Professional Documents
Culture Documents
SUBMITTED TO
MINISTRY OF ENVIRONMENT & FORESTS, GOI
PARYAVARAN BHAWAN, CGO COMPLEX,
LODHI ROAD, NEW DELHI-110003
CONTENTS
LIST OF FIGURES
LIST OF ANNEXURES
Annexure Description
I Typical Technical details of proposed products
II List of Raw materials
Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
1. Introduction
The unit obtained TOR for the proposed unit from SEAC, Maharastra and
submitted draft EIA Report based on Model TOR’s on April 5th 2014. The
proposed unit is located in Notified industrial Area, MIDC, Chincholi, As
the unit is within 5 KM from the proposed eco sensitive zone of the Nanaj
Sanctuary Great Indian Bustard sanctuary.
In the year 2014, Hon. Supreme Court had given directions to all State
Govts. to finalize the ESZs for all the PAs coming under them. Further,
directions were given by Hon. Supreme Court that in absence of finalized
ESZ or for a period till the ESZ gets finalized, a distance of 10 Km from
the boundary of PA would be treated as ESZ.
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Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
Hence this application is made for obtaining fresh TOR. As the unit is
located in IE, Chincholi which is notified industrial area established prior
to 2006 notification, Public hearing may be exempted for this unit.
The company recognized the vital role of R & D for becoming successful in the
generic market. The proposed project under consideration would be located at
Plot No. F-1, MIDC, Chincholi, Taluka -Mohol, Dist. Solapur, State –Maharashtra.
state.
The company has Headquarter in Hyderabad, India, and is catering to the ever
growing demand of Active Pharmaceutical Ingredients (API’s) from single State-
of-the-art manufacturing facility. Already established unit in Chincholi MIDC
(Maharashtra) and has built up a reputation for excellence on the foundations of
consistent high quality, a constantly expanding product portfolio and timely
launches of new API’s.
The in-house QC Laboratories are equipped with sophisticated instruments to
assure the quality of the raw materials, intermediates and API’s. The company
believes in quality by design and continuous improvement in all aspects of its
operations. By this endeavor, Sri Krishna Pharma necessitates to recognize in
the global market of Pharmaceuticals as an important partner for API’s.
3
Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
About Proponent
The management at Sri Krishna Pharmaceuticals Limited consists of highly
qualified and richly experienced persons who have given the company the edge
in terms of quality, consistency, timely delivery and ability.
The Group is headed by a technocrat with academic excellence. Dr. V.V. Subba
Reddy, Founder Chairman is a Post Graduate in Technology, Doctorate in
Science and a Post-Doctoral fellow from National Cancer Institute, NIH,
Maryland, USA. He also serves various trade associations, Government bodies
and Institutions as a representative of the pharmaceutical industry in India.
Quality Management: Strict quality control measures, Good Manufacturing
Practices (GMP) are integrated throughout the manufacturing process to ensure
strict adherence to the quality parameters for both in-process and finished
products.
3. Project Description
SKPL intends to manufacture 2545 TPM of API (Bulk Drug & Intermediates)
products. Product wise capacity is given below:
TABLE 2.0
PROPOSED PRODUCTS & CAPACITY
Quantity
S.No Name of the Products Remarks
in TPM
400 Starting from PNCB -4
1A Paracetamol- 4 stages
Stages
1100 Starting from Penultimate
1B Paracetamol – 2 stages
stage-2 Stages
2 Ibuprofen 500
3 Metformin 500
4 Domperidone 15
Dextromethorphan
5 20
Hydrobromide
6 Omega -3 10
Total 2545
By Product
Generates in the process
1 Acetic Acid 1788
and
sold to consumers
2 Soap 40.0
4
Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
Brief process description and process flow charts are given at Annexure I
The water requirement for process, domestic, gardening, boiler feed & for
cooling water make up is about 1430.0 KLD. The source of water is already
available from existing water works of MIDC and the same is adequate and
satisfactory. The water balance for daily consumption is presented below.
TABLE 3.0
Water Balance–Proposed
5
Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
High TDS and High COD stream would be treated in stripper followed by
MEE and ATFD. The resultant sludge would be disposed to TSDF,
Hyderabad. The Low TDS stream would be treated along with MEE/ATFD
condensates in biological ETP followed by RO. The RO rejects would be fed
back to MEE. The Permeate from RO would be used for cooling tower
make up. Domestic effluents are treated in sewage treatment plant. Thus
the treatment system proposed is based on “Zero Liquid Discharge” (ZLD)
Concept.
The schematic diagrams of ETP proposed are given in Figure 1.1 and
Figure 1.2 below
6
Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
Fig 1.1
Schematic Treatment Scheme of High TDS Effluents
Effluent from
Process and Equalization Neutralization Settling Aq. Distillate to
Stripper
Cement Plant/TSDF Recovery
Tank Tank Tank
Washings,
Scrubber
RO Reject
To TSDF
Condensate to
MEE Biological
Treatment
ATFD
Condensate to Biological Treatment
Sludge to TSDF
7
Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
Domestic effluent
Screen
Chamber
Effluents from utilities & MEE condensate
Holding
Tank
Sludge Holding
Tank
Sand
filter
Carbon
Filter Press Filter
Sludge to TSDF Sludge Cake
Ultra
Permeate for re-use RO
filtration
Rejects to MEE
8
Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
TABLE 4.0
Solid Wastes and Disposal
S. Schedule Quantity in
Type of waste Disposal
No No. TPM
Hazardous waste
1 ETP Sludge 34.3 30.0 CHWTSDF
MEE salts / ATFD
2511.0
2 salts and 34.3 CHWTSDF
inorganic residue
3 Spent carbon 28.2 47.5 CHWTSDF
Distillation
bottom Authorized cement
4 20.3 412.4
Residue/process Industries/ CHWTSDF
sludge
5 Spent solvents 28.5 52.0 CHWTSDF
Authorized cement
6 Iron sludge 28.1 580.0
Industries
Authorized recyclers/
7 Waste oil 5.1 0.2
CHWTSDF
Authorized recyclers/
8 oil from process 5.1 10.0
CHWTSDF
Send to E- waste
9 E- Waste - 0.240
Recycler
Return to supplier for
Used Lead acid
10 - 2 Nos. replacement in
batteries
exchange
Biodegradable waste
Composting and used
1 ETP Bio sludge - 12.9 as manure for
gardening
9
Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
4. Site Analysis
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Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
Topo graphic features of the site and 10 KM study area and base map are
given at Fig 1.3 & 1.4.
Plant & Green Belt Photographs are given at Fig. 1.5
Site lay out map is given at Fig 1.6
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Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
Fig 1.3
Topo Sheet of the 10 KM study area
12
Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
Fig 1.4
Base map of the study area
13
Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
Fig 1.5
Plant Photographs
14
Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
Fig 1.6
Site Lay Out Plan
15
Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
6. Resource requirements
6.1 Power Requirement and Supply/Source
The total power requirement for this proposed project will be 6000 HP.
The required power connection is available from MSEDCL.
TABLE 7.0
Capacity/
S.NO Details No Proposed
Production facilities
1 Production Blocks Nos 5
2 Clean rooms Nos 1
3 Boiler (coal Fired) TPH 2 x15 & 1x10*
4 DG sets KVA 2 X 1000
5 Cooling tower TR 5000
3
6 Softener/DM plant M /hour 2.5
7 Fresh water RO Plant M3/hour 2.5
Effluent handling & treatment facilities
8 Collection tanks- KL 400
Storage
9 Neutralization tanks KL 10
10 Stripper, MEE, ATFD KLD 2 X 400
11 RO & Biological KLD 600
treatment
12 Sewage treatment plant KL 40
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Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
The unit is proposed to build the plant in 25 Acres of land and out of which
6.0 acres will be built up area and 9.3 acres of green belt will be
developed. Below table provides the land statement. Detailed site lay out
plan outlining proposed activities is given at Figure 1.6
Table 8.0
Land Statement
S.No Purpose Units Extent
1 Built up area Acres 6.0
2 Green belt Acres 9.3
3 Open area Acres 9.7
Total Acres 25.0
The Proposed sources of air emissions from the plant are 15 TPH coal
fired Boilers two in number and 10 TPH boiler and 3 X 1000 KVA DG sets.
The process emissions containing Acetic acid & HCl are scrubbed with
caustic and scrubbed waste send to MEE. Below Table gives proposed
emission sources from the plant
Table 9.0
Emission Source Proposed
Table No 10.0
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Pre-Feasibility Report Sri krishna Pharmaceuticals Limited, Plot No. F-1
Project cost
Rs. In
Crores
Plant& machinery 50.0
Civil & Structural 20.0
Total 70.0
20% on plant &
Pipe lines & insulation machinery 14.0
10% on plant &
Electricals & instrumentation machinery 7.0
8% on plant &
Erection & commissioning & machinery and
painting structures 5.6
Safety & Environment 10.0
Furniture, fixtures, computers,
lighting etc 0.5
Total 107.10
Contingencies & pre-operative
expenses 17.5
Project cost say 125 Crores
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Annexure I
Typical technical details of the proposed products
PARACETAMOL
Process description and flow sheets
Stage-1 (Hydrolysis)
Para Nitro Chloro Benzene is treated with aqueous sodium hydoexide at a temperature of 135-
140oC in an autoclave and neutralized with sulphuric acid to get Para Nito Phenol.
Stage- 2 (Reduction)
Para Nitro Phenol is reduced in boiling water under mild acidic condition with iron poweder
and acetic acid to get Para Amino Phenol,
Stage -3 (Acetylation)
Para Amino Phenol is condensed with Acetic Anhydride in aqueous medium to get
paracetamol and acetic acid.
Stage-4 (Purification)
Paracetamol technical is dissolved in hot water, treated with carbon, crystallized to get
Paracetamol with is dred, milled and packed in LDPE lined HDPE bags.
CHEMICAL PATHWAY OF PARACETAMOL SYSNTHESIS
Cl ONa
NO2
NO2
PNCB
157.5 161
ONa OH
NO2
NO2
161
139
Para Nitro Phenol
(PNP)
7 + 18 Fe + 7H 2 O + 9FeO + 3Fe 3 O 4+ xC H C O O N a + xH O
3 2
xCH 3C O O H + xN aO H 82 18
18x55.84 7x18 60 40 6Fe 3 O 3 .5 (A v)
NO2 NH2 6 x 223.52
7 x 139 7 x 1 09
PNP Para Am ino Phenol
(PAP )
S T A G E I I I - P a r a c e t a m o l T e c h n ic a l
OH O OH
CH3 C
+ O + C H 3C O O H
CH3 C 60
NH2 O
109 102 NHCOCH3
151
PAP A c e tic A n h y d r id e P a r a c e ta m o l
S ta g e - IV - P a ra c e ta m o l P h a rm a
OH OH
A c t iv e C a r b o n
+ S pen t carbon
Ph arm a M L
NHCOCH3 NHCOCH3
PARACETAMOL
Hydrolysis
4-Nitrochlorobenzene
Caustic soda Lye Conversion of PNCB to Nitrophenol
Water (PNP)
Stage I
Aq layer
PNP
Reduction
PAP ML / Water
Dilute Acetic acid Conversion of PNP to
Iron powder Aminophenol (PAP)
Caustic soda Lye
Filtration Stage II
candle filter Iron sludge
Pharma ML
Acetylation
Acetic anhydride
Soda ash Conversion of 4-Aminophenol
EDTA (PAP) to Paracetamol technical
Hydros
SMBS
Stage III
Filtration
Pusher Centrifuge
Process water/Pharma ML
Acetaminophen Technical
Soda ash Carbon treatment
Activated carbon
Hydros
SMBS
Stage IV
Recrystallisation
(cooling)
Qty
S.No Name of raw material (Kgs/day)
1 PNCB 16062.7
2 Caustic Lye (48%) 8486.6
3 Sulphuric Acid 5998.5
4 Iron Powder 14476.4
5 Acetic Acid (20%) 6731.7
6 Acetic anhydride 10184.1
7 EDTA 13.3
8 Hydros 26.7
9 SMBS 13.3
10 Activated Corbon 120.0
Sodium Hydro Sulphite(Hydros)
11 13.3
12 Sodium Meta Bisulphite(SMBS) 13.3
13 Caustic flakes 93.3
Qty
S.No Name of raw material (Kgs/day)
1 PAP (1% ) moisture) 29218.0
2 Acetic anhydride 28008.2
3 EDTA 36.7
4 Hydros 73.3
5 SMBS 36.7
6 Activated Corbon 329.9
Sodium Hydro
7 Sulphite(Hydros) 36.7
Sodium Meta
8 Bisulphite(SMBS) 36.7
9 Caustic flakes 256.6
List of Raw Materials of Metformin HCl
Qty
S.No Name of raw material (Kgs/day)
1 Dicyanodiamide 8866.7
2 Dimethylamino hydrochloride 9566.7
3 Dimethyl formamide 11700.0
4 Toluene 6200.0
5 Methanol 2833.3
6 Activated carbon 533.3
7 Methanol 22700.0
List of Raw Materials of Domperidone
S.No Name of raw material Qty (Kgs/day)
1 Orthophenylene di amine(OPDA) 279.0
2 Methyl Aceto acetate(MAA) 299.5
3 Xylene 1196.0
4 Caustic lye 48 % 247.5
5 Carbon 18.5
6 Conc. HCl 30 % 368.5
7 1- bromo-3-chloro-propane 335.0
8 Toluene 1195.0
9 Potassium carbonate 315.0
10 Conc. HCl 30 % 320.0
11 Caustic lye 48 % 20.0
12 N- Methyl Piperidone 360.0
13 Ethyl chloro formate 480.0
14 CS Flakes 290.0
15 Toluene 1295.0
16 Methanol 505.0
17 Raney Nickel 10.0
18 Ammonia gas 75.0
19 Hydrogen 5.0
20 DCNB 515.0
21 K2 CO3 300.0
22 Toluene 860.0
23 Potassium carbonate 150.0
24 Potssium chloride 160.0
25 Toluene 1435.0
26 Methanol 860.0
27 Raney Nickel 35.0
28 Hydrogen 15.0
29 Urea 255.0
30 Caustic lye 47 % 820.0
31 Ammonium chloride 575.0
32 Carbon 5.0
33 Conc. HCl 30 % 210.0
34 Ammonia 30% 430.0
35 Soda ash 185.0
36 MIBK 1785.0
37 Methanol 4765.0
38 Carbon 20.0
39 Acetic acid 175.0
40 Ammonia 50.0
List of Raw Materials of Ibuprofen
Qty
S.No Name of raw material (Kgs/day)
1 Mono Chloro acetic acid 11431.8
2 Iso propyl alcohol 8381.8
3 Sulphuric acid 4170.0
4 Sodium bi carbonate 822.2
5 Sodium carbonate 205.6
6 Isobutyl benzene 12884.5
7 Acetyl chloride 8530.3
8 Aluminum chloride 14641.5
9 Conc. Hcl 30% 1273.2
10 Liq Ammonia 25 % 1273.2
11 Sodium metal 3163.8
12 Isopropyl alcohol 41793.8
13 CS Lye 48% 14681.1
14 Sodium dichromate dehydrate 8796.5
15 Sulphuric acid 16204.0
16 Acetone 40741.5
17 N- Hexane 22685.6
List of Raw Materials of Dextromethorphan
Hydrobromide
Qty
S.No Name of raw material (Kgs/day)
1 2-[1-Cyclohexyl) ethylamine 784.0
2 4- Methoxy phenyl acetic acid 862.7
3 O-xylene 3136.0
4 Phosphorous oxy chloride 1027.3
5 Sodium borohydride 192.7
6 C S lye 48 % 470.7
7 Toluene 1960.0
8 (-) Mandelic acid 687.3
9 Acetone 1764.0
10 Toluene 2085.3
11 Acetone 1254.0
12 C S lye 177.3
13 Toluene 957.3
14 Caustic 210.0
15 Methyl formate 462.7
16 Methanol 509.3
17 Toluene 816.7
18 Phosphoric acid 1474.0
19 Potassium hydroxide 400.0
20 Toluene 1936.7
21 Formaldehyde (40%) 62.7
22 Formic acid 78.7
23 Toluene 752.7
24 40% Hydroboric acid 431.3
25 Activated carbon 3.3
26 Toluene 880.0
27 Conc. HCl 441.3
List of Raw Materials of Omega-3
Qty
S.No Name of raw material (Kgs/day)
1 Sea water 15984.0
2 Dextrose 8658.0
3 Toluene 3330.0
4 Crude oil 1332.0
5 Alkali Solution 666.0