or traders. drums generated 6. Used oil kl/annum Collection, Storage, Transportation & disposal by selling to Registered Recyclers 8. Funds for pollution control measures The management is quite conscious of its responsibility for maintaining clear environment adequate funds can be provided for the pollution control measures as a part of overall project financing. Necessary provision for Environmental management system is in practice and will be part of practice in future expansion projects. 9. Monitoring facilities Company is ready to carry out any kind of monitoring proposed by pollution control board from time to time through outside agency. 10. Conclusion On the basis of information presented in the pre feasibility report on pollution control measures and after its implementation, there will be no emission from the plant beyond the norms specified by the Board as per the provisions of Water (Prevention and Control of Pollution) Act, 1974 and Air (Prevention and Control of Pollution) Act, M/s. Atlas Life Sciences 65