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KOSHER PHARMACEUTICALS PVT. LTD., SY. NO. 286, 289 (Part) AND 297 (Part),
JAGDEVPUR VILLAGE AND MANDAL, SIDDIPET DISTRICT, TELANGANA
UPDATED FORM I
Project No. 1216‐21‐02‐Amd December 2016
Kosher Pharmaceuticals Pvt. Ltd., H.No: 1‐48/3/2, Shankar Nagar, Chanda Nagar, Hyderabad – 500 050. Phone: +91 9849042616 Fax: 040‐66785427 E‐mail ID: [email protected]
STUDIES AND DOCUMENTATION BYTEAM Labs and Consultants B‐115‐117 & 509, Annapurna Block, Aditya Enclave, Ameerpet, Hyderabad‐500 038. Phone: 040‐23748 555/23748616, Telefax: 040‐23748666
SUBMITTED TO MINISTRY OF ENVIRONMENT AND FOREST AND CLIMATE CHANGE
GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAVAN, JOR BAGH ROAD, NEW DELHI
Kosher Pharmaceuticals Pvt. Ltd.
Form I Page 1
APPENDIX – I (See Paragraph – 6)
FORM I I) Basic Information S.No. Item Details 1 Name of the Project/s Kosher Pharmaceuticals Pvt. Ltd. 2 S. No in the Schedule 5 (f) – A ‐ Synthetic Organic Chemicals 3 Proposed capacity/area/length/tonnage to
be handled/command area/lease area/number of wells to be drilled
Area Existing: 6.5 Acres Existing Capacity: 57 TPM The present proposal is for Amendment of Boilers capacity in our existing Environmental Clearance. File No. J‐1011/173/2012‐IA II (I) dated: 18.09.2014.
Amendment in Boilers S.No Description As Per EC Amendment 1 Coal Fired Boilers 1 x 3 TPH 1 x 5 TPH
1 x 2 TPH 1 x 3 TPH*Total in Operation 5 TPH 5 TPH
Note: 1. No change in steam consumption 2. 1 x 3 TPH Boiler will be kept as standby 3.At any point of time maximum steam consumption will be 5 TPH
New/Expansion/Modernization Amendment of EC 5 Existing Capacity/Area etc. Existing Capacity: 57 TPM
Area Existing: 6.5 Acres 6 Category of Project i.e 'A' or 'B' “A” 7 Does it attract the general condition? If yes,
please specify No
8 Does it attract the Specific condition? If yes, please specify.
No
9 Location Plot/Survey/Khasra No. Sy. No. 286, 289 (Part) & 297 (Part), Village Jagdevpur Village Tehsil Jagdevpur Village District Siddipet District State Telangana
10 Nearest railway station/airport along with distance in km.
Railway Station: Raigir – 25 Km Airport : Rajiv Gandhi International Airport – 70 Km
11 Nearest Town, City, District Headquarters along with distance in kms.
Town & District HQ – Jagadevpur & Siddipet
12 Village Panchayats, Zilla Parishad, Municipal Corporation, Local body (complete postal address with telephone nos. to be given)
Jagadevpur
13 Name of the Applicant L. Tirupathi Reddy 14 Registered Address Sy. No. 286, 289 (Part) & 297 (Part),
Jagadevpur Village and Mandal, Siddipet District, Telanagana.
Kosher Pharmaceuticals Pvt. Ltd.
Form I Page 2
15 Address for Correspondence: Name L. Tirupathi Reddy Designation(Owner/Partner/CEO) Director Address Kosher Pharmaceuticals Pvt. Ltd.
H.No: 1‐48/3/2, Shankar Nagar, Chanda Nagar, Hyderabad – 500 050. Phone: +91 9849042616 Fax: 040‐66785427
Pin Code 500 050 E‐mail [email protected];
[email protected] Telephone Number Phone: +91 98490 42616 Fax No. 040‐23748666
16 Details of alternative Sites examined, if any. Location of these sites should be shown on a topo sheet.
Not Applicable, as the present proposal is for Amendment of Boilers capacity in our existing Environmental Clearance
17 Interlinked Projects Not applicable 18 Whether separate application of interlinked
project has been submitted? Not applicable
19 If yes, date of submission Not applicable 20 If no, reason Not applicable 21 Whether the proposal involves
approval/clearance under: if yes, details of the same and their status to be given. (a) The Forest (Conservation) Act, 1980? (b) The Wildlife (Protection) Act, 1972? (c) The C.R.Z Notification, 1991?
No
22 Whether there is any Government Order/Policy relevant/relating to the site?
No
23 Forest land involved (hectares) No 24 Whether there is any location pending
against the project and /or land in which the project is propose to be set up? (a) Name of the Court (b) Case No (c) Orders/directions of the Court, if any and its relevance with the proposed project.
No
Kosher Pharmaceuticals Pvt. Ltd.
Form I Page 3
(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.) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities /rates,
wherever possible) with source of information data 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)
NO Total Existing Area: 6.5 acres
1.2 Clearance of existing land, vegetation and buildings?
NO Industrial
1.3 Creation of new land uses? NO Existing – industrial 1.4 Pre‐construction investigations e.g.
bore houses, soil testing? YES Soil test done
1.5 Construction works? NO The present proposal is for Amendment of Boilers capacity in our existing Environmental Clearance
1.6 Demolition works? NO No structures for demolition 1.7 Temporary sites used for
construction works or housing of construction workers?
NO
1.8 Above ground buildings, structures or earthworks including linear structures, cut and fill or excavations
YES No major cut and fill or excavation is anticipated.
1.9 Underground works including mining or tunneling?
NO No underground works like mining and tunneling.
1.10 Reclamation works? NO 1.11 Dredging? NO 1.12 Offshore structures? NO 1.13 Production and manufacturing
processes? YES Enclosed in Annexure – I
1.14 Facilities for storage of goods or materials?
NO Raw materials and solvents shall be stored with in factory premises. Materials in bags and drums will be stored in properly designed warehouse with adequate safe guards. Bulk quantities of raw materials will be stored in Bulk Storage tanks in the tank farms with retention dykes.
1.15 Facilities for treatment or disposal of solid waste or liquid effluents?
YES High TDS and low TDS effluents are treated with in the plant premises. Organic waste is sent to cement plants for co‐incineration. Solid waste generated from Multiple Effect evaporators sent to TSDF. Details of waste treatment facilities presented in Annexure II.
1.16 Facilities for long term housing of operational workers?
NO No housing proposed
Kosher Pharmaceuticals Pvt. Ltd.
Form I Page 4
1.17 New road, rail or sea traffic during construction or operation?
NO
1.18 New road, rail, air waterborne or other transport infrastructure including new or altered routes and stations, ports, airports etc?
NO
1.19 Closure or diversion of existing transport routes or infrastructure leading to changes in traffic movements?
NO
1.20 New or diverted transmission lines or pipelines?
NO
1.21 Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or aquifers?
NO
1.22 Stream crossings? NO1.23 Abstraction or transfers of water
form ground or surface waters? YES Total water required is 88.7 KLD out of which 48.7 KLD
shall be met from bore wells/Tankers and the balance 40 KLD is recycled water.
1.24 Changes in water bodies or the land surface affecting drainage or run‐off?
NO
1.25 Transport of personnel or materials for construction, operation or decommissioning?
NO The present proposal is for Amendment of Boilers capacity in our existing Environmental Clearance
1.26 Long‐term dismantling or decommissioning or restoration works?
NO
1.27 Ongoing activity during decommissioning which could have an impact on the environment?
NO
1.28 Influx of people to an area in either temporarily or permanently?
YES The project shall increase the employment potential and hence may lead to migration to surrounding villages.
1.29 Introduction of alien species? NO 1.30 Loss of native species or genetic
diversity? NO No, as the present proposal is for Amendment of
Boilers capacity in our existing Environmental Clearance
1.31 Any other actions? NO
Kosher Pharmaceuticals Pvt. Ltd.
Form I Page 5
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): S.No. Information/checklist confirmation Yes/No Details thereof (with approximate quantities /rates,
wherever possible) with source of information data 2.1 Land especially undeveloped or
agricultural land (ha) No 6.5 acres.
Located at Sy. No. 286, 289 (Part) & 297 (Part), Jagadevpur Village and Mandal, Siddipet District, Telanagana
2.2 Water (expected source & competing users) unit: KLD
YES Total water required is 88.7 KLD out of which 48.7 KLD shall be met from bore wells/Tankers and the balance 40 KLD is recycled water. (Water Balance Enclosed in Annexure III)
2.3 Minerals (MT) NA 2.4 Construction material – stone,
aggregates, sand / soil (expected source – MT)
YES Will be sourced from the local villages.
2.5 Forests and timber (source – MT) NO 2.6 Energy including electricity and fuels
(source, competing users) Unit: fuel (MT), energy (MW)
YES The required energy shall be drawn from TSSPDCL. The power shall be drawn from DG set of 1 x 500 KVA capacity during load shut downs.
The other energy source is Coal Fired Boiler of 5 TPH to meet the steam requirement and standby boiler of capacity 3 TPH
2.7 Any other natural resources (use appropriate standard units)
NA
Kosher Pharmaceuticals Pvt. Ltd.
Form I Page 6
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.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates,
wherever possible) with source of information data 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)
YES Hazardous chemicals shall be used for manufacturing of Synthetic Organic Chemicals and intermediates. MSIHC rules shall be followed during storage, transportation and handling of raw materials. Hazardous chemicals and solvent shall be stored and handled in closed systems.
3.2 Changes in occurrence of disease or affect disease vectors (e.g. insect or water borne diseases).
NO
3.3 Affect the welfare of people e.g. by changing living conditions?
YES Shall increase the employment potential for locals and affect the living conditions for betterment.
3.4 Vulnerable groups of people who could be affected by the project e.g. hospital patients, children, the elderly etc.,
NO No sensitive receptors are present in the immediate vicinity of the site. The project shall not have any significant impact on vulnerable groups of people.
3.5 Any other causes NO
4. Production of solid wastes during construction or operation or decommissioning (MT/month) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates,
wherever possible) with source of information data 4.1 Spoil, overburden or mine wastes NO 4.2 Municipal waste (domestic and or
commercial wastes) NO Wastes from canteen, other commercial wastes like
paper, empty containers etc. The canteen wastes and commercial wastes shall be in the range of 30 kg/day
4.3 Hazardous wastes (as per Hazardous Waste Management Rules)
YES Hazardous waste generation during construction shall be limited to waste oils, batteries and containers of paints etc. The quantity of hazardous wastes generated during operation contain salts from evaporators, process residue, and solvent residues, ETP sludge and filtration media etc.
4.4 Other industrial process wastes YES Enclosed at Annexure IV 4.5 Surplus product NO 4.6 Sewage sludge or other sludge from
effluent treatment YES Sludge from Effluent treatment plant and evaporation
salts shall be sent to TSDF. 4.7 Construction or demolition wastes NO Construction activity involves creation of production
blocks, utilities like boiler, Chilling Plant etc and ZLD system.
4.8 Redundant machinery or equipment NO 4.9 Contaminated soils or other materials NO Structures of all waste treatment facilities are made of
concrete and also above ground to eliminate the possibility of any contamination due to seepage and for ease of maintenance.
4.10 Agricultural wastes NO 4.11 Other solid wastes YES Enclosed at Annexure IV
Kosher Pharmaceuticals Pvt. Ltd.
Form I Page 7
5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates,
wherever possible) with source of information data 5.1 Emissions from combustion of fossil
fuels from stationary or mobile sourcesYES Coal shall be used as fuel. Quantity of fuel and
emissions details are enclosed in Annexure V 5.2 Emissions from production processes YES Gaseous emissions from process are Ammonia,
Carbondioxide, Hydrogen Chloride, Hydrogen, Nitrogen, Nitrous oxide & Sulfur dioxide. NH3, HCl, and SO2 are sent to scrubbers. Sodium chloride from HCl scrubbing, while Sodium Bisulfite from Sulphur dioxide scrubbing and ammonium chloride from ammonia scrubbing are sent to ETP. Carbondioxide, Hydrogen, Nitrogen and Nitrous oxide gases are let into atmosphere by following standard operating procedure.
5.3 Emissions from materials handling including storage or transport
NO Material transfer takes place in closed pipeline systems using pumps with mechanical seals.
5.4 Emissions from construction activities including plant and equipment
YES Dust may rise during transport of material and construction activity. The dust emissions shall be mitigated by water spraying on the roads within the premises.
5.5 Dust or odors from handling of materials including construction materials, sewage and waste
NO Effluent from domestic usage will be treated in the treatment plant.
5.6 Emissions from incineration of waste NO 5.7 Emissions from burning of waste in
open air (e.g. slash materials, construction debris)
NO
5.8 Emissions from any other sources NO
Kosher Pharmaceuticals Pvt. Ltd.
Form I Page 8
6. Generation of Noise and Vibration, and Emissions of Light and Heat: S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates,
wherever possible) with source of information data with source of information data
6.1 From operation of equipment e.g. engines, ventilation plant, crushers
YES Material transport and construction equipment shall be source of noise, while transfer pumps, vacuum systems, DG sets are the sources of noise during operation.
6.2 From industrial or similar processes YES DG sets controlled by providing Acoustic Enclosures. DG sets will be used in case of power failure from TSSPDCL.
6.3 From construction or demolition YES Noise during construction shall be due to construction equipment and emergency DG sets.
6.4 From blasting or piling NO 6.5 From construction or operational
traffic NO The increased traffic shall not have any significant
impact. 6.6 From lighting or cooling systems NO6.7 From any other sources NO
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.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates,
wherever possible) with source of information data 7.1 From handling, storage, use or
spillage of hazardous materials NO All the hazardous materials will be stored in MS/HDPE
drums, in a covered shed and no contamination of soil is expected.
7.2 From discharge of sewage or other effluents to water or the land (expected mode and place of discharge)
NO All the waste from domestic operations sent to Effluent Treatment Plant. Treated effluent will be recycled to cooling towers.
7.3 By deposition of pollutants emitted to air into the land or into water
NO All the emissions from process are controlled by providing control equipment like scrubbers and bag filter.
7.4 From any other sources NO 7.5 Is there a risk of long term build up
of pollutants in environment from these sources?
NO
Kosher Pharmaceuticals Pvt. Ltd.
Form I Page 9
8.Risk of accidents during construction or operation of the Project, which could affect human health or the environment
S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data
8.1 From explosions, spillages, fires etc from storage, handling, use or production of hazardous substances
YES All Inbuilt Safety precautions will be adopted and there will not be any damage to environment or human health.
8.2 From any other causes NA 8.3 Could the project be affected by natural disasters
causing environmental damage (e.g. Floods, earthquakes, landslides, cloudburst etc)?
NO
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. No. Information/Checklist confirmation Yes/No Details thereof (with approximate
quantities/rates, wherever possible) with source of information data
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
YES The project shall enhance the socio economic status of the area, improving the employment. There are no major support industries required for this plant.
9.2 Lead to after‐use of the site, which could haven impact on the environment
NO
9.3 Set a precedent for later developments NO
9.4 Have cumulative effects due to proximity to other existing or planned projects with similar effects
NO The baseline environmental status of the surrounding areas is within the prescribed limits as observed from the Secondary data.
Kosher Pharmaceuticals Pvt. Ltd.
Form I Page 10
(III) Environmental Sensitivity S.No. Areas Name/
Identity Aerial distance (within 15 km.) Proposed project location boundary
1 Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value
NA
2 Areas which are important or sensitive for ecological reasons ‐ Wetlands, watercourses or other water bodies, coastal zone, biospheres, mountains, forests
YES Daulapuram RF – 1.6Km – NW Kondapuram RF – 4.96Km – NE Singaram RF – 6.1Km – NE Virareddipalli RF – 3.2Km – SE Vasalmarri RF – 5.9Km – SW Ibrahimpuram RF– 9.1Km – SE
3 Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration
NA
4 Inland, coastal, marine or underground waters NO 5 State, National boundaries NO 6 Routes or facilities used by the public for access to
recreation or other tourist, pilgrim areas NO
7 Defense installations NO 8 Densely populated or built‐up area YES Jagdevpur Village – 3 Km ‐NW direction
9 Areas occupied by sensitive man‐made land uses (hospitals, schools, places of worship, community facilities)
NA
10 Areas containing important, high quality or scarce resources (ground water resources, surface resources, forestry, agriculture, fisheries, tourism, minerals)
NO
11 Areas already subjected to pollution or environmental damage. (those where existing legal environmental standards are exceeded)
NO
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)
NO
Kosher Pharmaceuticals Pvt. Ltd.
Form I Page 11
(IV) Proposed Terms of Reference for EIA studies Scope of Work of EIA “...The EIA shall cover the following: Description of the proposed project: The first task:” Description of the proposed project” forms a vital component of the Environmental Impact Assessment (EIA) as it provides the basis for evaluating the likely causes of Environmental Impacts.
Existing Environment and Baseline Conditions: The baseline assessment will be carried out to identify potentially sensitive and critical areas that may be affected by the project in an area of 10 km surrounding the project location. The critical and sensitive targets shall be plotted on land use map of project impact area. The existing environment and baseline conditions should be established from:‐ Analysis of existing information published and secondary data. ‐Consultation with relevant statutory authorities, and Field visits for supplementation of missing gaps.
The key subject areas which the EIA shall address include Ecology and Nature conservation, Air quality, surface and water quality in project impact area, soil quality, cultural heritage, landscape, land use, noise quality, etc. Natural habitats like national parks, wildlife reserves, sanctuaries, sacred grove, protected areas, forests, wetlands, major rivers and waterways if any, shall also be identified and marked.
Assessment of Environmental Impacts: Based upon the results from the review of existing information, field visits, site data collection and consultation, for each component of environment (physical, biological and socio economic) the positive, negative, direct and indirect, temporary and permanent impacts will be evaluated along with an indication of the degree of impact, i.e., whether the impact is significant, moderate, minor or negligible. The degree of impact shall also be quantified by using state of the art air quality impact prediction models based on ISCST3 algorithms.
Environment Management Plan And Mitigation Plan: For each significant negative impact identified, specialist shall work closely with the engineering team/technical consultants to suggest practicable measures to avoid or mitigate the impact. The mitigation of environmental impacts will be by three mechanisms. =>Introduction of mitigation features through the engineering practices. =>Implementation of environmental controls during construction and operation. =>Legislative control involving compliance with Indian environmental laws. The Environmental management plan shall include an estimate of capital and recurring costs of mitigation measures and will identify the institutional framework for implementation.
Monitoring Plan: Having identified the significant environmental impact that is likely to arise as a result of the project, the project team shall specify what monitoring is required during the various phases of the project cycle. The monitoring plan will identify parameters and frequency of monitoring and responsible organization.
KOSHER PHARMACEUTICALS PVT. LTD., SY. NO. 286, 289 (Part) AND 297 (Part),
JAGDEVPUR VILLAGE AND MANDAL, SIDDIPET DISTRICT, TELANGANA
ANNEXURES
Project No. 1216‐21‐02‐Amd December 2016
Kosher Pharmaceuticals Pvt. Ltd., H.No: 1‐48/3/2, Shankar Nagar, Chanda Nagar, Hyderabad – 500 050. Phone: +91 9849042616 Fax: 040‐66785427 E‐mail ID: [email protected]
STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants B‐115‐117 & 509, Annapurna Block, Aditya Enclave, Ameerpet, Hyderabad‐500 038. Phone: 040‐23748 555/23748616, Telefax: 040‐23748666
SUBMITTED TO MINISTRY OF ENVIRONMENT AND FOREST AND CLIMATE CHANGE
GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAVAN, JOR BAGH ROAD, NEW DELHI
Kosher Pharmaceuticals Pvt. Ltd., Form I Annexures
Page 1
Fig.1.1 Location Map of M/s. Kosher Pharmaceuticals Pvt. Ltd.,
Kosher Pharmaceuticals Pvt. Ltd., Form I Annexures
Page 2
S
EWN
Fig 1.2 Plant Layout of M/s. Kosher Pharmaceuticals Pvt. Ltd.,
Kosher Pharmaceuticals Pvt. Ltd., Form I Annexures
Page 3
ANNEXURE - I
M/s. Kosher Pharmaceuticals Pvt. Ltd., obtained Environmental Clearance from Ministry of
Environment and Forests (MoEF) vide letter no. F. No. J-1011/173/2012-IA II (I) dated: 18.09.2014 at
Sy. No. 286, 289 (Part) & 297 (Part), Jagdevpur Village and Mandal, Siddipet District, Telangana. It is
proposed for Amendment of Boiler capacity in existing EC. Amendment in Boilers is presented in
Table A-1. The manufacturing capacity is presented in Table A-2.
Table A-1 Amendment in Boilers S.No Description As Per EC Amendment
1 Coal Fired Boilers 1 x 3 TPH 1 x 5 TPH 1 x 2 TPH 1 x 3 TPH*
Total in Operation 5 TPH 5 TPH Note: 1. No change in steam consumption 2. 1 x 3 TPH Boiler will be kept as standby 3.At any point of time maximum steam consumption will be 5 TPH
Table A-2 Manufacturing Capacity
S.No Name of the Product CAS No. Quantity (Kg/Day)
Quantity (TPM)
1 Aliskiren Hemifumarate 173334-58-2 200 6 2 Azacitidine 320-67-2 120 3.6 3 Esomeprazole Mg 217087-09-07 300 9 4 Irbesartan 138402-11-6 150 4.5 5 Monteluksat Sodium 151767-02-1 150 4.5 6 Ranolazin diHCl 95635-56-6 250 7.5 7 Sildenafil citrate 171599-83-0 100 3 8 Tadalafil 171596-29-5 300 9 9 Topiramate 97240-79-4 300 9 10 Udenafil 268203-93-6 45 1.4 11 Venlafaxine Hydrochloride 99300-78-4 250 7.5 12 Letrozole 112809-51-5 30 0.9 13 Losartan Potassium 124750-99-8 300 9 14 Metformin Hydrochloride 1115-70-4 1000 30 15 Robeprazole sodium 117976-90-6 150 4.5 Total(Worst case-4 Products) 1900 57
Note: The above products will be manufactured on campaign basis only. Only four productss will be in production at any given time.
Kosher Pharmaceuticals Pvt. Ltd., Form I Annexures
Page 4
List of By-Products S.No Name of the
Product Stage Name of the By-Product Capacity
Kg/day TPM 1 Azacitidine I Acetic Acid 118 3.5
Trimethyl silylalcohol 88.5 2.7 2 Tadalafil I Tri-fluoro acetic acid 135.6 4.1
II Diethylamine HCl 287.8 8.6 Dicyclohexyl urea 234.4 7
Kosher Pharmaceuticals Pvt. Ltd., Form I Annexures
Page 5
Process Description of Ranolazin diHCl Reaction Schemes
Process Description
1-[(2,6-dimethylphenyl) amino carbonyl methyl] piperazine is reacts with 1-(2-Methoxy
phenoxy)-2 epoxypropane in Acetone solvent media to get Ranolazine. . Schematic
diagram of Ranolazin diHCl Monohydrate is shown in Fig A – 3 and material balance for
of Ranolazin diHCl Monohydrate is presented in Table A - 3.
Fig A-3 Process Flow Diagram of Ranolazin diHCl
Table A- 3 Material Balance for Ranolazin diHCl
Stage-I Input Quantity
(Kg/day) Output Quantity
(Kg/day) Remarks
1-[(2,6~dimethylphenyl) amino carbonyl methyl] piperazine
170 Ranolazine 250 Final Product
1-(2-Methoxy phenoxy)-2,3-epoxy pro pane
123.9 Acetone Recovered 682.5 Recovery & Reuse
Acetone 700 Acetone Loss 3.5 Fugitive Loss Acetone to Residue 14 Solvent in Residue 1-[(2,6~dimethylphenyl)
amino carbonyl methyl] piperazine
25.4 Organic Residue
1-(2-Methoxy phenoxy)-2,3-epoxy pro pane
18.5 Organic Residue
Total Input 993.9 Total Output 993.9
Kosher Pharmaceuticals Pvt. Ltd., Form I Annexures
Page 6
ANNEXURE – II: Wastewater Treatment Facilities
The effluent generated from M/s. Kosher Pharmaceuticals Pvt. Ltd., is mainly from
process, washings, scrubbers, cooling towers & boiler blow downs and domestic effluent.
It is proposed to treat all HTDS effluent in stripper followed by MEE and ATFD. All LTDS
effluent including Domestic effluent shall be treated in Biological treatment followed by
RO system. RO Rejects sent to MEE and permeate is used for cooling towers as make up.
Total Effluent generated and mode of treatment is presented in Table A-4.
Table A-4 Quantity of Effluent Generated and Mode of Treatment Description Quantity
(KLD) Mode of Treatment
HTDS Effluents (TDS & COD> 15000 mg/l) Process 25.9 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/Boilers make-up and boiler.
Washings 3
Scrubber Effluent 2 Sent to MEE followed by ATFD, Biological treatment plant and RO. DM rejects 1
Total - I 31.9 LTDS Effluents (TDS & COD< 15000 mg/l)
Boiler Blow downs 2.5 Sent to Biological Treatment System followed by RO.
RO permeate reused for cooling tower makeup. RO rejects sent to MEE.
Cooling Tower Blow downs 7 Domestic 4
Total - II 13.5 Grand Total (I+II) 45.4
Kosher Pharmaceuticals Pvt. Ltd., Form I Annexures
Page 7
ANNEXURE – III: Water Balance
The total water requirement is 88.7 KLD out of which 48.7 KLD shall be drawn from bore
wells/Tankers and balance shall be recycled water. Water balance is presented in Table A-
5.
Table A-5 Total Water Balance Purpose INPUT (KLD) OUTPUT (KLD)
Fresh Water Recycled Water Loss Effluent Process 24.2 25.9 Washings 3 3 Scrubber 2 2 Boiler Feed 7 10 14.5 2.5 Cooling Tower 5 30 28 7 RO/DM Plant 1 1 Domestic 4.5 0.5 4 Gardening 2 2 Gross Total 48.7 40 45.0 45.44 Total 88.7 90.4
* Process effluents contain soluble raw materials, byproducts, solvents etc.
Kosher Pharmaceuticals Pvt. Ltd., Form I Annexures
Page 8
ANNEXURE – IV: Solid Waste Generation and Mode of Disposal
Solid wastes generated from the process shall be sent to TSDF/ Cement Industries for Co-
incineration. Stripper distillate shall send to TSDF/ Cement Industries for Co-incineration.
ETP Sludge and Evaporation salts from MEE, ATFD shall be sent to TSDF. Ash from
Boilers shall be sold to brick manufacturers. The total solid waste generated and mode of
disposal is presented in Table A-6.
Table A-6 Solid Waste Details S.No Description Units Quantity Mode of Disposal
1 Ash from Boiler TPD 9.78 Sold to Brick manufactures 2 Solvent residue TPD 1.58 Sent to TDSF/Cement Plants for Co-
incineration 3 Process Organic
residue TPD 1.55 Sent to TDSF/Cement Plants for Co-
incineration 4 Carbon Kg/day 60 Sent to TDSF/Cement Plants for Co-
incineration 5 Hyflow Kg/day 30 Sent to TSDF 6 Catalyst Kg/day 5 Sent to TSDF 7 Mixed Solvents KLD 20.8 Sent to authorized recovery units/
Cement plants for co-incineration 8 Spent Solvents KLD 37.68 Recovered within the plant premises. 9 Stripper Distillate KLD 1.45 Sent to Cement Industries for Co-
incineration. 10 Evaporation salts TPD 0.945 Sent to TSDF 11 ETP Sludge TPD 0.38 Sent to TSDF 12 Detoxified containers No.s/Yr 1000 Sold to authorized vendors 13 Waste oil LPM 110 Sent to Authorized Recyclers 14 Used batteries No.s/Yr 4 Sent to Authorized Recyclers
Kosher Pharmaceuticals Pvt. Ltd., Form I Annexures
Page 9
ANNEXURE – V: Stack Emissions Details
The sources of air pollution from the plant are proposed 5TPH Coal Fired boiler and
permitted 500 KVA DG Set. Permitted 3TPH Coal fired boiler will be kept as standby after
amendment. The emissions from the 5 TPH boiler are passed through bag filter. DG sets shall
be provided with stack heights based on the CPCB formula for effective stack height. The
emission rates of SPM, SO2, NOx and SPM from each stack are presented in Table A-7.
Table A-7 Stack Emission Details S.
No
Stack Connected to Stack Ht (m)
Dia of stack at top(m)
Temp. of exhaust
gases (0C)
Exit Velocity (m/sec)
Pollutant Emission Rate (g/sec)
PM SO2 NOx Permitted
1 3 TPH Coal Fired Boilers
30 0.5 180 8.5 0.09 0.14 0.35
2 2TPH Coal Fired Boilers
30 0.4 180 7.5 0.05 0.08 0.21
3 #DG Set 500 KVA 5 0.25 185 7.2 0.004 0.16 0.028 After Amendment
1 5 TPH Coal Fired Boiler
30 1.05 200 10 0.3 0.45 0.58
2 *3 TPH Coal Fired Boilers
30 0.5 180 8.5 0.09 0.14 0.35
3 #DG Set 500 KVA 5 0.25 185 7.2 0.004 0.16 0.028 #DG set will be used during load shut down periods only. * 1 x 3 TPH Coal fired boiler will be kept as standby.
Kosher Pharmaceuticals Pvt. Ltd., Form I Annexures
Page 10
ANNEXURE – VI: Process Emissions
The emissions from the process and their mode of treatment is presented in the below table
Table A-8.
Table A-8 Quantity of Process Emission Generated and Mode of Disposal
Product Name Stage Name of the Gas Quantity (Kg/ day)
Mode of Treatment
Azacitidine I Ammonia 8.4 To Scrubber Irbesartan III Nitrogen gas 1.9 Let out into atmosphere Nitrous Oxide gas 2.9 Let out into atmosphere Sildenafil Citrate I Sulfurdioxide 32.1 To Scrubber Hydrochloric Acid 18.3 To Scrubber Topiramate III Carbondioxide 47.1 Let into atmosphere Udenafil I Sulfur Dioxide 13.1 To Scrubber II Hydrogen Chloride 12.7 To Scrubber Sulfur Dioxide 11.1 To Scrubber Venlafaxine HCl II Hydrogen 0.9 Let into atmosphere III Carbon Dioxide 65.1 Let into atmosphere Letrozole I Carbon Dioxide 3.5 Let into atmosphere
KOSHER PHARMACEUTICALS PVT. LTD., SY. NO. 286, 289 (Part) AND 297 (Part),
JAGDEVPUR VILLAGE AND MANDAL, SIDDIPET 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: [email protected]