JSP Form I - environmentclearance.nic.in · 2 APPENDIX I (See paragraph - 6) FORM 1 (I) Basic...
Transcript of JSP Form I - environmentclearance.nic.in · 2 APPENDIX I (See paragraph - 6) FORM 1 (I) Basic...
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FORM-1
For
PROPOSED OF BULK DRUGS AND BULK DRUG
INTERMEDIATES MANUFACTURING UNIT
of
M/s. KRUFREN PHARMA
PLOT NO. C/251(251/2), GIDC, SAYKHA,
TAL: VAGRA, DIST: BHARUCH-392130 (GUJ.)
NABL Accredited Testing Laboratory
ISO 9001:2008 Certified Company
Aqua-Air Environmental Engineers P. Ltd.
403, Centre Point, Nr. Kadiwala School, Ring
Road, Surat - 395002
Prepared By:
NABL Accredited Testing Laboratory
ISO 9001:2008 Certified Company
Aqua-Air Environmental Engineers P. Ltd.
403, Centre Point, Nr. Kadiwala School, Ring
Road, Surat - 395002
NABL Accredited Testing Laboratory
ISO 9001:2008 Certified Company
Aqua-Air Environmental Engineers P. Ltd.
403, Centre Point, Nr. Kadiwala School, Ring
Road, Surat - 395002
Prepared By:
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APPENDIX I
(See paragraph - 6)
FORM 1
(I) Basic Information
Sr.
No.
Item Details
1. Name of the project/s M/s. KRUFREN PHARMA
2. S. No. in the schedule 5(f)
3. Proposed capacity/ area/ length/ tonnage
to be handled/ command area/ lease
area/ number of wells to be drilled
For detail Please refer Annexure – I
4. New/Expansion/Modernization New
5. Existing Capacity/Area etc. Proposed Capacity: 149 MT/Month
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: C/251(251/2)
Village Saykha
Tehsil Vagra
District Bharuch
State Gujarat
10. Nearest railway station/airport along with
distance in kms.
Nearest Railway Station: Bharuch = 30 kms
Nearest Airport: Surat = 70 kms
11. Nearest Town, city, District Headquarters
along with distance in kms.
Nearest town: Bharuch = 30 kms,
Nearest District Head quarter: Bharuch =
30 km
12. Village Panchayats, Zilla Parishad,
Municipal Corporation, local body
(complete postal address with telephone
nos. to be given)
Vill: Saykha, Tal: Vagra, Dist: Bharuch,
Gujarat.
13. Name of the applicant M/s. KRUFREN PHARMA
14. Registered Address Plot No: C/251(251/2), GIDC, Saykha, Tal:
Vagra, Dist: Bharuch-392130 (Guj.).
15. Address for correspondence: M/s. KRUFREN PHARMA Plot No: C/251(251/2), GIDC, Saykha, Tal:
Vagra, Dist: Bharuch-392130 (Guj.).
Name Mr. Kantilal L. Patel
Designation (Owner/Partner/Director) Partner
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Address B/201, Nilkanth Palace, GIDC, Ankleshwar-
393002, Dist: Bharuch (Guj.)
Pin Code 393002
e-mail [email protected]
Telephone No. +919998144307
Fax No. -
16. Details of Alternative Sites examined, if
any.
Location of these sites should be shown
on a topo sheet.
NA
17. Interlinked Projects NA
18. Whether separate application of
interlinked project has been submitted?
NA
19. If yes, date of submission NA
20. If no, reason NA
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) NA
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 No.
(c) Orders/directions of the Court, if any
and its relevance with the proposed
project.
NA
• Capacity corresponding to sectoral activity (such as production capacity for manufacturing, mining lease area and production capacity for mineral production, area for mineral exploration, length for linear transport infrastructure, generation capacity for power generation etc.).
4
(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.
No.
Information/Checklist confirmation Yes/
No
Details thereof with approximate
quantities frates, wherever possible)
with source of information data
1.1 Permanent or temporary change in land use, land cover or topography including increase intensity of land use (with respect to local land use plan)
No --
1.2 Clearance of existing land, vegetation
and Buildings?
Yes Minor site clearance activities shall be
carried out to clear shrubs and weed.
1.3 Creation of new land uses? No --
1.4 Pre-construction investigations e.g.
bore Houses, soil testing?
No
1.5 Construction works? Yes For detail Please refer Annexure – II
1.6 Demolition works? No There will not any demolition work at the site.
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 For detail Please refer Annexure – II
1.9 Underground works mining or
tunneling?
No --
1.10 Reclamation works? No --
1.11 Dredging? No --
1.12 Off shore structures? No --
1.13 Production and manufacturing
processes?
Yes For detail Please refer Annexure -III
1.14 Facilities for storage of goods or
materials?
Yes Dedicated storage area for storage of Raw Materials and finished products, solvents, etc. shall be provided.
1.15 Facilities for treatment or disposal of
solid waste or liquid effluents?
Yes Facilities for treatment or disposal of liquid effluents are given as Annexure – V & Facilities for treatment or disposal of solid waste is given as Annexure –VI.
1.16 Facilities for long term housing of
operational workers?
No The unit shall be running round the clock. The operational staff will be recruited locally and working in shift, hence no housing for the operational workers.
1.17 New road, rail or sea traffic during
Construction or Operation?
No There will not be any new road/rail or sea traffic during construction or operational phase.
1.18 New road, rail, air waterborne or other No --
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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?
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? No --
1.23 Abstraction or transfers of water form
ground or surface waters?
Yes Water Source: GIDC Water Supply
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 By road only.
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 either
temporarily or permanently?
No --
1.29 Introduction of alien species?
No --
1.30 Loss of native species or genetic
diversity?
No --
1.31 Any other actions? No --
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.
No.
Information/checklist confirmation Yes/
No
Details there of (with approximate
quantities frates, wherever possible) with
source of information data
2.1 Land especially undeveloped or
agricultural land (ha)
No The land is for Industrial Use
2.2 Water (expected source & competing
users) unit: KLD
Yes Water Source: GIDC Water Supply
Water balance is given as Annexure – IV
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2.3 Minerals (MT) No --
2.4 Construction material - stone,
aggregates,
and / soil (expected source - MT)
Yes Construction materials, like steel, cement,
crushed stones, sand, rubble, etc.
required for the project shall be procured
from the local market of the region.
2.5 Forests and timber (source - MT) No. --
2.6 Energy including electricity and fuels
(source, competing users) Unit: fuel
(MT), energy (MW)
Yes Power required from DGVCL is
Proposed = 100 KVA
D. G. Set : Proposed = 100 KVA
Fuel
Proposed
Briquettes of Bio-Coal/Coal: 1900
MT/day
HSD: 50 Lit/Day
2.7 Any other natural resources (use
appropriate standard units)
No --
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.
Sr.
No.
Information/Checklist confirmation Yes/
No
Details there of (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 For details please refer Annexure – VIII
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?
No --
3.4 Vulnerable groups of people who could
be affected by the project e.g. hospital
patients, children, the elderly etc.
No --
3.5 Any other causes No --
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4. Production of solid wastes during construction or operation or decommissioning (MT/month)
Sr.
No.
Information/Checklist confirmation Yes/
No
Details there of (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 --
4.3 Hazardous wastes (as per Hazardous
Waste Management Rules)
Yes Please refer Annexure –VI
4.4 Other industrial process wastes
No --
4.5 Surplus product
No --
4.6 Sewage sludge or other sludge from
effluent treatment
Yes
Please refer Annexure – VI
4.7 Construction or demolition wastes
No Construction waste shall be utilized for
leveling & land filling in the premises.
4.8 Redundant machinery or equipment
No --
4.9 Contaminated soils or other materials
No --
4.10 Agricultural wastes
No --
4.11 Other solid wastes Yes Please refer Annexure –VI
5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr)
Sr.
No.
Information/Checklist confirmation Yes/
No
Details there of (with approximate
quantities/rates, wherever possible)
with source of information data
5.1 Emissions from combustion of fossil
fuels from stationary or mobile
sources
Yes For details Please refer Annexure – VII.
5.2 Emissions from production processes
Yes Stack emission will remain within the
norms prescribed by CPCB. Please refer
Annexure – VII.
5.3 Emissions from materials handling
storage or transport
Yes The construction materials such as stones,
cements, bricks & coal may pollute the air by
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dust particles. But it will be controlled by
covering the trucks & trailers by clothes during
transportation.
5.4 Emissions from construction activities
including plant and equipment
Yes During construction work, the Nearby
buildings area will be covered by sheets or
clothes to avoid dust Contamination in air.
5.5 Dust or odors from handling of
materials including construction
materials, sewage and waste
No --
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 --
6. Generation of Noise and Vibration, and Emissions of Light and Heat:
Sr.
No.
Information/Checklist confirmation Yes/
No
Details there of (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 The Noise level will be within the
prescribed limit. Adequate preventive &
control measures will be taken at noisy
area. No significant noise, vibration or
emission of light & heat from the unit.
6.2 From industrial or similar processes No All machinery / equipment shall be well
maintained, shall have proper.
Foundation with anti-vibrating pads
wherever applicable to keep noise levels
within permissible limits.
Acoustic enclosures shall be provided for
DG set.
6.3 From construction or demolition No --
6.4 From blasting or piling No --
6.5 From construction or operational
traffic
No --
6.6 From lighting or cooling systems No --
6.7 From any other sources No --
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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:
Sr.
No.
Information/Checklist confirmation Yes/
No
Details there of (with approximate
quantities/rates, wherever possible) with
source of information data
7.1 From handling, storage, use or spillage
of hazardous materials
Yes For detail please refer Annexure – VIII
7.2 From discharge of sewage or other
effluents to water or the land
(expected mode and place of
discharge)
No --
7.3 By deposition of pollutants emitted to
air into and or into water
No --
7.4 From any other sources No --
7.5 Is there a risk of long term build up of
pollutants in the environment from
these sources?
No --
8. Risk of accidents during construction or operation of the Project, which could affect human health or the environment
Sr.
No.
Information/Checklist confirmation Yes/
No
Details there of (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 For detail please refer Annexure – VIII
8.2 From any other causes No --
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
Sr. No.
Information/Checklist confirmation
Yes/ No
Details there of (with approximate
quantities/rates, wherever possible)
with source of information data
9.1 Lead to development of supporting. lities, ancillary development or development stimulated by the
Yes For detail please refer Annexure – IX
10
(II) Environmental Sensitivity
Sr.
No.
Areas Name/
Identity
Aerial distance (within 15km.)
Proposed project location boundary
1 Areas protected under international
conventions, national or local legislation for
their ecological, landscape, cultural or other
related value
Yes Site is located in Saykha Industrial Area,
Saykha, Tal. Vagra, Dist. Bharuch,
Gujarat.
2 Areas which important for are or sensitive
Ecol logical reasons - Wetlands,
watercourses or other water bodies, coastal
zone, biospheres, mountains, forests
Yes Site is located in Saykha Industrial Area,
Saykha, Dist. Bharuch, Gujarat. Forest
area of Rajpipla is 100 kms away.
3 Area used by protected, important or
sensitive Species of flora or fauna for
breeding, nesting, foraging, resting, over
wintering, migration
Yes Site is located in Saykha Industrial Area,
Saykha, Tal. Vagra, Dist. Bharuch,
Gujarat.
4 Inland, coastal, marine or underground
waters
Yes Narmada River: 10 km (approx.) away
from Project Site
5 State, National boundaries No N.A.
6 Routes or facilities used by the public for
access to recreation or other tourist, pilgrim
areas
No Public transportation
7 Defense installations No N.A.
8 Densely populated or built-up area No Bharuch City: 5.24 lakh population.
9 Area occupied by sensitive man-made land
uses Hospitals, schools, places of worship,
community facilities)
No N.A.
project which could have impact on the environment e.g. • Supporting infrastructure (roads, power supply, waste or waste water treatment, etc.)
• housing development • extractive industry • supply industry • other
9.2 Lead to after-use of the site, which
could have an 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 --
11
10 Areas containing important, high quality or
scarce resources (ground water resources,
surface resources, forestry, agriculture,
fisheries, tourism, minerals)
No The project being in industrial area
does not affect agricultural land.
11 Areas already subjected to pollution
environmental damage. (those where
existing legal environmental standards are
exceeded)
No Site is located in Saykha Industrial
Area, Saykha, Tal. Vagra, Dist.
Bharuch, Gujarat.
12 Are as susceptible to natural hazard which
could cause the project to present
environmental problems (earthquake,
subsidence, landslides, flooding erosion, or
extreme or adverse climatic conditions)
No N.A.
IV). Proposed Terms of Reference for EIA studies: For detail please refer Annexure – X.
I hereby give undertaking that, the data and information given in the application and enclosures
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: 14/2/2019
Place: Saykha
Stamp and Signature of the Applicant
12
LIST OF ANNEXURES
SR. NO. NAME OF ANNEXURE Page No.
I List of Products with their Production Capacity 13
II Layout Map of the Plant 23
III Brief Manufacturing Process Description 24
IV Details of Water Consumption & Waste water Generation 86
V Details of Treatment Scheme and Disposal 88
VI Details of Hazardous /Solid Waste Generation, Handling and Disposal 92
VII Details of Stack and Vent 94
VIII Details of Hazardous Chemical Storage & Handling 95
IX Socio-Economic Impacts 96
X Proposed Terms of Reference for EIA studies 97
XI Toposheet 99
XII GIDC Plot Allotment Letter 100
XIII GIDC Waster Supply Letter 101
XIV TSDF Membership Certificate 102
13
ANNEXURE-I
LIST OF PRODUCTS WITH THEIR PRODUCTION CAPACITY
SR.
NO. NAME OF THE PRODUCTS CAS NO.
QUANTITY
MT/MONTH END-USE OF PRODUCT
1 NABIVILOL 152520-56-4 1 Beta-blocker
2 ZONISAMIDE 68291-97-4 10 Anti depression
3 FLUCONAZOLE 86386-73-4 10 Antifungal medication
4 LORATADINE 79794-75-5 1 Anti depression
5 GLIMEPRIDE 93479-97-1 1 anti diabetic
6 AMIODARONE
HYDROCHLORIDE 1951-25-3 10 irregular heartbeats
7 CILOSTAZOL 73963-72-1 10 intermittent claudication
8 APRIPITANT 170729-80-3 10 antiemetic
9 SEVELAMER HYDROCHLORIDE 152751-57-0 10 a noncalcemic phosphate
binder
10 NICARDIPINE
HYDROCHLORIDE 54527-84-3 1 Calcium channel blockers.
11 AMLODIPINE BESILATE 111470-99-6 10 calcium channel blockers.
12 GLIBENCLAMIDE 10238-21-8 10 anti diabetic
13 DESLORATADINE 100643-71-8 1 antihistamine
14 VENLAFLAXINE
HYDROCHLORIDE 99300-78-4. 10 antidepressant
15 TELMISARTAN 144701-48-4 10 anti hypertension
16 PREGABALIN 148553-50-8 10 Anxiety disorders
17 FEBUXOSTAT 144060-53-7 10 hyperuricemia.
18 Vildagliptin 274901-16-5 10 anti diabetic
19 VALSARTAN 137862-53-4 10 Anti Hypertensive
20 TOPIRAMATE 97240-79-4. 1 antiepileptic
21 ROPIVACINE 132112-35-7 1 local anesthetic
22 PEDOTIMODE 121808-62-6 1 antineoplastic
23 R&D -- 1
TOTAL 149
14
LIST OF RAW MATERIALS
SR. NO. RAW MATERIAL QUANTITY
(MT/MONTH)
CAS NO.
NABIVILOL
1 NSR-19C 0.39
2 Methanol 60.47 67-56-1
3 Acetonitrile 1.19 75-05-8
4 Diisopropyl ether 2.38 108-20-3
5 HCl (CP) 0.24 7647-01-0
6 NSR-19D 0.14
7 IPA HCl (20%) 1.35 7647-01-0
8 Hyflow 0.68 61790-53-2
ZONISAMIDE
1 NSR-28A 25.00
2 NSR-28B 37.50
3 NSR-28C 44.17
4 Methanol 250.00 67-56-1
5 Ammonia Solution 62.50 1336-21-6
6 Hydrochloric Acid 75.00 7647-01-0
7 Ethyl Acetate 62.50 141-78-6
8 Ethylene Dichloride 122.50 107-06-2
9 NSR-28D 21.58
10 1,4 Dioxane 16.33 123-91-1
11 Phosphorus Oxy chloride 81.67 10025-87-3
12 Toluene 612.50 108-88-3
13 Ethyl Acetate 1020.83 141-78-6
14 Activated Carbon 20.83 7440-44-0
15 Hyflow Super cell 8.33 61790-53-2
16 Sodium Chloride 43.75 7440-23-5
17 Anhydrous ammonia 416.67 7664-41-7
18 Acetone 83.33 67-64-1
19 Activated carbon 16.67 7440-44-0
20 Hyflow supercel 4.17 61790-53-2
LORATADINE
1 Sulfuric acid 1.8 7664-93-9
2 Ice 60.0 7789-20-0
3 NaOH 8.29 1310-73-2
4 MDC 161.04 75-09-2
5 M-6 5.81
6 SOCL2 6.63 7719-09-7
7 DMF 0.27 68-12-2
8 HCl 33.11 7647-01-0
9 NaOH 40.67 1310-73-2
10 Hyflow 1.26 61790-53-2
15
11 Ethylene dibromide 0.47 106-93-4
12 THF 36.00 109-99-9
13 Mg. Turmings 1.02 7439-95-4
14 Iodine 0.01 7553-56-2
15 Ice 43.68 7789-20-0
16 HCl 9.85 7647-01-0
17 NaOH 1.36 1310-73-2
18 Chloroform 62.30 67-66-3
19 Hexane 4.50 110-54-3
20 Sulfuric acid 19.41 7664-93-9
21 Ice 19.70 7789-20-0
22 NaOH 15.66 1310-73-2
23 Toluene 58.72 108-88-3
24 Toluene 40.42 108-88-3
25 Ethylchlororo formate 2.35 541-41-3
26 NaHCO3 3.36 144-55-8
27 Acetonitrile 5.63 75-05-8
28 Carbon 0.13 7440-44-0
29 Hyflow 0.13 61790-53-2
30 Ethylacetate 2.50 141-78-6
31 carbon 0.13 7440-44-0
32 Hyflow 0.13 61790-53-2
33 Acetonitrile 2.25 75-05-8
34 Charcoal 0.05 7440-44-0
35 Hyflow 0.05 61790-53-2
FLUCANOZOLE
1 Triazole 25.00 288-88-0
2 trimethyl Iodidie 34.33 6966-83-2
3 Potassium Hydroxide 18.83 1310-58-3
4 Tertiary butyl Alcohol 20.00 76-65-0
5 Triazole 11.60 288-88-0
6 HCl 26.60 7647-01-0
7 Ethyl Acetate 90.00 141-78-6
8 Ethyl Acetate 10.00 141-78-6
9 Oxalic Acid 11.00 144-62-7
10 Charcoal 1.33 7440-44-0
11 Hyflow 1.67 61790-53-2
12 Ammonia Sol 13.33 1336-21-6
GLIMEPRIDE
1 Sulfonamide 1.92 63-74-1
2 Trans isocynate 0.62 7517-76-2
3 Acetone 28.85 67-64-1
4 Potassium carbonate 1.92 584-08-7
5 Glimepride crude 1.92 93479-97-1
6 Methanol 1.92 67-56-1
7 Ammonia Solution 1.92 1336-21-6
16
8 Hyflow super cell 0.04 61790-53-2
9 Hydrochloric Acid 1.92 7647-01-0
10 Acetone 57.69 67-64-1
11 DIODO 11.11 22662-39-1
12 Hydroxylamine hydrochloride 2.78 5470-11-1
13 Toluene 55.56 108-88-3
14 Potassium carbonate 11.11 584-08-7
15 Hyflow super cell 0.22 61790-53-2
16 Activated carbon 0.22 7440-44-0
17 Hydrochloric acid 2.44 7647-01-0
18 Amiodarone Hydrochloride crude 11.11 1951-25-3
19 IPA 144.44 67-63-0
20 Activated carbon 0.22 7440-44-0
21 Hyflow super cell 0.22 61790-53-2
AMIODARONE HYDROCHLORIDE
1 DIODO 11.11 22662-39-1
2 Hydroxylamine hydrochloride 2.78 5470-11-1
3 Toluene 55.56 108-88-3
4 Potassium carbonate 11.11 584-08-7
5 Hyflow super cell 0.22 61790-53-2
6 Activated carbon 0.22 7440-44-0
7 Hydrochloric acid 2.44 7647-01-0
8 Amiodarone Hydrochloride crude 11.11 1951-25-3
9 IPA 144.44 67-63-0
10 Activated carbon 0.22 7440-44-0
11 Hyflow super cell 0.22 61790-53-2
CILOSTAZOL
1 1 cyclohexyal5 4 chlorobutyl
tetrazole 4.44
73963-42-5
2 Sodium hydroxide 3.56 1310-73-2
3 Tricapryal methyal ammonium
chloride 11.11
76925-99-0
4 Toluene 1.67 108-88-3
5 Methanol 33.33 67-56-1
6 6 hydroxy 2 oxo 1234 tetra
hydroxyl quanoline 6.67
54197-66-9
7 Ciostazole crude 11.11 73963-72-1
8 Methanol 166.67 67-56-1
9 Hyflow super cell 0.22 61790-53-2
10 Activated Carbon 0.22 7440-44-0
APRIPITANT
1
2-{1-[3,5-
Bis(trifluoromethyl)phenyl]ethoxy}
-3-(4-fluorophenyl)morpholine
hydrochloride
12.0 171482-05-6
2 Amidrazone 5.0 3314-35-0
17
3 Potassium carbonate 13.O 584-08-7
4 Dimethyal formamide 30.0 68-12-2
5 O-xylene 96.5 95-47-6
6 Purified water 180 7732-18-5
7 Sodium chloride 4.5 7440-23-5
8 Methanol 25.0 67-56-1
9 Activated charcoal 0.2 7440-44-0
SEVELAMER HYDROCHLORIDE
1 Allylamine 10.00 107-11-9
2 Hydrochloric acid 21.00 7647-01-0
3 Catalyst-A 0.10
4 Catalyst-B 0.10
5 Catalyst-C 0.10
6 Polyallylamine Hydrochlride 26.00 71550-12-4
7 Sodium hydroxide 4.10 1310-73-2
8 Epichlorohydrine 1.00 106-89-8
NICARDIPINE HYDROCHLORIDE
1 2-Methylethanol amine 0.74 109-83-1
2 Benzyl chloride 1.44 100-44-7
3 TEA 1.59 121-44-8
4 Ethyl acetate 4.44 141-78-6
5 HCl 1.48 7647-01-0
6 Liquid Ammonia 2.22 1336-21-6
7 3-Nitrobenzaldehyde 0.33 99-61-6
8 Methyl 3-aminocrotonate 0.22 14025-39-1
9 Toluene 6.67 108-88-3
10 IPA 3.33 67-63-0
11 Acetone 22.22 67-64-1
12 Methanol 2.22 67-56-1
13 Sodium chloride 0.37 7440-23-5
14 Sodium sulphate 0.37 7757-82-6
15 Liq. Ammonia 2.22 1336-21-6
16 HCl 1.67 7647-01-0
AMLODIPINE BESILATE
1 Ethyal 4-chloro aceto acetate 11.11 638-07-3
2 Hydroxyl Ethyal phalamide (HEP) 13.33 3891-07-4
3 Toluene 66.67 108-88-3
4 Acetic Acid 11.11 64-19-7
5 Methanol 0.22 67-56-1
6 Sodium hydride 5.56 7646-69-7
7 PHEEMA 11.11 88510-62-3
8 Ortho chloro benzaldehyde 5.56 89-98-5
9 Morpholine 0.44 110-91-8
10 Acetic acid 27.78 64-19-7
11 Methanol/IPA 38.89 67-56-1
12 Phthyloyl Amlodipne 11.11 88510-62-3
18
13 MMA 33.33 80-62-6
14 Amlodipne base on dry basis 11.11 88510-42-9
15 Benzene sulphonic Acid 6.78 98-11-3
16 Amlodipine base Crude 11.11 88510-42-9
17 IPA 55.56 67-63-0
18 Hyflow super cell 0.11 61790-53-2
GLIBENCLAMIDE
1 Butanone 21.85 78-93-3
2 5 chloro salicyclic acid 7.89 321-14-2
3 K2CO3 13.54 584-08-7
4 Dimethyl sulphate 13.14 77-78-1
5 EDC 31.38 25952-53-8
6 Dimethyl sulphate 13.14 77-78-1
7 Ester 0.00 533-23-3
8 Beta Phenyl ethylamine 4.91 3886-69-9
9 Sodium metal 0.08 7440-23-5
10 Methanol 1.44 67-56-1
11 EDC 54.09 25952-53-8
12 HCl 0.55 7647-01-0
13 Chloro sulphonic acid 32.20 7790-94-5
14 Amide sol 19.26 6485-52-5
15 Liq. Ammonia 114.50 1336-21-6
16 EDC 36.07 25952-53-8
17 Sulphonamide 12.96 63-74-1
18 NaOH 1.49 1310-73-2
19 CHIC 4.93 10238-21-8
20 Ammonia 1.23 1336-21-6
21 Hyflow 0.36 61790-53-2
22 Carbon 0.29 7440-44-0
23 Acetone 105.22 67-64-1
24 Methanol 234.53 67-56-1
25 HCl 6.49 7647-01-0
26 Hyflow 0.72 61790-53-2
27 Carbon 0.72 7440-44-0
DESLORATADINE
1 Loratadine 2.95 79794-75-5
2 Methanol 10.00 67-56-1
3 KOH 3.93 1310-58-3
4 MIBK 11.11 108-10-1
5 Charcoal 3.00 7440-44-0
6 Hyflow 3.50 61790-53-2
7 MIBK 0.83 108-10-1
VENLAFLAXINE HYDROCHLORIDE
1 Sodium methoxide 5.60 121-41-4
2 Methanol 5.00 67-56-1
3 PMPA 10.00 147127-20-6
19
4 Cyclohexane 9.30 110-82-7
5 IPA 25.00 67-63-0
6 Acetic acid 49.00 64-19-7
7 O-Xylene 16.60 95-47-6
8 Ethyl Acetate 6.00 141-78-6
9 Formic acid 19.00 64-18-6
10 Formaldehyde 16.70 50-00-0
11 NaOH 14.60 1310-73-2
12 Ethyl Acetate 90.00 141-78-6
13 Charcoal 0.40 7440-44-0
14 Ethyl Acetate 7.50 141-78-6
TELMISARTAN
1 Methanol 35.30 67-56-1
2 4- Amino 3-Methylbenzoic acid 14.84 2486-70-6
3 Sulphuric acid 14.23 7664-93-9
4 Liq. Ammonia 29.68 1336-21-6
5 MDC 56.70 75-09-2
6 TEA 13.14 121-44-8
7 Butryl chloride 12.87 141-75-3
8 Sodium Bicarbonate 1.53 144-55-8
9 Sodium Sulphate 3.87 7757-82-6
10 Hexane 50.94 110-54-3
11 Fuming Nitric acid 40.50 231-714-2
12 Sodium Bicarbonate 0.90 144-55-8
PREGABALIN
1 Sodium Hydroxide 18.99 1310-73-2
2 4-CMH 13.68
3 Liquid Bromine 12.25 7726-95-6
4 Activated carbon 0.68 7440-44-0
5 Hyflow 0.16 61790-53-2
6 Hydrochloric acid 24.62 7647-01-0
7 Pregabalin (Stage-I) 11.76 148853-50-8
8 IPA 70.57 67-63-0
VILDAGLIPTIN
1 DMF 5.40 68-12-2
2 Methylene dichloride 15.00 75-09-2
3 Potassium Carbonate 2.60 584-08-7
4 Isopropyl Acetate 5.04 67-63-0
5 Sulphate 3.75 7757-82-6
6 Sodium chloride 0.63 7440-23-5
7 Acetone 12.50 67-64-1
8 Charcoal 0.05 7440-44-0
FEBUXOSTAT
1 KSM 15.47 808-26-4
2 Isobutyl Bromide 11.62 78-77-3
3 Potassium Carbonate 18.34 584-08-7
20
4 Ammonium Hydroxide Hcl 3.23 1336-21-6
5 Sodium Carbonate 3.14 497-19-8
6 Sodium Hydroxide 2.97 1310-73-2
7 Hydrochloric Acid 2.89 7647-01-0
8 Acetone 7.50 67-64-1
VALSARTAN
1 L-Valine 25.64 72-18-4
2 Thionyl Chloride 41.28 7719-09-7
3 Methanol 152.05 67-56-1
4 Toluene 26.67 108-88-3
5 Acetone 81.03 67-64-1
6 Methyl Cyanobiphenyl 25.64 114772-53-1
7 Dibromodimethyl hydantion 18.97 77-48-5
8 AIBN 2.56 78-67-1
9 MDC 101.54 75-09-2
10 Ethyl Acetate 46.15 141-78-6
11 Potassium carbonate 12.82 584-08-7
12 DMF 145.13 68-12-2
13 Toluene 199.74 108-88-3
14 HCl 14.87 7647-01-0
15 Sodium Bicarbonate 24.36 144-55-8
16 MDC 169.23 75-09-2
17 Valeryl Chloride 11.54 638-29-9
18 Triethylamine 9.74 121-44-8
19 HCl 15.38 7647-01-0
20 Activated Carbon 2.56 7440-44-0
21 Xylene 88.21 1310-20-7
22 Tributyltinch Chloride 38.97 1461-22-9
23 Sodiumazide 7.69 26628-22-8
24 TBAB 0.51 1643-19-2
25 Sodium Hydroxide 10.26 1310-73-2
26 MDC 84.62 75-09-2
27 Activated Carbon 2.56 7440-44-0
28 Ethyl Acetate 23.08 141-78-6
29 Xylene 44.10 1310-20-7
TOPIRAMATE
1 D-Fructose 1.43 57-48-7
2 Acetone 20.00 67-64-1
3 Sulfuric Acid 1.43 7664-93-9
4 Sodium hydroxide 2.14 1310-73-2
5 Ethyl Acetate 0.71 141-78-6
6 IPA 0.71 67-63-0
7 Hexane 5.71 110-54-3
8 Topiramte satge1 1.43 97240-79-4
9 Sulfuryal chloride 0.71 7791-25-5
10 EDC 24.29 25292-53-8
21
11 Sodium bicarbonate 0.36 144-55-8
12 Sodium chloride 0.36 7440-23-5
13 Anhydrous Ammonia gas 0.36 7664-41-7
14 Ethyl acetate 0.36 141-78-6
15 Hexane 5.71 110-54-3
16 IPA 0.36 67-63-0
17 Activated carbon 0.16 7440-44-0
18 Hyflow super cell 0.03 61790-53-2
19 Topiramte crude 1.43 97240-79-4
20 IPA 4.29 67-63-0
21 Ethyl acetate 2.86 141-78-6
22 Hexane 15.71 110-54-3
23 Activated carbon 0.03 7440-44-0
24 Hyflow super cell 0.03 61790-53-2
ROPIVACINE
1 L-Pipecolic acid 0.95 3105-95-1
2 Hydrochloric acid 0.19 7647-01-0
3 L-Pipecolic acid Hydrochloric acid 0.95 3105-95-1
4 Phosphorous pentachloride 1.79 10026-13-8
5 Acetyl chloride 6.38 75-36-5
6 Acetone 34.67 67-64-1
7 Toluene 2.52 108-88-3
8 2,6 xylidine 1.40 87-62-7
9 Ethyl acetate 21.62 141-78-6
10 Hexane 34.24 110-54-3
11 Sodium hydroxide 0.48 1310-73-2
12 Sodium chloride 0.95 7440-23-5
13 Sodium sulphate Anhydrous 1.36 7757-82-6
14 2,6 pipecoloxylidide 0.95 27262-43-7
15 Potassium carbonate 0.39 584-08-7
16 Toluene 22.48 108-88-3
17 n - propyl bromide 2.19 106-94-5
18 IPA 4.00 67-63-0
19 Ethyl acetate 21.14 141-78-6
20 Activated charcoal 0.10 7440-44-0
21 Sodium bicarbonate 0.36 144-55-8
22 Sodium chloride 0.51 7440-23-5
23 Sodium sulphate Anhydrous 2.07 7757-82-6
24 Hyflow supercell 0.10 61790-53-2
PEDOTIMODE
1 Thiazolidine-4-carboxylic acid ethyl
ester HCl 1.50
86028-91-3
2 L-Pyroglutamic acid 1.06 98-79-3
3 Potassium carbonate 1.50 584-08-7
4 DCC (Dicyclohexylcarbodiimide) 1.72 538-75-0
5 Dichloromethane 20.00 75-09-2
22
6 Sodium hydroxide 0.33 1310-73-2
7 HCl 0.50 7647-01-0
8 Acetone 3.75 67-64-1
9 Methanol 2.50 67-56-1
24
ANNEXURE-III
BRIEF PROCESS DESCRIPTION
1. NABIVILOL :
MANUFACTURING PROCESS
Stage-I :
(25) 6-Fluro –[(25) (oxiran-2yl)-3,4 dihydro-2H Chromene is reacted with benyl amine in IPA to
get Stage I product.
Stage-II :
Stage I product is hydrogenated in methanol in presence of palladium catalyst.
Stage-III :
StageI I product is reacted in Isopropyl alcohol hydrochloride to get NEBIVOLOL HCL
CHEMICAL REACTION
Stage-I : Prepartion of NB-IX (NE-3)
Stage-II : Prepartion of NB-IX (NE-3)
O
F
N O
F
OH OH
Benzyl Nebivolol HCl
NE 3
Pd/C, H2
MethanolIPA HCl
.HCl.HCl
O
F
NH O
F
OH OH
Nebivolol HClNL 1
25
MATERIAL BALANCE
Input material Quantity (KG) Output material Quantity (KG)
Stage-I
Stage-VIII (NE-2) 0.009 Dry Product 0.0148
NSR-19C 0.0058 MeOH Recovery 0.0405
Methanol 0.045 CFML 0.055
Acetonitrile 0.01756 Losses 0.01
Diisopropyl ether 0.03526
HCl (CP) 0.0036
Total 0.12 Total 0.12
Stage-II
Stage-IX (NE-3) 0.02 MeOH Recovery 0.765
Methanol 0.85 Dry wet 0.0059
NSR-19D 0.002 CFML 0.04
IPA HCl (20%) 0.02 Losses MeOH 0.085
Hyflow 0.01
Total 0.9 Total 0.9
28
2. ZONISAMIDE :
MANUFACTURING PROCESS
4 hydroxy Coumarin is reacted with Hydroxyl Amine Hydrochloride and Sodium acetate to get
stage-1 intermediate, which is further reacted with Chloro Sulphonic acid and Phosphorus Oxy
chloride to get crude material, which is further purified using Acetone and activated carbon to
ger Zonisamide.
CHEMICAL REACTION
Stage-I: Preparation of methyl 1,2-benzoxazol-3-ylacetate from NSR-28A
Stage-II: Preparation of Zonisamide Technical from crude
Stage-III: Preparation of Zonisamide from Zonisamide Technical
O O
OH
4-hydroxy-2H-chromen-2-one
Methanol
NH2OHO
N
COOH
1,2-benzoxazol-3-ylacetic acid
Sodium acetate
Methanol
O
N
COOCH3
methyl 1,2-benzoxazol-3-ylacetateM W = 162.14
M W = 177 .15 M W = 191.18
O
N
S
O
OCl
Chlorosulphonic acid
1,2-benzoxazol-3-ylmethanesulfonyl chloride
POCl 3
Ammonia
1-(1,2-benzoxazol-3-yl)methanesulfonamide
Zonisimide
M W = 231 .65M W = 212 .22
O
N
S
O
O
NH2
O
N
COOCH 3
methyl 1,2-benzisoxazol-3-ylacetateM W = 191 .18
29
MATERIAL BALANCE
Input material Quantity (KG) Output material Quantity (KG)
Stage-I
NSR-28A 0.06 MeOH recovery 0.54
NSR-28B 0.09 Aq layer 1.25
NSR-28C 0.106 Filtrate 0.65
Methanol 0.6 Dry Product 0.045
Ammonia Solution 0.15
Hydrochloric Acid 0.18
Ethyl Acetate 0.15
Purified Water 1.15
Total 2.49 Total 2.49
Stage-II
Stage-I 0.07 Product 0.04
Ethylene Dichloride 0.294 EDC Distillation 0.2646
NSR-28D 0.0518 Toluene Distillation 1.323
1,4 Dioxane 0.0392 EA Distillation 2.205
Phosphorus Oxy 0.196 Aq layer 2.2
Toluene 1.47 Rest ML rec losses 0.73
Ethyl Acetate 2.45
Activated Carbon 0.05
Hyflow Super cell 0.02
Sodium Chloride 0.105 7440-23-5
Anhydrous ammonia 1 cy
Purified Water 2.016
Total 6.76 Total 6.76
Stage-III
Stage-II 0.04 Dry Product 0.024
Acetone 0.2 Filtrate 0.7
Purified water 0.44 Loss in Drying & Filtration 0.01
Activated carbon 0.04
Hyflow supercel 0.01
Total 0.73 Total 0.73
30
3. Fluconazole :
Process Description: Manufacturing Process:
CT Base is reacted with Tri Methyl Sulphoxonium Iodide in presence of Potassium Hydroxide &
tertiary Butyl Alcohol to give FL1. FL1 is then purified & recrystallised using Ethyl Acetate to give
FL2. FL2 to is then coverted to Flucanazole Oxalate by reacting with oxalic acid in presence of
IPA. The material is also charcoalised & filtered in aqueous media at this stage for purification to
give FL3. FL3 is then dissolved & recrystallised in IPA Water Mixture to give pure Flucanazole.
Chemical Reaction:
33
4. LORATADINE : Manufacturing Process:
M-5 is reacted with Sulphuric acid and quenched to give M-6. M-6 is then chlorinated using
Thionyl chloride and AlCl3 catalyst to give M-7. M-7 is then reacted with Grignard reagent and
then acidified to give M-8. M-8 is then acidified and quenched to give Loratidine Crude.
The crude is then purified first using Acetonitrile. The product is further purified using Ethyl
acetate. Pure Loratidine is obtained by one more purification in Acetonitrile.
Chemical Reaction:
38
5. Glimepride and its Intermediate
Process Description: Stage-1:
A sulphanmide react with Tran’s isocynate in reflux in acetone with potassium carbonate after
reaction complies CF the mass and we get crystal filtration and drying finally we get Glimepride
Crude
Stage-2:
A Glimepride crude Slurry prepare in methanol this slurry is to be charge in Water finally and
charge ammonia solution and filter through pre prepared hyflow bed and clear filtrate to be
acidified with hydrochloric acid filter the mass centrifuge the mass wash the cake with water till
neutral PH and unload the cake drying and dry material purification do with acetone filter the
mass wet cake drying milling sifting or micronized and finally we get pure Glimepride
Route of Synthesis:
Stage-1
39
Stage:-1
Sr. No Input Material Kg Output Material Kg
1 Sulfonamide 1.00 Glimepride crude 2.00
2 Trans isocynate 0.32 Acetone CF ml 14.90
3 Acetone 15.00 Process Emission 0.22
4 Potassium carbonate 1.00 Drying loss 0.20
Total 17.32 Total 17.32
Stage:-2
Sr. No Input Material Kg Output Material Kg
1 Glimepride crude 1.00 Glimepride 0.52
2 Methanol 1.00 Acetone CF ML 29.5
3 Ammonia Solution 1.00 Acidic Water CF ML 23.5
4 Hyflow super cell 0.02 Drying loss 0.32
5 Hydrochloric Acid 1.00 Process emission 0.10
6 Acetone 30.0 Spent Hyflow 0.08
7 Water 20.0
Total 54.02 Total 54.02
40
6. Amiodarone Hydrochloride and its Intermediate
Process Description: Stage-1:
A Mixture of hydroxyl hydrochloride O2 solution in water addition reaction with DIODO with
at higher temperature in Toluene media with potassium carbonate after compilation of reaction
work up with water and finally organic toluene layer charcolisation and mass hydrolysis with HCl
and finally we get crystal filtration and drying finally we get Amiodarone crude.
Stage-2:
A Amiodarone crude dissolve in IPA at reflux temperature and dissolve mass pass through
hyflow carbon bed and cooling chilling and we get final crystallization , filtration and wash the
cake with IPA and drying milling sifting and micronisation finally we get final product
Amiodarone hydrochloride
Route of Synthesis:
41
Material Balance
Stage:-1
Sr. No Input Material Kg Output Material Kg
1 DIODO 1.00 Amiodarone Hydrochloride crude 1.23
2 Hydroxylamine hydrochloride 0.25 Water AQ layer 8.5
3 Toluene 5.0 Toluene CF ml 5.5
4 Potassium carbonate 1.0 Drying loss 0.2
5 Hyflow super cell 0.02 Spent Carbon and Hyflow 0.08
6 Activated carbon 0.02
7 Hydrochloric acid 0.22
8 Water 8.0
Total 15.51 Total 15.51
Stage:-2
Sr. No Input Material Kg Output Material Kg
1 Amiodarone Hydrochloride crude 1.00 Amiodarone Hydrochloride 0.9
2 IPA 13.0 IPA CF ML 12.7
3 Activated carbon 0.02 Drying loss 0.25
4 Hyflow super cell 0.02 Process emission 0.11
Spent Carbon and Hyflow 0.08
Total 14.04 Total 14.04
42
7. Cilostazol Crude
Process Description: Stage-1:
A Sodium hydroxide dissolve in water and then charge hydro 2 oxo tetrahydroquonoline and
then charge tetrazole then charge trimethyal ammonium chloride then charge toluene and finally
flush with water heat to reaction mass till reflux temperature centrifuge and caustic treatment
centrifuge and dry the finally we get cilostazol Crude
Stage-2:
A Cilostazol we dissolve in methanol charcolisation and filter through pre prepared hyflow bed
and clear filtrate to be crysalise the mass centrifuge the mass wash the cake with methanol and
unload the cake for drying and dry material drying milling sifting or micronized and finally we
get pure cilostazol
43
Route of
Synthesis:
NO
H
O
N
N
NN
Cl
Na2SO4
NaOH
N O
H
O
NN
N
N
+
5-(4-Chloro-butyl)-1-cyclohexyl-1H-tetrazole
Catalyst
6-Hydroxy-3,4-dihydro-1H-quinolin-2-one
Cilostazol
44
Material Balance
Stage:-1
Sr. No Input Material Kg Output Material Kg
1 1 cyclohexyal5 4 chlorobutyl tetrazole 0.4 Crude 2.00
2 Sodium hydroxide 0.32 Toluene CF ml 1.1
3 Tricapryal methyal ammonium chloride 1.00 Process Emission 0.22
4 Toluene 0.15 Drying loss 0.30
5 methanol 3.0 Methanol CF ml 2.7
6
6 hydroxy 2 oxo 1234 tetra hydroxyl
quanoline 0.6 Water Washing 19.5
7 Water 20.00
8
Total 25.47 Total 25.47
Stage:-2
Sr. No Input Material Kg Output Material Kg
1 Ciostazole crude 1.00 Cilostazole 0.9
2 Methanol 15.00 Methanol CF ML 14.9
3 Hyflow super cell 0.02 Drying loss 0.1
4 Activated Carbon 0.02 Process emission 0.06
Spent Hyflow & Carbon 0.08
Total 16.04 Total 16.04
45
8. Sevelamer Hydrochloride and its Intermediate
Process Description: Stage-1:
A Mixture of Allylamine and Hydrochloric acid in low temperature with pressure of Nitrogen gas
to get Allylamine Hydrochloride. A Mixture of Allyamine Hydrochloride Catalyst A, B and C
and with controlled nitrogen gas to process of polymerization to get Plolyallyl amine
Hydrochloride.
Stage-2:
A Mixture of Sodium hydroxide, DM water and Polyallyamine Hydrochloride in the reaction
vessel at ambient temprature. Slowly add Epichlorohydrine to get gel formation at low
tempreture. Charge DM water and stir for 24 hrs to get final product.
Route of Synthesis:
Stage-1 :
NH2 CH2
Allylamine
+ NH2 CH2 .HClHCl
M. Weight: 57.09
C3H7NAllylamine Hydrochloride
C4H7ClN
M. Weight: 93.54
NH2 CH2 .HCl
Allylamine Hydrochloride
C4H7ClN
M. Weight: 93.54
Catalyst-A, B & C
Nitrogen gas
Polyallylamine Hydrochloride
Polymerization
46
Stage-2 :
Polyallylamine Hydrochloride
+ NaOH +
O
Cl
Water.HCl
Epichlorohydrine
C3H5ClO
M. Weight: 92.52
Sevelamer Hydrochloride
C6H12Cl2NO
M. Weight: 186.08
Material Balance
Stage:-1
Sr. No Input Material Kg Output Material Kg
1 Allylamine 1.00 Polyallylamine Hydrochlride 2.60
2 Hydrochloric acid 2.10 Water effluent 0.58
3 Catalyst-A 0.01
4 Catalyst-B 0.01
5 Catalyst-C 0.01
6 Nitrogen gas --
7 Water 0.05
Total 3.18 Total 3.18
Stage:-2
Sr. No Input Material Kg Output Material Kg
1 Polyallylamine Hydrochlride 2.60 Sevelemer Hydrochloride 1.00
2 Sodium hydroxide 0.41 Water effluent 8.09
3 Epichlorohydrine 0.10 Drying loss 0.25
4 Nitrogen gas -- Process emission 0.10
5 Water 6.33
Total 9.44 Total 9.44
47
9. Nicardipine Hydrochloride and its Intermediate
Process Description:
Stage-1:
Charge 2-methylethanol amine in presence of TEA with Benzyl chloride in SSR reactor. Heat to
reflex temperature to completion of reaction. Then slowly add hydrochloric acid and reaction
mass extracted in Ethyl acetate. Cooling, chilling and distilled ethyl acetate and get product in
liquid form.
Stage-2:
Charge 1-{2-[benzyl(methyl)amino]ethoxy}ethanol in presence of Isopropyl alcohol and Toluene
with 3-Nitrobenzaldehyde and Methyl 3-aminocrotonate in SSR reactor. Heat to reflex
temperature to completion of reaction. Then slowly add hydrochloric acid and reaction mass
extracted in Ethyl acetate. Cooling, chilling and CF to give Technical grade Nicardipine
Hydrochloride and purified with methanol, heat to clear solution, filtration and distillation of
methanol then charge acetone to give Nicardipine Hydrochloride.
Route of Synthesis:
Stage-1 :
HO
HN
2-methylaminoethanol
TEA/Benzyl chloride
OH
O
N
1-{2-[benzyl(methyl)amino]ethoxy}ethanol
48
Stage-2:
M. Weight: 209.28M. Weight: 115.13
NO CH3
CH3 OH
+N
+
O-
O
O
+
3-Nitrobenzaldehyde
NH2
CH3
O
O
CH3
Methyl 3-aminocrotonateC
12H
19NO
2C
7H
5NO
3
M. Weight: 151.12
C5H9NO2
NH
O
OCH3
N+
O-
O
ON
O CH3
CH3CH3
C26
H30
ClN3O
6
.HCl
Nicardipine Hydrochloride
M. Weight: 515.99
1-{2-[benzyl(methyl)amino]ethoxy}ethanol
Material Balance
Stage:-1
Sr. No Input Material Kg Output Material Kg
1 2-Methylethanol amine 1.00 Stage-I 1.50
2 Benzyl chloride 1.95 Ethyl acetate recovery 5.00
3 TEA 2.15 Water effluent 10.9
4 Ethyl acetate 6.00 Process emission 0.20
5 HCL 2.00
6 Liquid Ammonia 3.00
7 Water 1.50
Total 17.6 Total 17.6
Stage:-2
Sr. No Input Material Kg Output Material Kg
1 Stage-I 1.50 Nicardipine Hydrochloride 1.35
49
2 3-Nitrobenzaldehyde 0.45 Toluene recovery 8.25
3 Methyl 3-aminocrotonate 0.30 Acetone recovery 27.6
4 Toluene 9.00 IPA recovery 4.23
5 IPA 4.50 Sodium sulphate solid waste 0.50
6 Acetone 30.0 Sodium chloride solid waste 0.50
7 Methanol 3.00 Water effluent 15.82
8 Sodium chloride 0.50 Drying loss 0.25
9 Sodium sulphate 0.50 Process emission 0.50
10 Liq. Ammonia 3.00
11 HCl 2.25
12 Water 4.00
Total 59.0 Total 59.0
50
10. Amlodipine besilate and its Intermediate
Process Description: Stage-1 : ( PHEEMA)
A reaction of 4-methyal 4 chloro acetoacetae react with sodium hydride in presence of toluene
reaction with lot wise HEP till reaction complies with acetic acid and clean with methanol and
work up after work toluene layer distilled out completely and finally degas we get final liquid
product is PHEEMA
Stage-2:
PHEEMA reaction with OCB in Acetic acid in presence of morphline and Addition reaction after
reaction complies distilled out Acetic acid and add additional acetic acid and second reaction with
MAC and within the higher side temperature side after maintaining reaction complies batch
centrifugation and crude wet cake purification in methanol and finally cake wash with methanol
centrifugation and Drying and unload finally product is Pthyloyal amlodipine
Stage-3:
Pthyloyal amlodipine react with MMA staring and maintain centrifugation and finally cake wash
with water till neutral PH and wet cake as a crude wet cake Amlodipine besilate base
Stage-4:
Amlodipine besilate base wet cake hydrolysis in BSA solution starring and maintaining filtration
and finally cake wash with water till neutral PH and drying and packing finally we get final
product is Amlodipine besilate crude
Stage-5:
Amlodipine Besilate dissolves in IPA and filter throughhyflow bed in sparkler clear filtrate
crystallization centrifuge and drying sifting and packing and fillay we get final product is
Amlodipine besilate
52
Route of Synthesis:
Mono Methyl Amine
4-(2-Chlorophenyl)-3-ethoxycarbonyl-5-methoxy
carbonyl-6-methyl-2-(phthalimidoethoxy)
methyl-1,4-dihydropyridine (Phthaloyl Amlodipine)
MW 538.98
N
H
CH3
H3COOC COOC2H5
Cl
ON
O
O
MW 31.05
3-ethyl 5-methyl 2-[(2-aminoethoxy)
methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydro
pyridine-3,5-dicarboxylate
MW 408.87
N
H
CH3
H3COOC COOC2H5
Cl
ONH2
HCH3 N
O
O
+
2 Methyl-1-isoindole-1,3-dione
MW 161.16
53
3-ethyl 5-methyl 2-[(2-aminoethoxy)
methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydro
pyridine-3,5-dicarboxylate amlodipine Besylate
N
H
CH3
H3COOC COOC2H5
Cl
ONH2
H
3-ethyl 5-methyl 2-[(2-aminoethoxy)
methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydro
pyridine-3,5-dicarboxylate
MW 408.87
N
H
CH3
H3COOC COOC2H5
Cl
ONH2
H+
Benzene Sulfonic Acid
MW 158.17
SO3H
SO3H
.
MW 567.05
Material Balance
Stage:-1
Sr. No Input Material Kg Output Material Kg
1 Ethyal 4-chloro aceto acetate 1.00 PHEEMA 1.90
2 Hydroxyl Ethyal phalamide (HEP) 1.2 Water AQ layer 4.4
3 Toluene 6.0 Distilled Toluene 6.22
4 Acetic Acid 1.0 Process Emission 0.2
54
5 Methanol 0.02
6 Sodium hydride 0.5
7 Water 3.0
Total 12.72 Total 12.72
Stage:-2
Sr. No Input Material Kg Output Material Kg
1 PHEEMA 1.00 Phthyloyl Amlodipne 0.93
2 Ortho chloro benzaldehyde 0.5 IPA/Methanol CF ML 3.7
3 Morpholine 0.04 Acetic Acid CF ML 2.7
4 Acetic acid 2.5 Drying loss 0.1
5 Methanol/IPA 3.5 Process emission 0.11
Total 7.54 Total 7.54
Stage:-3
Sr. No Input Material Kg Output Material Kg
1 Phthyloyl Amlodipne 1.00 Amlodipne base on dry basis 0.68
2 MMA 3.0 MMA CF ML 3.42
3 water 6.0 Washing Water 5.8
Process emission 0.1
Total 10.0 Total 10.0
Stage:-4
Sr. No Input Material Kg Output Material Kg
1 Amlodipne base on dry basis 1.00 Amlodipine base Crude 1.4
2 Benzene sulphonic Acid 0.61 Water CF ML 8.0
3 water 8.0 Drying loss 0.21
Total 9.61 Total 9.61
Stage:-5
Sr. No Input Material Kg Output Material Kg
1 Amlodipine base Crude 1.00 Amlodipine besilate 0.9
2 IPA 5.0 IPA CF ML 4.9
3 Hyflow super cell 0.01 Drying loss 0.1
Process Emission 0.11
Spent hyflowsuper cell 0.1
Total 6.01 Total 6.01
55
11. Glibenclamide for EC:
Manufacturing Process:
5-chloro Salicylic acid is reacted with DMS in presence of Butanone and K2CO3 to give Ester. The
ester is then converted to Amide by reacting with β-Phenyl Ethyl amine. Amide is treated with
Chloro sulphonic acid and Ammonia to give Sulphonamide. The Sulphonamide is then treated
with CHIC to form CHIC salt. The CHIC salt is then converted to Glibenclamide by addition of HCl.
Chemical Reaction:
OH
O OH
Cl
+ (CH3) 2SO4
K2CO3/ EDC O
O O
Cl
CH3
CH3
5-chloro-2-hydroxybenzoic acid methyl 5-chloro-2-methoxybenzoate
NH2
O
O
Cl
CH3
NH
5-chloro-2-methoxy-N-(2-phenylethyl)benzamide
Sodium Metal, EDC
M. Wt : 289. 5
O
O
Cl
CH3
NH
5-chloro-2-methoxy-N-(2-phenylethyl)benzamide
M. Wt : 289. 5
Chlorosulphonic acid
Liq. ammonia
O
O
Cl
CH3
NH
SO
ONH2
M. Wt : 368. 5
+
O
O
Cl
CH3
NH
S
O
ONH
NH
O
( 1) NaOHLiq. Ammonia/Acetone
M. Wt : 493. 5
N
O
isocyanatocyclohexane
( 2) Methanol/HCl
56
Mass Balance:
STEP 1 ; ESTER PREPARATION
INPUT :
OUTPUT :
Raw Material Input , Kgs
Product Output, Kgs
CO2 Gas 0.189
Butanone 2.185
Distillate : 5- Chloro Salicyclic acid 0.789 Butanone 1.971
K2CO3 1.354 Mass : Dimethyl Sulphate 1.314 Mass 3.268
Total 5.642 Losses 0.214
Total 5.642
INPUT :
Raw Material Input , Kgs OUTPUT :
Mass 3.268
Product Output, Kgs
Water 4.303
Aqueous layer to ETP * 5.944
EDC 3.138
Organic layer 5.766
Dimethyl Sulphate 1.314 Losses 0.314
Total 12.024 Total 12.024
INPUT :
OUTPUT :
Raw Material Input , Kgs
Product Output, Kgs
Organic layer 5.766 Organic layer
Aqueous layer to ETP * 0.917
Water 0.717 Organic layer 4.990
Losses 0.577
Total 6.483 Total 6.483
INPUT : OUTPUT :
Raw Material Input , Kgs Product Output, Kgs
Organic layer 4.990 EDC 2.914
Total 4.990 Ester 0.861
Losses 0.998
Residue to Incinerator * 0.215
Total 4.988
STEP 2 : AMIDE PREPARATION
INPUT :
INPUT :
Raw Material Input , Kgs
Raw Material Input , Kgs
Ester 0.729 Distillate : Beta Phenyl Ethylamine 0.491 Methanol 0.182
Sodium metal 0.008 Layers:
Methanol 0.144 Aqueous layer to ETP * 1.220
EDC 5.409 Organic layer 5.757
HCl 0.055 Losses 0.541
Water 0.865 Total 7.701
Total 7.701
INPUT : OUTPUT :
Raw Material Input , Kgs
Product Output, Kgs
Organic layer 5.757 Aqueous layer to ETP * 1.642
Water 1.442 Organic layer 4.981
Total 7.200 Losses 0.576
Total 7.200
INPUT : OUTPUT :
Raw Material Input , Kgs Product Output, Kgs
Organic layer 4.981 EDC 2.308
Total 4.981 Organic layer with EDC 1.926
Losses 0.747
Total 4.981
STEP 3 : SULPHONAMIDE PREPARATION :
INPUT :
OUTPUT :
Raw Material Input , Kgs
Product Output, Kgs
Chloro Sulphonic acid 3.22493684 Hcl to scrubber 1
Amide solution 1.926
Sulphonamide Wet Cake 2.078
Liquor Ammonia 11.458 ML to ETP * 24.119
EDC 3.607
Losses 1.338
Water 11.543 Total 28.535
Total 28.535
INPUT : OUTPUT :
Raw Material Input , Kgs Product Output, Kgs
Sulphonamide Wet Cake 2.078 Sulphonamide Dry Cake 1.293
Total 2.078 Losses on drying 0.785
Total 2.078
Esterification & Distillation
Extraction
Water wash
Distillation
Amide Preparation ,
Distillation & Extraction
Water Wash
Distillation
Sulphonamide preparation &
Centrifuge
Drying
57
STEP 4 : CHIC SALT PREPARATION :
INPUT :
Raw Material Input , Kgs
OUTPUT :
Sulphonamide 1.296 Product Output, Kgs
NaOH 0.149 Nutchefilteration
CHIC 0.493 Solids to Incinerator * 0.097
Ammonia 0.123 Cake Centrifuge :
Hyflo 0.036 CHIC wet salt 1.800 Carbon 0.029 ML for recovery - I 8.646 Acetone 10.522 Losses 2.104 Total 12.648 Total 12.648
STEP 5 : GLIBENCLAMIDE :
INPUT : OUTPUT :
Raw Material Input , Kgs
Product Output, Kgs
Methanol 23.453 Nutchefilteration
CHIC salt 1.763 Solids for incinerator 0.216 HCl 0.649 Cake Centrifuge :
Water 15.873 CHIC wet salt 1.429 Hyflo 0.072 ML for recovery - II 17.775
Carbon 0.072 ML for ETP 17.772
Total 41.882 Losses 4.691 Total 41.882
INPUT : OUTPUT :
Raw Material Input , Kgs
Product Output, Kgs
Glibenclamide wet cake 1.429 Glibenclamide Dry Cake 1.000 Total 1.429 Losses on drying 0.429
Total 1.429
For Packing in Drums
ML FOR RECOVERY - I
INPUT : OUTPUT :
Raw Material Input , Kgs Product Output, Kgs
ML for recovery - I 8.646 Acetone distilled 6.825 Water 3.571 II crop 0.179 Total 12.217 Losses 1.297
ML to ETP * 3.917 Total 12.217
ML FOR RECOVERY - II
OUTPUT :
INPUT : Product Output, Kgs
Raw Material Input , Kgs Methanol 14.813
ML for recovery - II 17.775 Residue to Incinerator * 0.296 Total 17.775 Losses 2.666
Total 17.775
CHIC Salt Preparation ,
Filteration & Centrifuge
Glibenclamide Preparation,
Filteration & Centrifuge
Drying
Sifter
Microniser
Distillation
Distillation
58
12. Desloratadine for EC :
Manufacturing Process:
Loratidine is refluxed with Methanol. The Material is then extracted in MIBK after Methanol
removal. The product is then crystallized after distillation of MIBK to give Desloratidine.
Chemical Reaction:
60
13. Venlaflaxine Hydrochloride for EC :
Manufacturing Process:
Cyclohexanone is condensed with Para Methoxy Phenyl acetonitrile to give VF1. This VF1 is
reduced using palladium charcoal as catalyst. Acetic acid is used to get VF2 during this step. This
VF2 is reacted with Formic Acid & formaldehyde to Venlaflaxine base. Venlaflaxine
Hydrochloride is obtained by condensation of this base with IPA HCl.
Chemical Reaction:
Material Balance:
62
Step 3 Venlaflaxine Preparation
INPUT : OUTPUT :
Raw Material Input , Kgs Product Output, Kgs
VF2 Acetate 1.25 Mass 17.32
Formic Acid 1.90
Formaldehyde 1.67
Water 12.50
Total 17.32 Total 17.32
INPUT : OUTPUT :
Raw Material Input , Kgs Product Output, Kgs
Mass 17.32 Aq. To ETP * 23.22
NaOH 1.46 Mass 9.35
Water 4.79
Ethyl Acetate 9.00
Total 32.57 Total 32.57
INPUT : OUTPUT :
Raw Material Input , Kgs Product Output, Kgs
Mass 9.35 Cake to Inc. * 0.04
Charcoal 0.04 Mass 10.10
Ethyl Acetate 0.75
Total 10.14 Total 10.14
Raw Material Input , Kgs Product Output, Kgs
Mass 10.10 Distilled EA 8.70
EA 1.50 Losses 1.80
Mass 1.10
Total 11.60 Total 11.60
INPUT : OUTPUT :
Raw Material Input , Kgs Product Output, Kgs
Mass 1.10 Mass 2.10
IPA HCL 1.00
Total 2.10 Total 2.10
INPUT : OUTPUT :
Raw Material Input , Kgs Product Output, Kgs
Mass 2.10 EA Rec. 1.50
EA 0.75 Mass 1.10
Residue to Inc. * 0.25
Total 2.85 Total 2.85
INPUT : OUTPUT :
Raw Material Input , Kgs Product Output, Kgs
Mass 1.10 Losses 0.10
Venlafaxiine 1.00
Total 1.10 Total 1.10
Reaction
&pH Adjustment
Filtration
pH Adjustment
&Extraction
EA Recovery
Reaction
Centrifuge & Solvent
Recovery
Drying
63
14. Telmisartan for EC :
Manufacturing Process:
4-Amino-3-benzoic acid is esterifies to gives methyl-4-amino-3-bezoate, which reacted with
butryl chloride to produce butyramide derivative, which nitrated with fuming nitric acid to
produced nitro derivative, which reduced in presence of Palladium on charcoal and then
hydrolyzed to gives benzimidazole derivative. Benzimidazole is reacted with n-methyl o-
phenylene diamine to gives condensed product, which is reacted with bromo ester to gives telmi
ester, which hydrolyzed with potassium hydroxide to gives Telmisartan.
Chemical Reaction:
CH3
NH2
O
OH
CH3
CH3
O
O
NH2
O
TS-1
M wt - 165
CH3OH/H2SO4
65°C
Yield 94 %
CH3
CH3
O
O
NH2
CH3Cl
O CH3
CH3
O
O
NH CH3
O
CH3
CH3
O
O
NH CH3
OCH3
CH3
O
O
NH CH3
O
NO2
CH3
CH3
O
O
NH CH3
O
NO2
Pd/CharcoalAcetic Acid
CH3
CH3
CH3
O
O
NH
N
CH3
CH3
CH3
O
O
NH
N
CH3
CH3
H
O
O
NH
N
10% NaOH Sol.
Methanol
CH3
CH3
H
O
O
NH
N
CH3
CH3
NH
N
N
N
CH3Polyphospheric Acid
NH2
NHCH3
TS-1
TS-2
M wt - 235
TS-3
M wt - 280
TS-5
M wt - 232
TS-6
M wt - 218
TS-7M wt - 304
Fuming HNO3
-20 to -25°C
0 to 5°C
80°C
140 to 145°C
Yield 96 %
Yield 93 %
Yield 86 %
Yield 96 %
TEA/MDC
64
Mass Balance:
Qty (Kg) Raw material Material Qty(Kg)
3.53 Methanol ML to ETP 7.574
1.484 4-Amino 3-Methylbenzoic acid
1.423 Conc. Sulphuric acid
2.968 Liq. NH3
9.410 Total Output 1.53Loss 0.31
Qty (Kg) Raw material Material Qty(Kg)
1.53 TS-1 Soduim Sulpahte 0.387
5.670 MDC Aqs. Layer 12.240
1.314 TEA Recovered MDC+Hexane 6.0841.287 Butryl chloride ML to ETP 7.7050.153 Sodium Bicarbonate
0.387 Sodium Sulphate
12.240 Water
5.094 Hexane
27.675 Total Output 0.90Loss 0.359
Qty (Kg) Raw material Material Qty(Kg)
0.90 TS-2 ML to ETP 12.748
4.050 Fuming Nitric acid
0.090 Sodium Bicarbonate
9.000 DM Water
14.040 Total Output 1.00Loss 0.292
INPUT OUTPUT
TS-01
INPUT OUTPUT
TS-02
INPUT OUTPUT
TS-03
65
15. Pregabalin for EC :
Manufacturing Process
Sodium Hydroxide solution in Process water is chilled at 0-10°C and then charge R-(-)-3-
(Carbamoylmethyl)-5-methylhexanoic acid [R-(-)-CMH]. Addition of liquid Bromine is done at 0-
5°C then raise the temperature of the reaction mass up to 30-35°C. After reaction monitoring,
raise the temperature of the reaction mass to 55-60°C and apply carbon treatment. The clear
filtrate is then received in another reactor. Excess water is distilled off from the reaction mass.
The reaction mixture is acidified with concentrated Hydrochloric acid. Reaction mass is then up
to 80-85°C and after that gradual cooling to 25-30°C. The material is centrifuged after
maintaining of the reaction mass at 25-30°C for 4-6 hrs.
The dry material is then charged in IPA and raises the temperature to 80-85°C. Add DM water to
reaction mass at 80-85°C. Filter the clear reaction mass and chill it to 8-12°C. The material is then
centrifuged and dried in under vacuum.
Chemical Reaction
66
Material Balance
Stage - 1
Sr.
No.
Raw Material Quantity Kgs Out Put Quantity
Kgs
1
Process water 2590.0
Spent carbon and
hyflo 28.0
2 Sodium Hydroxide 347.2 Spent ML 3623.7
3 4-CMH 250.0 Loss on drying 62.5
4 Liquid Bromine 224.0 Out Put 162.5
5 Activated carbon 12.5
6 Hyflo 3.0
7 Hydrochloric acid 450.0
Total 3877 Total 3877
Stage - 2
Sr.
No.
Raw Material Quantity Kgs Out Put Quantity
Kgs
1 Pregabalin (Stage-I) 215.0 Spent ML 2150.00
2 IPA 1290.0 Loss o Drying 32.2
3 DM water 860.0 Out Put 182.8
Total 2365 Total 2365
67
16. Vildagliptin for EC :
MANUFACTURING PROCESS
Stage 1
Reaction of (2s)-1-(Chloroacetyl)-2-Cyanopyrrolidine (KSM-II) with 3-Amino-1-Hydro-
Xyadamantine (KSM-I) in presence of Potassium Carbonate and Dimethyl Formamide (DMF) as a
solvent gives Vildagliptin crude.
Stage 2
Vildagliptin crude is purified by treatment of Aq. Potassium Hydrogen Sulphate and Aq.
Potassium Carbonate in presence of Dichloromethane, followed by Acetone crystallization to
give Vildagliptin API.
MDC,Acetone and DMF are recovered and reused.Aqueous effluent is taken to ETP for
treatment.
CHEMICAL REACTION:
68
MATERIAL BALANCE:
Sr.
N0. Input material Quantity/ (KG) Output material
Quantity
/(KG)
1 KSM I 0.77
Vildagliptin 1
2 KSM II
0.72
Recovered Methylene
Dichloride 13.44
3 DMF 5.4 Recovered Acetone 10.12
4 Methylene dichloride 15
Recovered DMF 5.68
5 Potassium Carbonate
2.6
Vapor losses through
Vent 1
6 Isopropyl Acetate
5.04
Potassium
Carbonate(cake) 1.2
7 Sulphate 3.75
Hyflow + charcoal 1.6
8 Sodium chloride 0.63
Effluent to ETP 17.42
9 Acetone 12.5
10 Charcoal 0.05
11 Water 5
Total 51.46 Total 51.46
69
17. Febuxostat for EC :
MANUFACTURING PROCESS
Ethyl-2-(3-formyl-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate is reacted with
hydroxylamine hydrochloride to form oxide which is dehydrated with sodium formate & formic
acid to form Ethyl 2-(3-cyano-4-isobutoxyphenyl)-4-methyl-5-thiazolecarboxylate which on
hydrolysis gives Febuxostate. Process involves formation of Ethyl 2-(3-Formyl-4-
Isobutoxyphenyl)-4-Methylthiazole-5-carboxylate,Ethyl 2-(3-Cyano-4-Isobutoxyphenyl)-4-
Methyl-5-thiazole carboxylate and finally febuxostate. The reactions are carried out in three
different reactors .Acetone is recovered and reused while aqueous effluent is taken to ETP.
71
MATERIAL BALANCE
Sr.No. Input material Quantity
(KG) Output material
Quantity
(KG)
1 KSM 1547 Febuxostat 1000
2 Isobutyl Bromide 1162 Evaporation losses 565
3 Potassium
Carbonate 1834 Recovered Acetone 700
4 Ammonium
Hydroxide Hcl 323 Effluent to ETP 5451
5 Sodium
Carbonate 314
6 Sodium
Hydroxide 297
73
18. Valsartan for EC :
Manufacturing Process:
L – Valine reacts with thionyl chloride in the presence of methanol at 5degC which is further
refluxed for 12hrs and then concentrated , precipitated with acetone to give VST-01. Methyl
cyano bi phenyl reacts with dibromodimethylhydantion in the presence of AIBN and DCM at
reflux temp. for 13hrs which is further worked up, filtered , dried to give VST -02 . VST – 01 then
reacts with VST – 02 in the presence of potassium carbonate and dimethyl formamide at RT to
give VST -03,this is again treated with sodium bicarbonate in the presence of dichloromethane
and water where a base compound is obtained. This compound further reacts with valeryl
chloride and triethylamine at 5degC where it is worked up and charcolised to give VST -04
dissolved in xylene. This liquid mass further reacts with sodium azide , tributyltinchloride and
TBAB at 140degC for 42hrs ,it is further worked up and charcolised to give Valsartan.
74
Mass Balance:
INPUT OUTPUT
Qty
(Kg) Raw material Material Qty(Kg)
VST-1.HCl
1.000 L-Valine Recovered methanol 5.041 85 % of
Input
Methanol
1.610 Thionyl Chloride Recovered Toluene (Toluene
+ Thionyl Chloride)
1.525
5.930 Methanol Filtrate (Acetone + Toluene
Traces)
3.054
1.040 Toluene
3.160 Acetone
12.740 Total Output 1.000
Loss 2.120
INPUT OUTPUT
Qty
(Kg) Raw material Material Qty(Kg)
VST-2
1.000 Methyl Cyanobiphenyl Aqs. Layer (Water + MDC
Traces + AIBN)
4.179
0.740 Dibromodimethyl
hydantion
Recovered MDC 3.564 90% of
input DCM
0.100 AIBN Recovered E.Ac. (E.Ac.+ MDC
Traces)
0.090
3.960 MDC Filtrate (E.Ac.) 1.620
1.800 Ethyl Acetate
4.000 DM Water
11.600 Total Output 1.100
Loss 1.047
75
INPUT OUTPUT
Qty
(Kg) Raw material Material Qty(Kg)
VST-3
1.000 VST-02 Org. Layer (Toluene + Water
Traces)
7.551
0.800 VST-01.HCl Filtrate (Water + DMF + HCl +
Potassium Chloride )
21.024
0.500 Potassium carbonate
5.660 DMF
7.790 Toluene
0.580 HCl
15.000 DM Water
31.330 Total Output 1.000
Loss 1.756
INPUT OUTPUT
Qty
(Kg) Raw material Material Qty(Kg)
VST-4
1.000 VST-03.HCl Aqs.Layer (NaHCO3 + HCl +
MDC Traces + Water)
3.258
0.950 Sodium Bicarbonate Aqs.Layer (TEA + NaHCO3 +
HCl + MDC Traces + Water +
Excess Varelyl Chloride)
14.761
6.600 MDC Recovered DCM 5.610 85% of
input DCM
0.450 Valeryl Chloride Activated Carbon (Carbon +
Xylene)
0.150
0.380 Triethylamine
0.600 HCl
0.100 Activated Carbon
3.440 Xylene
15.400 DM Water
28.920 Total Output 4.390
Loss 0.751
76
INPUT OUTPUT
Qty
(Kg) Raw material Material Qty(Kg)
VALSARTAN
1.000 VST-04 Org. Layer (Xylene + Excess
Tributyltinch Chloride)
2.348
1.520 Tributyltinch Chloride Aqs. Layer (Water + Xylene
Traces +Excess Sodiumazide
+ TBAB + Sodium Hydroxide)
1.595
0.300 Sodiumazide Aqs. Layer (Water + MDC
Traces)
2.066
0.020 TBAB
Recovered DCM
2.805 85% of
input DCM
0.400 Sodium Hydroxide Activated Carbon (Carbon +
E. Ac.)
0.150
3.300 MDC Filtrate (Ethyl Acetate +
MDC)
1.515
0.100 Activated Carbon
0.900 Ethyl Acetate
1.720 Xylene
3.000 DM Water
12.260 Total Output 0.390
Loss 1.390
77
19. Topiramate and its Intermediate
Process Description: Stage-1:
A D-fructose hydrolyzed with sulfuric acid in acetone after reaction complies adjust the PH with
sodium hydroxide solution filter the salt filtration sodium sulfate salt to be remove as a spent and
clear filtration take for distillation after degassing add water and work up with IPA and hexane
and finally centrifuge the mass wash the cake with water cake drying finally get the final product
as Topiramte Stage 1
Stage-2:
Topramte stage 1 reaction done with sulfuryal chloride in EDC after reaction complies Reaction
mass work up with water and give sodium bi carbonate wash and finally EDC layer wash with
sodium chloride was after work up distilled out EDC completely and adjust the mass PH with
anhydrous ammonia filter the mass through charcoal and hyflow bed clear filter is to be distilled
out completely change Ethyl acetate and IPA and finally crystallization in hexane cooling and
chilling and filter the mass through centrifuge finally we get product as a Topiramate crude
Stage-3:
Topiramate crude dissolve in IPA and Ethyl acetate chrcolise the mass filter the clear filtrate heat
clear and hexane addition after crystallization filter the mass and finally wash the cake with water
drying milling sifting and packing and we get finally product as Topramate
78
Material Balance
Stage:-1
Sr. No Input Material Kg Output Material Kg
1 D-Fructose 1.00 Topiramte satge1 0.8
2 Acetone 14.0 Distilled Acetone 11.5
3 Sulfuric Acid 1.0 Hexane + water CF ML 9.5
4 Sodium hydroxide 1.5 Drying loss 0.25
5 Water 3.0 Sodium sulfate spent salt 3.34
6 Ethyl Acetate 0.5 Process emission 0.11
7 IPA 0.5
8 Hexane 4.0
Total 25.5 Total 25.5
79
Stage:-2
Sr. No Input Material Kg Output Material Kg
1 Topiramte satge1 1.0 Topiramte crude 0.8
2 Sulfuryal chloride 0.5 Distilled EDC 11.5
3 EDC 17.0 Hexane + ethyl+ IPA CFML 9.62
4 Sodium bicarbonate 0.25 Water aqueous layer 11.6
5 Water 10.5 Activated carbon and hyflow spent 0.5
6 Sodium chloride 0.25 Process emission 0.11
7 Anhydrous Ammonia gas 0.25
8 Ethyl acetate 0.25
9 Hexane 4.0
10 IPA 0.25
11 Activated carbon 0.11
12 Hyflow super cell 0.02
Total 34.13 Total 34.13
Stage:-3
Sr. No Input Material Kg Output Material Kg
1 Topiramte crude 1.00 Topiramte 0.7
2 IPA 3.00 Hexane + ethyl+ IPA CFML 15.7
3 Ethyl acetate 2.00 Drying loss 0.2
4 Hexane 11.00 Water CF ML 3.23
5 Activated carbon 0.02 Process emission 0.11
6 Hyflow super cell 0.02 Spent Carbon and Hyflow 0.1
7 water 3.00
Total 20.04 Total 20.04
80
20. Ropivacine and its Intermediate
Process Description:
Stage-1: L-Pipecolic acid hydrochloride
L-Pipecolic acid react with toluene in hydrolyzed with hydrochloride acid purified gives L-
Pipecolic acid hydrochloric acid
Stage-2:2,6 L- Pipiecoloxylidide
. L-Pipecolic acid hydrochloride reacts with phosphorous penta chlorides in presences of acetyls
chloride in toluene wash with acetone and re action with 2, 6 xylidine in reaction with ethyl
acetate in hexane with sodium chloride finally treat with sodium sulphate anhydrous gives 2,6 L-
Pipiecoloxylidide
Stage-3: Ropivacaine
2, 6 L- Pipiecoloxylidide react with n propyl bromide in presences of potassium carbonate in
toluene wash with IPA and ethyl acetate finally charcolised filtrated treated with sodium sulphate
finally gives Ropivacaine.
81
Route of Synthesis:
NH
COOH
NH
COOH
.HCl
HCl
NH
COCl
O2N
NH
HN
O
NH
COOH
NH
COCl
N
HN
O
.HCl
NH
HN
O
.HCl
Stage-I
Stage-III
ACCl/PCl5
Acetone
+ Acetone
2,6- L-Pipocoloxylidide
L-Pipecolic acid
2,6- L-Pipocoloxylidide
Stage-II
n-Propyl bromide
IPA/K2CO3
Ropivacaine
82
Material Balance
Stage:-1
Sr. No Input Material Kg Output Material Kg
1 L-Pipecolic acid 1.00 L-Pipecolic acid Hydrochloric acid 0.98
2 Hydrochloric acid 0.2 Water effluent 0.22
Total 1.2 Total 1.2
Stage:-2
Sr. No Input Material Kg Output Material Kg
1 L-Pipecolic acid Hydrochloric
acid 1.0 2,6 pipecoloxylidide 2.0
2 Phosphorous pentachloride 1.88 Toluene CF ML 6.7
3 Acetyl chloride 6.7 Acetone CF ML 35.1
4 Acetone 36.4 Ethyl acetate impurity layer 23.5
5 Toluene 2.65 AQ Layer 13.5
6 2,6 xylidine 1.47 Spent sodium sulpahte 4.0
7 Ethyl acetate 22.70 Sodium chloride AQ Layer 6.2
8 Hexane 35.95 Hexane CF ML 30.2
9 Sodium hydroxide 0.5 Drying loss 1.0
10 Purified water 11.0 Emission loss 0.48
11 Sodium chloride 1.0
12 Sodium sulphate Anhydrous 1.43
Total 122.68 Total 122.68
Stage:-3
Sr. No Input Material Kg Output Material Kg
1 2,6 pipecoloxylidide 1.0 Ropivacaine 1.05
2 Potassium carbonate 0.41 Water effluent 23.5
3 Toluene 23.60 Aq layer 8.5
4 n - propyl bromide 2.3 Toluene CF ML 21.7
5 IPA 4.2 Ethyl acetate CF Ml 19.5
6 Ethyl acetate 22.2 Spent charcoal and highf-low 2.1
7 Activated charcoal 0.1 Spent sodium sulfate 3.6
8 Sodium bicarbonate 0.38 Drying loss 0.25
9 Sodium chloride 0.54 Process emission 0.10
10 Sodium sulphate Anhydrous 2.17 IPA impurity layer 5.7
11 Hyflow supercell 0.1
12 Purified water 29
Total 86 Total 86.0
83
21. Pidotimod and its Intermediate
Process Description:
Thiazolidine-4-carboxylic acid ethyl ester HCl reacts with DCC in presences of L-Pyroglutamic
acid in dichloromethane after reaction product hydrolyzed with sodium hydroxide gives
Pidatimod.
Route of Synthesis:
S
NH
O O
.HCl
S
N
O OH
O
HN
O
Thiazolidine-4-carboxylic acid ethyl ester HCl
DCC/L-Pyroglutamic acid
Pidotimod
M.W : 197.5 M.W : 244.26
Material Balance
Sr. No Input Material Kg Output Material Kg
1
Thiazolidine-4-carboxylic acid
ethyl ester HCl 1.50 Pidotimod 1.00
2 L-Pyroglutamic acid 1.06 Dichloromethane recovery 18.8
3 Potassium carbonate 1.50 Acetone CF ML 3.50
4 DCC (Dicyclohexylcarbodiimide) 1.72 Methanol CF ML 2.20
5 Dichloromethane 20.0 Solid waste 2.10
6 Sodium hydroxide 0.33 Aq. Effluent 21.76
7 HCl 0.50 Drying loss 0.20
8 Acetone 3.75 Process emission 0.30
8 Methanol 2.50
10 Purified water 17.00
Total 49.86 Total 49.86
84
22. Aprepitatant and its Intermediate
Process Description:
A reaction with 2-{1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy}-3-(4-fluorophenyl)morpholine
hydrochloride and Amidrazone with potassium carbonate in presence of DMF anf o xylene work
with sodium chloride and wash with water and charcolise in methanol and finally dry product
Apripitatnt
Route of Synthesis:
85
Material Balance
Sr.
No Input Material Kg Output Material Kg
1
2-{1-[3,5-
Bis(trifluoromethyl)phenyl]ethoxy
}-3-(4-fluorophenyl)morpholine
hydrochloride
1.00 Apripitatant
0.9
2 Amidrazone 1.15 O-xylene 6
3 Potassium carbonate 3.50 DMF CF ML 4.1
4 Dimethyal formamide 2.5 Methanol CF ML 6.8
5 O-xylene 6.4 Charcoal Solid waste 0.54
6 Sodium chloride 0.45 Aq. Effluent 20.18
7 Methanol 6.0 Drying loss 0.4
8 Activated charcoal 0.22 Process emission 0.3
8 Purified water 18.0
Total 39.22 Total 39.22
86
ANNEXURE - IV
WATER CONSUMPTION & WASTEWATER GENERATION
Proposed
Sr. No. Category Proposed Scenario (m
3/day)
Water Consumption Waste Water Generation
1 Industrial
Process 28 33
Boiler 15 1.5
Cooling 5 0.5
Washing 2 1.5
Scrubber 2 2.7
2 Gardening 1.5 --
3 Domestic 2 1.2
4 R&D 0.026 0.025
Total (Industrial) 52 39.2
Total 55.526 40.425
Note:
- Total water requirement will be 55.526 KLD. Fresh water requirement will be 21.526 KLD.
Total 34 KLD will be reused within premises.
- MEE Condensate of 19 KLD will be reuse in boiler.
- RO permeate of 21 KLD will be reused in boiler.
- All domestic wastewater will be sent to Septic Tank & Soak Pit.
87
WATER BALANCE DIAGRAM
Total 55.526 KLD (Fresh Water: 21.526 KLD +
Reuse: 34 KLD)
Domestic: 2
KLD
Process: 28
KLD (Reuse:
21 + Fresh: 7)
Boiler:
15 KLD
(Reuse:
13 +
Fresh: 2)
Cooli
ng
Towe
r: 5
KLD
Wash
ing: 2
KLD
Gardeni
ng: 1.5
KLD
33 KLD
1.5
KLD 0.5 KLD 1.5 KLD
Soak Pit/
Septic Tank:
1.6 KLD
ETP: 26.525 KLD
RO: 26.525 KLD
Scrubber:
2 KLD
Scrubber: 1.4 KLD of
Dil. HCl will be reused
in Mfg. process.
Excess Qty. sold
under rule-9
permission.
Scrubber: 1.3 KLD of
Sodium sulphite will
be sold under rule-9
permission
Reject: 5.525 sent to
MEE
10 KLD (High COD & TDS)
+ 5.525 KLD (RO Reject) =
15.525 KLD MEE +
Stripper
23 KLD
(Low COD
& TDS)
Permeate: 21 KLD
reused in Boiler
Solvent Stripper
Solvent
Residue: 0.8
KLD
MEE: 14.725 KLD
Condensate:
13 KLD reused
in Boiler
MEE Salt: 1.5
MT/Day
Loss:
0.225
KLD
R&D:
0.026
KLD
0.0
25
KLD
88
ANNEXURE - V
EFFLUENT TREATMET PLANT DETAILS:
M/s. Krufren Pharma shall have an Effluent treatment plant consisting of primary, secondary,
tertiary treatment and advance treatment units. The details of up gradation ETP are as follows.
Stream I (RAW EFFLUENT Stream) (26.5 KLD)
DETAILS OF EFFLUENT TREATMENT PLANT (PROPOSED)
First all streams of wastewater shall be passed through O & G Trap (OGT-01) where O & G shall
be removed from the Top manually and Collected in O & G Collection Tank (OGCT-01) then
effluent will be collected in Equalization cum Neutralization Tank-1 (ENT-01) where the addition
and stirring of Acid/Alkali shall be done to maintain neutral pH of wastewater from Acid/Alkali
Dosing Tanks (ACDT-01/ALDT-01) as per requirement. Mixer is provided in ENT-01 for proper
mixing and prevents the settling of suspended solids.
Then after, neutralized wastewater shall be pumped to Flash Mixer (FM-01) where the
continuous addition and stirring of Alum solution is from Alum Dosing Tanks (ADT-01-A/B) as per
requirement. Then Polyelectrolyte shall be dosed from Polyelectrolyte Dosing Tank (PEDT-01) to
carry out flocculation with help of Mixer Mechanism. Then after, coagulated wastewater shall be
settled in Primary Settling Tank-1 (PST-01).
Clear supernatant from PST-01 shall be passed in Aeration Tank(AT-01). Here, biodegradation of
organic matter of the wastewater shall be carried out by bacteria (suspended growth) in the AT-
01 and for that oxygen shall be supplied by 2 nos. of air blowers through diffusers. Air blowers
also keep MLSS in suspension.
Then after, wastewater shall go to Secondary Settling Tank (SST-01). Here, the suspended solids
shall be settled. Sludge shall be removed from bottom of SST-01 and pumped to AT-1 to
maintain MLSS and excess activated sludge shall be sent to Sludge Drying Beds(SDB-01).
Clear supernatant from SST-02 shall be collected in Intermediate Sump (IS-01) by gravity.
Thereafter, the wastewater shall be passed through Pressure Sand Filter (PSF-01) to remove left
out TSS and Activated Carbon Filter (ACF-01) for final effluent polishing. After tertiary treatment,
effluent shall be collected in Treated Effluent Tank (TET-01) before passed through RO Unit (RO-
01) for advance treatment. RO permeate shall be collected in RO Permeate Tank (ROPT-01)
before reuse in plant and RO reject shall sent to MEE Feed Tank (MFT-01) for further treatment.
89
Sludge settled in PST-01 and excess sludge from SST-01 shall be sent to Sludge Beds (SDB-01) for
sludge dewatering. Then, dewatered sludge shall be stored in HWSA and then ultimate disposal
to TSDF. Leachate from SDB-01 and backwash from PSF-01 and ACF-01 shall be sent back to ENT-
01 for further treatment.
Stream II (High TDS stream) (10 KLD)
All High TDS streams of wastewater shall be collected in Equalization cum Neutralization Tank-2
(ENT-02).where Alkaline Lime shall be added from Alkali Dosing tank. Then after, effluent shall
have sent to Primary Settling Tank-2 (PST-02) where Alum and poly shall be added from ADT and
PDT-01 respectively. Mixer is provided in PST for Mixing of chemicals. Then Mixer will be
stopped and solids are allowed to settle at bottom.
Clear effluent from PCL-02 shall be collected in Holding Tank-1 (HT-01) before pumped to
strippers (ST-01) for removal of solvent. Effluent from stripper collected in MEE Feed Tank (MFT-
01). Then effluent shall be sent to Multiple Effect Evaporator (MEE-01) for further treatment
followed by Solid Dryer (SD-01) for solids dewatering. Condensate from MEE-01&SD-01 shall
collect in ME Condensate Tank (MECT-01) before reuse in utilities. Solids from SD-01 shall be
collected and stored in HWSA for disposal in TSDF.
Details of ETP Units: 26.5 KLD
Sr.
No. Name of Unit Tag No.
Size in Meters
(L X B X (LD+FB) Nos. MOC
1. Oil & Grease Tarp-01 OGT-01 3.0 x 0.7x (1.5+0.5) 1 RCC M30+ A/A
res. Lining
2. Oil & Grease Collection
Tank-01 OGCT-01 500 Lit 1 HDPE
3. Equalization cum
Neutralization Tank-1 ENT-01 4.0 x 3.0 x (2.5+0.5) 1
RCC M30+ A/A
res. Lining
4. Flash Mixer FM-01 1.0 x 1.0 (2.0+0.5) 1 RCC M30
5. Primary Settling Tank-1 PST-01 3.0 x 1.5 x (2.0+0.5) 1 RCC M30
6. Aeration Tank AT-01 6.0 x4.0 (4.0+0.5) 1 RCC M30
7. Secondary Settling Tank SST-01 3.0 x 1.5 x (2.5+0.5) 1 RCC M30
8. Intermediate Sump IS-01 2.0 x 1.5 (2.5+0.3) 1 RCC M30
9. Pressure Sand Filter PSF-01 30 M3/D 1 MSEP
10. Active Carbon Filter ACF-01 30 M3/D 1 MSEP
11. Treated Effluent Tank TET-01 4.0 x 3.0 x (2.5+0.5) 1 RCC M30
13. Sludge Drying Beds SDBs-01-A/B 4.0 x 3.0 3 RCC M30
14. RO Unit RO-01 30 KLD 1 As per Std.
90
15. RO permeate Tank ROPT-01 5 KLD 1 HDPE
16. Acid Dosing Tank ACDT-01 1000 Lit 1 HDPE
17. Alkali Dosing Tank ALDT-01 1500 Lit 1 HDPE
18. Alum Dosing Tank ADT-01 1000 Lit 1 HDPE
19. Poly Dosing Tank PEDT-01 500 Lit 1 HDPE
20. Nutrient Dosing Tank NDT-01 500 Lit 1 HDPE
DETAILS OF UNITS: (FOR HIGH COD & TDS STREAMS) (10 KLD )
Sr.
No. Name of Unit Tag No.
Size in Meters
(L X B X (LD+FB) Nos. MOC
1. Equalization cum
Neutralization Tank-2 ENT-02 3.0 x 2.0 (2.0 + 0.5) 1
RCC M30+ A/A
Bk. Lining
2. Primary Settling Tank -2 PST-02 2.0 x 2.0 x (2.5 + 0.5) 1 RCC M30
3. Holding Tank HT-01 2.0 x 2.0 x (2.5+0.3) 1 RCC M30
4. Stripper ST-01 10 KLD 1 SS316L
5. MEE Feed Tank MFT-01 2.0 x 2.0 x (3.0 SWD +
0.5) 1 RCC M30
6. Multi Effect Evaporator
(MEE-01) with Solid
Dryer (SD-01)
MEE-01/SD-
01 20KLD 1 SS316L
7. Condensate Storage
Tank CST-01 2000 Lit 1 HDPE
CHARACTERISTICS OF WASTEWATER BEFORE & AFTER TREATEMENT
Sr.
No. Parameter
Characteristics (mg/L)
Untreated Final Treated
1. pH 6.0-8.0 7.0-7.5
2. TDS 27,000 500
3. COD 25,000 200
4. BOD3 7,000 50
5. Ammonical Nitrogen 80 10
92
ANNEXURE-VI
DETAILS OF HAZARDOUS WASTE GENERATION & DISPOSAL
Sr.
No. Type Of Waste Category
Quantity
(MT/Month)
Source of
Generation
Mode of Treatment
and Disposal
1 Sodium sulphate Schedule-
(I)-(28.1) 4.77
Topiramate
Process
Collection, Storage,
Transportation and
Sell to end users
Having permission
Rule-9 2 Sodium chloride
Schedule-
(I)-(28.1) 6.19
Ropivacine
Process
3 Process Waste Schedule-
(I)-(28.1) 3.13
Glibenclamide
Process
Collection, Storage,
Transportation and
Disposal at common
TSDF Site.
4 ETP Sludge Schedule-
(I)-(35.3) 7.0 ETP Treatment
Collection, Storage,
Transportation and
Disposal to TSDF site.
5
Discarded
Drums/Container
s/Bags
Schedule-
(I)-(33.1) 240
Raw Material
and Storage
Collection, Storage,
Decontamination,
Reuse, Transportation
and sale to authorized
vendor.
6 Used Oil Schedule-
(I)-(5.1) 0.8
From Moving
Machineries
Collection, Storage,
Transportation, Reuse
and sale to authorized
recycles.
7 Spent carbon Schedule-
(I)-(28.3) 2.0
Ropivacaine
Process
Collection, Storage,
Transportation and
Disposal to TSDF site.
8 Spent Solvent Schedule-
(I)-(28.6) 760
Flucanozole
Process
Collection, Storage,
Transportation and
sale to authorized
users.
9 Distillation
Residue
Schedule-
(I)-(20.3) 33 Distillation plant
Collection, Storage,
Transportation and
sent for co-
processing in cement
industries or sent to
common incineration
of M/s. BEIL.
10 Dil. HCl (30%) Sch-(II)-B15 42 Scrubber
Collection, storage
and reuse in
Zonisamide process
(Reqd. qty 75
MT/Month) excess
quantity will be sell to
93
end users having rule-
9 permission.
11 Sodium Sulphite
(28%) Sch-(II)-B36 39 Scrubber
Collection, Storage,
Transportation and
Sell to end users
Having permission
Rule-9
12 Salt from MEE Schedule-
(I)-(35.3) 15 MEE Process
Collection, Storage,
Transportation and
Disposal to TSDF site.
94
ANNEXURE-VII
DETAILS OF STACK AND VENTS
Proposed Flue Gas Emission
Stack
no.
Stack
attached to
Fuel used & rate
of consumption
Stack
height
(m)
Parameters Permissible limits
1 Boiler (2.0
TPH)
Briquettes of Bio
Coal/Coal (1900
MT/Day)
30 SPM
SO2
NOx
Multi-cyclone separator
with bag filter
2 Thermo Pack
(1.0 lakhs
kcal/hr)
Briquettes of Bio
Coal/Coal (1900
MT/Day) or
Hi therm oil (100
Kl/Hr)
30 SPM
SO2
NOx
Multi-cyclone separator
with bag filter
3 D. G Set HSD (50 lit/day) 11 SPM
SO2
NOx
Adequate Stack Height
Proposed Process gas Emission
Sr.
No.
Source of
Emission
Vent (meter) Type of
Emission
APCE
Height Diameter
1 Process Vent
(Chlorination)
11 0.1 HCl Two stage Water scrubber
2 Process Vent
(Sulphonation)
11 0.1 SO2
Two stage Water + Alkali scrubber
95
ANNEXURE-VIII
STORAGE DETAILS OF HAZARDOUS CHEMICALS
SR.
NO
NAME OF THE MATERIAL TYPE OF
HAZARD
NUMBER OF
TANKS/CYLINDERS
MAXIMUMA QTY
TO STORE
1 HYDROGEN GAS FLAMMABLE 10 CYLINDERS 20 CYLINDERS
2 AMMONIA GAS CORROSIVE 04 CYLINDERS 04 CYLINDERS
3 CHLORINE GAS TOXIC 02 CYLINDERS 02 CYLINDERS
4 EDC TOXIC 01 TANK 5.0 KL
5 TOLUENE FLAMMABLE 01 TANK 5.0 KL
6 METHANOL FLAMMABLE 01 TANK 7.0 KL
7 ETHYL ACETATE FLAMMABLE 01 TANK 5.0 KL
8 ACETONE FLAMMABLE 01 TANK 5.0 KL
9 IPA TOXIC 01 TANK 5.0 KL
10 XYLENE FLAMMABLE 01 TANK 5.0 KL
11 MDC TOXIC 01 TANK 5.0 KL
96
ANNEXURE-IX
___________________________________________________________________________
SOCIO - ECONOMIC IMPACTS
1) EMPLOYMENT OPPORTUNITIES
The manpower requirement for the proposed project is being expected to generate some
permanent jobs and secondary jobs for the operation and maintenance of plant. This will
increase direct / indirect employment opportunities and ancillary business development to some
extent for the local population.
This phase is expected to create a beneficial impact on the local socio-economic environment.
2) INDUSTRIES
Required raw materials and skilled and unskilled laborers will be utilized maximum from the
local area. The increasing industrial activity will boost the commercial and economical status of
the locality, to some extent.
3) PUBLIC HEALTH
The company regularly examines, inspects and tests its emission from sources to make sure that
the emission is below the permissible limit. Hence, there will not be any significant change in the
status of sanitation and the community health of the area, as sufficient measures have been
taken and proposed under the EMP.
4) TRANSPORTATION AND COMMUNICATION
Since the existing factory is having proper linkage for the transport and communication, the
development of this project will not cause any additional impact.
In brief, as a result of the proposed project there will be no adverse impact on sanitation,
communication and community health, as sufficient measures have been proposed to be taken
under the EMP. The proposed project is not expected to make any significant change in the
existing status of the socio - economic environment of this region.
97
ANNEXURE-X
___________________________________________________________________
PROPOSED TERMS OF REFERENCE FOR EIA STUDIES
1. Project Description
• Justification of project.
• Promoters and their back ground
• Project site location along with site map of 5 km area and site details providing various
industries, surface water bodies, forests etc.
• Project cost
• Project location and Plant layout.
• Existing infrastructure facilities
• Water source and utilization including proposed water balance.
• List of Products and their capacity
• List of hazardous chemicals with their toxicity levels.
• Mass balance of each product along with the batch size
• Storage and Transportation of raw materials and products.
2. Description of the Environment and Baseline Data Collection
• Micrometeorological data for wind speed, direction, temperature, humidity and rainfall in 5
km area.
• Study of Data from secondary sources.
• Existing environmental status Vis a Vis air, water, noise, soil in 5 km area from the project site.
For SPM, RSPM, SO2, NOx.
• Ground water quality at 5 locations within 5 km.
• Complete water balance
3. Socio Economic Data
• Existing socio-economic status, land use pattern and infrastructure facilities available in the
study area were surveyed.
4. Impacts Identification and Mitigatory Measures.
• Impact on air and mitigation measures including green belt
• Impact on water environment and mitigation measures
• Soil pollution source and mitigation measures
• Noise generation and control.
• Solid waste quantification and disposal.
• Control of fugitive emissions
5. Environmental Management Plan
• Details of pollution control measures
• Environment management team
• Proposed schedule for environmental monitoring including post project
98
6. Risk Assessment
• Details on storage facilities
• Identification of hazards
• Consequence analysis
• Recommendations on the basis of risk assessment done
• Disaster Management Plan.
7. Information for Control of Fugitive Emissions
8. Post Project Monitoring Plan for Air, Water, Soil and Noise.
9. Occupational Health and Safety Program for the Project.