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 Annexure-
I

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Pre-Feasibility Report
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
Source of water
Nearest habitation and distance
from the site
Nearest surface water bodies
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
Vasudha Pharma Chem Limited
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
HMWS and partly from private
suppliers through tankers
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
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 Vasudha Pharma Chem Limited

i) 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 (CGMP) are integrated throughout the
manufacturing process to ensure strict adherence to 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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Pre-Feasibility Report 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.N Quantities in
Name of the Product TPM
o
Group- A
1 Domperidone Maleate 1.20
2 Loratidine 1.87
3 Cyclobenzaprine Hydrochloride 0.30
4 Ketorolac Tromethamine 0.50

5 Quetiapine Hemifumarate 0.72

6 Loperamide Hydrochloride 0.30
7 Donepezil Hydrochloride 0.05
8 Ebastine 0.05
Total 4.99
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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 Pre-Feasibility Report 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

Production Product Description

S.N
Product Name Capacity Drug/Intermediate/
o
TPM Multipurpose chemicals
1 Amitriptyline Hydrochloride 1.50 Bulk Drug
2 Cisapride Monohydrate 0.30 Bulk Drug
Cyclobenzaprine
3 1.50 Bulk Drug
Hydrochloride
Cyproheptadine
4 0.15 Bulk Drug
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

Fexofenadine
10 3.00 Bulk Drug
Hydrochloride
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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Pre-Feasibility Report 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 Waste Water Proposed

requirement in discharge in KLD Method of
KLD Treatment and
S.
Stream Disposal
No
Current After Current After
Expans Expansi
ion on
1. Process 27.12 9.7 30.44 MEE followed by
ATFD.
2 Washings 9.3 5.0 0.8 5.0 (Condensate to
ETP & RO)

3 Scrubbers, 1.5 5.0 1.5 5.0

R&D & QC

4 Boiler 12.0 30.0 2.0 3.0 ETP and RO and

re-use. RO
5 DM/Softener 3.0 3.0 rejects to MEE
ETP and RO
6 Cooling & 50.0 5.0
Regeneration

7 Domestic 2.0 5.0 2.0 4.0

8 Gardening 3.0 3.0 --- --

Total 27.8 128.12 16.0 55.44

3.5 Wastes generation and control systems

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Pre-Feasibility Report Vasudha Pharma Chem Limited

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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 Pre-Feasibility Report Vasudha Pharma Chem Limited

Fig 1.1
Schematic treatment scheme of high TDS effluents

Effluent from
Process and Strippe Aq. Distillate to
Equalization Neutralization Setting
r
Cement plants/TSDFRecovery
Tank Tank Tank
washings , Scrubber
R&D
RO Reject

To TSDF
MEE Condensate to
Biological
Treatment

Condensate to Biological Treatment

ATFD

Sludge To TSDF

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Pre-Feasibility Report Vasudha Pharma Chem Limited

Fig 1.2 Low TDS Effluent Treatment System

Domestic effluent

Screen
Effluents from utilities & MEE condensate Chambe

Clarifier1 Aeratio Clarifier2

Screen Equalization Neutralizatio Aeratio
Chamber Tank n Tank n Tank1 n Tank2

Holding
Tank

Sludge Holding
Tank Sand
filter

Carbon
Filter Press Filter
Sludge to TSDF
Sludge Cake

Ultra filtration
Permeate for re-use RO

Rejects to MEE
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Pre-Feasibility Report Vasudha Pharma Chem Limited

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 Pre-Feasibility Report 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.
Description Current After Remarks
No
Expansion

1 Spent Carbon 0.9 TPM 2.34 TPM

M/s. India Cements Ltd,
Vishnupuram, vadepally,
Distillation Nalgonda district for using in the
2 bottom Residue/ 3.0 TPM 9.64 TPM
kiln or to TSDF Dundigal
organic residue
Forced
3 Evaporation 4.9 TPM 22.28 TPM
salts
Sent to TSDF, Dundigal
Inorganic
4 -- 2.07 TPM
residue
5 ETP Sludge 1.0 TPM 5.0 TPM
6 Boiler ash -- 6.65 TPD Sold to brick manufactures
138 KL/ Recovered and reused within
7 Spent solvents 300 KL/month
month premises
Mixed spent 27.5 Authorized solvent recovery
8 45 KL/Month
solvents KL/month units/ cement Plants
Used oil/ waste Authorized
9 100 LPM 150 LPM
lubricating oil recyclers/preprocessors
Sent to the manufacturer for
150 200
10 Spent Catalyst recovery of catalyst/ TSDF,
kgs/month kgs/month
Dundigal
Detoxified
Container and
container liners
After Complete detoxification it
MS Drums 58Nos/M 100 Nos/M
11 shall be disposed to the outside
HDPE Drums 15 Nos/M 50 Nos/M
agencies
Carboys 70 Nos/M 150 Nos/M
Plastic bags 880Nos/M 2500 Nos/M
Glass bottles 51 Nos/M 150 Nos/M

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Pre-Feasibility Report Vasudha Pharma Chem Limited

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 – Remedy Health Products (Chocolate manufacturing unit)
West - 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 Direction Distance

from the from the
site site
1 Dulapalli N 1.6
2 Gajula Ramaram NW 3.0
3 Suraram NW 4.2

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Pre-Feasibility Report Vasudha Pharma Chem Limited

4 Bowrampet NW 5.0
5 Pochampalli N 6.3
6 Goudavalli N 7.2
7 Dundigal NW 9.2
8 Kajipalli NW 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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Pre-Feasibility Report Vasudha Pharma Chem Limited

Fig 1.3
Topo Sheet of the 10 KM study area

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Pre-Feasibility Report Vasudha Pharma Chem Limited

Fig 1.4
Base map of the study area

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Pre-Feasibility Report Vasudha Pharma Chem Limited

Fig 1.5

Plant & Green Belt Photographs

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Fig 1.6

Site Lay out plan

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Pre-Feasibility Report Vasudha Pharma Chem Limited

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

Capacity/ After
S.NO Details No Current Additions expansion
Production facilities

1 Production Blocks- Nos 4 - 4

2 Clean rooms Nos 9 - 9
Utilities

3 Boiler (Coal Fired) TPH 3 4 7

4 Bolier (Oil Fired) TPH 3 - 3
5 Thermic Oil heater 2 Lakh 1 - 1
Kcal/HR
6 DG sets KVA 1 X 250 500 1000
1 X 500
7 Cooling tower TR 720 250 970
8 Softner/DM plant M3/hour 1000 1000 2000
Effluent handling & treatment facilities
9 collection tanks- KL 35 30 65
Storage
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Pre-Feasibility Report Vasudha Pharma Chem Limited

10 Neutralisation tanks KL 35 30 65
11 Stripper ,MEE,ATFD KLD -- 60 60
12 RO & Biological KLD --- 50 50
treatment

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 Purpose Units Extent

1 Built up area Sq.M 4294.67
2 Green belt Sq.M 1338.40
3 Open area Sq.M 6510.93
Total Sq.M 12144.00
4 Area required for Proposed Sq M 2500.0
expansion

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

Table 9.0
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 Pre-Feasibility Report Vasudha Pharma Chem Limited

Emission Source – Current & Proposed

S.N Parameter Capacity Fuel Anticipated Control

o emissions system
Existing
1 Process --- -- HCl Scrubber
2 Boiler stack 3 TPH Oil SPM, SO2 & Stack Ht 30
NOx meters
3 Boiler Stack 3 TPH Coal SPM, SO2, Stack Ht 30
NOX meters &Multi
Cone dust
collector
4 DG sets 1x 500 KVA Diesel SPM, SO2 & Stack Ht 5
and NOx mts, Acoustic
1 X250 KVA enclosures
Proposed
(additions)
1 Boiler 4 TPH Coal SPM,SO2 & Bag filter
NOx &Stack Ht 30
meters
2 DG set 1x 500 KVA diesel SPM, SO2, Stack height of
NOX 5 meters &
acoustic
enclosure
3 Process -- -- NH3, CO2, Scrubber
HCl, Methyl
chloride, H2

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 Capacity
Name of the solvent MOC
No (KL)
1 2X 20 Methanol SS
2 20 Toluene SS
3 20 Acetone SS
4 20 IPA SS
5 20 Ethyl acetate SS
6 20 Acetic acid HDPE

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Pre-Feasibility Report Vasudha Pharma Chem Limited

7 12 CS Lye MS
8 12 Liquid Ammonia MS
9 10 Sulphuric acid MS
10 25 Secondary Container MS
11 15 Diesel MS
Total maximum storage capacity: 214 KL

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
Plant& machinery 250.0
Civil & Structural 100.0
Total 350.0
20% on plant &
Pipe lines & insulation machinery 20.0
10% on plant &
Electricals & instrumentation machinery 10.0
8% on plant &
Erection & commissioning & machinery and
painting structures 8.0
Safety & Environment 100.0
Furniture, fixtures, computers,
lighting etc 40.0
Total 528.0
Contingencies & pre-operative
expenses 22.0
Project cost say 5.5 Crores

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Pre-Feasibility Report Vasudha Pharma Chem Limited

Annexure I

Copy of EC & Certified Compliance report from MOEF, Bangalore

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Pre-Feasibility Report Vasudha Pharma Chem Limited

Annexure III

Process description and flow sheets

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