1.0 introduction -...
TRANSCRIPT
Pre-Feasibility Report Sri Krishna Pharmaceuticals Limited, Unit I
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1.0 Introduction
M/s. Sri Krishna Pharmaceuticals Limited. (hereinafter referred to as
“SKPL or Industry”) is located at C-4, IDA, Uppal, RangaReddy District in
Telangana. The unit was established in 1975 and obtained Environmental
Clearance from MOEF vide Order Post Ex facto No j-11011/151/2005-
IA.II(I) Dt Aug 11,2005 to manufacture Paracetamol with a capacity of 200
TPM. Subsequently obtained CFE of the Board vide letter No:
62/PCB/CFE/RO-I-RRD/HO/2010-2289 for change of product mix by
adding two low volume products with a total capacity of 193.42 TPM. As
product pricing came down drastically over the period, it is necessary to
achieve economic scale of production. In order to achieve this now Sri
Krishna Pharmaceuticals Limited proposed to expand the production
Capacity from 200 MTPM to 2021.68 MTPM
A copy of the environmental clearance obtained from MOEF, Government
of India in 2005 and certified copy of compliance report obtained MOEF,
Government of India, Bangalore Regional office is enclosed at Annexure
I
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2.0 Introduction of the Project
The salient features of the project are described in table below
TABLE 1
Salient Features of the Project
Location C-4, IDA Uppal, Rangareddy
District, Telangana
Longitude and latitude 17°23'33.7"N Latitude and
78°55'0.3"East Longitude.
Year of establishment 1975
Product category 5(F) Bulk Drugs & Intermediates
Project category as per EIA
notification
Category B ( Located in notified
industrial Estate
Proposed Activity Capacity expansion from 200 TPM
to 2021.68 TPM
Total investment on the plant Current - Rs. 35.0 Cores & Proposed
– Rs.90 Crores
Total Investment on
Environmental Infrastructure
Rs. 7.0 Crores (Current) Rs. 20
Crore ( Proposed) – Total 27Crores
Total area of the plant 5.2 Acres
Total area of green belt 1.8 Acres
Water requirement Fresh water requirement after
expansion – 600 KLD
Source of water Hyderabad Metro Water & Sewerage
Board and purchased from out side parties
Nearest habitation and distance from the site
Laxminarayana Nagar – Adjacent to the site on the Southern side
Nearest surface water bodies River Musi – 1.3 KM Hussain Sagar Lake - 7.8 KM in the upstream
Nearest reserve forest 7 Reserve Forests within 10 KM radius
Environmentally sensitive areas within 10 km radius
Hussain Sagar lake at 7.8 KM in the upstream of the site
Any national parks, wild life sanctuaries within 10 km radius
None in 10 KM radius (Kasu Brahmananda Reddy Park –
13.5 KM Nehru Zoo Park - 13.4 KM)
Nearest air port and distance Hyderabad 32 KM
Nearest railway station and
distance
Secunderabad- 13 KM
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i) About the Group &Promoters
Sri Krishna Pharmaceuticals Limited,established in the year 1975 under
the companies act 1956. manufacturing bulk drugs and intermediates
(APIs) started its operation in Telangana with its first unit in IDA Uppal to
manufacture Paracetamol. Subsequent to this, group has established a
formulation unit at IDA Nacharam in 2004, bulk drugs manufacturing unit
in Raikunta village, Shamshabad (Mandal) RR District, a Bulk Drug
Manufacturing unit at Plot No. B-14, MIDC, Chincholi in Solapur in the
year 2008.
It had taken over the company named M/s ArandyLaboratories Limited,
IDA Bollaram, Medak Dist and amalgamated in to Sri Krishna group as
unit-IV .
Sri Krishna Group is emerged as major supplier of API’s Internationally
through it’s efforts in quality and reliability. It is currently catering to the
needs of the domestic customers and customers in Europe, US,
Germany, Japan and Latin America.
The group is adopting cleaner environment technologies and complying to
the directions issued by APPCB from time to time. The industry made and
continuously making all efforts to treat liquid solid & Air to achieve
standards prescribed. Upgrading the facilities time to time as per the
technologies available.
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3.0 Project Description
3.1 Production Capacity
TABLE 2
List of Existing Products
S.No Name of the Product Quantities
in TPM
1. Paracetamol 188
2 Domperidone 4.05
3 Domperidone Maleate 1.372
Total 193.42
Bi- Products
Acetic acid (32%) 220
3.1.1 Proposed expansion:
It is now proposed to expand the production capacity of the existing 3
products. Below Table provides list of products and proposed capacities.
TABLE 3
Proposed Products & Capacity
S.No Product Name
Producti
on Capacity
TPM
Product
Description
Drug/Intermediate/Multipur
pose chemicals
1 Paracetamol (starting from PNCB Stage)
200.0 Bulk Drug
2 Paracetamol (Starting
from PAP stage) 1800.0
Bulk Drug
3 Domperidone
16.2 Bulk Drug
4 Domperidone Maleate 5.488 Bulk Drug
Total 2021.68
Bi Products
Acetic acid (90%) 846.9
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3.2 Manufacturing Process
The Manufacturing process for the above chemicals involves chemical
reactions like oxidation, reduction, acetylization, diazotization etc. The
products of reaction are purified, filtered and dried before packing the
final product. Brief process description and process flow charts are given
at Annexure III
3.3 Raw Materials
List of raw material product wise is given at Annexure II
3.4 Water Requirement
The water requirement will be met partly from HMWS & SB (Hyderabad
Metro Water Works and Sewerage Board) and partly from private
suppliers through tankers. The requirement for water in this unit is for
process and domestic purposes. The water balance for daily consumption
is presented below.
TABLE 4.0
Water Balance– Current & Proposed
S. No
Stream
Water requirement
in KLD
Waste Water
discharge in KLD
Proposed
method of treatment &
disposal
Current After Expansion
Current After Expansion
1 Process
16.58
131.6
23.5
100.26
MEE followed by ATFD.
(Condensate
to ETP & RO)
2 Washings,
R& D Lab 11.0 11.00
MEE followed
by ATFD.
(Condensate
to ETP & RO)
3 Scrubber 35.0 35.00 MEE followed
by ATFD.
(Condensate
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to ETP & RO)
4 Acetic Acid recovery
plant
51.20
MEE followed
by ATFD.
(Condensate
to ETP & RO)
5
DM/Softner
RO Plant back ashes
& rejects
30.0 30.00 ETP & RO ( RO Reject
to MEE)
6 Boiler 31.0 134
10.5
13.00
ETP & RO
( RO Reject
to MEE)
7 Cooling
towers 81.92
400
70.00
ETP & RO
( RO Reject
to MEE)
8 Domestic 18.0 30 15.0 24.00
ETP & RO
( RO Reject
to MEE)
9 Gardening 10.0 10 ----- -----
Total 157.50 781.60 49.0 334.46
3.6 Wastes generation and control systems
3.6.1 Liquid Effluents
As detailed in table 4.0 waste water generation after expansion would be
334.46 KLD. It is proposed to segregate effluents into high COD and High
TDS stream and Low COD and Low TDS streams
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
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make up. 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
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Fig 1.1 Schematic treatment scheme of high TDS effluents
Effluent from Process and Aq. Distillate to cement
Cement plants/authorized recyclers washings , Scrubber ,R&D
RO Reject To TSDF Condensate to Biological Treatment Condensate to Biological Treatment
Sludge to TSDF
Equalization
Tank
MEE
ATFD
Stripper Neutralization
Tank
Setting
Tank
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Fig 1.2 Low TDS Effluent Treatment System
Domestic effluent
Effluents from utilities & MEE condensate
Sludge to TSDF
Permeate for re-use
Rejects to MEE
Screen
Chamber
Sludge Holding Tank
Aeration
Tank2
Equalization
Tank
Neutralization
Tank
Clarifier
2
Holding
Tank
Filter Press Sludge Cake
Aeration
Tank1 Clarifier
1
Sand
filter
Carbon
Filter
Ultra
filtration RO
Screen
Chamber
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3.6.2 Solid wastes management
Hazardous and non - hazardous wastes generated from the proposed
expansion project are detailed below. Mode of disposal are also identified
and listed. Adequate storage of hazardous waste is ensured at the site
TABLE 5.0
Solid Wastes and Disposal
S.No Description
Quantity in TPM Remarks
Current After
Expansion
1 Spent
Carbon
5.0 19.52 Sent to TSDF/ Cement plant for Co-
incineration in rotary kilns
2 Iron sludge
from process
280 290.01
3 Calcium
sulphate
90 Nil ---
4 Calcium
acetate(
salts from
neutralizatio
n)
-
110.58
Sent to TSDF
Dundigal
5 Sodium
Acetate
(salts from
Scrubber)
-
73.80
Sent to TSDF Dundigal
6 Organic
residue
- 208.65 from Paracetamol
send to TSDF,
24.81 from other products disposed to cement
manufacturers for co-incineration
7 MEE
salts/ETP
Sludge
80 321.84 Sent to TSDF
Dundigal
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TOTAL 455 1049.21
Non Hazardous Wastes
8 Ash from
boilers
160.0 300.00 Sold to brick
manufacturers
Wastes with recyclable options
9 Recovered
Mixed
Solvents
- 3.8 Shall be sold out
after distillation
10 De-toxified
container &
container
liners
100
Nos/Month
200
Nos/Month After detoxification, disposed to outside
agencies
11 Waste /Used
Oil
50 LPM 100 LPM Authorized Recyclers
12 Used Lead
acid
batteries
4 Nos/3
years
4 Nos/3
years Return back to the
supplier
TSDF facility is about 54 KM from the site in RangaReddy District which is
created for catering the industries in this area. Transport of Hazardous
wastes to TSDF is done by the Ramkey. In case other hazardous wastes,
authorized recyclers will transport the wastes
4.0 Site Analysis
4.1 Plant Location
M/s Sri Krishna Pharmaceuticals Limited, is located at C-4, IDA Uppal,
Ranga Reddy District, Telangana. The site is situated at17°23'33.7"N
Latitude and 78°55'0.3"East Longitude. . The land area of the plant is 6.0
acres. The site is surrounded by habitation on the Southern direction,
other industries of IDA uppal are located on the Northern side of the site.
APIIC Road is dividing the site into two parts on eastern side and
company’s own land of 1 acre with green belt is located after the road.
Samshabadair port is located at about32 Km from the site. River Musi is
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located at about 1.3 KM from the site in southern direction in the down
stream of the plant
Charminar is located at about 8 KM from the site in South Western
direction and Hussainsagar lake is about 7.8 KM in the upstream of the
site. Ramanthapur cheruvu is about 1.2 KM from the site on the North-
Eastern direction.
Following 7 reserve Forests are there within 10 KM radius of the site
Table 6.0
Reserve Forests in the study area
S.No Reserve Forest Direction from
the site
Distance from
the site
1 Chengicherla NE 8.5 KM
2 Narapalli NE 8.3 KM
3 Medpalli E 7.0 KM
4 Mansurabad SW 3.6 KM
5 Kutubullapur W 8.2 KM
6 Kuntlur SW 9.0 KM
7 GurramGadda S 8.4 KM
Kasu Brahmananda Reddy Park (13.5 KM), Nehru Zoological Park (13.4
KM), Harina Vanasthali ( 22KM) are outside the 10 KM radius of the site
Topo graphic features of the site and 10 KM study area and base map are
given at Fig 1.3 & 1.4.
Plant Photographs are given at Fig. 1.5
Site lay out map is given at Fig 1.6
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Fig 1.3
Topo Sheet of the 10 KM study area
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Fig 1.4
Base map of the study area
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Fig 1.6
Plant Photographs
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Fig 1.5
Site Lay out plan
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5.0 Planning in Brief
The project is envisaged to be completed by March 2016
6.0 Resource requirements
6.1 Power Requirement and Supply/Source
The total power requirement is 3000 KVA. It shall be sourced from
TSCDDL and D.G sets as alternative to Power failure.
6.2 Production facilities , Utilities and effluent handling facilities
Apart from the existing facilities it is proposed to add additional Acetic
acid enrichment plant to recover 90% Acid, additional production
facilities like reactors within the existing blocks , utilities and effluents
treatment infrastructure with an additional investment of Rs. 90Cores.
The details are outlined in the below table
TABLE 7.0
Production facilities/Utilities/ETP – Existing & Proposed
S.NO Details
Capacity/
No Current Additions
After
expansion
Production facilities
1 Production Blocks- Nos 8 0 8
2 Clean rooms Nos 2 2 4
Utilities
3 Boiler ( coal Fired) TPH 10 20 23
4 DG sets KVA 1200 (2X
600)
1500 (2x 750
KVA)
2700
5 Cooling tower TR 2200 (1x1000
3x400)
3200 (1x1200
and 4x500)
5400
6 Softner/DM plant M3/hour 2.5 2.5 5
Effluent handling & treatment facilities
8 collection tanks-
Storage
KL 200 1500 1700
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9 Neutralisation tanks KL 1 2 3
10 Stripper ,MEE,ATFD KLD 100 1x250 350
11 RO & Biological treatment
KLD 0 400 400
6.3 Land Requirement
The unit currently have 5.2 acres of land and out of which 1.8 acres of
green belt is developed. The land requirement for proposed expansion
activities will be 5072 Square Meters which can be met from existing open
area. Below table provides the land statement. Detailed site lay out plan
outlining current and proposed expansion activities is given at Figure 1.5
Table 8.0
Land Statement
S.NO Purpose Units Extent
1 Built up area Sq.M 8092
2 Green belt Sq.M 7253
3 Open area Sq.M 5694
Total Sq.M 210392
4 Area required for Proposed expansion
Sq M 5072
7.0 Air Pollution
The Sources of air emissions from the plant are 1x 10 TPH coal fired boiler
& proposed 1 × 20TPH coal fired boiler and additional DG sets
The process emissions from the second phase contain Acetic Acid fumes,
SO2, and CO2. Acetic acid fumes and SO2 are scrubbed with caustic and
scrubbed waste send to MEE. The other gases expected in the process are
Carbon dioxide, which are let out into atmosphere Below Table gives
current proposed emission sources from the plant
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Table 9.0
Emission Source – Current & Proposed
S.NO Source Capacity
Fuel Anticipated
emissions
Control
system
Current
1 Boiler 10 TPH Coal SPM,SO2
&NOx
Bag filter
2 DG sets 2x600 KVA Diesel SPM, SO2,
NOX
Acoustic
enclosure
3 Process emissions -- -- Acetic
Acid,SO2
Scrubber
Proposed additions
4 Boiler ( coal Fired) 20 TPH Coal SPM,SO2
&NOx
Bag filter
5 DG sets 2x750 KVA Diesel SPM, SO2 &NOx
Acoustic Enclosure
6 Process emissions -- -- Acetic Acid,SO2
Scrubber
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8.0 Project Financial
The estimated cost of the expansion project is approximately 90 Crores.
Out of this Rs. 20 Crores will be for effluents treatment facilities and rest
for other process equipment and safety equipment
Project cost
Rs. In
lakhs
Plant& machinery 45
Civil &structural 5
Total 50
Pipe lines & insulation
20% on plant &
machinery 9
Electricals & instrumentation 10% on plant & machinery 4.5
Erection & commissioning & painting
8% on plant &
machinery and structures 4
Safety & Environment 20.00
Furniture, fixtures, computers, lighting etc 0.50
Total 88.0
Contingencies & pre-operative
expenses 2.0
Project cost 90.0
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Annexure I
Copy of EC& Certified Compliance report from MOEF,Bangalore
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Annexure II
List of Raw Materials
S.No Product LIST OF RAWMATERIAL
1 Paracetamol (starting from PNCB
Stage)
PNCB
Caustic Lye (48%)
Sulphuric Acid
Iron Powder
Acetic Acid (32.5%)
Acetic anhydride
EDTA
Hydros
SMBS
Activated Corbon
Sodium Hydro Sulphite(Hydros)
Sodium Meta Bisulphite(SMBS)
Caustic flakes
2 Paracetamol (Starting from PAP
stage)
PAP (1% ) moisture)
Acetic anhydride
Water(Recycled water from stage IV)
EDTA
Hydros
SMBS
Activated Corbon
Sodium Hydro Sulphite(Hydros)
Sodium Meta Bisulphite(SMBS)
Caustic flakes
3 Domperidone
OPDA
MAA
Xylene
Caustic Lye (48%)
Carbon
Conc. HCl(30%)
BCP
Potassium Iodide
Toluene
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Potassium carbonate
CPDB
Soda ash
MIBK
Methanol
Carbon
Acetic acid
Ammonia
4 Domperidone Maleate
OPDA
MAA
Xylene
Caustic Lye (48%)
Carbon
Conc. HCl(30%)
BCP
Potassium Iodide
Toluene
Potassium carbonate
CPDB
Soda ash
MIBK
Methanol
Carbon
Acetic acid
Ammonia
Maleic acid
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Annexure III
Process description and flow sheets
Brief manufacturing process of Paracetamol
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.
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CHEMICAL PATHWAY OF PARACETAMOL SYSNTHESIS
Stage I -P-Nitro Phenol:
Cl
+ 2NaOH + NaCl + H2O
ONa
NO2
161
NO2
PNCB157.5
Step 2.
ONa
NO2
161
+ 0.5 H2SO4
OH
NO2
+ 0.5 Na2SO4
0.5 x 142
139
Step 1.
2 x 40 58.5 18
Para Nitro Phenol
(PNP)
OH
NO2
+18 Fe+7H2O+9FeO+3Fe3O4+xCH3COONa + xH2O
82
7 x 139
18x55.847x18xCH3COOH + xNaOH
OH
NH27 x 109
60 40 6Fe3O3.5(Av)
6 x 223.52
7
Stage -II - P-Amino phenol:
PNP Para Amino Phenol
(PAP)
18
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O
O
STAGE III - Paracetamol Technical
OH
NH2
+CH3 C
O
CCH3
OH
NHCOCH3
+CH3COOH
60
151102109
PAP Acetic Anhydride Paracetamol
Stage - IV- Paracetamol Pharma
OH
NHCOCH3
OH
NHCOCH3
+Spent carbonActive Carbon
Pharma ML
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ACETAMINOPHEN
PROCESS FLOW DIAGRAM
4-Nitrochlorobenzene
Caustic soda Lye
Water
Stage I
Sulphuric acid
Aq layer
PNP
PAP ML / Water
Dilute Acetic acid
Iron powder
Caustic soda Lye
Stage II
Iron
sludge
Hydros
SMBS
Aq layer
PAP PAP ML
Pharma ML
Acetic anhydride
Soda ash
EDTA
Hydros
SMBS
Stage III
Hydrolysis
Conversion of 4-
Nitrochlorobenzene (PNCB) to 4-
Nitrophenol (PNP)
Neutralisat
ion
Reduction
Conversion of 4-Nitrophenol
(PNP) to 4-Aminophenol (PAP)
Filtration
through
candle
filter
Cooling and Filtration
through Pusher Centrifuge
Acetylation
Conversion of 4-Aminophenol
(PAP)
to Paracetamol technical
Filtration
through Pusher Centrifuge
Acetaminophen Technical
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Process water/Pharma ML
Soda ash
Activated carbon
Hydros
SMBS
Stage IV
Hydros
DM Water
Pharma ML
Acetaminophen pharma (wet)
Carbon treatment
Filtration through Leaf
filter and Polishing filter
Recrystallisation
(cooling)
Filtration through
Agitated Nutsche Filter
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DOMPERIDONE
BRIEF MANUFACTURING PROCESS
Stage-I :
Process: Orthophenylene diamine is condensed with Methyl Aceto acetate in Xylene .
Xylene is distilled off and the mass is filtered to get crude Stage I which is further
purified by dissolving in Lye solution and reprecipitating with hydrochloric acid.
Stage-II:
Process: The Stage–I compound obtained above is recated with 1-Bromo-3- chloro-
propane in Toluene in presence of anhydrous potassium carbonate. After the completion
of the reaction add water, the toluene layer is separated and washed with dilute alkali to
remove unreacted Stage I compound. The toluene layer is hydrolyzed in dilute
hydrochloric acid and the toluene layer is separated and distilled off to get the title
compound.
Stage –III-
Domperidone Technical
Process: The stage III compound is taken along with 5- Chloro -2,3- dihydro -1-
(Piperidine -4 yl)-1-H- Benzimidazole -2-one (which is purchased from out side) in
methyl Isobutyl Ketone in the presence of Soda ash. The contents are refluxed cooled,
filtered and washed with water to get the technical domperidone which is further dried.
Purification:
Process: The Technical Domperidone is dissolved in methanol and Acetic acid mixture,
carbon treatment is given and filtered. The filtrate is basified with gaseous Ammonia
and the precipitate is filtered & washed and dried to get Domperidone pharma.
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DOMPERIDONE MALEATE
BRIEF MANUFACTURING PROCESS
Stage-I:
Process: Orthophenylene diamine is condensed with Methyl Aceto acetate in Xylene .
Xylene is distilled off and the mass is filtered to get crude Stage I which is further
purified by dissolving in Lye solution and reprecipitating with hydrochloric acid.
Stage-II:
Process: The Stage–I compound obtained above is recated with 1-Bromo-3- chloro-
propane in Toulene in presence of anhydrous potassium carbonate. After the completion
of the reaction add water, the toluene layer is separated and washed with dilute alkali to
remove unreacted Stage I compound. The toluene layer is hydrolyzed in dilute
hydrochloric acid and the toluene layer is separated and distilled off to get the title
compound.
Stage –III-
Domperidone Technical :
Process: The stage III compound is taken along with 5- Chloro -2,3- dihydro -1-(
Piperidine -4 yl)-1-H- Benzimidazole -2-one (which is purchased from out side) in
methyl Isobutyl Ketone in the presence of Soda ash. The contents are refluxed cooled,
filtered and washed with water to get the technical domperidone which is further dried.
Purification
The technical Domperidone is dissolved in Methanol and Acetic Acid. Carbon treatment
is given and Maleic acid solution in methanol is added to the clear solution. The mass is
cooled to room temperature and filtered. The cake is washed with methanol and dried to
get Domperidone maleate pharma.
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CHEMICAL PATHWAY OF DOMPERIDONE SYNTHESIS
NH2
NH2
+ CH3 C
O
CH2 COOCH3
Xylene
Reflux
N
N
O + H2O + CH3OH
H
174
Methyl Aceto Acetate (MAA)
116
Ortho Phenylene
diamine (OPDA)
108
18 32
Isopropylidinyl-1,3-dihydrobenzimidazole-2-one
STAGE I - DOMPERIDONE
(Stage - I)
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STAGE II - DOMPERIDONE
N
N
HStage - I
174
O + Br - CH2 - CH2 - CH2 - Cl + K2CO3 + HCl NaOH
H2O
N
N
CH2 - CH2 - CH2 - Cl
(Stage - II)
210.5
H
O + C
CH3 CH3
58
+ KBr + KCl + CO2
119 74.5 44
1,3 - Bromo Chloro Propane(BCP)
157.5
O
N-(3-Chloropropyl)-1,3-dihydro
benzimidazole-2-one
STAGE III - DOMPERIDONE
N
N
210.5
O +
H
CH2 - CH2 - CH2 - Cl
Stage - II
N
N
Cl
H
N
H
251.5
Na2CO3
0.5 x 106 N
N
H
CH2
CH2
CH2
O +NaCl +CO2 + H2O
58.5 0.5x44 0.5x18
N
N
N
O
ClDomperidone
425.5
5-chloro-1-(piperidin-4-yl)-2,3-dihydro
benzimidazole-2-one
MIBK
O
STAGE IV - DOMPERIDONE PHARMA
DOMPERIDONE TECH DOMPERIDONE PHARMA
Carbon Treatment & Crystallizationfrom Methanol
Pre-Feasibility Report Sri Krishna Pharmaceuticals Limited, Unit I
39
DAMPERIDONE MALEATE
Stage I,II &III same as above.
DAMPERIDONE tech +MALEIC ACID ---------- DAMPERIDONE MALEATE