This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
ToR Amendment Tagoor Laboratories Private Limited
ANNEXURE – I
Details of Products as per Granted ToR and Amendment Required
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 1
ToR Amendment Tagoor Laboratories Private Limited
S. No Product Name
Production Capacity Ton /Month Therapeutic
category As per granted ToR
Amendment Required
34 Rabeprazole Sodium 10.0 15.0 Ant ulcerative 35 Rupatadine fumarate 2.0 2.0 Antihistamine 36 Telmisartan 2.0 2.0 Anti Hypertensive 37 Terbinafine hydrochloride 8.0 15.0 Anti fungal 38 Valsartan 2.0 2.0 Anti Hypertensive 39 1-Benzy-4-piperidone 5.0 5.0 Drug Intermediate 40 1-Benzyl-4-chloropiperidine 5.0 5.0 Drug Intermediate 41 1-Benzylpiperidin-4-ol 5.0 5.0 Drug Intermediate 42 1-Methylpiperidin-4-amine 5.0 5.0 Drug Intermediate 43 4-Aminopiperidine 5.0 5.0 Drug Intermediate 44 4-Hydroxy piperidine 5.0 5.0 Drug Intermediate 45 4-Phenylpiperidine 1.0 1.0 Drug Intermediate 46 4-piperidinopiperidine 1.0 1.0 Drug Intermediate
47 N-tert-Butoxycarbonyl-4-hydroxy piperidine 5.0 5.0 Drug Intermediate
Total ( Worst Combination of any 12 Products at any given point of time)
140.0 200.0
Note:
The above Listed Products, we will manufacture either Finished Product or any Intermediate stage of finished Product as per given quantity by not increasing the
production capacity of 200 MT/Month.
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 2
Type of Fuel -- Agro waste /Indian Coal Coal Consumption TPD 48 Ash Content % 35 Sulphur Content % 0.4 No. of Stacks No 1 Height of stack M 32 Diameter of Stack M 0.6 Temperature of Flue Gas
oC 220
Velocity of Flue Gas m/s 15 Particulate Matter gm/sec 1.8 Sulphur dioxide emission
gm/sec 2.67
Oxides of Nitrogen emission
gm/sec 5.13
Pollution control equipment
- Cyclone separator followed by suitable pack of Bag filters
Note : 6.0 TPH Agro waste /Coal fired boiler (Stand by )
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 6
ToR Amendment Tagoor Laboratories Private Limited
STACK EMISSION DETAILS FOR THERMO PACK BOILER
Particulars Units 2,00,000 kcal/hr. Thermo pack Boiler (Existing)
Thermo pack Boiler Capacity Kcal/hr. 2,00,000
Type of Fuel -- Agro waste/ Coal
Stack Temperature Before Air preheater
oC 250
Stack Temperature After Air preheater
oC 180
Stack Height m 9.0
Fuel Consumption per Day TPD 0.75
Diameter m 0.30
STACK EMISSION DETAILS FOR DG SETS
Capacity In KVA
Emission of SPM in mg/Nm3
Emission Of SO2 in mg/Nm3
Emission of NOx In mg/Nm3
Stack dia. in m
Flue Gas Temp. in OC
Stack Height in m
Flue gas Velocity in m/sec.
1000 KVA (Proposed)
80 50 60 0.2 300 10 16
1000 KVA (Proposed)
80 50 60 0.2 300 10 16
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 7
ToR Amendment Tagoor Laboratories Private Limited
ANNEXURE -VII
Details of Process Emission as per Granted ToR and Amendment Required
S. No.
Name of the Gas
Quantity In Kg/Day
As per granted ToR
Amendment Required Treatment Method
1 Sulphur dioxide 697 1724 Scrubbed by using C.S.Lye Solution
2 Hydrogen chloride 330 1183 Scrubbed by using
chilled water media
3 Hydrogen Bromide 420 311 Scrubbed by using C. S.
Lye solution
4 Nitrogen 17 45 Dispersed into the atmosphere
5 Carbon dioxide 662 863 Dispersed into the atmosphere
6 Hydrogen 16 34 Diffused by using Nitrogen through Flame arrestor
7 Ammonia 68 104 Scrubbed by using chilled water media
8 Oxygen 136 794 Dispersed into the atmosphere
9 Chloro Methane 209 242 Scrubbed by using C.S.Lye Solution
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 8
ToR Amendment Tagoor Laboratories Private Limited
ANNEXURE – X CONSOLIDATED STATEMENT- POLLUTION DETAILS ASPER TOR AMENDMENT
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 9
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)
Form-I
Form - 1
Appendix- I (See Paragraph-6)
(I) Basic Information S.
No. Item Details
1 Name of the Project/s
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)Expansion of Existing Bulk Drugs & Intermediates manufacturing unit
2 S.No. in the Schedule
5(f) Synthetic organic chemicals industry (dyes & dye intermediates; bulk drugs and intermediates excluding drug formulations; synthetic rubbers; basic organic chemicals, other synthetic organic chemicals and chemical intermediates)
3
Proposed capacity / area / length / tonnage to be handled /command area / lease area / number of wells to be drilled
16 Details of Alternate Sites examined, if any. Location of these sites should be shown on a toposheet.
Not Applicable
17 Interlinked Projects Not Applicable
18 Whether separate application of interlinked project has been submitted.
Not Applicable
19 If yes, date of submission Not Applicable 20 If no, reason Not Applicable
21
Whether the proposal involves approval / clearance under: if yes, details of the same and their status to be given (a) The Forest (Conservation) Act, 1980? (b) The Wildlife (Protection) Act, 1972?
Not Applicable
Prepared by Rightsource Industrial Solutions Pvt. Ltd. 2
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)
Form-I
S.
No. Item Details
(c) The C.R.Z. Notification, 1991?
22 Whether there is any Government Order / Policy relevant / relating to the site
No, Government Order / Policy relevant / relating to the site are applicable.
23 Forest Land involved (hectares) No Forest land is involved in the project
24
Whether there is any litigation pending against the project and / or land in which the project is proposed to 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 litigations pending against the project.
(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.)
with sources of information data Green belt and others
1.6 Demolition works? No No major demolition work is envisaged
1.7 Temporary sites used for construction works or housing of construction works?
No
Majority of the labor will be hired from nearby villages so no housing or shelter facilities required for construction workers. However existing facilities are sufficient like drinking and sanitation facilities for workers during working hours.
1.8
Above ground buildings, structures or earthworks including linear structures, cut and fill or excavations
No Not Applicable
1.9 Underground works including mining or funneling?
No Not Applicable
1.10 Reclamation Works? No Not Applicable 1.11 Dredging? No Not Applicable 1.12 Offshore structures? No Not Applicable
1.13 Production and manufacturing processes? Yes
List of products, By-Products and capacities for TOR Amendment was Enclosed as in Additional Information and Manufacturing Process is Enclosed as Appendix - I
1.14 Facilities for storage of goods or materials? Yes
Common facility for storage of raw materials and finished products will be provided
Prepared by Rightsource Industrial Solutions Pvt. Ltd. 4
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)
1.15 Facilities for treatment or disposal of solid waste or liquid effluents?
Yes
Solid Waste: The Solid & hazardous waste generated in plant will be disposed as per rules. The Details of Solid/Hazardous Waste Details as per Amendment Required enclosed as Annexure in Additional Information File Liquid waste: Industrial effluent of 154 KL/ day is generated and will be treated in ZLD System.
1.16 Facilities for long term housing of operational workers?
No The workforce is recruited from nearby villages. No long term housing of operational workers
1.17 New road, rail or sea traffic during construction or operation?
No
Road traffic is likely to increase both during construction and operation stage for transportation of man and material. However, existing transport routes are adequate for the increase in traffic. No additional transport infrastructure is required due to the proposed project
1.18
New road, rail, air waterborne or other transport infrastructure including new or altered routes and stations, ports, airports etc?
No No, additional transport infrastructure is required due to the present proposal.
1.19
Closure or diversion of existing transport routes or infrastructure leading to changes in traffic movements?
No Not Required
1.20 New or diverted transmission lines or pipelines?
No Not Required
1.21 Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or
No Not Required
Prepared by Rightsource Industrial Solutions Pvt. Ltd. 5
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)
1.23 Abstraction or transfers of water from ground or surface waters?
Yes
The total water requirement is 377 KL/day for the proposed project and Source of Water: Surface water Allotment from State Government /Ground Water
1.24 Changes in water bodies or the land surface affecting drainage or run-off?
No None (There will not be any changes in water bodies or the land surface affecting drainage or runoff)
1.25 Transport of personnel or materials for construction, operation or decommissioning?
No The raw materials and products will be transported during construction and operation phase
1.26 Long-term dismantling or decommissioning which could have an impact on the environment?
No Not Applicable
1.27 Ongoing activity during decommissioning which could have an impact on the environment?
No Not Applicable
1.28 Influx of people to an area in either temporarily or permanently?
Yes The Estimated employment generation for this proposed project is about 135 Direct employees.
1.29 Introduction of alien species? No No New species are introduced.
1.30 Loss of native species or genetic diversity?
No No Loss of native species or genetic diversity.
1.31 Any other actions? No None envisaged 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):
2.1 Land especially undeveloped or agricultural land (ha)
No Total 11.80 Acres (47752.9 Sq.m) is of Industrial Land
2.2 Water (expected source & Yes The total water requirement is 377 KL/day
Prepared by Rightsource Industrial Solutions Pvt. Ltd. 6
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)
Form-I
competing users) Unit : KLD for the proposed project and Source of
Water: Surface water Allotment from River /Ground Water The Details as per Amendment Required are enclosed in Additional Information file
2.3 Minerals (MT) No Not Applicable
2.4 Construction material – stone, aggregates, and / soil (expected source- MT)
No Construction materials like stone, steel aggregates, sand & cement will be sourced locally.
2.5 Forests and timber (source-MT) No No Timber will be used.
2.6
Energy including electricity and fuels (source, competing users) Unit : fuel (MT), energy (MW)
Yes
Details as per Amendment Required The power requirement for the plant is 2000 KVA. Boilers: The existing 6.0 TPH Coal fired/ Agro
waste fired Boiler will be kept as standby
and 2,00,000 kcal/hr Thermo pack Boiler
will be Continued.
Proposed to install 12.0 TPH Coal fired/
Agro waste fired Boiler.
DG Sets: For emergency power supply industry is proposing two no’s DG sets of 1000 KVA and Existing:250 KVA will be dropped,
2.7 Any other natural resources (use appropriate standard units)
No None
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.
3.1 Use of substance or materials, which are hazardous (as per MSIHC rules)
Yes The number of chemicals will be used for the production of Synthetic Drugs & Intermediates which have been
Prepared by Rightsource Industrial Solutions Pvt. Ltd. 7
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)
Form-I
to human health or the environment (flora, fauna and water supplies).
mentioned in the list of raw materials given in the Additional Information as Annexure.
3.2 Changes in occurrence of disease or affect disease vectors (e.g. insect or water borne diseases)
No No such occurrence is envisaged, since effluent generated will be treated properly.
3.3 Affect the welfare or people e.g. by changing living conditions?
Yes
The proposed expansion will generate direct and indirect employment opportunities during construction as well as operation phase for the local people based on their qualification and work experience.
3.4
Vulnerable groups of people who could be affected by the project e.g. hospital patient’s, children, the elderly etc.,
No None
3.5 Any other causes No None 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 sources of information data
4.1 Spoil, overburden or mine wastes No
Not Applicable
4.2 Municipal waste (domestic and or commercial wastes)
Yes
Commercial waste like empty cement bags, Iron scrap etc. will be sold to scrap buyers after the construction phase. Domestic waste like used paper, label, cartoons will be disposed to the scrap buyers. Organic waste from canteen will be disposed as per the local Panchayath / Municipal disposal mechanism.
4.3 Hazardous wastes (as per Hazardous Waste Management Rules)
Yes Hazardous wastes Details for ToR Amendment are Enclosed as Annexure in additional information
4.4 Other industrial process wastes Yes The detailed Solid & Hazardous wastes for ToR Amendment are Enclosed as Annexure in additional information
Prepared by Rightsource Industrial Solutions Pvt. Ltd. 8
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)
Form-I
S.
No. Information / Checklist
confirmation Yes /No
Details thereof (with approximate quantities /rates, wherever possible ) with sources of information data
4.5 Surplus product No None
4.6 Sewage sludge or other sludge from effluent treatment
Yes ETP sludge is sent to TSDF
4.7 Construction or demolition wastes No
Minimal quantity of debris, scraps, excavated soil used cement bags, iron/steel scrap and cardboards waste could be generated during additional construction.
4.8 Redundant machinery or equipment
No None
4.9 Contaminated soils or other materials
No None
4.10 Agricultural wastes No None 4.11 Other solid wastes No None
5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr)
Emissions from combustion of fossil fuels from stationary or mobile sources
Yes
Gaseous emission like SO2, NOx, CO and particular matter shall be generated from Boilers and DG sets which will be maintained under prescribed limit. DG sets will be used during only power break down. Adequate stack height of Boilers and DG sets provided for effective dispersion of pollutants.
5.2 Emissions from production processes
Yes Proper control measures will be adopted to control emission as per prescribed Standard
5.3 Emissions from handling including storage and transport
Yes Fugitive emissions from material handling, loading /unloading and transport of material will be minimal due to closed loop system.
5.4 Emissions from construction activities
Yes This will be restricted to the construction phase and to the construction site only. It
Prepared by Rightsource Industrial Solutions Pvt. Ltd. 9
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)
with sources of information data including plant and equipment
will be minimized by sprinkling water.
5.5
Dust or odors from handling of materials including construction materials, sewage and waste.
Yes Dust will be generated from loading and unloading of raw material and finished products.
5.6 Emissions from incineration of waste
No No incinerator is proposed.
5.7
Emissions from burning of waste in open air (e.g. slash materials, construction debris)
No No waste will be burnt in open air.
5.8 Emissions from any other sources
Yes Dust Emissions from Ball Mill will be mitigated by providing Inbuilt bag filters.
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 sources of information data
6.1 From operation of equipment e.g. engines, ventilation plant, crushers
Yes
Material transport shall be source of noise during construction, while transfer pumps, vacuum systems are the sources of noise during operation. The equipment in the plant are designed for noise levels not exceeding 90 dB (A). Proper encasement of noise generating sources is done to control the noise levels below 75 dB (A) at plant boundary. Maintenance of all equipment is carried out regularly to reduce noise. A proper green belt is developed which acts as a noise barrier.
6.2 From industrials or similar processes Yes
Pumps, motors, gearboxes etc will generate little bit of noise and will be mitigated with regular maintenance. Apart from all these a thick plantation of green belt will be developed along the periphery
Prepared by Rightsource Industrial Solutions Pvt. Ltd. 10
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)
Form-I
S.No. Information /Checklist confirmation
Yes/ No
Details thereof (with approximate quantities /rates, wherever possible )
with sources of information data of the compound wall to arrest the noise nuisance during the operation phase.
6.3 From construction or demolition Yes Temporary noise generation during construction activities
6.4 From blasting or piling No Not Applicable
6.5 From construction or operational traffic
Yes Noise due to movement of trucks during construction and operation phase
6.6 From lighting or cooling systems Yes Adequate Lighting shall be provided in unit and also local ventilation system shall be provided
6.7 From any other sources No Not Applicable 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 sources of information data
7.1 From handling, storage, use or spillage of hazardous materials
Yes
Hazardous materials will be used and stored with due safety and care at site. All the norms under the Manufacture, Storage and Import Of Hazardous Chemicals (MSIHC) Rules and amendments thereafter will be complied.
7.2
From discharge of sewage or other effluents to water or the land (expected mode and place of discharge )
No ETP will be installed and will be designed for zero effluent discharge
7.3 By deposition of pollutants emitted to air into the land or into water
No
All possible air pollutants will be scrubbed/ filtered properly by various pollution control equipment before emitting into atmosphere. The norms will be maintained through regular monitoring and analysis of vent gases.
7.4 From any other sources No None 7.5 Is there a risk of long term build up No None
Prepared by Rightsource Industrial Solutions Pvt. Ltd. 11
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)
Form-I
of pollutants in the environment from these sources?
8. Risk of accidents during construction or operation of the Project, which could affect human or the environment
S.No. Information /Checklist confirmation
Yes/ No
Details thereof (with approximate quantities /rates, wherever possible ) with sources of information data
8.1
From explosions, spillages, fires etc from storage, handling, use or production of hazardous substances
No
No explosions will occur during construction. During production operations, 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 No None
8.3
Could the project be affected by natural disasters causing environmental damage (e.g. floods, earthquakes, landslides, cloudburst etc)?
No
As the area is plain, there are no chances of landslides & there is no history of cloud burst. No natural disasters are envisaged, since site is in an area where such occurrences do not arise.
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 activates in the locality.
S.No. Information /Checklist confirmation
Yes /No
Details thereof (with approximate quantities /rates, wherever possible )
with sources 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
Yes
The proposed project will prove beneficiary for the localities as it provides: Additional direct and indirect employment
Prepared by Rightsource Industrial Solutions Pvt. Ltd. 12
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)
Form-I
S.No. Information /Checklist confirmation
Yes /No
Details thereof (with approximate quantities /rates, wherever possible )
with sources of information data or waste-water treatment etc.)
• Housing development
• Extractive industries
• Supply industries
• Other
9.2 Lead to after use of the site, which could have an impact on the environment
No None
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)
Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related values.
No -
2.
Areas which are important or sensitive for ecological reasons- Wetlands, water courses or other water bodies, coastal zone, biospheres. Mountains, forests
Yes
Reserve Forests • Fairly dense Jungle near
Gopavaram - 1.2 KMs (WNW) • Dense Mixed Jungle near
Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration.
No None
4. Inland, coastal, marine or underground waters
No None
5. State, National boundaries No None
6. Routes or facilities used by the public for access to recreation or other tourist, pilgrim areas
No None
7. Defense installations No None
8. Densely populated or built-up area Yes Mandal head quarter Tallapudi is 8.50 kms
9.
Areas occupied by sensitive man-made land uses (hospitals, schools, places of worship, community facilities )
Yes Mandal head quarter Tallapudi is 8.50 kms
10.
Areas containing important, high quality or scarce resources (ground water resources, surface resources, forestry, agriculture, fisheries, tourism, minerals)
Yes
Reserve Forests • Fairly dense Jungle near
Gopavaram - 1.2 KMs (WNW) • Dense Mixed Jungle near
Areas already subjected to pollution or environmental damage.(those where existing legal environmental standards are exceeded)
No None
12.0
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
The project is located in seismic zone II (Least Active) as per IS: 1893 (Part-1) 2002. Therefore, possibility of earthquake is not anticipated. So there will be no effect of natural hazards on the project.
Prepared by Rightsource Industrial Solutions Pvt. Ltd. 15
ToR Amendment Tagoor Laboratories Private Limited
APPENDIX-I
1-BENZYL-4-CHLOROPIPERIDINE
Process Description:
Stage-1:
Benzyl amine reacts with reacts with Acryclic acid methyl ester in presence of Methanol to give stage-1 product.
Stage-2:
Staeg-1 product reacts with Sodium Methoxide in presence of Hydrochloric acid and Toluene to give satge-2 product.
Stage-3:
Stage-2 product reacts with Hydrochloric acid and water in presence of Chloroform and Caustic Solution to give 1-Benzyl-4-Chloro-Piperidone.
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 2
ToR Amendment Tagoor Laboratories Private Limited
Flowchart:
Stage-1
Stage-2
1-BENZYL-4-CHLOROPIPERIDINE
Benzylamine Acryclic acid methyl esterMethanol
Methanol RecoveryEffluent water
Toluene RecoveryEffluent water
Stage-1Sodium MethoxideHydrochloric acidToluene
1-BENZYL-4-CHLOROPIPERIDINE
Material Balance:
Material Balance of 1-Benzyl-4-Chloro-Piperidone Stage-1
Batch Size: 200.00 Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Benzylamine 140.00 Stage-1 330.00 Acryclic acid methyl ester 224.85 Methanol Recovery 285.00 Methanol 300.00 Methanol loss 10.00 Water 400.00 Effluent water 400.00 (Water-400) 0 Organic residue 39.85 Process residue – 34.85
Distillation residue-5 (Methanol-5)
Total 1064.85 Total 1064.85
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 3
ToR Amendment Tagoor Laboratories Private Limited
Material Balance of 1-Benzyl-4-Chloro-Piperidone Stage-2
Batch Size: 200.00 Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-1 330.00 Stage-2 263.00 Sodium Methoxide 63.70 Toluene Recovery 380.00 Hydrochloric acid 43.00 Toluene loss 12.00 Toluene 400.00 Effluent water 544.54 Water 400.00 (Water-400,Sodium Chloride-
68.97,Methanol-75.57) 0
Organic residue 37.16 Process residue-29.16
Distillation residue-8 (Toluene-8)
Total 1236.70 Total 1236.70
Material Balance of 1-Benzyl-4-Chloro-Piperidone Stage-3
Batch Size: 200.00 Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-2 263.00 1-Benzyl-4-Chloro-Piperidone 200.00 Hydrochloric acid 38.65 Chloroform Recovery 475.00 Chloroform 500.00 Chloroform Loss 25.00 Caustic solution 50.00 Effluent water 383.93 Water 300.00 (Water-300,Water from Caustic
solution 50,Generated Methanol-33.93)
0
Process emission 63.38 (carbondioxide-46.55, oxygen-
16.83) 0
Organic residue 4.34 Process residue -4.34 Total 1151.65 Total 1151.65
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 4
ToR Amendment Tagoor Laboratories Private Limited
1-BENZYL-4-PIPERIDONE
Process Description:
Stage-1:
Benzyl amine reacts with reacts with Acryclic acid methyl ester in presence of
Methanol to give stage-1 product.
Stage-2:
Staeg-1 product reacts with Sodium Methoxide in presence of Hydrochloric acid and
Toluene to give satge-2 product.
Stage-3:
Stage-2 product undergoes Hydrolysis with Sodium Hydroxide and Hydrochloric acid
in presence of Chloroform to give 1-Benzyl-4-Piperidone.
Water 300.00 Process emission 50.45 (carbondioxide-50.45) Organic residue 18.41 Process residue -18.41 Total 1222.88 Total 1222.88
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 8
ToR Amendment Tagoor Laboratories Private Limited
1-BENZYL-PIPERIDIN-4-OL
Process Description:
Stage-1:
N-Benzyl-4-Piperidone undergoes Hydrogenation with Hydrogen in presence of Palladium Carbon and Methanol to give 1-Benzyl-piperidin-4-ol
Route of Synthesis:
Stage-1
N
O
N-Benzyl-4-piperidone
C12H15NO189.25
+ H2
2.02
Methanol,Pd/C
N
OH
C12H17NO
191.27
1-Benzyl-piperidin-4-ol
Flowchart:
Stage-1
1-BENZYL-PIPERIDIN-4-OL
N-Benzyl-4-PiperidoneHydrogen Methanol
Methanol RecoveryEffluent water
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 9
ToR Amendment Tagoor Laboratories Private Limited
Material Balance:
Material Balance of 1-Benzyl-Piperidin-4-ol .Stage-1
Batch Size: 200.00 Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg N-Benzyl-4-Piperidone 209.00 1-Benzyl-piperidin-4-ol 200.00 Hydrogen 2.20 Methanol Recovery 285.00 Methanol 300.00 Methanol loss 10.00 Water 400.00 Effluent water 400.00 (Water-400) 0 Organic residue 16.20 Process residue – 11.20
Distillation residue-5 (Methanol-5)
Total 911.20 Total 911.20
1-METHYLPIPERIDIN-4-AMINE
Process Description:
Stage-1:
1-methylpiperidin-4-one undergoes amination with Ammonia in presence of Methanol to give
1-Methylpiperidin-4-Amine
Route of Synthesis:
Stage-1:
1-methylpiperidin-4-one
N
O
CH3
C6H11NO113.16
Methanol,Methanolic ammonia
Raney Nickel,H2 gas
1-methylpiperidin-4-amine
N
NH2
CH3
C6H14N2
114.19
NH3
17.03
+ 0.5 O2
16.00
+
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 10
Material Balance of 1-Methylpiperidin-4-Amine Stage-1
Batch Size: 200.00 Kg Name of the input Quantity in
Kg Name of the out put Quantity
in Kg 1-methylpiperidin-4-one 209.00 1-Methylpiperidin-4-Amine 200.00 Ammonia 31.35 Methanol Recovery 385.00 Methanol 400.00 Methanol Loss 10.00 Raney nickel 10.00 Effluent water 407.00 Hydrogen gas 2.00 (Water-400,Methanolic ammonia-
5,Hydrogen-2) 0
Methanolic ammonia 5.00 Raney nickel recovery 10.00 Water 400.00 Process emission 29.46 (oxygen-29.46) 0 Organic residue 15.89 Process residue -10.89
Distillation residue-5 (Methanol-5)
Total 1057.35 Total 1057.35
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 11
ToR Amendment Tagoor Laboratories Private Limited
4-AMINO PIPERIDINE Process Description: Stage-1: N-carbethoxy-4-amino-Piperidine reacts with Sodium hydroxide and Hydrochloric acid in presence of water and Chloroform to give 4-Amino-Piperidine. Route of Synthesis: Stage-1
Material Balance of 4-Amino-Piperidine. Stage-1 Batch Size: 200.00 Kg
Name of the input Quantity in Kg
Name of the out put Quantity in Kg
N-Carbethoxy-4-amino piperidine 367.00 4-Amino-Piperidine 200.00 Sodium Hydroxide 85.15 Chloroform Recovery 285.00 Hydrochloric acid 77.45 Chloroform loss 15.00 Chloroform 300.00 Effluent water 622.39 Water 400.00 (Water-400, sodium chloride-
124.41,Ethanol-97.98) 0
Process emission 93.58 (Carbon dioxide-93.58) 0 Organic residue 13.63 Process residue – 13.63 Total 1229.60 Total 1229.60
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 12
ToR Amendment Tagoor Laboratories Private Limited
4-HYDROXY PIPERIDINE
Process Description: Stage-1: N-Methyl-4-Piperidone reacts with Ethylchloroformate in presence of Toluene to give Satge-1 product. Stage-2: Stage-1 product undergoes Hydrogenation with Hydrogen gas in presence of Toluene and Raney nickel to give Stage-2 product. Stage-3: Stage-2 product undergoes hydrolysis with sodium hydroxide in presence of Toluene to give 4-Hydroxy piperidine. Route of Synthesis: Stage-1:
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 14
ToR Amendment Tagoor Laboratories Private Limited
Acetic acid 3.00 Effluent Water 359.09 C.S.Lye 2.00 (Water-350, Toluene-5,
Sodium acetate-4.09) 0
Water 350.00 Process Emission 57.98 (Chloromethane-57.98) 0 Organic Residue 14.48 Process residue-9.48
Distillation residue-5 (Toluene-5)
Total 1009.55 Total 1009.55
Material balance of 4-Hydroxy Piperidine Stage-2
Batch Size:100Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-1 188.00 Stage-2 180.00 Hydrogen 2.05 Toluene Recovery 332.00 Raney Nickel 10.00 Toluene Loss 15.00 Toluene 350.00 Raney Nickel reuse 10.00 Water 300.00 Effluent Water 302.00 (Water-300,Toluene-2) 0 Organic Residue 11.05 Process residue-10.05
Distillation residue-1 (Toluene-1)
Total 850.05 Total 850.05
Material balance of 4-Hydroxy Piperidine Stage-3
Batch Size:100Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-2 180.00 4-Hydroxy Piperidine 100.00 Sodium hydroxide 83.20 Toluene Recovery 285.00 Toluene 300.00 Toluene Loss 10.00 Water 300.00 Effluent Water 459.68 (Water-300,Ethanol-
47.7,Sodium carbonate-109.98,Toluene-2)
0
Organic Residue 8.52 Process residue-5.52
Distillation residue-3 (Toluene-3)
Total 863.20 Total 863.20
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 15
ToR Amendment Tagoor Laboratories Private Limited
4-PHENYLPIPERIDINE
Process Description:
Stage-1:
4-Phenyl-piperidin-4-ol reacts with Sulphuric acid and Sodium Hydroxide in presence of Toluene to give 4-Phenyl Piperidine
Sodium Hydroxide 53.25 Toluene Recovery 285.00 Sulphuric acid 65.25 Toluene loss 10.00 Toluene 300.00 Effluent water 521.47 Water 400.00 (Water-400, sodium Sulphate-
94.52,Generated water-23.95,Toluene-3)
0
Process emission 10.62 (Oxygen-10.62) 0 Organic residue 9.41 Process residue – 7.41
Distillation residue-2 (Toluene-2)
Total 936.50 Total 936.50
4-PHENYLPIPERIDINE
Process Description: Stage-1: 4-Phenyl-piperidin-4-ol reacts with Sulphuric acid and Sodium Hydroxide in presence of Toluene to give 4-Phenyl Piperidine Route of Synthesis: Stage-1
NH
OH
4-Phenyl-piperidin-4-olC11H15NO
177.24
+ H2SO4
98.08
+ 2 NaOH
80.00
Toluene NH
4-Phenyl-piperidineC11H15N
161.24
+ Na2SO4
Sodium sulphate
142.04
+ 2 H2O
36.03
+ 0.5 O2
16.00
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 17
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 37
ToR Amendment Tagoor Laboratories Private Limited
Material Balance of Atorvastatin Calcium Stage-5
Batch Size:200Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-4 268.00 Stage-5 210.00 Sulfuric Acid 2.50 Mixed Solvent Rceovery
(Methanol + Acetone-23.58,Tert-butanol-30.28)
433.86
Methanol 400.00 Methanol Loss 8.00 Water 300.00 Effluent Water 288.03 (Water-285.53,Sulfuric acid-2.5) 0 Organic residue 30.61 Process residue -18.61
Distillation residue-12 (Methanol-12)
Total 970.5 Total 970.50
Material Balance of Atorvastatin Calcium Stage-6
Batch Size:200Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-5 210.00 Atorvastain Calcium 200.00 Calcium Acetate 18.48 Acetic acid Recovery 11.13 Isopropyl Alcohol 400.00 Isopropyl Alcohol Recovery 380.00 Activated Carbon 10.00 Isopropyl Alcohol Loss 20.00 Spent Carbon Recovery 10.00 Organic residue 17.35 Process residue-17.35 Total 638.48 Total 638.48
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 38
ToR Amendment Tagoor Laboratories Private Limited
BUPROPION Route of synthesis: Stage-1 1-(3-Chloro-phenyl)-propan-1-one undergoes Bromination with in presence of MDC and Water to give Stage-1 Product. Stage-2 Stage-1 product undergoes condensation with tertiary-Butyl amine in presence of Toluene and Ethyl acetate to give Bupropion. Route of synthesis: Stage-1
Process residue-10.53 Organic impurities-4.53 (Sodium methoxide-6) Distillation residue-5 (Toluene-5)
Total 513.50 Total 513.50
Material Balance of Carisoprodol Stage-2
Batch Size: 100.0 Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-1 72.00 Stage-2 93.00 Isopropylamine 147.00 Isopropylamine Recovery 114.00 Isopropylamine Loss 3.00 Organic Residue 9.00
Process residue -6
Distillation residue-3 (Isopropyl Amine-3)
Total 219.00 Total 219.00
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 44
ToR Amendment Tagoor Laboratories Private Limited
Material Balance of Carisoprodol Stage-3
Batch Size: 100.0 Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-2 93.00 Stage-3 105.00 Sodium cyanate 27.80 Chloroform Recovery 475.00 Chloroform 500.00 Chloroform Loss 20.00 Toluene 400.00 Toluene Recovery 385.00 Hydrochloric acid (35%) 45.00 Toluene Loss 10.00 Sulphuric acid 10.00 Effluent water 517.42 Water 450.00 (Water-450,Sodium chloride-
24.92, water from HCl-29.5,Sulfuric Acid-10,Toluene-3)
0
Organic Residue 13.38
Process residue-6.38
Distillation residue-7 (Chloroform-5,Toluene-2)
Total 1525.80 Total 1525.80
Material Balance of Carisoprodol Stage-4
Batch Size: 100.0Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage -3 105.00 Carisoprodol 100.00 Methanol 300.00 Methanol Recovery 285.00 Activated carbon 5.00 Methanol Loss 10.00 Water 400.00 Effluent water 400.00 (Water-400) 0 Spent carbon 5.00 Organic Residue 10.00
Process residue-5
Distillation residue-5 (Methanol-5)
Total 810.00 Total 810.00
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 45
ToR Amendment Tagoor Laboratories Private Limited
CLOPIDOGREL BISULPHATE
Process Description:
Stage-1:
2-Amino-2-(2-chlorophenyl) acetic acid reacts with sulphuric acid and Methanol in presence of Ammonia and Toluene to give Stage-1 Product.
Stage-2:
Stage-1 Product undergoes resolution with L-(+) tartaric acid in presence of Methanol and Acetone to give Stage-2 Product.
Stage-3:
2-(thiophen-2-yl)ethanol reacts with Para Toluene Sulphonyl chloride in presence of Sodium hydrate and Toluene to give Stage-3 Product. Stage-4: Stage-3 Product reacts with Stage-2 product in presence of MDC, Ethyl acetate and Ammonia to give Stage-4 Product. Stage-5: Stage-4 Product reacts with Formaldehyde, sulphuric acid in presence of Acetone and Sodium bicarbonate to give Stage-5 Product. Stage-6: Stage-5 Product undergoes recrystalisation in presence of Acetone, Acetonitrile and Methanol to give Clopidogrel Bisulphate.
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 46
O-Xylene 500.00 Process emission 84.00 Phosphorous penta oxide 50.00 (Carbon dioxide-84) 0 Water 600.00 Organic residue 93.18 Process residue -76.18
Distillation residue-17 (Methanol-10,Toluene-7)
Total 2912 Total 2912.00
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 67
ToR Amendment Tagoor Laboratories Private Limited
Material Balance of Cyproheptadine Hydrochloride Stage-2
BatchSize:500Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg N –Methyl-4-Piperidone 205.00 Stage-2 200.00 Hydrogen 4.00 Methanol Recovery 570.00 Methanol 600.00 Methanol Loss 12.00 Water 800.00 Effluent Water 800.00 (Water-800) 0 Organic residue 27.00 Process residue-9
Distillation residue-18 (Methanol-18)
Total 1609.00 Total 1609.00
Material Balance of Cyproheptadine Hydrochloride Stage-3
BatchSize:500Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-2 200.00 Stage-3 216.00 Thionyl chloride 207.00 Toluene Recovery 570.00 Sodium Hydroxide 70.00 Toluene Loss 12.00 Sodium bicarbonate 20.00 Chloroform Recovery 475.00 Toluene 600.00 Chloroform Loss 25.00 Chloroform 500.00 Effluent Water 963.26 Water 800.00 (Water-800,Sodium chloride-
Water 1500.00 Process Emission 27.41 (Ammonia-27.41) Organic Residue 37.33 Process residue-33.33
Distillation residue-4 ( Toluene-2,THF-2)
Total 3551.00 Total 3551.00
Material Balance of Cyproheptadine Hydrochloride Stage-5
BatchSize:500Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-4 462.00 Cyproheptadine Hydrochloride 500.00 IPAHCl(30%) 786.00 IPA Recovery 570.00 Water 800.00 IPA Loss 12.00 Effluent Water 916.26 (Water-759,generated water-
27.26,water from HCl-130) 0
Organic residue 49.74 Process residue-31.74
Distillation residue- (IPA-18)
Total 2048.00 Total 2048.00
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 69
ToR Amendment Tagoor Laboratories Private Limited
DESLORATADINE
Process Description:
Stage-1
3-[2-(3-chlorophenyl)-ethyl] pyridine-2-carbonitrile reacts with Potassium hydroxide, Hydrochloric acid in presence of n-Butanol to give Stage-1 product.
Stage-2
Staeg-1 product undergoes cyclisation with Phosphorous penta chloride to give Stage-2 product.
Stage-3
Stage-2 product reacts with 4-Chloro-1-methyl piperdine, Magnesium, Hydrochloric acid in the presence of THF to give Stage-3 product.
Stage-4
Stage-3 Product undergoes dehydaration with Sulfuric acid and Sodium Hydroxide in presence of Ethyl acetate and n-Hexane to give Stage-4 product.
Stage-5
Stage-4 product reacts with ethyl chloro formate in the presence of Toluene and Cyclo hexane to give Stage-5 product.
Stage-6
Stage-5 product reacts with Sodium hydroxide, Hydrochloric acid in the presence of Methanol to give Desloratadine .
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 70
Stage -7Stage-10Methyl iso butyl ketoneAmmonium hydroxide (30%)Sodium hydroxide Ammonium chloride Water
Effluent water
Domperidone
Material Balance:
Material Balance of Domperidone Stage-1
Batch Size: 840Kg Name of the input Quantity
in Kg Name of the output Quantity
in Kg Methyl acrylate 411.00 Stage -1 483.00 Mono methyl amine 76.00 Methanol loss 100.00 Methanol 100.00 Organic residue 4.00 Total 587 Total 587
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 91
ToR Amendment Tagoor Laboratories Private Limited
Material Balance of Domperidone Stage-2
Batch Size: 840Kg Name of the input Quantity
in Kg Name of the output Quantity
in Kg Stage -1 483.00 Stage -2 211.00 Sodium methoxide 169.00 Chloroform recovery 6745.00 Chloroform 7100.00 Chloroform loss 355.00 Water 4830.00 Effluent water
(Water-4787) 4787.00
By products (Sodium acetate -195, Methanol-250.98)
445.98
Process emission (Oxygen)
38.02
Total 12582 Total 12582
Material Balance of Domperidone Stage-3
Batch Size: 840Kg Name of the input Quantity
in Kg Name of the output Quantity
in Kg Stage -2 211.00 Stage -3 275.00 Ethylchloroformate 259.25 Toluene recovery 1074.00 Toluene 1130.00 Toluene loss 56.00 Process emission
(Chloromethane) 94.14
Organic residue 101.11 Total 1600.25 Total 1600.25
Material Balance of Domperidone Stage-4
Batch Size: 840Kg Name of the input Quantity
in Kg Name of the output Quantity
in Kg Stage -3 275.00 Stage -4 258.00 Methanol 250.00 Spent raney nickel
recovery 5.00
Ammonia 56.20 By product (Ammonia sulphate)
95.00
Sulphuric acid 70.20 Generated water 29.00 Raney Nickel 5.00 Methanol recovery 238.00 Hydrogen 4.00 Methanol loss 12.00 Organic residue 23.40 Total 660.4 Total 660.4
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 92
ToR Amendment Tagoor Laboratories Private Limited
Material Balance of Domperidone Stage-5
Batch Size: 840Kg Name of the input Quantity
in Kg Name of the output Quantity
in Kg Stage -4 258.00 Stage -5 544.00 1,4-Dichloro-2-nitro-benzene (DCNB)
310.00 Effluent water (Water-2300 Soda ash -103.5)
2403.50
Soda ash 103.50 Process emission (Hydrogen Chloride)
24.00
Water 2300.00 Total 2971.5 Total 2971.5
Material Balance of Domperidone Stage-6
Batch Size: 840Kg Name of the input Quantity
in Kg Name of the output Quantity
in Kg Stage -5 544.00 Stage-6 389.00 Methanol 820.00 Methanol recovery 779.00 Raney nickel 5.00 Methanol loss 17.00 Hydrogen 4.00 Toluene recovery 494.00 Toluene 520.00 Toluene loss 10.00 Water 300.00 Effluent water
(Water-300, Toluene-16) 316.00
Raney nickel recovery 5.00 Process emission
(Oxygen) 53.11
Organic residue Process residue-105.89 Distillation Residue-24 (Methanol-24)
129.89
Total 2193 Total 2193
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 93
ToR Amendment Tagoor Laboratories Private Limited
Material Balance of Domperidone Stage-7
Batch Size: 840Kg Name of the input Quantity
in Kg Name of the output Quantity
in Kg Stage-6 389.00 Stage-7 550.00 Urea 138.00 Effluent water
Hydrogen gas 1.12 (Water-300,Generated water-10.41,Sulfuric acid-28.39)
0
Water 300.00 Spent Raney Nickel Recovered 5.00 Organic residue 21.12
Process residue-3.12 Distillation residue-18 (Methanol-18)
Total 1000.12 Total 1000.12
Material Balance of Itopride Hydrochloride Stage-3 Batch Size: 100.0Kg
Name of the input Quantity in Kg
Name of the out put Quantity in Kg
Stage-2 54.00 Stage-3 105.00 3,4-Dimethoxy benzoyl chloride 55.50 Toluene Recovery 380.00 Toluene 400.00 Toluene Loss 12.00 Water 200.00 Effluent water 204.00 (Water-200,Toluene-4) 0 Organic Residue 8.50
Process residue-4.50 Distillation residue-4 (Toluene-4)
Total 709.50 Total 709.50
Material Balance of Itopride Hydrochloride Stage-4 Batch Size: 100.0Kg
Name of the input Quantity in Kg Name of the out put Quantity in Kg Stage-3 105.00 Itopride Hydrochloride 100.00 Methanol 500.00 Methanol Recovery 475.00 Isopropyl alcohol 500.00 Methanol Loss 10.00
Activated carbon 3.50 Isopropyl alcohol Recovery
475.00
Water 200.00 Isopropyl alcohol Loss 10.00 Effluent water 200.00 (Water-200) 0 Spent carbon 3.50 Organic residue 35.00
Process residue-5 Distillation residue-30 (Methanol-15, Isopropyl alcohol-15)
Total 1308.5 Total 1308.50
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 123
ToR Amendment Tagoor Laboratories Private Limited
ITRACONAZOLE
Process Description: Stage-1 1-(4-Methoxy-Phenyl)-piperazine reacts with 1-Bromo-4-nitro-benzene in presence of MDC and Methanol to give Stage-1 Product. Stage-2: Stage-1 Product reacts with Hydrogen in presence of Pd/c catalyst and DMF to give Stage-2 Product. Stage-3: Stage-2 product reacts with Phenyl Chloro formate in presence of Sodium bicarbonate and MDC to give Stage-3 product. Stage-4: Stage-3 product reacts with Hydrazine hydrate in presence of 1,4-Dioxane to give Stage-4 product. Stage-5: Stage-4 Product reacts with Formamidine in presence of Acetic acid and acetone to give Stage-5 product. Stage-6: Stage-5 product reacts with 2-Bromo-Butane in presence of Potassium carbonate and Methanol to give Stage-6 product. Stage-7: Stage-6 product reacts with Hydrobromic acid in presence of Sodium carbonate nd Methanol to give stage-7 Product. Stage-8: Step-A: 2,4Dichloroacetopheneone reacts with Glycerol and Bromine in presence of Toluene, PTSA and n-Butanol to give Step-A product. Step-B: Step-A product reacts with Benzyl Chloride in presence of Toluene and Methanol to give Stage-8 Product. Stage-9: Stage-8 Product reacts with 1,2,4-Triazole in presence of Potassium Carbonate , Sodium Hydroxide ,DMF and water to giveStage-9 Product. Stage-10: Stage-9 Product reacts with Methanol Sulfanyl Chloride in presence of TEA, MDC and water to give Stage-10 product. Stage-11: Stage-10 Product undergoes condensation with Stage-7 Product in presence of potassium hydroxide and Methanol to give Itraconazole.
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 124
Water 500.00 Process Emission 18.24 (Carbon dioxide-18.24) 0 Organic residue 19.10 Process residue-16.1
Distillation Residue-3 (DMF-3)
Total 1120.00 Total 1120.00
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 136
ToR Amendment Tagoor Laboratories Private Limited
KETOROLAC TROMETHAMINE Process Description Stage-1 5-chloro-2-benzoylpyrrole reacts with Methyl-gama-methoxy –butanoate in presence of Acetone to give Stage-1 product. Stage-2 Stage-1 Product undergoes condensation with Tromethamine in presence of Acetone to give Ketorolac Tromethamine. Route of synthesis Stage-1
HN Cl
O
5-Chloro-2-benzoyl pyrroleC11H8ClNO
205.64
+methyl-gama-methoxybutanoate
OCH3O
H3C
O
C6H12O3
132.16
+ NaOH
40.00
N
O
COOH
KetorolacC15H13NO3
255.27
+ NaCl
58.44
+ 2 CH3OH
64.08
Acetone
Stage-2
NO
COOH
KetorolacC15H13NO3
255.27
Tromethamine
NH2
HO OH
OH+
C4H11NO3
121.14
Acetone
NO
COOH
NH2
HO OH
OH
.
ketorolac tromethamineC19H24N2O6
376.40
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 137
Material Balance of Ketorolac Tromethamine Stage-1
Batch Size: 100Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg 5-chloro-2-benzoylpyrrole 59.00 Stage-1 70.00 Methyl-gama-methoxy butanonate
37.85 Acetone Recovery 475.00
Sodium hydroxide 11.45 Acetone Loss 15.00 Acetone 500.00 Methanol Recovery 16.75 Water 500.00 Effluent water 516.75 (water-500,Sodium chloride-
16.75) 0
Organic Residue 14.80 Process residue-4.8,
Distillation residue -10 ( Acetone-10)
Total 1108.30 Total 1108.30
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 138
ToR Amendment Tagoor Laboratories Private Limited
Material Balance of Ketorolac Tromethamine Stage-2
Batch Size: 100Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-1 70.00 Ketorolac Tromethamine 100.00 Acetone 300.00 Acetone Recovery 285.00 Tromethamine 34.00 Acetone Loss 7.00 Carbon & hyflow 10.00 Effluent water 400.00 Water 400.00 (water-400) 0 Spent carbon & hyflow 10.00 Organic residue 12.00 Process residue-4
Distillation residue – 8 (Acetone-8)
Total 814.00 Total 814.00
LANSOPRAZOLE
Process Description Stage-1 2, 3-Lutidine reacts with Hydrogen Peroxide and Nitric Acid in Presence of Acetic
acid to give stage-1 product.
Stage-2 Stage-1 Product reacts with 1, 1, 2- trifluoroethanol and Acetic Anhydride in
presence of Potassium Carbonate to give stage-2 product.
Stage-3 Stage-2 product undergoes chlorination with Thionyl Chloride in presence of Toluene to give stage-3 product. Stage-4 Stage-3 product undergoes condensation with 1H-Benzoimidazole-2-thiol in
presence of Sodium Hydroxide to give stage-4 product.
Stage-5 Stage-4 product undergoes oxidation with Hydrogen peroxide in presence of IPA to
give Lansoprazole.
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 139
Stage-1: Diphenyl acetonitrile reacts with 1, 2-Dichloroethane in presence of TBAB, Toluene and Methanol to give Stage-1 Product.
Stage-2: Stage-1 product reacts with Sulphuric acid and water in presence of Acetic acid and IPA to give Staeg-2 product.
Stage-3: Stage-2 Product reacts with Hydrobromic acid in presence of Acetic acid to give Stage-3 Product.
Stage-4:
Stage-3 product reacts with Thionyl chloride in presence of Toluene to give Stage-4 product.
Stage-5:
Stage-4 Product reacts with Dimethyl amine in presence of Toluene, water to give Stage-5 product.
Stage-6:
Step-A:
4-Chloro Phenyl magnesium bromide reacts with 4-oxo-piperidine-1-carboxylic acid ethyl ester in presence of Toluene and Hydrobromic acid to give Step-A Product.
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 146
ToR Amendment Tagoor Laboratories Private Limited
Step-B:
Step-A Product reacts with Sodium hydroxide in presence of Methanol, Toluene to give Stage-6 Product.
Stage-7:
Stage-5 reacts with stage-6 in presence of Potassium Carbonate, Potassium Iodide and acetone to give stage-7 Product.
Stage-8:
Stage-7 Product undergoes Salt formation with Hydrochloric acid in presence of Acetone to give Loperamide Hydrochloride.
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 160
ToR Amendment Tagoor Laboratories Private Limited
Toluene-2) Water 600.00 Process Emission 8.92 (Nitrogen-8.92) 0 Organic Residue 16.37 Process residue-6.37
Distillation Residue-10 (Toluene-10)
Total 1128.50 Total 1128.50
Material Balance Of Losartan Potassium Stage-2
Batch Size:100kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-1 70.00 Stage-2 130.00 Trityl chloride 82.50 MDC Recovery 475.00 TEA 30.00 MDC Loss 10.00 MDC 500.00 Methanol Recovery 475.00 Methanol 500.00 Methanol Loss 10.00 Water 500.00 Effluent Water 530.00 (Water-500,TEA-30) 0 Process emission 10.78 (Hydrogen chloride-10.78) 0 Organic Residue 41.72 Process residue-11.72
Distillation Residue-30 (Methanol-15,MDC-15)
Total 1682.50 Total 1682.50
Material Balance Of Losartan Potassium Stage-3
Batch Size:100kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-2 130.00 Stage-3 140.00 N-Bromosuccinimide (NBS) 48.25 Methylenedichloride
Recovery 380.00
Sodium meta bisulphate 10.00 Methylenedichloride Loss 8.00 Methylenedichloride 400.00 Ethyl Acetate Recovery 190.00 Ethyl Acetate 200.00 Ethyl Acetate Loss 4.00 Water 600.00 Effluent Water 613.00 (Water-600,
Sodium meta bisulphate-10, Ethyl acetate-3,)
0
Organic Residue 53.25
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 161
ToR Amendment Tagoor Laboratories Private Limited
Process residue-38.25 (Organic impurities-11.34 succinimide-26.91) Distillation Residue-15 (Ethyl acetate-3,MDC-12)
Total 1388.25 Total 1388.25
Material Balance Of Losartan Potassium Stage-4
Batch Size:100kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-3 140.00 Stage-4 99.00 Butyl chloro formyl imidazole (BCFI)
47.35 Methanol Recovery 760.00
TBAB 5.00 Methanol Loss 20.00 Methanol 800.00 Effluent Water 730.76 Sodium hydroxide 9.95 (Water-700,
Sodium bromide-25.76, TBAB-5)
0
Water 700.00 By-Product 65.24 (trityl alcohol-65.24) 0 Organic Residue 7.30 Process residue- 7.30
Distillation Residue-20 (Methanol-20)
Total 1702.3 Total 1695
Material Balance Of Losartan Potassium Stage-5:
Batch Size:100kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-4 99.00 Losartan Potassium 100.00 Potassium hydroxide 13.05 Methanol Recovery 380.00 Methanol 400.00 Methanol Loss 10.00 Activated Carbon 15.00 Effluent Water 406.15 Water 400.00 (Water-400,
Generated water-4.15) 0
Spent Carbon 15.00 Organic Residue 15.90 Process residue-5.90
Distillation residue-10 (Methanol-10)
Total 927.05 Total 927.05
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 162
ToR Amendment Tagoor Laboratories Private Limited
NEBIVOLOL HYDROCHLORIDE Process Description: Stage-1:
(R)-2-(benzyl amino)-1-(6-fluro-3, 4-dihydro-2H-chromen-2-yl) ethanol react with 6-Fluro-3, 4-dihydro-2-(oxiran-2- yl)-2H chromene in presence of diisopropylethylamine, Methanol,HCl to form NBL/Stage-1. Stage-2: NBL/Stage-I reacts with Pd/C in presence of methanol and treated with IPA HCL to form Nebivolol hydrochloride Pharma (Stage-2). Route of synthesis Stage-1
Pd/carbon 2.00 Methanol Loss 20.00 Hydrogen 0.80 Pd/carbon 2.00 IPA HCl 80.00 IPA Recovery 50.00 IPA Loss 30.00 Organic residue 42.44 Process residue -22.44
Distillation residue-20 (Methanol-20)
Total 1150.80 Total 1150.80
NORTRIPTYLINE HYDROCHLORIDE
Process Description:
Stage-1:
[3-(10,11-Dihydro-dibenzo[a,d]cyclohepten-5-ylidene)-propyl]-dimethyl-amine Hydrochloride reacts with ethyl chloro formate in presence of Sodium Hydroxide and toluene to give Stage-1 product.
Stage-2:
Stage-1 Product undergoes Hydrolysis with Potassium Hydroxide in presence of Isopropyl alcohol an Hydrochloric acid to give Stage-2 product.
Stage-3:
Stage-2 product undergoes Salt formation in presence of IPA.HCl and Acetone to give Nortriptyline Hydrochloride.
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 165
di-tert butyl dicarbonate 114.66 Toluene Recovery 385.00 Toluene 400.00 Toluene Loss 10.00 Water 400.00 Effluent water 493.53 (Water-381.10, Ethanol-
24.20,Toluene-3, Tert butyl pyrocarbonate-85.23)
0
Process emission 8.37 (Oxygen-8.37) 0 Organic residue 7.76 Process residue – 5.76
Distillation residue-2 (Toluene-2)
Total 1004.66 Total 1004.66
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 170
ToR Amendment Tagoor Laboratories Private Limited
OMEPRAZOLE MAGNESIUM DIHYDRATE Process Description: Stage-1: Omeprazole reacts with Ammonium hydroxide and Magnesium sulfates to give Omeprazole Magnesium dihydrate. Route of Synthesis: Stage-1:
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 171
ToR Amendment Tagoor Laboratories Private Limited
Material Balance: Material Balance Of Omeprazole Magnesium Dihydrate
Stage-1 Batch Size: 100.0Kgs Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Omeprazole 103.00 Omeprazole Magnesium
Dihydrate 100.00
Ammonium hydroxide (20%) 25.75 Effluent water 540.27 Magnesium sulfate 17.90 (Water-500,Water from
ammonium hydroxide-20.60, Ammonium sulfate-19.67)
Activated carbon 5.00 Spent carbon 5.00 Water 500.00 Organic Residue 6.38 (Process residue-6.38) Total 651.65 Total 651.65
OMEPRAZOLE SODIUM
Process Description
5-Methoxy-2-(4-methoxy-3,5-dimethyl-pyridin-2-ylmethanesulfinyl)-1H-benzoimidazole (Omeprazole) Product reacts with sodium hydroxide in the presence of Methanol to give Omeprazole sodium.
Sodium hydroxide 54.00 Methanol Recovery 380.00 Methanol 400.00 Methanol Loss 10.00 Organic Residue 26.00 Process residue-16
Distillation residue-10 (Methanol-10)
Total 916.00 Total 916.00
OMEPRAZOLE
Process description:
Stage-1
3,5-Dimethyl-pyridine undergoes Oxidation with Hydrogen peroxide in presence of Acetic acid to give Stage-1 product
Stage-2
Stage-1 product undergoes Nitration with Nitric acid in presence of Sulphuric acid & Methanol to give Stage-2 product
Stage-3
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 173
ToR Amendment Tagoor Laboratories Private Limited
Stage-2 product reacts with Dimethylsulphate in presence of Chloroform & Methanol to give Stage-3 product
Stage-4
Stage-3 product reacts with Ammonium persulphate and Ammonium sulphate in presence of Toluene & Methanol to give Stage-4 product
Stage-5
Stage-4 product undergoes Chlorination with Thionyl chloride in presence of Toluene , IPA & Acetone to give Stage-5 product
Stage-6
Stage-5 product undergoes Condensation with 2-Mercapto-5-methoxy benzimidazole in presence of Toluene, Sodium hydroxide & Water to give Stage-6 product
Stage-7
Stage-6 product undergoes Oxidation with Hydrogen peroxide in presence of Acetic acid & Dichloromethane to give Omeprazole product
Route of Synthesis:
Stage-1
N
3,5-Dimethyl-pyridineC7H9N
107.15
+ H2O2
34.01
Acetic acidN+
+O-
3,5-Dimethyl-pyridine 1-oxideC7H9NO
123.15
H2O18.02
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 174
ToR Amendment Tagoor Laboratories Private Limited
Stage-2
MethanolN+
+O-
3,5-Dimethyl-pyridine 1-oxideC7H9NO
123.15
H2O18.02
+ 2 NH3
34.06
H2SO4
98.08
+ HNO3
63.01
N+
O-
NO2
3,5-Dimethyl-4-nitro-pyridine 1-oxide
C7H8N2O3
168.15
+
Ammonium sulphate
NH4+
NH4+
S
O
O-O O-
(NH4)2SO4
132.14
+
Stage-3
Methanol, Chloroform
N+
O-
NO2
3,5-Dimethyl-4-nitro-pyridine 1-oxide
C7H8N2O3
168.15
Dimethylsulphate
SO
O
OO
+
C2H6O4S
126.13
+ 2 NaOH
80.00
+ CH3COOH
60.05
CH3OH+
32.04
N+
O
OMe
CH3SO4-
C10H17NO6S
279.31
+ CH3COONa
82.03
+ NaNO2
69.00
+ 2 H2O
36.03Methyl sulphate salt formation of 1,4-Dimethoxy-3,5-dimethyl-pyridinium
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 175
in Kg Stage-5 715.00 Stage-6 1000.00 2-Mercapto-5-methoxy benzimidazole
615.00 Toluene Recovery 3800.00
Caustic lye 630.00 Toluene Loss 80.00 Toluene 4000.00 Effluent Water 1431.00 Water 5000.00 (Water-500,
Generated water-116 Sodium chloride-377, Toluene-60, Water form Caustic lye-378)
0
Water recovery 4589.00 Organic Residue 60.00 Distillation Residue-60
(Toluene )
Total 10960 Total 10960
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 181
ToR Amendment Tagoor Laboratories Private Limited
Material Balance of Omeprazole Stage-7
Batch Size: 920Kg Name of the input Quantity
in Kg Name of the output Quantity
in Kg Stage-6 1000.00 Omeprazole 920.00 Hydrogen peroxide 230.00 Dichloromethane
Recovery 2375.00
Sodium Hydroxide flakes 150.00 Dichloromethane Loss 50.00 Ammonia 4.00 Effluent Water 831.00 Acetic acid 250.00 (Water-200,
Generated water-55 Sodium hydroxide flakes-150,Ammonia-4, Acetic acid -250, Hydrose-10, Triethylamine-30, EDTA-5, Water from hydrogen peroxide-127)
0
Dichloromethane 2500.00 Water recovery 5900.00 Hydrose 10.00 Spent carbon 5.00 Activated carbon 5.00 Organic Residue 103.00 EDTA 5.00 Process residue-28
Distillation Residue-75 (Dichloromethane )
Triethylamine 30.00 Water 6000.00 Total 10184 Total 10184
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 182
ToR Amendment Tagoor Laboratories Private Limited
OXATOMIDE
Description: Stage-1: 1- (diphenyl methyl) piperazine reacts with 1-(3-chloropropyl)1,3-dihydro-2H-benzimidazol-2-one, in presence of Methyl Iso butyl ketone ,Soda ash, Water, sodium hydroxide, Con HCl, to give Staeg-1 product. Stage-2:
Stage-1 Product undergoes purification with Methanol and Carbon to give Oxatomide.
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 205
ToR Amendment Tagoor Laboratories Private Limited
Stage –3
-OOC
HO
C16H25NO5
311.37
S(+)Pregabalin mandalate salt
H3C
H3C
NH3+
COOH
COOH
OH
Mandelic acid
C8H8O3
152.14
C8H17NO2
159.23
S(+)Pregabalin
THF
H3C
H3C
NH2
COOH
+NaOH
Flow Chart:
2-(1-Cyano-3-methyl-butyl)-malonic acid diethyl esterEthanolPotassium hydroxideAcetic acidRaney nickelIPAHydrogen gas
Ethanol Recovery IPA Recovery
stage-1
IPA Recoverystage-2
THF Recovery IPA Recovery
stage-3
Stage-1(S)-Mandelic acidIsopropyl alcohol
Stage -2TetrahydrofuranIsopropyl alcohol
Pregabalin
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 206
ToR Amendment Tagoor Laboratories Private Limited
PREGABALIN Material Balance:
Material Balance Of Pregabalin Stage-1
Batch Size: 200.0Kgs Name of the input Quantity
in Kg Name of the out put Quantity
in Kg 2-(1-Cyano-3-methyl-butyl)-malonic acid diethyl ester
753.00 Stage-1 445.00
Ethanol 200.00 Ethanol Recovery 461.08 Potassium hydroxide 165.00 Ethanol loss 10.00 Acetic acid 176.95 IPA Recovery 333.00 Raney nickel 5.00 IPA Loss 12.00 IPA 350.00 Raney Nickel Reuse 5.00 Hydrogen gas 11.30 Effluent water 836.44 Water 600.00 (Water-547.29,Poatassium
acetate-289.15)
Process emission 129.52 (Carbon dioxide-129.52) 0 Organic residue 29.21 Process residue-24.21
Distillation residue-5 (IPA-5)
Total 2261.25 Total 2261.25
Material Balance Of Pregabalin Stage-2
Batch Size: 200.0Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-1 445.00 Stage -2 413.00 (S)-Mandelic acid 213.00 IPA Recovery 475.00 Isopropyl alcohol 500.00 IPA Loss 10.00 Water 300.00 Effluent water 300.00 (Water-300) Organic residue 260.00 Process residue-
11-Piperazin-1-yl-4a,11a-dihydro-dibenzo[b,f] [1,4]thiazepine Di hydrochloride reacts with 2-Chloroethoxy ethanol in presence of Sodium carbonate, Toluene and water to give Stage-1 product.
Stage-2:
Stage-1 product reacts with Fumaric acid in presence of Acetone to give Quetiapine Fumarate.
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 208
ToR Amendment Tagoor Laboratories Private Limited
Route of Synthesis:
Stage-1
S
NN
NH . 2 HCl
11-Piperazin-1-yl-4a,11a-dihydro-dibenzo[b,f][1,4]thiazepine Di hydrochloride
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 218
ToR Amendment Tagoor Laboratories Private Limited
Material balance of Rabeprazole Sodium Stage-5
Batch Size: 500Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-4 420.00 Stage-5 510.00 2-Mercaptobenzimidazole 240.00 Toluene Recovery 380.00 Sodium hydroxide 127.00 Toluene Loss 10.00 Toluene 400.00 Methanol Recovery 380.00 Methanol 400.00 Methanol Loss 10.00 Water 400.00 Effluent Water 646.31 (Water-400,Sodium
chloride-184.45,Generated water-56.86,Toluene-5)
0
Organic Residue 50.69 Process residue-35.69,
Distillation residue-15 (Toluene-5, Methanol-10)
Total 1987.00 Total 1987.00
Material balance of Rabeprazole Sodium Stage-6
Batch Size: 500Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-5 510.00 Stage-6 500.00 Sodium Hypochlorite (8%) 1388.00 MDC Recovery 570.00 MDC 600.00 MDC Loss 30.00 Toluene 150.00 Toluene Recovery 143.00 Sodium hydro sulphate 12.00 Toluene Loss 5.00 MMA in Methanol 10.00 Effluent Water 1775.87 Water 400.00 (Water-400,Sodium
Chloride-86.87,water from sodium hypochlorite-1277, ,MMA-10, Toluene-2)
Organic Solid Waste 46.13 Process residue-43.13
Distillation residue-3 (Toluene-3)
Total 3070.00 Total 3070.00
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 219
ToR Amendment Tagoor Laboratories Private Limited
Material balance of Rabeprazole Sodium Stage-7
Batch Size: 500Kg Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-6 500.00 Rabeprazole Sodium 500.00 Sodium Hydroxide 56.00 Acetone Recovery 280.00 Acetone 300.00 Acetone Loss 15.00 Activated Carbon 10.00 Generated water 25.00 Spent carbon 10.00 Organic Residue 36.00 (Process residue-31,
Distillation residue-5 (Acetone-5)
Total 866.00 Total 866.00
RUPATADINE FUMERATE
Process Description:
Stage-1:
8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo(5,6)cyclohepta(1,2-b)pyridine react with 3-chloromethyl-5-methylpyridine in presence of sodium hydroxide, water, TBAB, Ethyl acetate to give stage-1 product.
Stage-2 :
Stage-1 product reacts with But-2-enedioic acid in presence of Methanol, Acetone to give Rupatadine Fumerate
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 228
ToR Amendment Tagoor Laboratories Private Limited
Material, balance of Telmisartan Stage-3
Batch Size:100kg Name of the input Quantity
in Kg Name of the output Quantity
in Kg Stage-2 67.00 Stage-3 110.00 1,7'-Dimethyl-2'-propyl-3' a,4',5',6',7',7'a-hexahydro-1H, 3'H-[2,5']bibenzoimidazolyl
68.15 Acetone recovery 475.00
Potassium Hydroxide 12.25 Acetone loss 15.00 Acetone 500.00 Effluent water 430.00 Water 400.00 (Water-400,
Generated water-3.95, Potassium bromide-26.05)
0
Organic Residue 17.40 Process Residue-7.40
Distillation Residue-10 (Acetone-10)
Total 1047.40 Total 1047.40
Material, balance of Telmisartan Stage-4
Batch Size:100kg Name of the input Quantity
in Kg Name of the output Quantity
in Kg Stage-3 110.00 Telmisartan 100.00 Potassium Hydroxide 11.45 Methanol Recovery+
Generated Methanol 386.49
Acetic acid 12.32 Methanol Loss 12.00 DMF 100.00 MDC Recovery 380.00 Methanol 400.00 MDC Loss 8.00 MDC 400.00 DMF Recovery 95.00 Activated Carbon 5.00 DMF Loss 2.00 Water 600.00 Effluent water 620.13 (Water-600, Potassium
Acetate-20.13)
Spent Carbon 5.00 Organic Residue 30.15 Process Residue-7.15
Distillation Residue-23 (MDC-12,Methanol-8,DMF-3)
Total 1638.77 Total 1638.77
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 229
ToR Amendment Tagoor Laboratories Private Limited
TERBINAFINE HYDROCHLORIDE
Process Description: Stage-1 Napthyl methyl chloride reacts with Methyl amine in the presence of to give stage-1 product. Stage-2 Pinacolone undergoes Alkylation in the presence of Potassium carbonate, Acetone and Hydrochloric acid to give stage-2 product. Stage-3 Stage-2 Product reacts with acrolein in the presence of DIPE to give stage-3 product. Stage-4 Step-A: Stage-3 Product reacts with Isopropyl alcohol in presence of Aluminium Isopropoxide to give Step-A Product. Step-B: Step-A product reacts with Hydrochloric acid in presence of Toluene and Methanol to give stage-4 Product. Stage-5 Stage-4 Product reacts with Stage-1 in presence of Potassium Carbonate, Methanol, Toluene and Ethyl acetate to give Terbinafine Hydochloride
TERBINAFINE HYDROCHLORIDE
Route of synthesis:
Stage-1:
Methyl amine
H2N CH3
31.06
HCl
Napthyl methyl chloride
Cl
+
C11H9Cl
176.64 C12H14ClN207.70
Methanol .
N-Methyl-1-napthalene methylamine HCl
NH3C CH3
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 230
ToR Amendment Tagoor Laboratories Private Limited
Stage-2:
Pinacolone
CH3
OH3C
H3CH3C
C6H12O
100.15
H3C
H3C
H3C
CH
C6H10
82.14
3,3-Dimethyl-but-1-yne
+ K2CO3 +
138.20
Acetone+ 2 HCl
72.92
2 KCl
149.10
+ + CO22 H2O
36.04 44.01Stage-3:
H3C
H3CH3C
CH
C6H10
82.14
3,3-Dimethyl-but-1-yne
+
Acrolein
OH2C
C3H4O
56.06
H3CH3C
H3C
CHO
6,6-Dimethyl-hept-2-en-4-ynal
+
C9H12O136.19
DIPE
H2
2.00
Stage-4:
Step-A
H3CH3C
H3C
CHO
6,6-Dimethyl-hept-2-en-4-ynal
C9H12O
136.19
+
Isopropyl alcohol
CH3H3C
OH
C3H8O
60.09
H3CH3C
H3COH
6,6-Dimethyl-hept-2-en-4-yn-1-ol
C9H14O138.20
Aluminium isopropoxide
+
Acetone
H3C
O
CH3
C3H6O
58.07
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 231
ToR Amendment Tagoor Laboratories Private Limited
Step-B
H3CH3C
H3COH
6,6-Dimethyl-hept-2-en-4-yn-1-ol
C9H14O
138.20
+
36.5
HCl
H3C
H3C
H3C
Cl
1-Chloro-6,6-dimethyl-hept-2-en-4-yne
C9H13Cl
156.65
H2O+
18.0
Stage-5:
Toluene
1-Chloro-6,6-Dimethyl Hept-2-ene-4-yne
H3C
H3C CH3
Cl
C9H13Cl156.65
+
N
CH3H3CCH3
CH3
Terbinafine HydrochlorideC21H26ClN
327.89
+ KCl
+ 1/2K2CO3
69.10
74.55
+ 1/2CO2
22.0
+ 1/2H2O
9.0
. HCl
HCl
C12H14ClN
207.70
.
N-Methyl-1-napthalene methylamine HCl
NH3C CH3
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 232
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 233
ToR Amendment Tagoor Laboratories Private Limited
Material Balance:
Material Balance of Terbinafine Hydrochloride Stage-1
Batch Size: 250.0Kgs Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Napthyl methyl chloride 150.00 Stage-1 166.00 Mono methyl amine 27.00 Toluene Recovery 285.00 Toluene 300.00 Toluene Loss 10.00 MDC 500.00 MDC Recovery 475.00 Water 450.00 MDC Loss 15.00 Effluent water 453.00 (Water-450, Toluene-3) 0 Organic Residue 23.00 Process residue-11
Distillation residue-12 (Toluene-2, MDC-10)
Total 1427.00 Total 1427.00
Material Balance of Terbinafine Hydrochloride Stage-2
Batch Size: 250.0Kgs Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Pinacolone 100.00 Stage-3 77.00 Potassium carboante 138.00 Acetone Recovery 190.00 Hydrochloric acid 73.00 Acetone Loss 5.00 Acetone 200.00 Effluent water 584.85 Water 400.00 (Water-400,Generated water-35.98,
Potassium chloride-148.87)
Process emission 43.94 (Carbondioxide-43.94) Organic Residue 10.21 Process residue-5.21
Distillation residue-5 (Acetone-5)
Total 911.00 Total 911.00
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 234
ToR Amendment Tagoor Laboratories Private Limited
Material Balance of Terbinafine Hydrochloride Stage-3
Batch Size: 250.0Kgs Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-2 77.00 Stage-2 122.00 Acrolein 52.55 DIPE Recovery 475.00 DIPE 500.00 DIPE Loss 25.00 Water 400.00 Effluent water 400.00 (Water-400) Process emission 1.88 (Hydrogen -1.88) Organic Residue 5.67 Process residue-5.67 Total 1029.55 Total 1029.55
Material Balance of Terbinafine Hydrochloride Stage-4
Batch Size: 250.00Kgs Name of the input Quantity
in Kg Name of the out put Quantity
in Kg Stage-3 122.00 Stge-4 126.00 Isopropyl alcohol 250.00 Isopropyl alcohol Recovery 190.00 Hydrochloric acid 31.00 Isopropyl alcohol Loss 5.00 Toluene 400.00 (Mixed Solvent)
Toluene recovery + Generated Acetone
432.00
Methanol 400.00 Toluene Loss 12.00 Aluminium Isopropoxide 20.00 Methanol Recovery 380.00 Water 500.00 Methanol Loss 10.00 Effluent water 538.23 (Water-500, Generated water-
S. No. Description Page no. 1.0 Executive Summary 1 2.0 Introduction of the Proposed Project 2 2.1 Project Proponent 2 2.2 Brief description of the project 3
2.3 Need for the project and its importance to the country and or region 3-4
2.4 Demand-Supply Gap. 4-5
2.5 Employment Generation(Direct and Indirect) due to the project 5
3.0 Project description 5 3.1 Product and Production Capacity 8 3.2 Raw materials required and Quantities 11 3.3 Manufacturing Process 11 3.4 Resource – Utilize and Recycling 12
3.4.1 Water 12
3.4.2 Power Requirement 12 3.4.3 Fuel Requirement 12 3.5 Quantity of wastes generated 12
3.5.1 Waste Water Generation and utilization 12 - 13 3.5.2 Solid waste generation and Disposal 13
3.6 Schematic representations of the feasibility drawing which give information of EIA purpose 14
4.0 Site Analysis 15 4.1 Connectivity 15 4.2 Land Form, Land use and Land ownership. 15 4.3 Existing Infrastructure 15 4.4 Soil classification 15 4.5 Climatic data from secondary sources 15 4.6 Social Infrastructure available 16 5.0 Planning in brief 16 6.0 Proposed infrastructure 16 6.1 Industrial Area 16 6.2 Residential Area 16 6.3 Green Belt 16 6.4 Social Infrastructure 16 - 17 6.5 Water management 17 6.6 Sewerage System 17 6.7 Industrial Waste Management 17 7.0 Rehabilitation and Resettlement (R&R) Plan 17
8.0 Project Schedule and Cost estimate 17 9.0 Analysis of project 17
LIST OF TABLES
Table No Description Page no. 3.1 Proposed Products and Existing Products and their
Production Capacities 8 - 10
3.2 List of By-Products 10 - 11 3.3 Water Requirement Details 13 3.4 Wastewater generation and Treatment Method 13 3.5 Solid and hazardous waste generation and Disposal 13 -14
LIST OF FIGURES
Figure No Description Page no. 1.1 Location Map 6 1.2 Google Earth Map Showing Tagoor Laboratories Private
Limited 7
LIST OF FLOW CHART
Flow Chart No Description Page no.
3.1 Generalized Flow Chart for Bulk Drug Manufacturing 11
Tagoor Laboratories Private Limited Pre Feasibility Report
1.0 EXECUTIVE SUMMARY
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt
Ltd) is a partnership firm and it is registered office at Duplex No: 29, Lakshmi Gayatri
The objective of this pre- feasibility study is to provide information on proposed to
Expansion of Existing Bulk Drug & Intermediate manufacturing unit of Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)
located at Survey No: 29, Tupakulagudem (V) Tallapudi (M), West Godavari (Dist.),
Andhra Pradesh.
2.1 Project Proponent
Mr. Penmetsa Subramanyam Raju, Managing partner of the company is young
and energetic personality with vast experience in pharmaceutical industry
Mr. Subramanya Raju has work experience of more than 18 years in bulk drugs
industry. He has worked in senior position as Director-manufacturing in Vasudha
group of industries and helped to emerge as one of the leading group in bulk drug
Page 2
Tagoor Laboratories Private Limited Pre Feasibility Report
industry. During his tenure in Vasudha Pharma Chem Limited, he had managed 3
units situated in jeedimetla, kazipally, and Visakhapatnam looking after production,
research and development, packing, dispatch of the finished intermediates and APIs
at right time, conforming to the specifications. Added to this, he is actively involved in
discussing with the customers for extracting business by increasing the yields and
reducing production cost to meet the demand of the customers. He has visited many
countries in Europe & Asia for exhibiting the bulk drug products. Mr. Subramanyam
Raju is also Managing Partner of Sri Venkateswara Industries which manufactures
the intermediates & bulk drugs, situated in Hyderabad. Considering his skills and
abilities, M/s Shree Jaya Laboratories Pvt Ltd., have offered him the post of Director
during February 2012 and he assumed charge of the Director during February 2012
and has taken charge as Chairman during April 2013 looking after the entire
production, research and development activities of the organization. He has
improved the turnover of the company from 28 crores to 120 crores within a short
span of one year.
Mr. Subramanyam Raju is experienced in manufacturing, process development,
project management, scale up to operations, quality systems and the aqua culturing
technically.
Mr. Subramanyam Raju was also awarded Hon. Doctorate by the international
university in Colombo during November 2013. He has also acquired more than
20acres of land in west Godavari district of Tallapudi Mandal for establishment of
Vensar and Vensub laboratories for manufacturing APIs. All the relevant licenses for
commencement of the units were obtained and the land is made ready for
construction works.
Dr. Pericherla Kasiviswanadharaju, the partner of the company is technically
qualified person, having rich experience in organic synthesis. He recently finished his
Ph. D from prestigious institute BITS Pilani, Rajasthan and his technical background
is an additional asset to the industry. Presently, he is involved in purchase,
marketing and research and development departments.
Page 3
Tagoor Laboratories Private Limited Pre Feasibility Report
2.2 Brief description of the project Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt
Ltd) is proposed to expansion of Existing Bulk Drug & Intermediate manufacturing
unit at Survey No: 29, Tupakulagudem (V) Tallapudi (M), West Godavari (Dist.),
Andhra Pradesh.
2.3 Need for the project and its importance to the country and region
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt
Ltd) is proposed to expansion of existing Bulk Drug & Intermediate manufacturing
unit at Survey No: 29, Tupakulagudem (V) Tallapudi (M), West Godavari (Dist.),
Andhra Pradesh.
• Availability of the well-connected road and railway network for easy
transportation of the construction equipments and materials, Raw materials
and finished products.
• Easy availability of skilled and unskilled labor for construction of Plant and its
operation.
The Indian pharmaceutical industry currently tops the chart amongst India's science-
based industries with wide ranging capabilities in the complex field of drug
manufacture and technology. A highly organized sector, the Indian pharmaceutical
industry is estimated to be worth $ 4.5 billion, growing at about 8 to 9 percent
annually. It ranks very high amongst all the third world countries, in terms of
technology, quality and the vast range of medicines that are manufactured. It ranges
from simple headache pills to sophisticated antibiotics and complex cardiac
compounds; almost every type of medicine is now made in the Indian
pharmaceutical industry.
The Indian pharmaceutical sector is highly fragmented with more than 20,000
registered units. It has expanded drastically in the last two decades. The
Pharmaceutical and Chemical industry in India is an extremely fragmented market
with severe price competition and government price control The Pharmaceutical
industry in India meets around 70% of the country's demand for bulk drugs, drug
intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals, and
injectibles. There are approximately 250 large units and about 8000 Small Scale
Units, which form the core of the pharmaceutical industry in India (including 5 Central
Public Sector Units).
Page 4
Tagoor Laboratories Private Limited Pre Feasibility Report
The Indian pharma industry, which is expected to grow over 16 per cent per annum
between 2017 and 2020, will outperform the global pharma industry, which is set to
grow at an annual rate of 5 per cent between the same period!. The market is
expected to grow to US$ 55 billion by 2020, thereby emerging as the sixth largest
pharmaceutical market globally by absolute size, as stated Indian Ambassador to the
US. Branded generics dominate the pharmaceuticals market, constituting nearly 80
per cent of the market share (in terms of revenues).
India has also maintained its lead over China in pharmaceutical exports with a year-
on-year growth of 11.44 per cent to US$ 12.91 billion in FY 2015-16, according to
data from the Ministry of Commerce and Industry. Imports of pharmaceutical
products rose marginally by 0.80 per cent year-on-year to US$ 1,641.15 million.
Overall drug approvals given by the US Food and Drug Administration (USFDA) to
Indian companies have nearly doubled to 201 in FY 2015-16 from 109 in FY 2014-
15. The country accounts for around 30 per cent (by volume) and about 10 per cent
(value) in the US$ 70-80 billion US generics market.
2.4 Demand-Supply Gap.
There is a quite considerable gap between supply and demand for, fine chemicals,
bulk drugs and intermediates. Very few players are in the market who can offer
continuous supply. The company wants to bridge this gap between demand and
supply by expanding the production capacity and thereby, making good business.
Company's marketing edge comes from its direct and close contact with the
customers. Their products are major strength of their customers. Each stage of their
product is been monitored /checked for their quality to ensure quality product
reaches their customer. They plan to launch new products every year to satisfy the
need of their customers as per the market demand.
2.5 Employment Generation (Direct and Indirect) due to the project
Approximate employment generation due to proposed unit is 135. Apart from this
there will be significant non estimated employment generation at the supplier firms
and service industry providing services to the company. Company shall be giving
preference to people from economically weaker sections for employment in various
semi-skilled/unskilled jobs thereby contributing to their upliftment.
Page 5
Tagoor Laboratories Private Limited Pre Feasibility Report
3.0 Project Description
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt
Ltd) is proposing the Expansion of existing Bulk Drug and Intermediates
Manufacturing Unit with production capacity of 200.0TPM
The Location map is shown at Figure - 3.1 and Google earth map showing Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)
plant is shown at Figure - 3.2.
The site central GPS - coordinates are Latitude: 17009’30.20” North
Longitude: 81035’23.36” East.
The project site does not offer any negative impact on the local area, but rather it has
a positive impact on socio economic conditions of the habitants around it because of
employment to locals.
The Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories
Pvt Ltd) is 26 kms away from National Highway NH – 16 and 22 kms from
Kovvuru Railway station.
Page 6
Tagoor Laboratories Private Limited Pre Feasibility Report
FIGURE 1.1: LOCATION MAP
Project Site
Page 6
Tagoor Laboratories Private Limited Pre Feasibility Report
FIGURE 1.2: GOOGLE EARTH MAP SHOWING TAGOOR LABORATORIES PRIVATE LIMITED
Page 7
Tagoor Laboratories Private Limited Pre Feasibility Report
3.1 Proposed Products and Existing Products and their Production Capacities
Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt
Ltd) is proposing to Expansion of existing Bulk Drug and Intermediates
Manufacturing Unit Capacity of 200.0 TPM and the list of proposed products and
Existing Products are shown in Table 3.1 & 3.2.
Table 3.1: Proposed Products and Quantities as per Required TOR Amendment
30 Pantoprazole Sodium Sesqui Hydrate 20.00 164579-32-2 Ant ulcerative
31 Pimozide 2.00 2062-78-4 Antipsychotic 32 Pregabalin 2.00 148553-50-8 Epileptic 33 Quetiapine Hemifumarate 2.00 111974-72-2 Antipsychotic 34 Rabeprazole Sodium 15.00 117976-90-6 Ant ulcerative 35 Rupatadine fumarate 2.00 182349-12-8 Antihistamine 36 Telmisartan 2.00 144701-48-4 Anti Hypertensive 37 Terbinafine hydrochloride 15.00 78628-80-5 Anti fungal 38 Valsartan 2.00 137862-59-4 Anti Hypertensive 39 1-Benzy-4-piperidone 5.00 3612-20-2 Drug Intermediate 40 1-Benzyl-4-chloropiperidine 5.00 67848-71-9 Drug Intermediate 41 1-Benzylpiperidin-4-ol 5.00 4727-72-4 Drug Intermediate 42 1-Methylpiperidin-4-amine 5.00 41838-46-4 Drug Intermediate 43 4-Aminopiperidine 5.00 13035-19-3 Drug Intermediate 44 4-Hydroxy piperidine 5.00 5382-16-1 Drug Intermediate 45 4-Phenylpiperidine 1.00 771-99-3 Drug Intermediate 46 4-piperidinopiperidine 1.00 4897-50-1 Drug Intermediate
47 N-tert-Butoxycarbonyl-4-hydroxy piperidine 5.00 109384-19-2 Drug Intermediate
Total ( Worst Combination of any 12 Products at any given point of time)
200.00
Note:
The above Listed Products, we will manufacture either Finished Product or any Intermediate stage of finished Product as per given quantity by not increasing the
production capacity of 200 MT/Month.
Page 9
Tagoor Laboratories Private Limited Pre Feasibility Report
The By-Products will be produced according to the combination of required products manufacturing.
Page 10
Tagoor Laboratories Private Limited Pre Feasibility Report
3.2 Raw materials required and Quantities
All the raw materials required for manufacturing of above products will be sourced
from local market.
3.3 Manufacturing Process
The manufacturing process of bulk drugs and Intermediates consists of chemical
synthesis extending to stages of processing involving different type of chemical
reactions. The generalized Flow chart for bulk drug manufacturing is shown in Flow chart 3.1.
Flow Chart 3.1: Generalized Flow Chart for Bulk Drug Manufacturing
3.4 Resource – Utilize & Recycling 3.4.1 Water Water requirement of the project for domestic and industrial activity during operation
phase will be 377 KLD. The water requirement will be met through Surface water
Allotment from State Government / Ground water sources. The detailed water
requirement shown in below Table 3.3
Page 11
Tagoor Laboratories Private Limited Pre Feasibility Report
Table 3.3: WATER CONSUMPTION DETAILS
S.No Purpose Water consumption In KLD
1 Process 152.5 2 Washings 6.0 3 Boiler make up 70.5 4 Cooling towers make up 119.0 5 Scrubbing system 18.0 6 Domestic 6.0 7 Gardening 5.0
Total 377.0 Total Water consumption of 377 KLD. 209 KLD of water will be recovered (from
Process: 90 KLD & Water Recycled from ZLD System: 119 KLD). Hence, Total
fresh water requirement is 377KLD -209 KLD = 168 KLD.
3.4.2 Power Requirement Power requirement of proposed project will be made available through Andhra
Pradesh Southern Power Distribution Company Limited (APSPDCL). The
total power requirement for the unit is 2000 KVA respectively
D.G. sets of Existing 250 KVA will be dropped and Proposed to install 1000 KVA DG
Set 2 no’s to meet the emergency power requirement of the plant.
3.4.3 Fuel Requirement The existing 6.0 TPH Coal fired/ Agro waste fired Boiler will be kept as standby and
2,00,000 kcal/hr Thermo pack Boiler will be Continued.
Proposed to install 12.0 TPH Coal fired/ Agro waste fired Boiler and total fuel
requirement of coal will be around 48.75 MT /Day and it will be procured from local
sources.
3.5 Quantity of wastes to be generated
3.5.1 Waste Water Generation and utilization
Total effluent will generate in the project is 150.0 KLD. The treated water will be
reused for plant operations.
Page 12
Tagoor Laboratories Private Limited Pre Feasibility Report
The HTDS waste water from Process after neutralization taken for treatment in
stripper followed by MEE and ATFD, vapor condensate collected and transferred to
Biological Treatment. LTDS waste water including domestic sewage, floor Washes,
Utilities waste water taken along with Vapour Condensate from MEE & ATFD for
Biological Treatment. Treated effluent from BTP sent to RO, RO permeate collected
and RO rejects are sent to MEE followed by ATFD for evaporation and separation of
salts. Evaporation salts collected and sent to TSDF. MEE & ATFD vapour
condensates collected & reused along with RO permeate in plant operations.
Table 3.4: Waste water generation and Treatment Method
Unit HTDS KLD
LTDS KLD
Effluent Generation
in KLD
Treatment Method
Process 63 35 98 HTDS effluent sent to ETP with MEE System LTDS effluents treated in ETP – RO Plant / RO Rejects to MEE System and RO permeate to reuse, Condensate from MEE to reuse and MEE residue to ATFD.
Washings 0 6 6
Boiler Blow down 0 10 10
Cooling towers Blow down 0 15.5 15.5
Scrubbing system 15 0 15 Domestic 0 5.5 5.5
Total 78 72 150
3.5.2 Proposed Solid and Hazardous waste generation and Disposal The types of Solid and Hazardous wastes generated from the project, method of
disposal is shown in below table 3.5.
Table 3.5: Proposed Solid / Hazardous waste generation and Disposal S. No Name of the
Hazardous Waste Quantity
Disposal Method
1 Organic waste (Process Residue)
2211 Kg/Day Sent to Cement Industries
2 Spent Carbon 336 Kg/Day Sent to Cement Industries
3 Solvent Distillation Residue 2001 Kg/Day Sent to Cement Industries
4 Inorganic Waste 725 Kg/Day Sent to TSDF
5 Spent Mixed Solvents 4000 Sent to authorized
Page 13
Tagoor Laboratories Private Limited Pre Feasibility Report
S. No Name of the Hazardous Waste
Quantity Disposal Method
Kg/Day recyclers/Cement Industries
6 ETP Sludge 500 .00 Kg/Day Sent to TSDF
7 MEE Salts 8684 Kg/Day Sent to TSDF
8 Organic Evaporative Liquid ( from MEE Stripper) 1560 Kg/Day Sent to Cement Industry
9 Used Oils 500L/Annum SPCB Authorized Agencies for Reprocessing/Recycling
10 Detoxified Containers 800 No’s /
Month After Detoxification sent to outside agencies.
11 Used Lead Acid Batteries 4 No’s/ Annum
Send back to suppliers for buyback of New Batteries
Solid waste generation and Disposal
12 Ash from boilers 17100 Kg/Day
Sent to Brick Manufacturers
3.6 Schematic representations of the feasibility drawing which give
information of EIA purpose.
The applicability of the S.O.1533 for the proposed project was explored by
considering different possibilities & provision made in the said notification.
Considering the products & project location of the proposed project it is noticed that
the proposed project falls under Category 5 (f) “A” of the Schedule-I of EIA
Notification S.O.1533.
As per the provision of the SO 1533, it is necessary to get Environmental Clearance
by applying to MoEF&CC along with the Environmental Impacts Assessment Study
Report for the proposed project prior to commissioning of the project activities.
Therefore the EIA is required to conduct to comply with provisions of SO 1533 made
for Category 5 (f) “A” of schedule –I of the notification.
4.0. Site Analysis 4.1 Connectivity Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt
Ltd) located at Survey No: 29, Tupakulagudem (V) Tallapudi (M), West Godavari
(Dist.), Andhra Pradesh.
Page 14
Tagoor Laboratories Private Limited Pre Feasibility Report
• Gopavaram village is at a distance of 1.43 KMs in N Direction from the site.
• Kovvur is a Town; it is at a distance of 20 KMs in SE side from the project site.
• Site is at a distance of 24 KMs from Rajahmundry in SE direction.
• Nearest State Highway from the site is SH-42 (Koyyalagudem- Nallajerla) at a
distance of 17 KMs in W side from the project site.
• Nearest National Highway from the site is NH-5 (Rajahmundry - Anakapalle) at a
distance of 26 KMs in SE side from the project site.
4.2 Land Form, Land use and Land ownership. The land use of the Area of 11.8 Acres (47752.9 Sq.m) will be permanently changed
to industrial purpose.
4.3 Existing Infrastructure.
The Proposed project proposed to Expansion of existing Bulk Drug and
Intermediates Manufacturing Unit which is 26 kms away from NH-17 and Mandal
head quarter Tallapudi is 8.50 kms (ESE) from the project site.
4.4 Soil classification
The predominant soils in the district are Sandy loams, black cotton soils and coastal
sands.
4.5 Climatic data from secondary sources. Annual Max Temp is 36.80C
Annual Min Temp is 19.50C
Normal Annual Rainfall is 1078 mm
4.6 Social Infrastructure available.
Well developed social infrastructure facilities are available at nearby Habitations.
5.0 Planning Brief
Proposed plant activities will be started after getting statutory clearance form related
authorities. The project will be completed within two years. Further project
Page 15
Tagoor Laboratories Private Limited Pre Feasibility Report
management will take care of all the rules and regulation of statutory authority and
provide all necessary control measures
6.0 Proposed Infrastructure
6.1 Industrial Area The infrastructure and other facilities are already well developed in Tallapudi, which
is a Mandal head quarter.
6.2 Residential Area The employees who will work in the industry are from nearby villages and hence no
proposal for residential area for employees.
6.3 Green Belt: 16461.5 SQM (34.50 %) of Green Belt will be developed and maintained. 6.4 Social Infrastructure: Facilities like roads, communication, Banks, ATM's and medical facilities are
available.
Amenities: Education Schools including middle, secondary and higher secondary schools, social welfare hostels Medical and Health Community Health Centre & Primary Health center are
available in Tallapudi which is 8.50 kms ESE of proposed project site.
Power and water- All the villages are electrified and drinking water facilities are
extended to all villages.
Rail and Road- The project site is very well connected by road through National
Highway No. 16 and nearest railway station is Kovvur.
6.5 Water management Water requirement will be met through ground water.
Page 16
Tagoor Laboratories Private Limited Pre Feasibility Report
6.6 Sewerage System: There will be no discharge of industrial effluent as company proposing Zero Liquid
Discharge (ZLD) system. The treated effluent will be reused.
6.7 Industrial Waste Management: Due to proposed project, the effluent from cooling and Plant/Equipment washing will
be generated and treated in the well designed Effluent Treatment Plant. The treated
effluent will be reused.
7.0 Rehabilitation and Resettlement (R & R) Plan Rehabilitation & Resettlement (R & R) plan is not applicable to this proposed project.
8.0 Project Schedule & Cost Estimates Proposed project activities will be started after getting statutory clearance form
related authorities. The project will be completed within two years.
The project cost for proposed Project is 4500 Lakhs (45 Crores) will be used for