Pre-Feasibility Report
Vasudha Pharma Chem Limited
1. Introduction
M/s. Vasudha Pharma Chem Limited. is located at Plot No 39 A & B,
IDA, Jeedimetla, Ranga Reddy District in Andhra Pradesh. The unit was
established in 1994-1995 and obtained Environmental Clearance from
MOEF vide Order Post Ex facto No j-11011/144/2005-IA.II(I) Dt Aug 11,
2005
to manufacture Bulk Drugs with a capacity of 60.0 TPA and
subsequently obtained CFE of the Board in the Year September 2012. In
order to meet the market demand it is proposed to expand the production
capacity from 60.0 TPA to 240.0 TPA.
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 AnnexureI
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Vasudha Pharma Chem Limited
2. Introduction of the Project
The salient features of the project are described in table below
TABLE 1
Salient Features of the Project
Location
Longitude and latitude
Year of establishment
Product category
Project category as per EIA
notification
Proposed Activity
Total investment on the plant
Total Investment on Environmental
Infrastructure
Total area of the plant
Total area of green belt
Water requirement
Plot No 39 A & B,IDA,
Jeedimetla, Ranga Reddy District,
Andhra Pradesh
17031’07.9” N Latitude and
78026’52.4” E Longitude
1994-1995
5(F) Bulk Drugs & Intermediates
“A”( As the unit is located in 10 Km
radius of Bollaram & patancheru
cluster which is notified under CEPI)
Capacity expansion from 60.0 TPA to
240 TPA
Current - Rs. 31.40 Crores & Proposed
– Rs. 5.5 Crores
Rs. 50.0 Lakhs (Current) Rs. 3.0 Crore
( Proposed)
12144.0 Sq.Mts
1338.4 Sq.Mts
Total
water requirement after
expansion 128.12 KLD
Fresh water requirement- 92.62 KLD
Recycled water-35.5 KLD
Source of water
HMWS and partly from
suppliers through tankers
Nearest habitation and distance
from the site
Nearest surface water bodies
Shapurnagar (V) at a distance of 0.5
Km from the Plant
Kotha Cheruvu at a distance of 1.7
Kms from the plant
Dulapalli reserve forest at a distance
of 1.6 Kms in North direction
None
Nearest reserve forest
Environmentally sensitive areas
within 10 km radius
Any national parks, wild life
sanctuaries within 10 km radius
Nearest air port and distance
Nearest railway station and
distance
Industrial Estates/Clusters in 10
KM radius
private
None
Rajiv Gandhi International Airport,
Shamshabad is nearly 32 Kms from
the plant
Bharatnagar at a distance of 4.6 Kms
from the plant
Chintal, Jeedimetla, Kajipalli
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Pre-Feasibility Report
i)
Vasudha Pharma Chem Limited
Introduction of the company and proponent
Vasudha Pharma Chem Limited was incorporated as a public limited
company under the Companies Act, 1956 at Hyderabad in the state of
Andhra Pradesh, India during the year 1994 - 95. The company is
engaged in the manufacturing of Active Pharmaceutical Ingredients
(APIs), Pharma Intermediates for catering to the domestic as well as
international market.
The company recognized the vital role of R & D for becoming successful in
the generic market. Initially, the focus was on development of cost
effective processes for intermediates related to Piperidone & Piperidine
derivatives. By 2003 -04, the company gained world class expertise and
became
the
prominent
manufacturer
of
Piperidone
&
Piperidine
derivatives in the world. Subsequently, the company forward integrated
from intermediates of Piperidone & Piperidine derivatives to APIs and later
on diversified into large product portfolio of about 15 APIs spreading
across several therapeutic areas.
About Proponent
The management at Vasudha Pharma Chem 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 company is headed by Mr. M.V. Ramaraju, Chairman & Managing
Director, and a post graduate in Organic Chemistry with 38 years
experience in the field of Active Pharmaceutical Ingredients (APIs). He
served in South India Research Institute (SIRIS) from 1972 to 1976. He
founded
Arvind
Chemicals
in
1976
for
manufacturing
of
Pharma
intermediates and Hyfabs in 1979 for fabrication of chemical equipment.
He was founder managing director of Hicel
Pharma (P) Ltd for
manufacturing Analgin from 1984 to 1989. He had closed his different
entities/activities and founded Vasudha Pharma Chem Limited (VPCL) in
1994 -95. He has brought the company to the present scale with active
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Pre-Feasibility Report
Vasudha Pharma Chem Limited
involvement in production, product development, marketing strategies,
and capacity expansion and up gradation of facilities to CGMP standards.
About the unit
Vasudha Pharma Chem Limited established this manufacturing unit in the
year 1994-1995 and obtained Environmental clearance from Ministry of
Environment with a capacity to manufacture Bulk Drugs with a capacity of
60.0 TPA. The unit obtained US FDA approval and exporting its product
to many regulatory markets of the World. Plant layout are enclosed as
Annexure I
Quality Management: Strict quality control measures, Current Good
Manufacturing
Practices
manufacturing
process
(CGMP)
to
ensure
are
strict
integrated
adherence
throughout
to
the
the
quality
parameters for both in-process and finished products.

Manufacturing facilities inspected and approved by local Drug
Authorities.

COS has been approved by EDQM

WHO -GMP certification for APIs
The company has also filed five DMFs with USFDA and five with EDQM of
its APIs. The company has also filed DMFs for its various products with
European, Chinese, Japanese and Russian regulatory authorities.
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Vasudha Pharma Chem Limited
3. Project Description
3.1 Production Capacity
Currently the unit is permitted to manufacture 15 drugs in two groups
with a total capacity of 4.99 TPM any one group at a given point of time
as detailed below
TABLE 2
LIST OF EXISTING PRODUCTS
S.No
Name of the Product
Quantities in
TPM
Group- A
1
Domperidone Maleate
1.20
2
Loratidine
1.87
3
0.30
4
Cyclobenzaprine Hydrochloride
Ketorolac Tromethamine
5
Quetiapine Hemifumarate
0.72
6
Loperamide Hydrochloride
0.30
7
Donepezil Hydrochloride
0.05
8
Ebastine
0.05
Total
4.99
0.50
Group - B
1
Amitriptyline Hydrochloride
1.43
2
Cisapride Monohydrate
0.68
3
Oxatomide
0.43
4
Des Loratidine
0.52
5
Meclizine Di Hydrochloride
0.30
6
Pregabaline
0.92
7
Cyproheptadine Hydrochloride
0.67
TOTAL
4.97
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Vasudha Pharma Chem Limited
3.1.1 Proposed expansion:
It is now proposed to expand the production capacity of the existing 13
products along with 5 new products. Below Table provides list of products
and proposed capacities.
TABLE 3
PROPOSED PRODUCTS & CAPACITY
S.No Product Name
Production
Capacity
TPM
Product Description
Drug/Intermediate/
Multipurpose chemicals
1
Amitriptyline Hydrochloride
1.50
Bulk Drug
2
Cisapride Monohydrate
0.30
Bulk Drug
1.50
Bulk Drug
0.15
Bulk Drug
3
4
Cyclobenzaprine
Hydrochloride
Cyproheptadine
Hydrochloride
5
Des Loratadine
0.70
Bulk Drug
6
Domperidone
3.00
Bulk Drug
7
Domperidone Maleate
1.50
Bulk Drug
8
Donepezil Hydrochloride
0.15
Bulk Drug
9
Ebastine
0.30
Bulk Drug
10
Fexofenadine
Hydrochloride
3.00
Bulk Drug
11
Ketorolac Tromethamine
2.00
Bulk Drug
12
Loperamide Hydrochloride
1.50
Bulk Drug
13
Loratadine
2.50
Bulk Drug
14
Nebivolol Hydrochloride
0.70
Bulk Drug
15
Olmisartan
1.00
Bulk Drug
16
Oxatomide
0.17
Bulk Drug
17
Pimobendan
0.01
Bulk Drug
18
Pimozide
0.03
Bulk Drug
Total
20.00
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Vasudha Pharma Chem Limited
3.2 Manufacturing Process
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 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
Water
requirement in
KLD
S.
No
Stream
1.
Process
2
Washings
3
Scrubbers,
R&D & QC
4
Boiler
5
DM/Softener
6
Cooling
&
Regeneration
7
Domestic
2.0
8
Gardening
Total
Waste Water
discharge in KLD
Proposed
Method of
Treatment and
Disposal
Current
After
Current
After
Expans
Expansi
ion
on
27.12
9.7
30.44 MEE followed by
ATFD.
9.3
5.0
0.8
5.0 (Condensate to
ETP & RO)
1.5
5.0
1.5
5.0
12.0
30.0
2.0
3.0 ETP and RO and
re-use. RO
3.0 rejects to MEE
ETP and RO
5.0
5.0
2.0
4.0
3.0
3.0
---
--
27.8
128.12
16.0
55.44
3.0
50.0
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Vasudha Pharma Chem Limited
3.5 Wastes generation and control systems
3.5.1 Liquid Effluents
As detailed in table 4.0 waste water generation after expansion would be
55.44 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
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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Vasudha Pharma Chem Limited
Fig 1.1
Schematic treatment scheme of high TDS effluents
Effluent from
Process and
Equalization
Tank
washings , Scrubber
R&D
Neutralization
Tank
Setting
Tank
Stripper
Aq. Distillate to
plants/TSDFRecovery
Cement
RO Reject
To TSDF
MEE
ATFD
Condensate to
Biological
Treatment
Condensate to Biological Treatment
Sludge To TSDF
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Vasudha Pharma Chem Limited
Fig 1.2 Low TDS Effluent Treatment System
Domestic effluent
Screen
Chamber
Effluents from utilities & MEE condensate
Screen
Chamber
Equalization
Tank
Neutralization
Tank
Clarifier
1
Aeration
Tank1
Aeration
Tank2
Clarifier
2
Holding
Tank
Sludge Holding
Tank
Sludge to TSDF
Sand
filter
Carbon
Filter
Filter Press
Sludge Cake
Permeate for re-use
RO
Ultra
filtration
Rejects to MEE
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Vasudha Pharma Chem Limited
3.5.2 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
Quantity
S.N
o
Description
1
Spent Carbon
0.9 TPM
2
Distillation
bottom Residue/
organic residue
3.0 TPM
3
Forced
Evaporation
salts
4.9 TPM
4
Inorganic
residue
5
ETP Sludge
6
Boiler ash
7
Spent solvents
8
Mixed spent
solvents
9
Current
Remarks
After
Expansion
2.34 TPM
9.64 TPM
M/s.
India
Cements
Ltd,
Vishnupuram,
vadepally,
Nalgonda district for using in the
kiln or to TSDF Dundigal
22.28 TPM
Sent to TSDF, Dundigal
-1.0 TPM
2.07 TPM
5.0
TPM
--
6.65 TPD
138 KL/
month
300 KL/month
27.5
KL/month
45 KL/Month
Used oil/ waste
lubricating oil
100 LPM
150 LPM
10
Spent Catalyst
150
kgs/month
200
kgs/month
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Detoxified
Container and
container liners
MS Drums
HDPE Drums
Carboys
Plastic bags
Glass bottles
58Nos/M
15 Nos/M
70 Nos/M
880Nos/M
51 Nos/M
100 Nos/M
50 Nos/M
150 Nos/M
2500 Nos/M
150 Nos/M
Sold to brick manufactures
Recovered
premises
and
reused
Authorized
solvent
units/ cement Plants
within
recovery
Authorized
recyclers/preprocessors
Sent to the manufacturer for
recovery of catalyst/ TSDF,
Dundigal
After Complete detoxification it
shall be disposed to the outside
agencies
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Pre-Feasibility Report
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TSDF facility is about 10.3 KM from the site in Ranga Reddy 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. Site Analysis
4.1 Plant Location
M/S
Vasudha
Pharma
Chem
Limited,Unit-I,
plot
no.39
A&B,IDA,
Jeedimetla, Rangareddy (Dist),Andhra Pradesh. The site is situated
at17031’07.9” N Latitude and78026’52.4” E Longitude. The land area of
the plant is 3 acres. The nearest habitation from the site is Shapurnagar
(V) at a distance of 0.5 km. The nearest railway station located at
Bharatnagar at a distance of 4.6 Kms from the Plant. There are no
ecologically sensitive areas like national parks, sanctuaries within 10 km
radius of the site.
The site is surrounded by other industries of IDA Jeedimetla. Following
are the surroundings of the site
North –Fabrication Unit
South – Road and Sai home care Products (Jet
mosquito mats
manufacturing unit)
East –
West -
Remedy Health Products (Chocolate manufacturing unit)
Narasimha group of companies (Fabrication Units- 5Nos)
Following 8 reserve Forests are there within 10 KM radius of the site
Table 6.0
Reserve Forests in the study area
S.No
Reserve Forest
1
2
3
Dulapalli
Gajula Ramaram
Suraram
Direction
Distance
from
the from
the
site
site
N
1.6
NW
3.0
NW
4.2
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Pre-Feasibility Report
4
5
6
7
8
Bowrampet
Pochampalli
Goudavalli
Dundigal
Kajipalli
Vasudha Pharma Chem Limited
NW
N
N
NW
NW
5.0
6.3
7.2
9.2
8.9
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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Vasudha Pharma Chem Limited
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 1.5
Plant & Green Belt Photographs
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Fig 1.6
Site Lay out plan
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5.0 Planning in Brief
The project is envisaged to be completed by March 2015, and the
production shall be initiated thereon. Consultants are identified for
preparing the detailed project report.
6. Resource requirements
6.1 Power Requirement and Supply/Source
The total power requirement is 750 KVA.
It shall be sourced from
APCDDL 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
production facilities, utilities and effluents treatment infrastructure with
an additional investment of Rs. 3.5 Crores. The details are outlined in the
below table
TABLE 7.0
Production facilities/Utilities/ETP – Existing & Proposed
S.NO Details
Capacity/
No
After
Current Additions expansion
Production facilities
1
2
Production BlocksClean rooms
Utilities
Nos
Nos
4
9
-
4
9
3
4
5
Boiler (Coal Fired)
Bolier (Oil Fired)
Thermic Oil heater
3
3
1
4
-
7
3
1
6
DG sets
TPH
TPH
2 Lakh
Kcal/HR
KVA
500
1000
250
1000
970
2000
30
65
7
8
9
1 X 250
1 X 500
Cooling tower
TR
720
3
Softner/DM plant
M /hour
1000
Effluent handling & treatment facilities
collection tanksKL
35
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Vasudha Pharma Chem Limited
Storage
Neutralisation tanks
Stripper ,MEE,ATFD
RO & Biological
treatment
KL
KLD
KLD
35
----
30
60
50
65
60
50
6.3 Land Requirement
The unit currently have 3 acres of land and out of which 0.33 acres of
green belt is developed.
The land requirement for proposed expansion
activities will be 2500.0 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
1
2
3
4
Purpose
Built up area
Green belt
Open area
Total
Area required for Proposed
expansion
Units
Sq.M
Sq.M
Sq.M
Sq.M
Sq M
Extent
4294.67
1338.40
6510.93
12144.00
2500.0
7.0 Air Pollution
The Sources of air emissions from the plant are 3 TPH oil fired boiler & 3
TPH coal fired Boiler and proposed 4 TPH coal fired boiler and additional
DG sets
The process emissions from the second phase contain NH3, HCl, Methyl
chloride are scrubbed with caustic and scrubbed waste send to MEE. The
other gases expected in the process are Carbon dioxide, H2 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
Parameter
Capacity
Fuel
Anticipated
emissions
Control
system
HCl
SPM, SO2 &
NOx
SPM, SO2,
NOX
Scrubber
Stack Ht 30
meters
Stack Ht 30
meters &Multi
Cone
dust
collector
Stack Ht
5
mts,
Acoustic
enclosures
1
2
Existing
Process
Boiler stack
--3 TPH
-Oil
3
Boiler Stack
3 TPH
Coal
4
DG sets
1x 500 KVA
and
1 X250 KVA
Diesel
SPM, SO2 &
NOx
1
Proposed
(additions)
Boiler
4 TPH
Coal
SPM,SO2 &
NOx
2
DG set
1x 500 KVA
diesel
SPM, SO2,
NOX
3
Process
--
--
NH3, CO2,
HCl, Methyl
chloride, H2
Bag
filter
&Stack Ht 30
meters
Stack height of
5
meters
&
acoustic
enclosure
Scrubber
8.0 Bulk Chemical Storages:
Following bulk chemical storage facilities are proposed for expansion
activity
Table No 10.0
Storage facilities of bulk chemicals
Sr
No
1
2
3
4
5
Capacity
(KL)
2X 20
20
20
20
20
Name of the solvent
Methanol
Toluene
Acetone
IPA
Ethyl acetate
MOC
SS
SS
SS
SS
SS
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7
8
9
10
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Vasudha Pharma Chem Limited
20
Acetic acid
12
CS Lye
12
Liquid Ammonia
10
Sulphuric acid
25
Secondary Container
15
Diesel
Total maximum storage capacity: 214 KL
HDPE
MS
MS
MS
MS
MS
9. Project Financial
The estimated cost of the expansion project is approximately 5.5 Crores.
Out of this Rs. 3 Crores will be for effluents treatment facilities and rest
for other process equipment and safety equipment
Project cost
Rs. In
lakhs
250.0
100.0
Total
350.0
Plant& machinery
Civil & Structural
Pipe lines & insulation
Electricals & instrumentation
Erection & commissioning &
painting
Safety & Environment
Furniture, fixtures, computers,
lighting etc
20% on plant &
machinery
10% on plant &
machinery
8% on plant &
machinery and
structures
20.0
10.0
8.0
100.0
Total
Contingencies & pre-operative
expenses
40.0
528.0
22.0
Project cost say 5.5 Crores
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Annexure I
Copy of EC & Certified Compliance report from MOEF, Bangalore
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Annexure III
Process description and flow sheets
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