2013 12 26 Dec 2013 1435253631364 PDF

M/s. Syn- Finechem Laboratories Pvt. Ltd.
LIST OF CONTENTS
S. No Content Name Page No’s
1 Form -I 1-12
2 List of Products 13
3 List of Raw Materials 14-18
4 Process Description 19-54
5 Water Consumption Details 55
6 Waste water Details 56-57
7 ETP Flow Chart 58
8 Solid Waste Details 59-60
9 Stack Emission Details 61-62
10 Process Emission Details 63
11 Spent Solvents 64
12 Pre-feasibility Report 65-67
13 Draft TOR 68-69
14 Project Report 70-85
ENCLOSURES
15 Copy of GOs Enclosed
16 Industrila area Notification Enclosed
17 Pollution Load Details Enclosed
18 Topo Map Enclosed
19 Site Plan Enclosed
20 Copy of CFO Enclosed
21 CFO Compliance Report Enclosed
22 TSDF Membership Enclosed
23 Consultant Details Enclosed
Prepared by Rightsource Industrial Solutions Pvt Ltd

APPENDIX-I
FORM -1
I) Basic information
S.NO ITEM DETAILS

1. Name of the project/s M/s. Syn- Finechem Laboratories Pvt. Ltd.
2. S.No.in the schedule 5 (f)
3. Proposed capacity Proposed production capacity – 4.7 TPM
/area/length/tonnage Source of water: Bore well water.
to be handled/command area/lease Total project area: 1350.00 SQM.
area/ number of wells to be drilled
4 New/Expansion/Modernization Expansion
5. Existing Capacity/Area etc. Existing Area: 1350.00 SQM. This will remain
same. Expansion will be within the existing
premises.
6. Category of Project i.e.’A’ or ‘B’ B
7. Does it attract the general Yes, Plant site is situated within 10kms radius
condition? If yes, please specify. from critically polluted area. Bollaram, IDA.
8. Does it attract the specific No
condition? If yes, please specify.
9. Location Syn- Finechem Laboratories Pvt. Ltd.
#D -151,Phase –III,I.D.A, Jeedimetla
Rangareddy District
Andhra Pradesh.
10. Nearest railway station/airport Sanathnagar railway station – 10Kms
along with distance in kms. Hyderabad (Shamshabad Air port) – 45 Kms
11. Nearest Town, City, District Hyderabad – 10 Kms
Headquarters along with distance
in kms.
12. Village Panchayats, Zilla Parishad, IALA (Industrial Area Local Authority)
Municipal Corporation, Local Body Jeedimetla
(Complete postal addresses with
telephone nos. to be given)
13. Name of the applicant Dr. B.S. Reddy
14. Registered Address M/s. Syn- Finechem Laboratories Pvt. Ltd.
#D -151,Phase –III,I.D.A, Jeedimetla
Rangareddy District
Andhra Pradesh.
15. Address for correspondence: Rightsource Industrial Solutions Pvt Ltd

Plot No.203, H.No.5-36/203,Prashanti nagar,
IDA, Kukatpally, Hyderabad-500072
Name Dr. B.S.Reddy

Designation (Owner/Partner/CEO) Managing Director
Address M/s. Syn- Finechem Laboratories Pvt. Ltd.
Plot No.203, H.No.5-36/203,Prashanti nagar,
IDA, Kukatpally, Hyderabad-500072
Andhra Pradesh.
Prepared by Rightsource Industrial Solutions Pvt Ltd. 1

Pin Code 500 072

E-mail info@rightsource.co.in
synfine@sify.com
Telephone No. 040-23075699, 40126589
Fax No. 040-23070602
16. Details of alternative sites N.A.
examined, if any. Location of these
sites should be shown on a topo
sheet
17. Interlinked Projects Nil
18. Whether separate application of N.A.
interlinked project has been
submitted?
19. If Yes, date of submission N.A.
20. If no, reason N.A.
21. Whether the proposal involves
approval/clearance under: if yes, Nil
details of the same and their status
to be given.
(a) The Forest (Conservation) Act,
1980?
(b) The Wildlife (Protection) Act,
972?
(c) The C.R.Z Notification, 1991?
22. Whether there is any Government G.O.Ms No.62 (Ban Notification),Dt.20/04/1999
Order/Policy relevant/relating to the Now it is Cleared as per G.O.Ms No.64, (Ban
site? relaxation), Dt.25/07/2013.
Enclosed.
23. Forest land involved (hectares) NIL
24. Whether there is any litigation
pending against the project and/or
land in which the project is propose NIL
to be setup?
(a) Name of the court
(b) Case No.
(c) Orders/directions of the Court, if
any and its relevance with the
proposed 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.)
S. No Information/Checklist Yes/No Details thereof(with approximate
confirmation quantities/rates, wherever
possible)with source of information
data
1.1 Permanent or temporary No It is expansion of the existing plant, No
change in land use, land change in land use, land cover or
cover or topography including topography.
increase in intensity of land
use (with respect to local land
use plan)
1.2 Clearance of existing land, No There will be no clearance of existing
vegetation and buildings? land, vegetation or building.
1.3 Creation of new land uses? No No creation of land use.
1.4 Pre-construction No NA
investigations e.g. bore
houses, soil testing?
1.5 Construction works? No Site paln Enclosed
1.6 Demolition works? No No demolition work

1.7 Temporary sites used for No No temporary housing facilities would be
construction works or housing provided. All labors would come from
of construction workers? nearby villages.
1.8 Above ground buildings, No No construction work is envisaged as the
structures or earthworks expansion will be within the premises.
including linear structures, cut
and fill or excavations.
1.9 Underground works including No Not envisaged. No Mining or Tunneling
mining or tunneling? Works.
1.10 Reclamation works? No Not envisaged. No Reclamation Works
1.11 Dredging? No No Dredging Work.
1.12 Offshore structures? No No Offshore Works.
1.13 Production and manufacturing Yes Enclosed
processes?
1.14 Facilities for storage of goods Yes Existing storage area will be used for
or materials? storage of goods and materials during
operation phase.
1.15 Facilities for treatment or Yes Municipal Solid Waste will be collected
disposal of solid waste or and segregated & handed over to local
liquid effluents? authorized body for further disposal
Domestic effluent will be treated in

Septic tanks & Soak pits.
Effluent will be treated in ETP
ETP sludge & Hazardous waste will be

sent to TSDF for further disposal.

1.16 Facilities for long term No No housing facilities will be provided for
housing of operational operational workers. Most of the workers
workers? are locals and nearby villages.
1.17 New road, rail or sea traffic No Not envisaged.
during construction or
operation?
1.18 New road, rail, air, waterborne No Not envisaged.
or other transport
infrastructure including new or
altered routes and stations,
ports, airports etc?
1.19 Closure or diversion of No Not envisaged.
existing transport routes or
infrastructure leading to
changes in traffic
movements?
1.20 New or diverted transmission No Not envisaged.
lines or pipelines?
1.21 Impoundment, damming, No No
culverting, realignment or other
changes to the hydrology of
watercourses or aquifers?
1.22 Stream crossings? No There is no stream passing through the
site.
1.23 Abstraction or transfers of Yes Water requirement will be met from the
water from ground or surface Bore well water.
waters?
1.24 Changes in water bodies or No There will not be any changes in water
the land surface affecting bodies or the land surface affecting
drainage or run-off? drainage or run-off.
1.25 Transport of personnel or No NA
materials for construction,
operation or
decommissioning?
1.26 Long-term dismantling or No No dismantling or decommissioning or
decommissioning or restoration works
restoration works?
1.27 Ongoing activity during No NA
decommissioning which could
have an impact on the
environment
1.28 Influx of people to an area in Yes Workers /Employees will be increased
either temporarily or and the working hours are in shifts /
permanently? general.
1.29 Introduction of alien species? No No Introduction of alien species
1.30 Loss of native species or No No Loss of native species or genetic
genetic diversity? diversity
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 )
S.No Information/Checklist Yes/No Details thereof (with approximate

confirmation quantities/rates, wherever possible)
with source of information data
2.1 Land especially undeveloped or No Nil
agricultural land (ha)
2.2 Water (expected source & Yes 31.80 KLD

competing users) unit: KLD Source of water: Bore well water.
2.3 Minerals (MT) No No Minerals required

2.4 Construction material – stone, No NA
aggregates, sand/soil
(expected source (MT)
2.5 Forests and timber (source MT) No No Timber will be used.
2.6 Energy including electricity and Yes • Electricity–250 H.P from - APCPDCL
fuels (source, competing users)
Unit: fuel (MT), energy (MW) • Generator: Existing - 63 KVA -1 No
In addition to the above existing, the

industry proposing another Generators –
125 KVA – 1 No
Fuel: HSD about 150 Liters per day

(For Existing & Proposed)
Steam: Boiler (Coal Fired) 2.0TPH – 1 No
• Fuel: Coal – 5.0 TPD
2.7 Any other natural resources No None

(use appropriate standard
units)

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.

confirmation quantities/rates, wherever
possible)with source of information
data
3.1 Use of substances or Yes Enclosed list of hazardous chemicals
materials, which are are used in the products. Hazardous
hazardous (as per MSIHC Chemicals are stored as per
rules) to human health or the manufacture, storage and import of
environment (flora, fauna, and hazardous chemical rules 1989.
water supplies)
3.2 Changes in occurrence of No Effluent will be sent to ETP-ZLD
disease or affect disease System.
vectors (e.g. insect or water All solid wastes will be stored in the
borne diseases) covered platform with leachate
collection system and sent to TSDF /
Authorized agencies.
Process emissions will be scrubbed in
the scrubbers.
3.3 Affect the welfare of people No Not applicable .it is only capacity load
e.g. by changing living enhancement.
conditions?
3.4 Vulnerable groups of people No None
who could be affected by the
project e.g. hospital patients,
children, the elderly etc.,
3.5 Any other causes No Nil
4. Production of solid wastes during construction or operation or decommissioning

(MT/month)

confirmation quantities/rates, wherever possible) with
source of information data
4.1 Spoil, overburden or mine No No Spoil, overburden or mine wastes
wastes
4.2 Municipal waste Yes Municipal Solid Waste will be collected
(domestic and or segregated & Disposed to authorized party for
commercial wastes) further disposal. The commercial waste from
the administration building is generated and is
to scrap vendors.
4.3 Hazardous wastes (as Yes Details of hazardous wastes generated from
per Hazardous Waste the enhanced capacities /loads are given.
Management Rules)
4.4 Other industrial process Yes Details of the industries process wastes from
wastes the enhances capacities /loads are given.
4.5 Surplus product No Surplus production is not envisaged since

production will be as per the market demand
only.
4.6 Sewage sludge or other Yes Domestic waste water sent to septic tank and
sludge from effluent overflow to ETP.
treatment ETP sludge generation details are given
4.7 Construction or No No demolition waste will be generated.

demolition wastes
4.8 Redundant machinery or No Not envisaged
equipment
4.9 Contaminated soils or No Not envisaged
other materials
4.10 Agricultural wastes No Not Applicable
4.11 Other solid wastes No Details of other solid waste are given.
5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr)
S.N Information/Checklist Yes/No Details thereof (with approximate

o confirmation quantities/rates, wherever possible)
5.1 Emissions from combustion of Yes About 5.0 TPD Coal will be used in Boiler
fossil fuels from stationary or and about 150/liters/day diesel will be
mobile sources used in D.G. sets emission details are
given.
5.2 Emissions from production No There is no polluting emission from the
processes. production process.
5.3 Emissions from materials Yes Pumps will be used for handling of liquid
handling including storage or raw materials and trolleys will be used for
transport solid / powder type raw materials Vent
condensers are provided for all storage
tanks, centrifuges, catch pots.
5.4 Emissions from construction No It is capacity / load enhancement.
activities including plant and
equipment
5.5 Dust or odors from handling of No No construction activity taken place.
materials including Septic tank will be provided both during
construction materials, construction and operation of the plant.
sewage and waste Hence no odors will be released into
atmosphere.
5.6 Emissions from incineration of No No incineration of waste in the site
waste
5.7 Emissions from burning of No No burning activity in the site. No
waste in open air (e.g. slash emissions will generate
materials, construction debris)
5.8 Emissions from any other No None
sources.

6. Generation of Noise and Vibration, and Emissions of Light and Heat

6.1 From operation of equipment Yes Noise will be generated from the
e.g. engines, ventilation plant, utilities section. Silencers will be
crushers provided for D.G. Sets.
6.2 From industrial or similar Yes Noise from process utilities will be
processes within the limits. About 56dB(A)
6.3 From construction or No No construction will taken place.
demolition
6.4 From blasting or pilling No None, No blasting or pilling during
construction
6.5 From construction or No None
operational traffic
6.6 From lighting or cooling No Negligible.
systems
6.7 From any other sources No Nil
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 Yes/No Details thereof (with approximate

7.1 From handling, storage, Yes Spillages such as wastewater /solid
use or spillage of wastes/raw material are possible and the
hazardous materials risk of this would be limited to within the
premises of the manufacturing facilitate.
Precautionary measures are
implementing in the existing permitted
industry and will continue for spillage
control and to avoid contamination of land
or water from the pollutants or raw
materials.
Suggestions from the safety consultants
will be followed to avoid the risk and
prevent accidents.
7.2 From discharge of sewage Yes 12.92 KLD Domestic sewage will be sent
or other effluents to water to soak pit. Process effluent will be
or the land (expected mode treated and evaporated and recycled
and place of discharge) within the plant.
7.3 By deposition of pollutants Yes Possibility of deposition of pollutants
emitted to air into the land emitted to air into the land / water can’t be
or into water ruled out and the precautions taken by
the industries to control such emissions
by adopting the suitable controlling
equipment will be provided such as Bag
filters ,Scrubbers etc.
7.4 From any other sources No Process emissions are controlled by

scrubbers.
7.5 Is there a risk of long term No Not envisaged. Industry will implement all
build up of pollutants in the latest pollution control equipment and will
environment from these adopt them build up of pollutants in the
sources? environment from the industrial activity.
8. Risk of accidents during construction or operation of the Project, which could affect
human health or the environment

8.1 From explosions, spillages, Yes All the safety precautions will be taken
fires etc from storage, by the industry to avoid such
handling, use or production of accidents.
hazardous substances
8.2 From any other causes Yes Static Electricity
8.3 Could the project be affected No Not envisaged.

by natural disasters causing
environmental damage (e.g.
floods, earthquakes,
landslides, cloudburst etc)?
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.

9.1 Lead to development of Yes Supporting infrastructure such as
supporting laities, ancillary roads, power supply, waste or waste
development or development water treatment etc. may be impacts
stimulated by the project which on the project activities however the
could have impact on the impact from such activates will be
environment e.g. limited.
* Supporting infrastructure
(roads, power supply, waste
or waste water treatment,
etc.)
* Housing development No No roads will be laid, since plant site is

well connected to road. Power supply
will be obtained from public supply and
there will not be any effect on the
environment .Waste water generation
from the process will be treated and

reused, waste water treatment plant
will be constructed and there will not
be any impact on the environment.
* Extractive industries No Not envisaged. Possibility of extractive

industries cannot be ruled out.
* Supply industries Yes Not envisaged.
* Other No Not envisaged.
9.2 Lead to after-use of the site, No Not envisaged.

which could have an impact on
the environment
9.3 Set a precedent for later No Not envisaged.
developments
9.4 Have cumulative effects due to No Marginal cumulative effects envisaged.
proximity to other existing or
planned projects with similar
effects
10. Environmental Sensitivity
S.No Areas Name/ Aerial distance (within 25 km)

Identity Proposed project location
boundary
1 Areas protected under No Note envisaged .There is no Eco
international conventions, sensitive area near the plant site.
national or local legislation for
their ecological, landscape,
cultural or other related value
2 Areas which are important or No Not envisaged .There is no wetland
sensitive for ecological reasons near the plant site.
– Wetlands, watercourses or
other water bodies, coastal
zone, biospheres, mountains,
forests
3 Areas used by protected, No Not envisaged.

important or sensitive species
of flora or fauna for breeding,
nesting, foraging, resting, over
wintering, migration

4 Inland, coastal, marine or No Nil

underground waters
5 State, National boundaries No None with in 10 KM radius
6 Routes or facilities used by the No Not envisaged.

public for access to recreation
or other tourist, pilgrim areas
7 Defense installations No No defense establishments within the
area.
8 Densely populated or built-up No ---
area
9 Areas occupied by sensitive No There is no habitation /sensitive,
man-made land uses (hospitals, manmade, land used within the
schools, places of worship, specified distance.
community facilities)
10 Areas containing important, No NA
high quality or scarce
resources (ground water
resources, surface resources,
forestry, agriculture, fisheries,
tourism, minerals).
11 Areas already subjected to No NA

pollution or environmental
damage. (Those where existing
legal environmental standards
are exceeded)
12 Areas susceptible to natural No Not envisaged.
hazard which could cause the
project to present
environmental problems
(earthquakes, subsidence,
landslides, erosion, flooding or
extreme or adverse climatic
conditions)

LIST OF PRODUCTS
S. No Product Name CAS Number Quantity In Quantity In

Kg/Month Kg/Day
1 Bosentan 174227-18-0 750.00 25.00
2 Dapagliflozin Propanediol 960404-48-2 1000.00 33.33
3 Ponatinib 943319-70-8 1500.00 50.00
4 Posaconazole 171228-49-2 1000.00 33.33
5 Vildagliptin 274901-16-5 450.00 15.00
Total 4700.00 156.67
S. No Product Name CAS Number Therapeutic Quantity In Quantity In

category Kg/Month Kg/Day
1 Bosentan 174227-18-0 Antihypertensive 750.00 25.00
2 Dapagliflozin 960404-48-2 1000.00
Propanediol 33.33
3 Ponatinib 943319-70-8 Antineoplastics 1500.00 50.00
4 Posaconazole 171228-49-2 Antifungal 1000.00
Agents 33.33
5 Vildagliptin 274901-16-5 Antidiabetics. 450.00 15.00
Total 4700.00 156.67
Prepared by Rightsource Industrial Solutions Pvt Ltd 13

1. BOSENTAN
S. No Raw Material Consumption/ Consumption/

Batch in Kgs Day in Kgs
1 2-Cyanopyrimidine 21.00 10.50
2 Sodium meth oxide 1.00 0.50
3 Methanol 450.00 225.00
4 Ammonium chloride 11.00 5.50
5 Cyclohexane 150.00 75.00
6 2-(2-Methoxy-phenoxy) malonic
40.00
acid dimethyl ester 20.00
7 Sodium methoxide 9.00 4.50
8 HCl solution 34.50 17.25
9 4-tert-butylbenzenesulfonamide 26.00 13.00
10 Potassium oxy chloride 38.00 19.00
11 Potassium carbonate 17.00 8.50
12 Sodium Hydroxide 49.00 24.50
13 Tetrabutylammonium bromide 1.50 0.75
14 Ethylene Glycol 7.00 3.50
15 Toluene 600.00 300.00
16 THF 400.00 200.00

2. DAPAGLIFLOZIN PROPANEDIOL

1 Gluconolacotone 30.00 25.00
2 Trimethylsilane Chloride 145.00 120.83
3 N-Methylmorpholine 150.00 125.00
4 MDC 600.00 500.00
5 Toluene 410.00 341.67
6 Sod.Dihydrogen phosphate 2.00 1.67
7 Sodium chloride 18.00 15.00
8 4-Bromo-1-chloro-2-(4-ethoxy benzyl)
45.00
benzene 37.50
9 N-BuLi 132.00 110.00
10 Methanesulfonic acid 40.00 33.33
11 Methanol 550.00 458.33
12 THF 250.00 208.33
13 Sodium bicarbonate 16.00 13.33
14 n-Hexane 95.00 79.17
15 Triethyl silane 30.00 25.00
16 Acetonitrile 300.00 250.00
17 Propylene glycol 4.00 3.33
18 Isopropyl acetate 200.00 166.67
19 Cyclohexane 150.00 125.00

3. PONATINIB

1 4-(4-Methyl-piperazin-1-yl 35.00 35.00
methyl)-3-trifluoromethyl
phenyl amine
2 3-Iodo-4-methyl-benzoyl 36.00 36.00
chloride
3 Ethyl-diisopropyl amine 17.00 17.00
4 Tetrahydrofuran 110.00 110.00
5 Ethyl acetate 56.00 56.00
6 3-Ethylnyl-imidazo [1, 2-b] 16.00 16.00
pyridazine
7 Acetonitrile 100.00 100.00
8 MDC 200.00 200.00
9 n-Hexane 50.00 50.00

4. POSACONAZOLE

1 4-Hydroxyphenyl-piperazinyl 145.00 48.33
triazolone
2 DMSO 1130.00 376.67
3 Sodium hydroxide 97.00 32.33
4 Tosyl sulfonyl methyl ester 146.00 48.67
5 Ethyl acetate 1470.00 490.00
6 Sodium chloride 146.00 48.67
7 Isoproponal 8540.00 2846.67
8 Hydrochloric acid (35%) 78.00 26.00
9 Methanol 2320.00 773.33
10 Acetone 1900.00 633.33
11 Hydrogen 1.00 0.33
12 Palladium carbon 25.00 8.33
13 MDC 900.00 300.00

5. VIDAGLIPTIN

1 Amantadine Hydrochloride 78.00 19.50
2 Conc. Nitric acid 107.00 26.75
3 Conc. Sulfuric acid 1435.00 358.75
4 Sodium hydroxide 1719.00 429.75
5 MDC 6200.00 1550.00
6 Cyclohexane 73.00 18.25
7 (S)-1-(2-Chlororacetyl)pyrrolidine-2- 37.00 9.25
carbonitrile
8 Potassium carbonate 80.00 20.00
9 Potassium Iodide 1.00 0.25
THF 660.00 165.00
Ethyl acetate 470.00 117.50

1. BOSENTAN
Process Description
Stage-1
Pyrimidine-2-carbonitrile reacts with Ammonium chloride in presence of Methanol as a

solvent media to give Stage-1 as a product.
Stage-2
Stage-1 product reacts with 2-(2-Methoxy-phenoxy) malonic acid dimethyl ester in

presence of Methanol as a solvent media to give Stage-2 as a product.
Stage-3
Stage-2 product reacts with Phosphorous oxychloride, 4-tert-butylbenzenesulfonamide,

Potassium carbonate and Ethylene glycol in presence of Toluene as a solvent media to
give Bosentan as a product.

BOSENTAN
Route of Synthesis
Stage-1
NH
HCl
N CN N
NH2
N N
Methanol
NH4Cl
+
Sodium methoxide Pyrimidine-2-carboxamidine
Pyrimidine-2 Ammonium Chloride
Hydrochloride
-carbonitrile 53.49
C5H3N3 C5H7ClN4
105.10 158.59
Stage-2
NH OCH3 OCH3
HCl O
N
NH2 O
N Methanol
+ O OCH3 + NaOCH3
Pyrimidine-2-carboxamidine 2-(2-Methoxy-phenoxy) Sodium methoxide

Hydrochloride -malonic acid dimethyl ester 54.02
C5H7ClN4 C12H14O6
158.59 254.24
OH OCH3
O
N
N
N OH
N NaCl
+ 3 CH3OH +
5-(2-Methoxy-phenoxy) Methanol Sodium Chloride
-[2,2']bipyrimidinyl-4,6-diol 3X32.04=96.12 58.44
C15H12N4O4
312.28

Stage-3
Step-A
OH OCH3
O
N
N
N OH
N Toluene
+ POCl3 + 4 NaOH
5-(2-Methoxy-phenoxy) Phosphorous Sodium Hydroxide

-[2,2']bipyrimidinyl-4,6-diol oxychloride 4X40=160.00
C15H12N4O4 153.33
312.28
Cl OCH3
O
N
N
N Cl
N Na3PO4 NaCl + 3H2O
+ +
4,6-Dichloro-5-(2-methoxy-phenoxy) Sodium phosphate Sodium chloride 3X18=54.00

-[2,2']bipyrimidinyl 58.44
163.94
C15H10Cl2N4O2
349.12

Step-B
Cl OCH3
O O
O S
N NH2 OH
N H3C
N Cl
+ H3C HO
N CH3 + K2CO3 +
4-tert-Butyl-benzene Potassium Ethylene glycol

4,6-Dichloro-5-(2-methoxy-phenoxy)
sulfonamide carbonate
-[2,2']bipyrimidinyl 62.07
138.21
C15H10Cl2N4O2 C10H15NO2S
349.12 213.30
Toluene
H3C O
H3C S
NH OCH3
H3C O
O
N
N
N O
N HO
+ 2 KCl + CO2 + H2O
Potassium chloride 44.00 18.00

Bosentan
C27H29N5O6S 2X74.55=149.10
551.61

BOSENTAN
Flow Chart
Pyrimidine-2-carbonitrile
Ammonium chloride Stage-1 Methanol Rec
Methanol
Stage-1
2-(2-Methoxy-phenoxy)
malonic acid dimethyl ester Stage-2 Methanol Rec
Methanol
Stage-2
Phosphorous oxychloride Toluene Rec
Stage-3
Potassium carbonate Effluent water
Ethylene glycol
Toluene
BOSENTAN

BOSENTAN
Material Balance
Material Balance of Bosentan

Stage-1
Batch Size: 50Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
2-Cyanopyrimidine 21.00 Stage-1 25.00
Sodium meth oxide 1.00 Methanol Recovery 142.00
Methanol 150.00 Methanol Loss 7.00
Ammonium chloride 11.00 Cyclohexane Recovery 143.00
Cyclohexane 150.00 Cyclohexane Loss 7.00
Organic Residue 9.00
(Organic Impurities-8,Methanol-
1)
Total 333.00 Total 333.00

Stage-2
Batch Size: 50Kgs
in Kg in Kg
Stage-1 25.00 Stage-2 38.00
2-(2-Methoxy-phenoxy) malonic Methanol Recovery 284.00
40.00
acid dimethyl ester
Methanol 300.00 Methanol Loss 15.00
Sodium methoxide 9.00 Effluent water 304.30
HCl solution 30.00 (Water-250,Methanol-15.1,
Hydrochloric acid-30,Sodium
chloride-9.2)
Water 250.00 Organic Residue 12.70
(Organic Impurities-11.7,
Methanol-1)


Stage-3
Batch Size: 50Kgs
in Kg in Kg
Stage-2 38.00 Bosentan 50.00
4-tert-butylbenzenesulfonamide 26.00 Toluene Recovery 569.00
Potassium oxy chloride 38.00 Toluene Loss 30.00
Potassium carbonate 17.00 THF Recovery 380.00
Sodium Hydroxide 49.00 THF Loss 20.00
Tetrabutylammonium bromide 1.50 Effluent water 1300.99
Hydrochloric acid 4.50 (Water-1200,Generatedwater-8.59,
Sodium phosphate-50.2,
Sodium chloride-17.9,
Potassium chloride-18.3, Tetra
butyl ammonium bromide-1.5,
Hydrochloric acid-4.5)
Ethylene Glycol 7.00 Process Emissions 5.41
Toluene 600.00 (Carbon dioxide)
THF 400.00 Organic Residue 25.60
Water 1200.00 (Organic Impurities-24.6,Toluene-
1)
Total 2381.00 Total 2381.00

2. DAPAGLIFLOZIN PROPANEDIOL
Process Description:
Stage-1
Gluconolacotone reacts with Trimethyl silane and N-Methyl morpholine in presence of

MDC as a solvent media to give Stage-1 as a product.
Stage-2
Stage-1 reacts with 4-Bromo-1-chloro-2-(4-ethoxy benzyl) benzene and Methanol in

presence of Toluene as a solvent media to give Stage-2 as a product.
Stage-3
Stage-2 reacts with Triethylsilane in presence of MDC as a solvent media to give

Stage-3 as a product.
Stage-4
Stage- 3reacts with S (+)-1, 2-propanediol in presence of Methanol as a solvent media
to give Dapagliflozin Propanediol

DAPAGLIFLOZIN PROPANEDIOL
Route of Synthesis
Stage-1
O O O
HO
CH3
4
HO OH 4 H3C Si Cl N
HO + CH3 + CH3
3,4,5-Trihydroxy-6-hydroxymethyl Trimethylsilyl Chloride N-Methyl morpholine

-tetrahydro-pyran-2-one C3H9ClSi C5H11NO
C6H10O6 4X108.64=434.56 4X101.15=404.60
178.14
MDC
O O
TMSO O
TMSO OTMS
4 N
TMSO HCl
+ CH3
3,4,5-Tris-trimethylsilanyloxy N-Methyl morpholine
-6-trimethylsilanyloxymethyl Hydrochloride
-tetrahydro-pyran-2-one C5H12ClNO
C18H42O6Si4
4X137.61=550.44
466.86

Stage-2
O O
Cl O CH3 TMSO
TMSO OTMS
Br
+ OTMS + 4 H2O + CH3OH
4-Bromo-1-chloro-2-(4-ethoxy 3,4,5-Tris-trimethylsilanyloxy 4X18=72.00 Methanol

-benzyl)-benzene -6-trimethylsilanyloxymethyl 32.04
C15H14BrClO -tetrahydro-pyran-2-one
C18H42O6Si4
325.63
466.86
Toluene n-BuLi
Cl
O
HO
OCH3
HO OH
OH CH3
4 H 3C Si OH
O CH3
+ CH3 HBr + 1/2O2
+
2-[4-Chloro-3-(4-ethoxy-benzyl)-phenyl]-6 Trimethyl-silane Hydrogen Oxygen gas
-hydroxymethyl-2-methoxy-tetrahydro 4X90.20=361.80 bromide 1/
2X32=16.0
pyran-3,4,5-triol 80.91
C22H27ClO7
438.90

Stage-3
Cl
O
HO
OCH3
HO OH
CH3
OH H3C
Si
O CH3
H H2O
+ CH3 +
2-[4-Chloro-3-(4-ethoxy-benzyl)-phenyl]-6 Triethylsilane 18.00
-hydroxymethyl-2-methoxy-tetrahydro
C6H16Si
pyran-3,4,5-triol
C22H27ClO7 116.28
438.90
MDC
Cl
O
HO
HO OH
OH CH3
H3C
O CH3 Si
+ OH CH3OH
CH3 +
Dapagliflozin Tech
C21H25ClO6 Triethylsilnol Methanol
408.87 C6H16OSi 32.04
132.28

Stage-4
Cl
O
HO
HO OH
OH HO OH
O CH3
+ CH3 + H 2O
Dapagliflozin Tech S-(+) Propane-1,2-diol
18.00
C21H25ClO6 C3H8O2
408.87 76.09
Cyclohexane
Cl
O
HO
HO OH
OH HO OH
H 2O
O CH3
CH3
Dapagliflozin Propanediol
C24H35ClO9
502.98

Flow Chart
Gluconolacotone
Trimethylsilane Chloride
Stage-1 MDC Rec
N-Methylmorpholine
MDC
Stage-1
4-Bromo-1-chloro-2-(4-ethoxy
benzyl) benzene Stage-2 Toluene Rec
N-BuLi
Toluene
Stage-2
Triethyl silane Stage-3 MDC Rec
MDC
Stage-3
Propylene glycol
Stage-4 Methanol Rec
Isopropylacetate
Methanol

Material Balance
Material Balance of Dapagliflozin Propanediol

Stage-1
Batch Size: 40.0Kgs
Name of the input Quantity in Name of the out put Quantity
Kg in Kg
Gluconolacotone 30.00 Stage-1 65.00
Trimethylsilane Chloride 145.00 MDC Recovery 285.00
N-Methylmorpholine 150.00 MDC Loss 15.00
MDC 300.00 Toluene Recovery 151.00
Toluene 160.00 Toluene Loss 8.00
Sod.Dihydrogen phosphate 2.00 Effluent water 329.50
Sodium chloride 2.00 (Water-150, Sod. Di hydrogen
phosphate-2, Sodium chloride-2,
N-Methyl morpholine HCl-92.5
N-Methylmorpholine-82,Toluene-1)
Water 150.00 Organic Residue 85.50
(Organic Impurities-85.5)


Stage-2
Batch Size: 40.0Kgs
in Kg in Kg
Stage-1 65.00 Stage-2 60.00
4-Bromo-1-chloro-2-(4-ethoxy Methanol Recovery 279.00
45.00
benzyl) benzene
N-BuLi 132.00 Methanol Loss 15.00
Methanesulfonic acid 40.00 Toluene Recovery 236.00
Methanol 300.00 Toluene Loss 13.00
Toluene 250.00 THF Recovery 237.00
THF 250.00 THF Loss 13.00
Sodium bicarbonate 10.00 n-Hexane Recovery 89.00
Sodium chloride 10.00 n-Hexane Loss 5.00
n-Hexane 95.00 Effluent water 512.68
Water 400.00 (Water-390.1,Trimethylsilnol-
50.4,HydrogenBromide-11.18,
Methanol-1,Sodium bicarbonate-
10,Sodium chloride-10,Methane
sulfonic acid-40)
Process Emissions 2.23
(Oxygen-2.23)
Toluene-1)
Total 1597.00 Total 1597.00


Stage-3
Batch Size: 40.0Kgs
in Kg in Kg
Stage-2 60.00 Stage-3 50.00
Triethyl silane 30.00 Acetonitrile Recovery 284.00
Acetonitrile 300.00 Acetonitrile Loss 15.00
MDC 300.00 MDC Recovery 285.00
Sodium bicarbonate 6.00 MDC Loss 15.00
Sodium chloride 6.00 Effluent water 343.98
Water 300.00 (Water-297.6,Triethylsilnol-18.2,
Methanol-4.38,Triethylsilane-11.8,
Sodiumbicarbonate-6,
Sodiumchloride-6)
Acetonitrile-1)
Total 1002.00 Total 1002.00


Stage-4
Batch Size:40.0Kgs
in Kg in Kg
Stage-3 50.00 Dapagliflozin Propanediol 40.00
Propylene glycol 4.00 Isopropyl acetate Recovery 188.00
Isopropyl acetate 200.00 Isopropyl acetate Loss 10.00
Cyclohexane 150.00 Cyclohexane Recovery 142.00
Methanol 250.00 Cyclohexane Loss 8.00
Water 200.00 Methanol Recovery 235.00
Methanol Loss 13.00
Effluent water 206.00
(Water-200,Methanol2,
Propylene Glycol-4)
(Organic Impurities- 10,
Isopropyl acetate-2)

3. PONATINIB
Process Description
Stage-1
4-(4-Methyl-piperazin-1-yl methyl)-3-trifluoromethyl phenyl amine reacts with3-Iodo-4-

methyl-benzoyl chloride and Ethyl-diisopropyl amine in presence of Ethyl acetate as
solvent media to give Stage-1 as a product.
Stage-2
Stage-1 reacts 3-Ethylnyl-imidazo [1, 2-b] pyridazine in presence of MDC as solvent

media to give Ponatinib as product.

PONATINIB
Route of Synthesis
Stage-1
CH3
N
O H3C
I
Cl H3C N CH3
F
H2N
F H3C + CH3 CH3
F +
4-(4-Methyl-piperazin-1-ylmethyl) 3-Iodo-4-methyl-benzoyl Ethyl-diisopropyl-amine
-3-trifluoromethyl-phenylamine chloride C8H19N
C14H19F3N3 C8H6ClIO
129.24
273.30 280.49
Ethyl acetate
CH3
H3C
O
I F H3C N CH3
N
H F Cl
F H
+ CH3 CH3
H3C
3-Iodo-4-methyl-N-[4-(4-methyl-piperazin Ethyl-diisopropyl-amine
-1-ylmethyl)-3-trifluoromethyl Hydrochloride
-phenyl]-benzamide
C8H20ClN
C21H23F3IN3O
165.70
517.33

Stage-2
CH3
N
N
O
N MDC
I F N
N
H F C
F +
H3C CH
3-Iodo-4-methyl-N-[4-(4-methyl-piperazin 3-Ethynyl-imidazo
-1-ylmethyl)-3-trifluoromethyl [1,2-b]pyridazine
-phenyl]-benzamide C8H5N3
C21H23F3IN3O 143.15
517.33
N CH3
N N N
C
N
C
H3C
F
NH
F
F
O
+ HI
Ponatinib Hydrogen iodide

C29H27F3N6O 127.91
532.56

PONATINIB
Flow Chart
4-(4-Methyl-piperazin-1
-yl methyl)-3-trifluoromethyl
phenyl amine Stage-1 Ethylacetate Rec
3-Iodo-4-methyl-benzoyl chloride
Ethyl-diisopropyl amine
Ethylacetate
Stage-1
3-Ethylnyl-imidazo Stage-2 MDC Rec
[1, 2-b] pyridazine
MDC
PONATINIB

PONATINIB
Material Balance
Material Balance of Ponatinib

Stage-1
Batch Size: 50.0Kgs
in Kg in Kg
4-(4-Methyl-piperazin-1-yl Stage-1 55.00
methyl)-3-trifluoromethyl phenyl 35.00
amine
3-Iodo-4-methyl-benzoyl chloride 36.00 THF Recovery 104.00
Ethyl-diisopropyl amine 17.00 THF Loss 6.00
Tetrahydrofuran 110.00 Ethyl acetate Recovery 52.00
Ethyl acetate 56.00 Ethyl acetate Loss 3.00
Water 60.00 Effluent water 81.79
(Water-60, Ethyl-di isopropyl amine
HCl-21.79)
Ethyl acetate-1)

Material Balance of Ponatinib

Stage-2
Batch Size: 50.0Kgs
in Kg in Kg
Stage-1 55.00 Ponatinib 50.00
3-Ethylnyl-imidazo [1, 2-b] MDC Recovery 190.00
16.00
pyridazine
Acetonitrile 100.00 MDC Loss 10.00
MDC 200.00 Acetonitrile Recovery 95.00
n-Hexane 50.00 Acetonitrile Loss 5.00
Water 200.00 n-Hexane Recovery 46.00
n-Hexane Loss 3.00
(Water-200,Hydrogen iodide-
13.5)
n-Hexane-1)

4. POSACONAZOLE
Stage-1
4-Hydroxyphenyl-piperazinyl triazolone reacts with Tosyl sulfonyl methyl ester and

sodium hydroxide in the presence of DMSO as solvent media to give Stage-1 as
product.
Stage-2
Stage-1 product reacts with Hydrogen in the presence of Palladium carbon as Catalyst
by using Acetone as solvent media to give Stage-2 as product.
Stage-3
Stage-2 product undergoes purification with IPA, MDC as solvent media to give
Posaconazole as product

POSACONAZOLE
Route of Synthesis:
Stage-1
F F
N
N N OTs
O
N N O O
HO N
+ N + NaOH
N
2-[(1S,2S)-1-Ethyl-2-benzyloxypropyl]-2,4-dihydro-4 (5R,Cis)-Toluene-4-sulfonic acid-5-(2,4- 40.0

-[[4-(4-hydroxyphenyl)-1-piperazinyl]phenyl]-3H difluorophenyl)-5-(1H-1,2,4-triazol-1-yl)
-1,2,4-triazol-3-one methyltertahydrofuran-3-yl methyl ester
C30H35N5O3 C21H21F2N3O4S
513.63 449.47
DMSO
O CH3
F F
N
O N N N
N O
O
N CH3
N
N
Benzylated Posaconazole
C44H48F2N8O4 O
ONa
790.90 S
O
+ H2O +
p-Toluene sulfonic
18.0
acid sodium salt
C7H7NaO3S
194.18

Stage-2
O CH3
F F
N
O N N N
N O
O
N CH3
N
N
+ H2
Benzylated Posaconazole
Hydrogen
C44H48F2N8O4 2.0
790.90
Acetone
O CH3
F F
N
O N N N
N OH
O
N CH3
N
N +
Toluene
Posaconazole (Crude)
C7H8
C37H42F2N8O4
92.14
700.78

Stage-3
O
F F CH3
N
O N N N
N OH
O
N CH3
N
N
Posaconazole (Crude)
C37H42F2N8O4
700.78
MDC
O
F F CH3
N
O N N N
N OH
O
N CH3
N
N
Posaconazole (Pure)
C37H42F2N8O4
700.78

POSACONAZOLE
Flow Chart:
4-Hydroxyphenyl-piperazinyl
triazolone
DMSO Stage-1 Ethyl acetate Rec
Tosyl sulfonyl
methyl ester
Ethyl acetate
Stage-1
Methanol
Stage-2 Acetone Rec
Hydrochloric acid (35%)
Sodium hydroxide
Acetone
Stage-2
MDC Stage-3 MDC Rec
Isoproponal Isoproponal Rec
POSACONAZOLE

POSACONAZOLE
Material Balance:
Material Balance of Posaconazole

Stage-1
Batch Size: 100.0Kgs
in Kg in Kg
4-Hydroxyphenyl-piperazinyl 145.00 Stage-1 183.00
triazolone
DMSO 1130.00 DMSO Recovery 1073.00
Sodium hydroxide 24.00 DMSO Loss 57.00
Tosyl sulfonyl methyl ester 146.00 Ethyl acetate Recovery 1396.00
Ethyl acetate 1470.00 Ethyl acetate Loss 74.00
Sodium chloride 146.00 Isoproponal Recovery 4778.00
Isoproponal 5030.00 Isoproponal Loss 252.00
Hydrochloric acid (35%) 12.00 Effluent water 2326.50
Water 2080.00 (Water-2080,Generated water-5.1,
Sodium Hydroxide-12.7,
Sodium chloride-146,
water from HCl-7.80,
pToluenesulfonicacidsodiumsalt-54.9,
Tosyl sulfonyl methyl ester-20)
Total 10183.00 Total 10183.00


Stage-2
in Kg in Kg
Stage-1 183.00 Stage-2 110.00
Methanol 2320.00 Acetone Recovery 1803.00
Hydrochloric acid (35%) 66.00 Acetone Loss 95.00
Sodium hydroxide 73.00 Methanol Recovery 2201.00
Acetone 1900.00 Methanol Loss 116.00
Hydrogen 1.00 Isoproponal Recovery 1519.00
Isoproponal 1600.00 Isoproponal Loss 80.00
Palladium carbon 25.00 Toluene Recovery 21.30
Water 6500.00 Palladium carbon Reuse 25.00
(Water-6500,Acetone-2,
Methanol-2,Water from HCl-43,
Sodium Hydroxide-73)
Isopropanol-1)
Total 12668.00 Total 12668.00

Stage-3
in Kg in Kg
Stage-2 110.00 Posaconazole 100.00
MDC 900.00 MDC Recovery 855.00
Isoproponal 1910.00 MDC Loss 45.00
Isoproponal Recovery 1812.00
Isoproponal Loss 96.00
(Organic Impurities10,
Isopropanol-2)
Total 2920.00 Total 2920.00

5. VIDAGLIPTIN
Stage-1
Amantadine Hydrochloride reacts with Sulfuric acid, Nitric acid and Sodium hydroxide in
the presence of MDC as solvent media to give Stage-1 as product.
Stage-2
Stage-1 product reacts with (S)-1-(2-Chlororacetyl) pyrrolidine-2-carbonitrile, Potassium

carbonate in the presence of THF as solvent media to give Vidagliptin as product.

VIDAGLIPTIN
Route of Synthesis:
Stage-1
Cl
MDC
NH2 H
+ H2SO4 + HNO3 + 4NaOH
Amantadine Hydrochloride Sulfuric acid Nitric acid Sodium

C10H18NCl 63.01 hydroxide
98.0
187.75 4X40.0=160.0
HO
Na2SO4 + NaNO2 + NaCl + 4H2O
NH2 +
3-Amino-adamantan-1-ol 142.04 69.0 58.5 4X18=72.0

C10H17NO
167.25

Stage-2
HO
N
NH2 Cl THF
+
+ K2CO3
O CN
3-Amino-adamantan-1-ol (S)-1-(2-Chloroacetyl)pyrolidine Potasisum
C10H17NO -2-carbonitrile carbonate
C7H9ClN2O
167.25 138.21
172.61
HO O CN
NH
N
+ KCl + KOH + CO2
Viladagliptin 74.55 56.11 44.0

C17H25N3O2
303.40

VIDAGLIPTIN
Flow Chart:
Amantadine Hydrochloride
Conc. Nitric acid
Conc. Sulfuric acid Stage-1 MDC Rec
Sodium hydroxide
MDC
Stage-1
(S)-1-(2-Chlororacetyl
)pyrrolidine-2-carbonitrile Stage-2 THF Rec
Potassium carbonate
Potassium Iodide
THF
VIDAGLIPTIN

VIDAGLIPTIN
Material Balance:
Material Balance of Vidagliptin

Stage-1
Batch Size: 60.0Kgs
in Kg in Kg
Amantadine Hydrochloride 78.00 Stage-1 50.00
Conc. Nitric acid 107.00 MDC Recovery 5890.00
Conc. Sulfuric acid 1435.00 MDC Loss 310.00
Sodium hydroxide 1719.00 Cyclohexane Recovery 69.00
MDC 6200.00 Cyclohexane Loss 4.00
Cyclohexane 73.00 Effluent water 6735.30
Water 5000.00 (Water-5000,Generated water-30.1,
Sodium nitrite-28.8,Sodium
Chloride-24.4,Sodium hydroxide-
1652)
Inorganic solid waste 59.42
(Sodium sulphate-59.42)
Spent sulfuric acid 1394.00
Total 14612.00 Total 14612.00

Material Balance of Vidagliptin

Stage-2
Batch Size: 60.0Kgs
in Kg in Kg
Stage-1 50.00 Vidagliptin 60.00
(S)-1-(2-Chlororacetyl)pyrrolidine- THF Recovery 627.00
37.00
2-carbonitrile
Potassium carbonate 80.00 THF Loss 33.00
Potassium Iodide 1.00 Ethyl acetate Recovery 446.00
THF 660.00 Ethyl acetate Loss 24.00
Ethyl acetate 470.00 Potassium Hydroxide Recovery 32.47
Potassium Iodide 1.00
Inorganic Solid waste 43.20
(Potassium chloride-43.2)
Process Emissions 25.50
(Carbondioxide-25.5)
(Organic Impurites-5.83)
Total 1298.00 Total 1298.00

WATER REQUIREMENT DETAILS
S. No Purpose Water Requirement

In KLD
1 Process 5.80
2 Washings 1.00
3 Boiler Make up 12.00
4 Cooling towers Make up 10.00
5 Scrubbing system 1.00
6 Domestic 1.00
7 Gardening 1.00
Total 31.80

WASTE WATER DETAILS
S. No Purpose Effluent
In KLD
1 Process 6.92
2 Washings 1.00
3 Boiler Blow down 2.00
4 Cooling Towers Blow down 2.00
5 Scrubbing system 1.00
6 Domestic 0.70
Total 13.62

HTDS & LTDS DETAILS
S. No Purpose HTDS LTDS Effluent Disposal Method

In KLD In KLD In KLD
1 Process 6.92 0.00 6.92 HTDS Effluent sent to
2 Washings 0.00 1.00 1.00 MEE system and
3 Boiler Blow down 2.00 0.00 2.00 Condensate to ETP.
4 Cooling towers Blow 0.00 2.00 2.00 LTDS effluents treated
down in ETP-RO Rejects to
5 Scrubbing system 1.00 0.00 1.00 ME system and RO
permeate to reuse,
Condensate from MEE
to reuse and MEE
residue to AFTD.
6 Domestic 0.00 0.70 0.70 Septic tank followed
by Soak pit
Total 9.92 3.70 13.62

M/s. BASR Fine Chemicals Pvt. Ltd.
FLOW CHART FOR EFFLUENT TREATMENT
Effluent Treatment Flow

Type
HTDS/HCOD Collection  Equalization & neutralization 
Stripper  MEE  ATFD  TSDF
MEE Condensate will be Reused.
HTDS Collection Equalization & neutralization 
MEE  ATFD  TSDF
MEE Condensate will be Reused.
LTDS/LCOD Collection ETP (Biological Treatment) 
Sand Filter  Carbon Filter  Booster pump to
Membrane Filter set  RO Plant  RO Reject to
MEE RO Permeate to Reused.

M/s. BASR Fine chemicals Pvt. Ltd.
SOLID WASTE DETAILS
S. No Name of the Solid Waste Quantity Disposal Method

In
Kg/Day
1 Organic solid waste 48.00 Sent to Cement Industries
2 Inorganic solid waste 7.10 Sent to TSDF
3 Spent carbon 19.00 Sent to Cement Industries
4 Evaporation salts 174.00 Sent to TSDF
5 Boiler ash 1175.00 Sent to Brick Manufacturers
6 ETP Sludge 0.33 Sent to TSDF
7 Spent solvents 4834.65 Recovery & Reuse

M/s. BASR Fine chemicals Pvt. Ltd.
HAZARDOUS WASTE DETAILS
S. No Description Quantity Mode of Disposal
1 Waste Oils & Grease 100Ltrs/Annum APPCB Authorized Agencies for

Reprocessing/Recycling
2 Detoxified Containers 100No’s/Month After Detoxification sent back to
suppliers/APPCB Authorized
Parties
3 Used Lead Acid 4 No’s/ Annum Send back to suppliers for buyback
Batteries of New Batteries

STACK EMISSIONS FOR BOILER
Particulars Units 2.0 TPH Coal

fired Boiler
Type of Fuel -- Indian Coal
Coal Consumption TPD 5.0
Ash Content % 47
Sulphur Content % 0.8
Nitrogen Content % 1.07
No. of Stacks No 1
Height of stack M 30
Diameter of Stack M 0.60
o
Temperature of Flue Gas C 95
Velocity of Flue Gas m/s 6.5
Particulate Matter at outlet of Bag filter gm/sec 0.21
(Based on 115 mg/Nm3 at outlet)
Sulphur dioxide emission gm/sec 0.46
Oxides of Nitrogen emission gm/sec 0.57

STACK EMISSIONS FOR DG SETS
Capacity Emission Emission Emission Stack Flue Stack Flue gas

In KVA of SPM Of SO2 of NOx dia. Gas Height Velocity
in in in In m Temp. in (m) In m/sec.
Mg/Nm3 Mg/Nm3 Mg/Nm3 in OC
63 KVA 30.0 15.0 18.0 0.10 120 5 14.13

(Existing)
125KVA 60.0 85.0 110.0 0.30 220 10 16.10

(Proposed)

PROCESS EMISSION DETAILS
NON POLLUTING EMISSION
S. No Name of the Gas Quantity In Treatment Method

Kg/Day
1 Carbon dioxide 9.09 Dispersed into Atmosphere
2 Oxygen 1.85 Dispersed into Atmosphere

LIST OF SPENT SOLVENTS
S. No Name of the product Name of the solvent Solvent Solvent

Recovery Recovery
In Kg/Batch In Kg/Day
1 Bosentan Methanol 426.00 213.00
Cyclohexane 143.00 71.50
Toluene 569.00 284.50
THF 380.00 190.00
2 Dapagliflozin Propanediol MDC 570.00 475.00
Toluene 387.00 322.50
Methanol 514.00 428.33
THF 237.00 197.50
n-Hexane 89.00 74.17
Acetonitrile 284.00 236.67
Isopropyl acetate 188.00 156.67
3 Ponatinib THF 104.00 104.00
MDC 190.00 190.00
Acetonitrile 95.00 95.00
n-Hexane 46.00 46.00
4 Posaconazole DMSO 1073.00 357.67
Isoproponal 8109.00 2703.00
Acetone 1803.00 601.00
Methanol 2201.00 733.67
MDC 855.00 285.00
5 Vidagliptin MDC 5890.00 1472.50
THF 627.00 156.75
Total 26885.00 10158.84

PRE FEASIBILITY REPORT

1. Executive Summary NA
2. Introduction of the project/ Background information. -
(i) Identification of project and project proponent. In case NA

of mining project, a copy of mining Lease/ letter of
intent should be given.
(ii) Brief description of nature of the project. R& D and Pilot scale Manufacturing
Of Bulk Drugs & Intermediates.
(iii) Need for the project and its importance to the Enclosed
country and or region
(iv) Demand-Supply Gap. -
(v) Imports vs. Indigenous production. -
(vi) Export Possibility. Yes
(vii) Domestic / export Markets. Yes
(viii) Employment Generation (Direct and Indirect) due to DIRECT- 55

the project. INDIRECT- 20
3. Project Description
(i) Type of project including interlinked and R& D and Pilot scale Manufacturing
interdependent projects, if any Of Bulk Drugs & Intermediates.
(ii) Location (map showing general location, specific Enclosed

location, and project boundary & Project site layout)
with coordinates.
(iii) Details of alternate sites considered and the

basis of selecting the proposed site, particularly
the environmental considerations Gone into should --
be highlighted.
(iv) Size or magnitude of operation. Small Scale Industry(SSI)
(v) Project description with process details (a schematic Enclosed

diagram/ flow chart showing the Project layout,
components of the project etc. should be given)
(vi) Raw material required along with estimated Enclosed
quantity, likely source, marketing area of final
product/ s, Mode of transport of raw Material And
Finished Product.
(vii) Resource optimization/ recycling and reuse envisaged NA
in the project, if any, should be Briefly outlined.
(viii) Availability of water its source, Energy/ power Bore well water.
Requirement and source should be given.

(ix) Quantity of wastes to be generated (liquid and solid) ---

and scheme for their Management/disposal.
(x) Schematic representations of the feasibility Drawing NA

which give information of EIA purpose.
4. Site Analysis
(i) Connectivity. ---

(ii) Land Form, Land use and Land ownership. Industrial Land
(iii) Topography (along with map). Yes
(iv) Existing land use pattern (agriculture, non- Industrial Land

agriculture, forest, water bodies (including area
under CRZ) ), shortest distances from the periphery
of the project to periphery of the forests, national
park, wild life sanctuary, eco sensitive areas, water
bodies (distance from the HFL of the river), CRZ.
In case of notified industrial area, a copy of the
Gazette
Notification should be given.
(v) Existing Infrastructure. Industrial Land

(vi) Soil classification Mixed Soil
(vii) Climatic data form secondary sources. Will be submitted in EIA Report
(viii) Social Infrastructure available. --
5. Planning Brief
(i) Planning Concept (type of industries, facilities, NA

transportation etc) Town and Country Planning /
Development authority Classification
(ii) Population Projection
(iii) Land use planning (breakup along with green belt

etc).
(iv) Assessment of Infrastructure Demand (Physical &

Social).
(v) Amenities /Facilities.
6. Proposed Infrastructure
(i) Industrial Area (Processing Area). --
(ii) Residential Area (Non Processing Area). ---
(iii) Green Belt. 469.90 SQM (It is 33% of the total

site area)

(iv) Social Infrastructure. ---
(v) Connectivity (Traffic and Transportation Road/Rail/ ---

Metro/ Water ways etc)
(vi) Drinking Water Management (Source & Supply Potable water

of water)
(vii) Sewerage System. Septic tank flowed by soak pit
(viii) Industrial Waste Management. MEE System in Plant
(ix) Solid Waste Management. TSDF, Dundigal village,

Quthbullapur (M), Rangareddy (Dt.)
(x) Power Requirement & Supply / source. 250 H.P, APSPDCL
7. Rehabilitation and Resettlement (R & R) Plan
(i) Policy to be adopted (Central/ State) in respect NA

of the project affected persons including home
oustees, land oustees and landless laborers (a
brief outline to be given)
8. Project Schedule & Cost Estimates
(i) Likely date of start of construction and likely -----
date of completion ( Time schedule for the
Project to be given).
(ii) Estimated project cost along with analysis in terms of 4.50 Crores
economic viability of the project.
9. Analysis of proposal (Final Recommendations)
(i) Financial and social benefits with special These types of industries will
emphasis on the benefit to the local people contribute in development of local
Including tribal population, if any, in the area. villagers because of employment to
the locals.

Proposed Draft Terms of Reference for Preparation of EIA & EMP

For M/s. Syn- Finechem Laboratories Pvt. Ltd.
01. Executive summary of the project

02. Justification of the project
03. Promoters and their back ground
04. Regulatory framework
05. A map indicating location of the project and distance from severely polluted areas
06. Project site location along with site map of 10 km area and site details providing various
industries, surface water bodies, forests etc.
07. A copy of Gazette Notification issued by the Govt. of Andhra Pradesh indicating location
of the project in Notified Industrial Area
08. Plant Layout
09. Infrastructure facilities including power sources
10. Total cost of the project along with total capital cost and recurring costs environmental
pollution control measures
11. Present land use based on satellite imagery for the study area of 10 km radius.
12. Details of the total land and break-up of the land use for green belt and other
uses
13. Location of National Park/Wild life sanctuary/Reserve Forest within 10 km radius
of the project
14. List of products along with the production capacities
15. Maximum number of products and its production capacity to be manufactured at a time
(worst-case scenario)
16. Detailed list of raw material required and source, mode of storage and transportation.
17. Explore the use of solvent other than benzene
18. Manufacturing process details along with the chemical reactions and process flow chart.
19. Site-specific micro-meteorological data using temperature, relative humidity, hourly
wind speed and direction and rainfall is necessary
20. Ambient air quality monitoring at 6 locations within the study area of 10 km., aerial
coverage from project site
21. One season site-specific micro-meteorological data using temperature, relative humidity,
hourly wind speed and direction and rainfall and AAQ data (excluding monsoon season) for
PM2.5, PM10, SO2, NOx and VOCs including
22. The monitoring stations should take into account the pre-dominant wind direction,
population zone and sensitive receptors including reserved forests. Data for water and noise
monitoring should also be included
23. Air pollution control measures proposed for the effective control of gaseous
emissions within permissible limits. Multicyclone followed by bag filter to be
provided to boiler to control particulate emissions
24. Name of all solvents to be used in the process and details of solvent recovery system.
25. Design details of ETP, incinerator, boiler, and scrubbers/bag filters etc.
26. Details of water and air pollution and its mitigation plan
27. An action plan to control and monitor secondary fugitive emissions from all the Sources
28. Determination of atmospheric inversion level at the project site and assessment of ground
level concentration of pollutants from the stack emission based on Site-specific
meteorological features
29. Air quality modelling for proposed plant
30. Action plan for Zero Liquid Discharge of effluent should be included. Segregation of the
Wastewater should be based on the pollution load and high TDS effluent should be treated in
MEE
31. Ground water quality monitoring minimum at 6 locations should be carried out.
32. Geological features and Geo-hydrological status of the study area and ecological status
(Terrestrial and Aquatic)
33. The details of solid and hazardous wastes generation, storage, utilization and disposal
particularly related to the hazardous waste calorific value of hazardous waste and detailed
characteristic of the hazardous waste. Action plan for the disposal of fly ash generated from
boiler should be included
34. Precautions to be taken during storage and transportation of hazardous chemicals should
be clearly mentioned and incorporated
35. Membership for the disposal of liquid effluent in CETP or Zero Liquid discharge action
plan and solid/hazardous waste in TSDF
36. An action plan to develop green belt in 33 % area
37. Occupational health of the workers needs elaboration including evaluation of Noise, heat,
illumination, dust, any other chemicals, metals being suspected in Environment and going
into body of workers either through inhalation, ingestion or through skin absorption and steps
taken to avoid musculo-skeletal disorders (MSD), backache pain in minor and major joints,
fatigue etc. Occupational Hazards specific pre-placement and periodical monitoring should
be carried out
38. Socio-economic development activities should be in place
39. Note on compliance to the recommendations mentioned in the CREP guidelines
40. Detailed Environment management Plan (EMP) with specific reference to details of air
pollution control system, wastewater management, monitoring frequency, responsibility and
time bound implementation plan for mitigation measure should be provided
41. Any litigation pending against the project and/or any direction/order passed by any Court
of Law against the project, if so, details thereof
42. A tabular chart with index for point wise compliance of above TORs

# Syn-Finechem Laboratories Pvt. Ltd.
PROJECT REPORT
R&D, PILOT SCALE MANUFACTURE
OF
BULK DRUGS AND INTERMEDIATES
Syn-Finechem
Laboratories Pvt. Ltd.
OFFICE
# D-151, Phase – IIII D A, Jeedimetla,
Hyderabad – 500055 Andhra Pradesh, India.
Tel: 040-23095094Fex: 040-23194700
70
CONTENTS
A. Glimpse
B. Brief Details of the Project
C. About Promoters & group concern
D. Product Description
E. Market Survey
F. Infrastructure facilities
G. Technical Know-How
H. Selling and Marketing Arrangement.
I. Swot Analysis
J. Risk factors and mitigation
K. Proposed Layout of Plant
71
GLIMPSE
Name of the Unit : Syn-Finechem Laboratories Pvt. Ltd.
Constitution : PRIVATE LIMITED

.
Proposed Location of Unit : D-151, Phase - III
IDA, Jeedimetla,
Hyderabad - 500055
Andhra Pradesh.
Corporate Office : Syn-Finechem Laboratories Pvt. Ltd

D-151, Phase _ III, IDA, Jeedimetla
Hyderabad - 500055.
Line of Activity : R&D and Pilot scale Manufacturing of Bulk Drugs

. And Intermediates
Installed Capacity : 4.7 TPM
Managing Director : 1. Dr. B. Saida Reddy
Director 2. Mrs. B. Chandra Kala
Director 3. Mr. B. Kartheek Reddy
Director 3. Mr. B. Ashwik Reddy
72
COST OF PROJECT:
Particulars Amount
Rs in laks
Land 100.00
Building, Civil works& site development 100.00
Plant and Machinery 100.00
Furniture, Fixtures and other assets 50.00

Preliminary Pre operative 40.00
Liasoning work 20.00
Marginal money for working capital 40.00
Total 450.00
Means of Finance
Promoters Capital 100.00
Working capital 100.00
Total 450.00
Brief Details of the Project:

Syn-Finechem Laboratories Pvt. Ltd. is incorporated by technocrats of varied
experience, with the main object of producing Bulk drug, Bulk drug intermediates for
MNCs, with its registered Office situated in Hyderabad, considered as capital of Drugs
and Pharmaceutical companies in India. The Company acquired 1600 Sq.Meters of
land in D-151, Phase – III, IDA, Jeedimetla, Hyderabad (Dt), Andhra Pradesh.
The company is planning to set-up in house R & D facility to develop new products.
The plant is designed for production of any product at any time, depending upon
prevailing demand, without making any major alteration to the equipment.
Land & site development:

The Company acquired 1600 Sq.Mts. of land in D-151, Phase – III, IDA, Jeedimetla,
Hyderabad (Dt), Andhra Pradesh. Out of the 1600 Square Meters of land acquired, the
company proposes to utilize around 1200 SQM of land towards establishing the
manufacturing facilities, administrative block, utilities and storage areas and towards
Roads Development. The company has allocated the balance area of 400 SQM for
green-belt development.
73
Building and Civil Work:
The company has constructed the basic structures required for housing the machinery
& equipment, stores at a cost of Rs. 3.50 Crores Cost for civil works is around 1.00
Crores. The buildings are completed erecting the machinery & equipment. A detailed
statement of area-wise civil works completed by the Company as on date is prepared.
Plant & Machinery:
All the Plant and Machinery required for the proposed project would be procured
indigenously and the Cost for the equipment is around 450.00 Lakhs.
Plant & Machinery
1 Production Block
250.00
2 QC & QA
50.00
3 Ware House
20.00
4 Utility Blocks
a) Service Block
30.00
b) Boiler Block
10.00
c) Power Generation& Main controls
10.00
d) HT Yard
10.00
5 Effluent Treatment Plant (ETP)
70.00
Total Plant & Machinery
450.00
Furniture fixtures and other Assets:

The furniture and fixture proposed to be purchased include production furniture, fixture
involving production tables, workers stools, office cabinets and racks, executive tables,
chairs, office filling cabinets. Vehicles will be purchased for facilitating movements or
workers and materials.
74
Implementation Schedule:
Activity Time frame for completion
Acquisition of land and Land Acquired
development
Construction of factory Constructed
buildings
Plant and Machinery. -
Process Equipment Installed and under working condition
-
Commercial Production August-2003
Preliminary and preoperative expenses:

Preliminary and preoperative expenses are estimated at Rs. 40.0 lacs from the start up
time of this project till the commencement of commercial production. The expenses
include Rents, travel cost, salary and wages, legal and professional charges and
interest during the construction period. The cost also includes the expenses incurred in
the production trial runs before commencement of commercial production.
THE PROMOTERS
Dr. B. Saida Reddy, Doctorate in Chemistry, has work experience of more than
25years Bulk Drug industries.
Mrs. B. Chandra Kala, Post Graduate in Economics, has work experience of more than
10 years.
Mr. B. Kartheek Reddy, B. Tech in Electrical Engineering, has work experience of more
than 5 years.
Mr. B. Ashwik Reddy, B. Tech in Chemical Engineering from IIT, has experience in
Designing of Reactors, Condensers and Distillation Columns.
75
PRODUCT DESCRIPTION
Intermediates which are the active ingredients with medicinal properties and are the
best raw materials for making Bulk Drugs and Formulations which are specific dosage
forms of a Bulk Drug or of a combination of different Bulk Drugs and the final form in
which the drugs are sold i.e. syrups, injections, tablets, and capsules.
The Company proposes to manufacture the following products and their
intermediates.
PROPOSED PRODUCTS
S. No Product Name Quantity In

Kg/Month
1 Bosentan 750.00
2 Dapagliflozin Propanediol 1000.00
3 Ponatinib 1500.00
4 Posaconazole 1000.00
5 Vildagliptin 450.00
Total 4700.00
MARKET SURVEY
The field of Bulk Drugs and intermediates is broad-based. It covers all products and
preparations used in the production of pharmaceutical formulations. The bulk drugs
industry segment in India has been able to establish its presence in the international
markets and more than 60 percent of its produce is exported. This segment has
managed tremendous growth, with production of only Rs. 0.18 billion in 1960, rising to
Rs. 10.0 billion by 2005 and hence meeting 70 percent of the domestic requirement.
The segment is a net foreign exchange earner producing export quality drugs; with bulk
drugs export accounting for 60 percent of the total pharma industry exports. Exports of
bulk drugs are growing by 30 percent per year. But given the size of the world market,
supply from India is miniscule – India’s exports account for only 1.0 percent of the
worldwide demand. In terms of the inputs used in production of drugs the industry faces
low cost of inputs at competitive rates helped by the presence of a well developed
chemical industry.
76
As the manufacture of most bulk drugs is neither capital intensive nor technology
intensive, process re-engineering encouraged the growth of production bases. There
are a large number of bulk drug manufacturers in India, including many small scale
industries. This has increased competition, leading to a drop in prices and consequently
lower margins. Most bulk drugs under the DPCO sell below the government
administered prices due to stiff competition and lower import tariffs.
PHARMACEUTICAL INDUSTRY – GLOBAL SCENARIO
As per IMS Retail Drug Monitor, sales through pharmacies in thirteen leading markets
for the year to August 2003 are $ 298.7 Billion. According to the IMS World Review, in
2004, global audited sales of pharmaceuticals rose 8% (at a constant dollar rate) to
reach US $ 400.6 Billion. IMS world Review tracks actual sales of approximately 90% of
all prescription drugs and certain over-the-counter (OTC) products in more than 70
countries. Using proprietor data projection methodologies to estimate total global
pharmaceuticals sales, which grew to US $ 430.3 Billion in 2005. Despite economic
challenges in the worlds leading markets and a lower-than-normal number of new
product introductions, the global pharmaceutical industry experienced good growth in
2005.
PHARMACEUTICAL INDUSTRY – DOMESTIC SCENARIO

The Indian Pharmaceutical Industry today is in the front rank of India’s Science-based
industries with wide ranging capabilities in the complex field of drug manufacture and
technology. The Indian Pharmaceutical industry is estimated to be worth US $ 8.0
billions at present, growing at a CAGR of over 15 % annually. If India‘ s high
Economic growth rate holds steady, the pharmaceuticals market will triple to $ 24 billion
by 2015 and become one of the world` s top 10 markets according to a study by
McKinsey and company ,a leading management consulting firm. At a compounded
annual growth rate of 15.0 %, the absolute growth of $ 24 billion will be next to the
growth potential of the US and China, and in the same league as the growth in Japan
and Canada and the UK. Five factors will drive the growth of the Indian
77
Pharmaceuticals market over the next decade; Doubling of disposable incomes and
the increase in numbers of middle class households , significant expansion of medical
infrastructure, greater penetration of health insurance, a gradual shift in disease profile
and adoption of patented products, and finally population growth.
It ranks very high in the third world, in terms of technology, quality and range of
medicines manufactured. Playing a key role in promoting and sustaining development in
the vital field of medicines, the Indian Pharmaceutical Industry boasts of quality
producers and many units approved by regulatory authorities in USA and UK.
Internationally Companies associated with this sector have stimulated, assisted and
spearheaded this dynamic development in the past 50 years and helped to put India on
the pharmaceutical map of the world.
The Indian Pharmaceutical sector has more than 20,000 registered units. It has
expanded drastically in the last two decades. The leading 250 pharmaceutical
Companies control 70% of the market. The pharmaceutical industry in India meets
around 70% of the country’s demand for bulk drugs, drugs intermediates,
pharmaceutical formulations, chemicals, tablets, capsules, orals and injectables. There
are about 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). These units
produce the complete range of pharmaceutical formulations, i.e. medicines ready for
consumption by patients and about 350 bulk drugs, i.e. chemicals having therapeutic
value and used for production of pharmaceutical formulations.
PHARMACEUTICAL INDUSTRY – HYDERABAD SCENARIO

Hyderabad has emerged as major drug manufacture city with a presence in global
market. Pharma industry in the state contribute more than one third to the country’s total
production. During 2005-06, the State produced bulk drugs and formulations worth US $
2.5 billion.
78
The exports from the state stood at US $ 1.0 billion in 2004-05 registering an annual
growth of more than 20%. The sector accounts for about 20 % of the total exports from
state.
Most of the companies have set up their R&D facilities in the state, thus making the
state the pharmaceutical capital of the country.
Hyderabad has developed as a major production center for bulk drugs due to the
location if the many major Pharmaceutical Industries such as Dr. Reddy’s Laboratories,
Aurobindo Pharma, Neuland Laboratories, Siris, Hetaro Drugs, Divis Labs, Natco
Pharma Limited, Matrix Labs, Nicholas Piramal etc., besides a large number of medium
and small industries manufacturing bulk drugs of all kinds.
To name a few Ge, AstraZeneca, Biocon, Cipla, Strides Arcolab, Himalaya drugs,
Karnataka antibiotics and pharmaceuticals ltd, Hinkle and Micro labs.
In support of this growth in Hyderabad and Bangalore, many basic chemical units and
drug intermediate units have also come up to meet the input requirements of Bulk Drug
manufacturing Companies. Large numbers of these units are still dependent on supply
of basic chemicals mainly from Mumbai, Gujarat and other parts of the country involving
heavy expenditure on transport and transit risks.
So, considering the above factors, it is assured that setting up of basic drug
intermediate unit near Hyderabad will be of better prospect as we can meet the needs
of the Bulk Drug units located in and around Hyderabad. The products can be supplied
to the bulk consumers speedily and at lower prices reducing transport cost and time and
transit risks. The products can also be exported easily of proper marketing tie-ups are
made with the overseas bulk drug manufacturers in the due course as there is good
export potential for the basic drugs and intermediates.
79
UTILITIES
a) Power
Requirement of power and its arrangements:
The company has 74 H.P. power connected and required 176 HP for the proposed
project from state electricity board. The company also having 1DG set of 63 8KVA and
to acquire 1 more DG set of 125 KVA as standby arrangement.
b) Water
Requirement of Water
The unit requires about 31.80 KLD of water per day for process and other uses. The
required amount of water can be obtained by Bore well water.
C) Boiler
The company proposes to install 2.0 MT/Hr coal fired boilers.
c) Man power:
The man power requirement of project is as under:
Particulars No. of Functional Area
employees
Key managerial staff 5 Finance, Marketing, Production, Quality
control, R&D, Logistics etc.
Administration 10 Office work
Skilled and semi 40 Production Process, Maintenance, stores,
skilled Safety & Un skilled workers
Total 55
Qualified and Skilled man power is available in and around Hyderabad on permanent
and temporary basis. We can also utilize services of experts on ad-hoc basis for
production of specialty products.
80
The company is planning to have good team of employees in all areas. Looking in to
long term planning, company will take all the necessary steps to develop a good team of
work force. The company will provide all basic amenities to staff such as Medical
Health, children education, transport, canteen facility, transport, clothing, financial
assistance, family welfare etc.
The company will organize training classes for all the staff in the areas of Process up
gradation, Quality control, cost reduction techniques, safety etc.
d) EFFLUENT (WASTEWATER), SOLID WASTE TREATMENT & DISPOSAL:

The industry shall adopt and follow an environmental management plan for abatement
of pollution and overall enhancement of the quality of environment in and around the
unit.
About 12.92 KL / day of effluent (wastewater) is generated from process and utilities.
The Company proposes to have a full pledged Effluent Treatment Plant (ETP) to treat
the effluent as per the norms.
Part of the treated effluent would be recycled and used for the process.
Part of treated effluent is sent for JETL for final treatment. The residue collected from
forced evaporation and solid waste/ Semisolid would be stored in HDPE drums/Bags
and disposed to TSDF facility.
e) GREEN BELT DEVELOPMENT:

Green belt with selected perennial plant species developed in all around the site. This is
to be considered as an essential requirement against pollution though it may add to the
initial costs of the project. The green belt is considered essential because of the
following:
• Plants act as pollutant sinks

• Green belt helps in noise attenuation
• Green belt balances ambient oxygen and carbon dioxide levels
• Green belt leads to a significant drop in air temperature near the manufacturing
shed.
81
TECHINCAL KNOW-HOW
The process of manufacturing Bulk drug Intermediates is semi-automatic with proven

technology. The process requires supervision of experienced in-charge to control yield
and quality. No specialized know-how is required for the process. The input mix is
standardized and the output is standardized in weight.
To supervise day to day production process, the company will appoint technically
qualified and experienced persons having relevant experience in the line of
manufacturing of Bulk drug intermediates.
The Unit will have well experienced, skilled and dedicated work force.
Selling and Marketing Arrangement:
The Company, by virtue of its well experienced directors in the field of Bulk drugs and
pharmaceuticals, has well established market connections. The company directors have
good relations with top executives of many reputed pharma companies and traders by
virtue of which fresh orders can be organized at any given time. Many recognized
companies assured their orders to the company and many more orders are expected
based on the completion of facility and regular production.
Our products and their intermediates are used in many organizations, and it is proposed
to enter into long term contract with these organizations. To name a few
S. No Name of the Company/trader

1 MSN Labs Pvt.Ltd.– Hyderabad
2 Sionc Pharma-Vizag
3 Dr.Reddy’s Ltd-Hyd
4 Astra Zeneca-UK
5 Apicore Labs Pvt.Ltd.-India
6 Alfa-aesar-UK
7 Sigma-Aldrich-USA
8 Zydus 82cadila-Mumbai
9 Lifeline industries-Mumbai
82
10 Micro labs-Bangalore
11 Auctus Pharma Limited
12 Hinkle Pharma
13 Cipla
14 Laurua Labs Ltd -.India
Also, the Company proposes to have its own market network by appointing experienced
marketing staff and dealers to sell the products.
The company also approached many prospective buyers who have assured to give their
requirement on conversion basis (Buy back arrangements) so that the company can
have both self products and conversion market also. This will enable the company to
have better control in plant operation, better market and financial flexibility.
SWOT Analysis
Strengths:
• The Promoters are technically qualified, well experienced and financially sound
besides possessing the required managerial competence and business skills to
make proposed project and successful and profitable venture.
• Procurement of raw material is very easy, since Hyderabad and Bangalore being
major pharma production center in India.
• The Project is located in the Heart of Industrial area Hyderabad
• Well Developed Industry with Strong Manufacturing Base and present industry
conditions are favorable.
• Access to pool highly trained scientists.
• Competencies in technology and process development
• Cost competitiveness in Global Market.
Opportunities:
• Significant Export potential
• Licensing deals with MNCs
• Marketing alliances to sell MNC products in domestic market
• Contract manufacturing arrangements with MNCs
• Supply of generic drugs to developed markets

83
Threats:
• Product patient regime poses serious challenge to domestic industry unless it

invests in research and development.
• R&D efforts of Indian pharmaceutical companies hampered by lack of enabling

regulatory requirement. For instance, restrictions of animal testing outdated
patent office.
• Drug Price Control Order puts unrealistic ceilings on product prices and
profitability and prevents pharmaceutical companies from generating investible
surplus.
• Lowering of tariff protection
• The new MRP based excise duty regime threatens the existence of many small
scale pharma units, especially in the states of Andhra Pradesh and Maharashtra
that were involved in contract manufacturing for the larger, established players.
These companies are now shifting their manufacturing from these states to
states like Himachal Pradesh, Uttaranchal that enjoy tax holidays.
Risk Factors and mitigation
1. The company is promoted by first generation entrepreneurs
Though the Company is promoted by first generation entrepreneurs, the Promoters are
technically qualified, well experienced and financially sound besides possessing the
required managerial competence and business skills to make proposed project a
successful and profitable venture. Further the Company has identified and proposes to
appoint professionals in key areas of Production, Research & Development, marketing,
logistics and Finance.
2. The Company operates in a globally competitive business environment.

Growing competition may force the company to reduce the prices of its products
and services, which may reduce its revenues and margins and/or decrease its
market share, either of which could have a materially adverse effect on its
business, financial condition and results of operations.
The company aims to keep abreast with the dynamic business scenario and will broad-
based its product mix. The Company, continuous R&D activities, will develop better
process technology, improved process yield, sourcing of raw material at competitive
price and development of new products/processes.
84
3. The prices of Raw Material/solvent consumed by the Company are susceptible
to volatility. A majority of these raw materials are basic chemical, the demand for
which is not dependent on demand by pharmaceutical industry. The other
industries, which are generally much bigger consumer of such chemicals, tend to
determine market prices of such basic chemicals; such volatility may affect
company’s profitability.
The raw materials consumed are general chemicals and are available in India as well as
in many countries around the world at competitive prices. The company does not see
any problem in procuring the raw material/solvent at competitive prices.
4. Expansions: Enhancement in production capacity by primary/main producers

in our country may drive the industry into excess production.
All the major producers are having plans to go for expansion in the production facilities.
The other primary producers are having high fixed overheads and their market is
through dealers. But the Company is having established market connections
85

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M/s. Syn- Finechem Laboratories Pvt. Ltd.

S. No Content Name Page No’s

3 List of Raw Materials 14-18

4 Process Description 19-54

5 Water Consumption Details 55

6 Waste water Details 56-57

7 ETP Flow Chart 58

8 Solid Waste Details 59-60

9 Stack Emission Details 61-62

10 Process Emission Details 63

12 Pre-feasibility Report 65-67

13 Draft TOR 68-69

14 Project Report 70-85

15 Copy of GOs Enclosed

16 Industrila area Notification Enclosed

17 Pollution Load Details Enclosed

18 Topo Map Enclosed

19 Site Plan Enclosed

20 Copy of CFO Enclosed

21 CFO Compliance Report Enclosed

22 TSDF Membership Enclosed

23 Consultant Details Enclosed

Prepared by Rightsource Industrial Solutions Pvt Ltd

S.NO ITEM DETAILS

15. Address for correspondence: Rightsource Industrial Solutions Pvt Ltd

Name Dr. B.S.Reddy

Prepared by Rightsource Industrial Solutions Pvt Ltd. 1

Pin Code 500 072

Prepared by Rightsource Industrial Solutions Pvt Ltd. 2

1.6 Demolition works? No No demolition work

Domestic effluent will be treated in

Effluent will be treated in ETP

ETP sludge & Hazardous waste will be

Prepared by Rightsource Industrial Solutions Pvt Ltd. 3

Prepared by Rightsource Industrial Solutions Pvt Ltd. 4

2. Use of Natural resources for construction or operation of the Project (such as

S.No Information/Checklist Yes/No Details thereof (with approximate

2.2 Water (expected source & Yes 31.80 KLD

2.3 Minerals (MT) No No Minerals required

In addition to the above existing, the

Fuel: HSD about 150 Liters per day

Steam: Boiler (Coal Fired) 2.0TPH – 1 No

• Fuel: Coal – 5.0 TPD

2.7 Any other natural resources No None

Prepared by Rightsource Industrial Solutions Pvt Ltd. 5

3. Use, storage, transport, handling or production of substances or materials, which

S.No Information/Checklist Yes/No Details thereof (with approximate

4. Production of solid wastes during construction or operation or decommissioning

S.No Information/Checklist Yes/No Details thereof (with approximate

4.5 Surplus product No Surplus production is not envisaged since

4.7 Construction or No No demolition waste will be generated.

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr)

S.N Information/Checklist Yes/No Details thereof (with approximate

Prepared by Rightsource Industrial Solutions Pvt Ltd. 7

6. Generation of Noise and Vibration, and Emissions of Light and Heat

S.No Information/Checklist Yes/No Details thereof (with approximate

S. No Information/Checklist Yes/No Details thereof (with approximate

7.4 From any other sources No Process emissions are controlled by

S. No Information/Checklist Yes/No Details thereof (with approximate

8.3 Could the project be affected No Not envisaged.

9. Factors which should be considered (such as consequential development) which

S. No Information/Checklist Yes/No Details thereof (with approximate

* Housing development No No roads will be laid, since plant site is