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Apotex Pharmachem India Pvt. Ltd., PLOT NO. 1 A, 4th PHASE, BOMMASANDRA INDUSTRIAL AREA, JIGINI LINK ROAD, ANEKAL TALUK, BANGALORE DISTRICT,
KARNATAKA STATE
FORM I
Project No. 0417‐21‐02 April 2017
M/s. Apotex Pharmachem India Pvt.Ltd. Plot No: 1 A,4th Phase, Bommasandra Industrial Area Anekal Taluk, Bangalore‐560099 Fax No: 080‐22891034 E‐mail: [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, FOREST AND CLIMATE CHANGE
GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI
.
Form I Page 1
APPENDIX – I (See Paragraph – 6)
FORM I I) Basic Information S.No. Item Details 1 Name of the Project/s M/s. Apotex Pharmachem India Pvt. Ltd. 2 S. No in the Schedule 5 (f) – B category (Synthetic Organic Chemicals) 3 Proposed capacity/area/length/tonnage to
be handled/command area/lease area/number of wells to be drilled
Area Existing: 5.23 Acres Permitted Production Capacity: 49.6 TPA Capacity after Expansion: 54.74 TPA Environmental Clearance. 1. File No. J‐1011/181/2006‐IA II (I) dt: 31.08.2006. Capital Cost for proposed expansion: R. 25 crores
4 New/Expansion/Modernization Expansion 5 Existing Capacity/Area etc. Existing Capacity: 49.6 TPA
Area Existing: 5.23 Acres 6 Category of Project i.e 'A' or 'B' “B” 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. Plot No. 1A, Bommasandra Industrial Area, 4th Phase Village Yeranda Halli Tehsil Jigani Hobli of Anekal District Bangalore State Karnataka
10 Nearest railway station/airport along with distance in km.
Bangalore Railway station ‐ 27 km Bangalore airport ‐ 58 km
11 Nearest Town, City, District Headquarters along with distance in kms.
Bangalore Urban District Headquarters ‐ 21 km
12 Village Panchayats, Zilla Parishad, Municipal Corporation, Local body (complete postal address with telephone nos. to be given)
Yeranda Halli
13 Name of the Applicant P. Yoganjaneya Reddy Vice President and Site Head
14 Registered Address M/s Apotex Pharmachem India Pvt. Ltd. Plot no. 1A, Bommasandra Indl. Area, 4th Phase, Yeranda Halli Village, Jigani Hobli of Anekal Taluk, Bangalore.
15 Address for Correspondence: Name P. Yoganjaneya Reddy Designation(Owner/Partner/CEO) Vice President and Site Head Address M/s Apotex Pharmachem India Pvt. Ltd.
Plot no. 1A, Bommasandra Indl. Area, 4th Phase, Yeranda Halli Village, Jigani Hobli of Anekal Taluk, Bangalore.
.
Form I Page 2
Pin Code 560 099 E‐mail [email protected] Telephone Number 080 – 22891000 / 1014 Fax No. 080 ‐ 2289 1034
16 Details of alternative Sites examined, if any. Location of these sites should be shown on a topo sheet.
Not Applicable
17 Interlinked Projects Not applicable 18 Whether separate application of interlinked
project has been submitted? ‐NA‐
19 If yes, date of submission ‐NA‐ 20 If no, reason 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?
‐NA‐
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
.
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 The proposal is for expansion of existing bulk drug and intermediate manufacturing unit with existing site are of 5.23 acres.
1.2 Clearance of existing land, vegetation and buildings?
NO The proposal is for expansion of existing bulk drug and intermediate manufacturing unit with existing site are of 5.23 acres.
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 and soil load bearing capacity established
1.5 Construction works? YES Construction activity involves creation of enhancement of production block, Utilities, enhancement of ZLD system.
1.6 Demolition works? NO The proposal is for expansion of existing bulk drug and intermediate manufacturing unit. The proposed expansion activity involves creation of enhancement of production block, Utilities, enhancement of ZLD system
1.7 Temporary sites used for construction works or housing of construction workers?
NO Construction labor from local villages shall be employed.
1.8 Above ground buildings, structures or earthworks including linear structures, cut and fill or excavations
YES Storage facilities shall be constructed. 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 flame proof ware houses.
1.15 Facilities for treatment or disposal of solid waste or liquid effluents?
YES High TDS and low TDS effluents are treated in ZLD system. Organic waste is sent to cement plants for co‐ processing or to TSDF. Details of waste treatment facilities presented in Annexure II
1.16 Facilities for long term housing of operational workers?
NO Operational workers stay in surrounding villages.
.
Form I Page 4
1.17 New road, rail or sea traffic during construction or operation?
YES Construction materials shall be transported to the site. The traffic density of the existing connecting road is negligible.
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 opipelines?
NO
1.21 Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or aquifers?
NO
1.22 Stream crossings? NO All raw materials, solvents and waste streams are pumped through pipe lines above ground level.
1.23 Abstraction or transfers of water form ground or surface waters?
YES Total water required shall be met from KIADB Industrial water supply. Permitted water consumption is 145 KLD. Total water required after expansion shall be 285 KLD out of which 175 KLD is fresh water requirement and balance 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?
YES The construction material shall be drawn from local sources within 10 km. There is no transport of personnel, as the construction workers shall be drawn from local villages.
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 proposed project shall increase the employment potential.
1.29 Introduction of alien species? NO1.30 Loss of native species or genetic
diversity? NO There are no major losses of tree/shrub species.
1.31 Any other actions? NO
.
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) YES Existing Site area: 5.23 acres
Located at Plot no. 1A, Bommasandra Indl. Area, 4th Phase, Yeranda Halli Village, Jigani Hobli of Anekal Taluk, Bangalore.
2.2 Water (expected source & competing users) unit: KLD
YES Total water required shall be met from KIADB Industrial water supply. Permitted water consumption is 145 KLD. Total water required after expansion shall be 285 KLD out of which 175 KLD is fresh water requirement and balance 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 Shall 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 (T), energy (MW)
YES The required energy shall be drawn from BESCOM. No additional DG sets are proposed for expansion. Existing Standby DG sets of 2 x 1010 KVA, 1 X 625 KVA and 2 x 500 KVA will be used during load shut down by BESCOM. It is proposed to establish 1 x 3 TPH and 1 x 2 TPH PNG/Oil fired boilers. Proposed 1 x 2 TPH boiler will be kept as standby. PNG consumption after expansion is 5000 cum/hr.
Existing boilers of capacity 0.6 TPH and 1.5 TPH Oil fired fired boilers shall be dismantled after expansion.
2.7 Any other natural resources (use appropriate standard units)
NA
.
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. 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 activities involve creation of
enhancement of production blocks, Utilities and enhancement of ZLD system.
4.8 Redundant machinery or equipment NO 4.9 Contaminated soils or other materials NO All pipe lines including pipe lines of waste streams
are above ground level 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
.
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. Emissions details are
enclosed in Annexure V5.2 Emissions from production processes YES Gaseous emissions from process are ammonia, HCl,
SO2, are scrubbed in two stage scrubbers while carbondioxide gas is let out into atmosphere using standard operating procedure. Hydrogen gas let out into atmosphere through water column.
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 Domestic wastewater sent to Sewage Treatment Plant and treated wastewater reused for gardening.
5.6 Emissions from incineration of waste NO Organic waste streams are sent to cement plants for co‐incineration.
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
.
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. 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 NO 6.7 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 drums,
in a covered shed and no contamination of soil is expected. Same philosophy will be followed for the after expansion
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 Sewage Treatment Plant and treated wastewater reused for gardening
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.
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
.
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 by increasing the demand for housing, improving the employment.
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.
.
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 Ragihalli RF – SW – 7.6 km Kakere RF – NW – 8.7 km Bannerghatta National Park – SW – 7.6 km from plant boundary.
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 Nearest habitation from the site is
Bommasandra at a distance of 4 Km in NE 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
Apotex Pharmachem India Pvt. Ltd., PLOT NO. 1 A, 4th PHASE, BOMMASANDRA INDUSTRIAL AREA, JIGINI LINK ROAD, ANEKAL TALUK, BANGALORE DISTRICT,
KARNATAKA STATE
ANNEXURES
Project No. 0417‐21‐02 April 2017
M/s. Apotex Pharmachem India Pvt.Ltd. Plot No: 1 A,4th Phase, Bommasandra Industrial Area Anekal Taluk, Bangalore‐560099 Fax No: 080‐22891034 E‐mail: [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, FOREST AND CLIMATE CHANGE
GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI
Form I Annexures
Page 1
Fig
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Form I Annexures
Page 2
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Fig A.2 Plant Layout after Expansion of M/s. Hindys Lab Pvt. Ltd.,
Form I Annexures
Page 3
ANNEXURE - I
M/s. Apotex Pharmachem India Pvt. Ltd., located at Plot No.1 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: 31.08.2006.
The unit had renewed consent for operation (CFO) vide Letter No. PCB/055/HPI/2015-
16/H1189 dated 17.12.2015. It is proposed to increase the manufacturing capacity from
49.6 TPA to 54.74 TPA within the Existing land of 5.23 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 S.No Name of Product Capacity
(TPA) 1 Enalapril Maleate 2 2 Torsemide USP 0.2 3 Candesartan Cilexetil 0.2 4 Olmesartan medoxomil 1 5 Perindopril Arginine 0.2 6 Ramipril 0.5 7 Perindopril 2 8 Pantoprazole sodium 2 9 Lansoprazole 3 10 Esomeprazole Magnesium 0.5 11 Voriconazole 0.2 12 Eletriptan HBr 0.3 13 Naratriptan 0.1 14 Zolmitriptan 0.2 15 Rizatriptan Benzoate 0.2 16 Almotriptan Malate 0.2 17 Finasteride Intermediate 0.05 18 Ranolazine 2 19 Tolteridone 0.2 20 Trospium Chloride 0.5 21 Varenicline Tartrate 0.2 22 Fesoterodine fumarate 0.2 23 Pramipexol 0.1 24 Dolasetron Mesylate 0.2 25 Raloxifene 1 26 Exemestane 0.1 27 Letrozole 0.05 28 Capecitabine 0.2
Form I Annexures
Page 4
29 Paliperidone 0.2 30 Risperidone 0.2 31 Etravirine 0.2 32 Raltregravir 0.2 33 Valganciclovir 3 34 Entecavir 0.005 35 Eszopiclone 0.2 36 Gatifloxacine hydrochloride 0.1 37 Levothyroxine sodium 0.2 38 Mycophenolate Mofetil 25 39 Tizanidine 1.2 40 Rasagiline Mesylate 0.05 41 Riluzole 0.3 42 Cabergolin 0.05 43 Alprazolam 0.5 44 Donepezil HCl 0.3 45 Linezolid 0.2 46 Febuxostat 0.1
Total 49.605
Form I Annexures
Page 5
Table A-2 Manufacturing Capacity –After Expansion Sl.No Product Capacity
(TPA) 1 Alcaftadine 0.05 2 Almotriptan Maleate 0.15 3 Alprazolam 0.1 4 Apixaban 0.05 5 Atomoxitine Hydrochloride 0.1 6 Azelastine 0.03 7 Cabergoline 0.05 8 Canagliflozin 0.2 9 Candesartan Cilexetil 1.5
10 Carvidelol 1 11 Dabigatron Etexilate Mesilate 2 12 Deferasirox 1.5 13 Donepezil hydrochloride 0.3 14 Dronedarone Hydrochloride 1 15 Eletriptan Hydrobromide 0.6 16 Enalapril Maleate 1.5 17 Entecavir 0.01 18 Esomeprazole Magnesium 0.5 19 Eszopiclone 0.07 20 Etravirine 0.2 21 Exemestane 0.05 22 Febuxostat 0.1 23 Fesoterodine Fumerate 0.1 24 Fingolimod Hydrochloride 0.03 25 Gatifloxacin Hemihydrate 0.05 26 Ivacaftor 0.05 27 Lansoprazole 3 28 Letrozole 0.01 29 Levothyroxine Sodium 0.05 30 Linagliptin 0.05 31 Linezolid 1 32 Liothyronine Sodium 0.03 33 Lurasidone Hydrochloride 0.3 34 Mycophenolate Mofetil 20 35 Mycophenolate Sodium 1 36 Naratriptan Hydrochloride 0.1 37 Olmesartan Medoxomil 3 38 Olopatadine Hydrochloride 0.03 39 Paliperidone 0.1 40 Perampanel 0.01 41 Perindopril Arginine 0.5 42 Perindopril tert. Butylamine 1.5 43 Pramipexole Dihydrochloride 0.03
Form I Annexures
Page 6
44 Prasugrel Base 0.1 45 Prasugrel Hydrochloride 0.3 46 Raloxifene Hydrochloride 2 47 Raltegravir Potassium 0.2 48 Ramipril 0.5 49 Ranolazine 5 50 Rasagiline Mesylate 0.05 51 Riluzole 0.15 52 Risperidone 0.05 53 Rivaroxaban 0.1 54 Rizatriptan Benzoate 0.1 55 Saxagliptin Hydrochloride 0.1 56 Tetrabenazine 0.1 57 Tizanidine Hydrochloride 0.3 58 Tolterodine Tartrate 0.1 59 Tolvaptan 0.05 60 Torsemide 0.2 61 Trospium chloride 0.15 62 Valgancyclovir Hydrochloride 2 63 Varenicline Tartrate 0.05 64 Voriconazole 0.5 65 Zolmitriptan 0.04 66 Atorvastatin Calcium 0.2 67 Dolutegravir 0.4
Total 54.74
Form I Annexures
Page 7
Reaction Schemes of Atorvastatin Calcium
O
OCH 3
CH 3
OC H 3
C H 3
C H 3
O
N H 2
O
OCH 3
CH 3
OC H 3
C H 3
C H 3
O
N C
O
OCH 3
CH 3
OC H 3
C H 3
C H 3
O
N H 2
O
O
N
NH
OC H 3
C H 3
OH
OH
F
2
C a2 +
O
F
C H 3
C H 3
O N H
O
S T A G E - I
( 4 R , 6 R ) - 2 - [ 6 - ( 2 - a m in o e t h y l ) - 2 , 2 -d im e t h y l - 1 , 3 - d io x a n - 4 - y l ] a c e t i ca c id t e r t - b u t y l e s t e r
M . W t : 2 7 3
( 4 R - c is ) - 1 , 1 , - d im e t h y le t h y l - 6 -c y n o m e t h y l - 2 , 2 - d im e t h y l - 1 , 3 -d io x a n e - 4 - a c e t a t e
2 H 2 , R a n e y N i
M e t h a n o l
M . W t : 2 6 9
( 4 R , 6 R ) - 2 - [ 6 - ( 2 - a m in o e t h y l ) - 2 , 2 -d im e t h y l - 1 , 3 - d io x a n - 4 - y l ] a c e t i ca c id t e r t - b u t y l e s t e r
+
2
4 H 2 O
2 N a C I
2 C H 3 C O O H
A t o r v a s a t i n C a l c i u m ( P h a r m a )
2 H C I M . W t : 3 6 . 5 ( x 2 )6 N a O H
M W t : 1 1 5 4
M W t : 1 8 ( x 4 )
M W t : 5 8 . 5 ( x 2 )
A c e t i c a c idM W t : 6 0 ( x 2 )
M W t : 7 4 ( x 2 )t e r t - B u t a n o l
T e t r a h y d r o f u r a nC a lc iu m a c e t a t e ( M . W t : 1 5 8 )
+ +2 ( C H 3 ) 3 O H
2 ( C H 3 ) 2 C ( O N a ) 2
M . W t : 1 2 0 ( x 2 )
2 , 2 - D is o d iu m p r o p o x id e
S T A G E - I I
4 - ( 4 - f l u o r o p h e n y l - 2 - i s o b u t y r y l - o x o -N - p h e n y l - B u t y r a m id e
2
M W t : 4 1 7 ( x 2 ) M W t : 2 7 3 ( x 2 )
M W t : 2 7 3 ( x 6 )
Process Description of Atorvastatin Calcium:
Stage I: (4R-cis)-1,1,-dimethylethyl-6-cynomethyl-2,2-dimethyl-1,3-dioxane-4-acetate is
reduced in the presence of Raney nickel in methanol and in sodium hydroxide used to
yield (4R,6R)-2-[6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-yl]aceticacid tert-butyl ester.
Stage II: 4-(4-flurophenyl-2-isobutyryl-oxo-N-phenyl-butyramide is reacted with (4R,6R)-
2-[6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxane-4yl]aceticacid tert-butylester in the presence
of Sodium hydroxide and Hydrochloricacid followed by treated with Calciumacetate in
tetrahydrofuran and ethyl acetate to yield Atorvastatin calcium (Pharma).
Form I Annexures
Page 8
A t o r v a s t a t i n c a l c i u m ( P h a r m a )
W a t e r
W a s t e w a t e r
S o d i u m h y d r o x i d e
( 4 R ,6 R ) - 2 - [ 6 - ( 2 - a m i n o e t h y l ) - 2 ,2 -d i m e t h y l - 1 ,3 - d i o x a n - 4 - y l ] a c e t i ca c i d t e r t - b u t y l e s t e r
4 - ( 4 - f l u o r o p h e n y l - 2 - i s o b u t y r y l -o x o - N - p h e n y l - B u t y r a m i d e
H y d r o c h l o r i c a c i d
t e r t - b u t a n o l
A c e t i c a c i d
t - B u t y l a c e t i c a c i d
T e t r a h y d r o f u r a n
C a l c i u m a c e t a t e
2 ,2 - D i s o d i u m p r o p o x i d e
A c t i v a t e d c a r b o n
E t h y l a c e t a t e
n - H e x a n e
S o d i u m c h l o r i d e
T e t r a h y d r o f u r a n
S p e n t c a r b o n
E t h y l a c e t a t e
n - H e x a n e
( 4 R - c i s ) - 1 ,1 , - d i m e t h y l e t h y l -6 - c y n o m e t h y l - 2 ,2 - d i m e t h y l -1 ,3 - d i o x a n e - 4 - a c e t a t e
R a n e y n i c k e l
( 4 R ,6 R ) - 2 - [ 6 - ( 2 - a m i n o e t h y l ) - 2 ,2 - d im e t h y l - 1 ,3 - d i o x a n - 4 - y l ] a c e t i c a c i dt e r t - b u t y l e s t e r
M e t h a n o l
S T A G E - I
S T A G E - I I
R a n e y n i c k e l
M e t h a n o lS o d i u m h y d r o x i d e
W a t e r W a s t e w a t e r
Fig A.3 Process Flow Diagram of Atorvastatin Calcium
Table A-3 Material Balance of Atorvastatin Calcium Stage I Input Quantity
(Kg/day) Output Quantity
(Kg/day) Remarks
(4R-cis)-1,1,-dimethylethyl-6-cynomethyl-2,2-dimethyl-1,3-dioxane-4-acetate
0.4 Stage I Product 0.4 To Stage II
Raney Nickel 21 Methanol Recovered 723.5 Recovered & Reused Sodium Hydroxide 36 Methanol Loss 2.6 Fugitive Loss Methanol 750 Methanol to Wastewater 7.5 To Wastewater Hydrogen 0.0 Methanol to Residue 16.1 Solvent in Residue Water 179 (4R-cis)-1,1,-
dimethylethyl-6-cyno methyl-2,2-dimethyl-1,3-dioxane-4-acetate
0.0 Organic Residue
Raney Nickel 21.4 Inorganic Residue Sodium Hydroxide 35.7 To Waste water Water 178.5 To Waste water Total Input 985.7 Total Output 985.7
Form I Annexures
Page 9
Stage II Input Quantity
(Kg/day) Output Quantity
(Kg/day) Remarks
Stage I Product 0.4 Atorvastatin Calcium 0.5 Final Product 4-(4-flurophenyl-2-isobutyryl-oxo-N-phenyl-butyramide
1 t-Butanol 0.1 To Wastewater
Sodium Hydroxide 0 Sodium Chloride 0.1 To Wastewater Hydrochloric acid 0.1 Acetic acid 0.1 To Wastewater Pivalic acid 29 2,2 - Di Sodium
Propoxide 0.1 To Wastewater
Toluene 321 Toluene Recovered 311.7 Recovered & Reused Cyclo Hexane 1121 Toluene Loss 1.3 Fugitive Loss Isopropyl Alcohol(IPA) 1964 Toluene to Residue 8.4 Solvent in Residue Calcium Acetate 0.1 Cyclo Hexane Recovered 1087.4 Recovered & Reused Ethyl Acetate 1714 Cyclo Hexane Loss 4.5 Fugitive Loss Sodium Carbonate 25.0 Cyclo Hexane to
Residue 29.1 Solvent in Residue
Water 7568 IPA Recovered 1894.8 Recovered & Reused Activated Carbon 14 IPA Loss 9.8 Fugitive Loss IPA to Wastewater 23.6 To Wastewater IPA to Residue 35.3 Solvent in Residue Ethyl Acetate Recovered 1653.6 Recovered & Reused Ethyl Acetate Loss 6.9 Fugitive Loss Ethyl Acetate to
Wastewater 8.6 To Wastewater
Ethyl Acetate to Residue 44.6 Solvent in Residue Stage I Product 0.2 Organic residue 4-(4-flurophenyl-2-
isobutyryl-oxo-N-phenyl-butyramide
0.3 Organic residue
Pivalic acid 28.6 To Wastewater Activated Carbon 14.3 Organic residue Calcium Acetate 0.0 To Wastewater Sodium Carbonate 25.0 To Wastewater Water 7568.4 To Wastewater Total Input 12757 Total Output 12757.0
Form I Annexures
Page 10
ANNEXURE – II: Wastewater Treatment Facilities
The main sources of effluent generation from the plant are from process, washings,
scrubber effluent, blow downs from boiler and cooling tower, and domestic effluents. The
effluents generated in the process, separation techniques and during purification contain
organic residues of raw materials, solvents, and products. Some of the raw materials used
in the process are also inorganic in nature. Hence the effluents contain both organics and
in-organics in various quantities leading to high COD and TDS levels respectively. The
quantity of effluents 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
Permitted After Expansion
HTDS Effluents Process
6.5 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 6.5 12 LTDS Effluents
Washings 45.5 40 Sent to Biological Treatment System followed by RO. RO permeate reused for cooling tower makeup. RO rejects sent to MEE.
Scrubbers -- 4 Boiler Blow downs 2.2 10 Cooling Tower Blow downs
5.5 20
Domestic 14.8 26 Sent to Sewage Treatment Plant and treated wastewater reused for green belt development.
Total II 68 100 Grand Total (I+II) 74.5 112
Form I Annexures
Page 11
ANNEXURE – III: Water Balance
Water is required for process, scrubbers, washing, cooling tower makeup, steam
generation and domestic purposes. The required water shall be drawn from KIADB
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 after expansion is
presented in Table A-5.
Table A-5 Total Water Balance – After Expansion Purpose INPUT (KLD) OUTPUT (KLD)
Fresh Water Recycled Water Loss Effluent Process 8 8 Washings 40 40 Scrubber 4 4 Boiler Feed 40 30 10 Cooling Tower 39 84 103 20 RO/DM Plant 4 4 Domestic 30 4 26 Gardening 10 26 10 Gross Total 175.0 110 147.0 112.0 Total 285.0 259
Form I Annexures
Page 12
ANNEXURE – IV: Solid Waste
Solid wastes are generated from the process shall be sent to TSDF/ Cement Industries for
Co-incineration. The inorganic residue, evaporation salts from MEE and ATFD and ETP
Sludge shall be sent to TSDF. Total solid waste generated and mode of disposal is
presented in Table A-6.
Table A-6 Total Solid Waste Generated and Mode of Disposal S.
No Description Quantity Unit Method of disposal
Permitted After Expansion
1 Used or Spent Oil 4 10 KL/A Disposed to KSPCB authorized party for Reprocess
2 Wastes or residue containing Oil
0.1 4 MT/A
3 Process Residue 6 25 MT/A 4 Spent carbon 35.5 36 MT/A 5 Off specification
products 25 MT/A
6 Date expired products 25 MT/A 7 Spent catalyst
3 MT/A Disposed to KSPCB
authorized Party Recycling/Reused
8 Spent Solvents 1716 2300 KL/A Disposed to KSPCB authorized party for Reprocess
9 Empty barrels/ containers/ liners contaminated with hazardous chemicals/ wastes
6000 6000 No’s/A Disposed to authorized handler after through washing
10 Exhaust Air or Gas cleaning residue
3
3 MT/A Disposed to KSPCB authorized party for TSDF 11 Chemical sludge from
waste water treatment
9 100 MT/A
12 Evaporation salts 110 150 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 authorized party for Reprocess
15 Battery Waste As Actual generated No’s/A
Form I Annexures
Page 13
ANNEXURE – V: Stack Emissions Details
Existing Standby DG sets of 2 x 1010 KVA, 1 X 625 KVA and 2 x 500 KVA will be used during
load shut down by BESCOM. It is proposed to establish 1 x 3 TPH and 1 x 2 TPH PNG/Oil
fired boilers. Proposed 1 x 2 TPH boiler will be kept as standby. PNG consumption after
expansion is 5000 cum/hr. Existing boilers of capacity 0.6 TPH and 1.5 TPH Oil fired /PNG
fired boilers shall be dismantled after expansion. DG sets shall be provided with stack heights
based on the CPCB formula for effective stack height.
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 Existing
1 1.5TPH Oil Fired Boiler *
21 0.3 140 6 -- 0.03 0.12
2 0.6 TPH Oil Fired Boiler*
21 0.3 140 6 -- 0.002 0.005
3 2 x 1010 kva** 7 0.2 170 10 0.09 0.25 0.38 4 1 x 625 kva** 5 0.2 200 7.0 0.002 0.031 0.04 5 2 x 500 kva** 5 0.2 200 6.8 0.002 0.025 0.04
Proposed 1 1 x 3 TPH
PNG/Oil Fired Boiler
30 0.8 160 8.5 -- 0.4 0.21
2 1 x 2 TPH PNG/Oil Fired Boiler #
30 0.4 160 7.0 -- 0.08 0.28
* Will be dismantled after expansion ** DG sets will be used during load shut down. # Shall be kept as standby
~ I•• ..
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/No. :(fR = q~fq'(OI, ~
Telegram: PARYAVARANBANGALORE
~:Telephone:
~~
\tffi{ ~~ . .
Ii" ~iJili ~ CFJ ~
GOVERNMENT OF INDIAMINISTRY OF ENVIRONMENT & FORESTS
~ cf)\~k1~ (~ ~)
Regional Office (Southern Zone)Kendriya Sadan, 4th Floor, E&F Wings, 17th Main Road,
2nd Block, Koramangala, Bangalore - 560 034.
F. No. EP112.11350 IKarnataka
28th April 2017
To
Mr. Yoganjaneya Reddy, Site Head,Apotex Pharmachem India Private LtdPlot No 1 A, Bommasandra Industrial Area,4th Phase, Jigani Link Road,Bangalore 560 099,
Sub: Expansion of bulk drug unit located at Bommasandra by Mis Apotex Pharma India Ltd.Environmental Clearance issued vide Ref No. J- 110 I 1I18112006-IA.II (I) dt: 31.08.2006 --Request for certified compliance report -regarding.
Sir,
This is in response to your letter Ref APIPLIEHS/007/20 17-2018 dated 2ih April 2017 requestingfor a certified copy of the compliance report, I am to state that the project was recently monitoredby this office on 28th October 2016 and it has been noted that this project is complying with theconditions of the above said environmental clearance. Detailed monitoring report for this project isuploaded in the Ministry's environmental clearance website and is available athttp://environmentclearance.nic.in/.
~r~c
(Dr U Sridharan)Scientist "0"
..
Apotex Pharmachem India Pvt. Ltd., PLOT NO. 1 A, 4th PHASE, BOMMASANDRA INDUSTRIAL AREA, JIGINI LINK ROAD, ANEKAL TALUK, BANGALORE DISTRICT,
KARNATAKA STATE
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]
