1.0 introduction -...

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Pre-Feasibility Report Sri Krishna Pharmaceuticals Limited, Unit I 1 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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Page 1: 1.0 Introduction - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/EIA/150420157B9XC3JIPrefeasibilityreport.pdfNearest railway station and distance Secunderabad-

Pre-Feasibility Report Sri Krishna Pharmaceuticals Limited, Unit I

1

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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Pre-Feasibility Report Sri Krishna Pharmaceuticals Limited, Unit I

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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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Pre-Feasibility Report Sri Krishna Pharmaceuticals Limited, Unit I

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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

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DAMPERIDONE MALEATE

Stage I,II &III same as above.

DAMPERIDONE tech +MALEIC ACID ---------- DAMPERIDONE MALEATE