Api DPR
Api DPR
PREPARED FOR
“MANUFACTURING OF ACTIVE
PHARMACEUTICAL INGREDIENTS (API)”
AT
PLOT NO. 63, KADECHUR INDUSTRIAL AREA,
YADAGIR TALUK & DISTRICT, KARNATAKA
NEW PROJECT BY
Prepared By
AM ENVIRO ENGINEERS
[ISO 9001-2015 CERTIFIED COMPANY]
(QCI/NABET Accreditation No. NABET/EIA/1922/IA0056)
No. 14/1, 2nd Floor, HARIKRUPA, Pattalamma Temple Street,
Basavanagudi, Bengaluru - 560 004
Ph. No. : 080 2657 6577
Pre-Feasibility Report JOINTX INDUSTRIES PRIVATE LIMITED
TABLE OF CONTENTS
1. EXECUTIVE SUMMARY................................................................................................................. 5
2. INTRODUCTION OF THE PROJECT/BACKGROUND INFORMATION...................6
I. IDENTIFICATION OF PROJECT AND PROJECT PROPONENT..........................................6
II. BRIEF DESCRIPTION OF NATURE OF THE PROJECT.............................................................6
III. NEED FOR THE PROJECT AND ITS IMPORTANCE TO THE COUNTRY OR
REGION
6
IV. DEMAND AND SUPPLY GAP.................................................................................................................7
V. IMPORTS V/S. INDIGENOUS PRODUCTION...............................................................................7
VI. EXPORT POSSIBILITY...................................................................................................................................8
VII. DOMESTIC/ EXPORT MARKETS.....................................................................................................8
VIII. EMPLOYMENT GENERATION (DIRECT AND INDIRECT) DUE TO THE
PROJECT
8
3. PROJECT DESCRIPTION................................................................................................................ 9
I. TYPE OF PROJECT INCLUDING INTERLINKED AND INTERDEPENDENT
PROJECT IF ANY
9
II. LOCATION (MAP SHOWING GENERAL LOCATION, SPECIFIC LOCATION,
AND PROJECT BOUNDARY & PROJECT SITE LAYOUT) WITH COORDINATES
9
III. DETAILS OF ALTERNATE SITES CONSIDERED AND THE BASIS OF
SELECTING THE PROPOSED SITE, PARTICULARLY THE ENVIRONMENTAL
CONSIDERATIONS GONE INTO SHOULD BE HIGHLIGHTED.............................................13
IV. SIZE OR MAGNITUDE OF OPERATION......................................................................................14
V. RAW MATERIAL REQUIRED ALONG WITH ESTIMATED QUANTITY LIKELY
SOURCE MARKETING AREA OF FINAL PRODUCT/S, MODE OF TRANSPORT OF
RAW MATERIAL AND FINISHED PRODUCT..................................................................................15
VI. RESOURCE OPTIMIZATION/RECYCLING AND REUSE ENVISAGED IN THE
PROJECT IF ANY SHOULD BE BRIEFLY OUTLINED..................................................................15
VII. AVAILABILITY OF WATER ITS SOURCE, ENERGY/POWER REQUIREMENT
AND SOURCE SHOULD BE GIVEN........................................................................................................... 16
Pre-Feasibility Report JOINTX INDUSTRIES PRIVATE LIMITED
LIST OF TABLES
LIST OF FIGURES
FIGURE: 3.2 GOOGLE IMAGE SHOWING 500 M RADIUS FORM THE PROJECT SITE 11
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
1. EXECUTIVE SUMMARY
M/s. Mansfield Pharma Pvt. Ltd has been allotted an area of 2.0 acres by KIADB for
“Manufacturing of Active Pharmaceutical Ingredients (API’s)” at Plot No. 63, Kadechur
Industrial area, Yadagir Taluk & District, Karnataka State. The proposed production
capacity of API’s is 40 TPM.
TABLE 1.1: SALIENT FEATURES OF THE PROJECT
S. Description
No. Details
1. Name of the project Manufacturing of Active Pharmaceutical
Ingredients (API’s) by M/s. Mansfield Pharma Pvt.
Ltd
2. Location of the project Plot No. 63, Kadechur Industrial area, Yadagir
Taluk & District, Karnataka State
3. Total land requirement 8089.8 Sqmt (2 Acres)
for the project
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
M/s. Mansfield Pharma Pvt. Ltd has proposed to establish the API manufacturing unit
at Plot No. 63, Kadechur Industrial Area, Yadagir Taluk & District of Karnataka State
with a total capacity of 40 TPM.
Drug discovery for therapeutic use to improve the human health is a fast changing
field. To keep pace with international developments, Indian pharmaceutical
industry needs to constantly upgrade their product portfolio and production
volumes. Under similar circumstances, M/s. Mansfield Pharma Pvt. Ltd proposed for
manufacturing of Active Pharmaceutical Ingredients. The project area comes under
notified Industrial Area. Hence the project falls under item no -5(f) of schedule to
th
EIA notification, dated 14 September 2006.
iii. Need for the project and its importance to the country or region
The drugs demand in India is increasing due to rapid growth of population. The
requirement addition at the present rate will not be able to meet the projected
demand and would result in a large drug deficit. To mitigate the gap between
demands and supply Govt. of India is facilitating large scale capacity additions at
shorter time through public and private investments. India with its large talented
manpower, cost effective chemical synthesis, legal & financial framework is poised
to become sourcing destination of bulk drugs to the global market.
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
Over the years, the production of bulk drug has made significant progress. The drug
& pharmaceutical industry in India meets around 70% of the country's demand for
bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets,
capsules, orals and injectibles. There are about 250 large Pharmaceuticals
manufacturers and suppliers and about 8000 Small Scale Pharmaceutical & Drug
Units which form the core of the pharmaceutical industry in India (including 5
Central Public Sector Units). These bulk drugs and pharmaceuticals manufacturers
produce the complete range of pharmaceutical formulations i.e. medicines ready for
consumption by patients and about 350 bulk drugs i.e. chemicals having therapeutic
value and used for production of pharmaceutical formulations. (Source:
pharmaceutical-india.com)
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
multi- national companies are now looking at India not only for its traditional
strengths in manufacturing but also as a highly attractive location for research and
development (R&D), particularly in the conduct of clinical trials and other services.
The consumption potential offered by more than one billion inhabitants, rising
affluent customers and the changing lifestyles offer huge potential domestically for
the sector. Currently, the Indian pharmaceutical industry is one of the world’s
largest and most developed, ranking 4th in volume terms and 13th in value terms.
The country accounted for 8 percent of global production and 2 percent of world
markets in pharmaceuticals. Most of the domestic pharmaceutical drug
requirements are met by the domestic industry. In the segment of Active
Pharmaceutical Ingredients (APIs) India ranks third in the world producing about
500 different APIs. (Source: Pharmexcil.org).
The company has no plans to export its products outside the country. All the products
produced are requirement of domestic market.
Over 60 per cent of India’s bulk drug production is exported. India’s pharmaceutical
exports are to the tune of Rs 87 billion, of which formulations contribute nearly 55 per
cent and the rest 45 per cent comes from bulk drugs.
M/s. Mansfield Pharma Pvt. Ltd has planned to employees about 45 no’s to operate the
unit.
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
3. PROJECT DESCRIPTION
To cater the needs of the market, M/s. Mansfield Pharma Pvt. Ltd. has proposed to
establish Active Pharmaceutical Ingredients (API) manufacturing unit at Plot No. 63,
Kadechur Industrial area, Yadagir Taluk & District, Karnataka.
There are no interlinked or interdependent projects.
ii. Location (map showing general location, specific location, and project
boundary & Project site layout) with coordinates
The project site is located at Kadechur Industrial area, Yadagir Taluk & District,
Karnataka. The project site co-ordinates ranges from Latitude – 16.516351° to
16.516921° and Longitude – 77.313712° to 77.31450°. The location map showing is as
shown below.
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
Project site
FIGURE: 3.2 GOOGLE IMAGE SHOWING 500 M RADIUS FORM THE PROJECT SITE
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
iii. Details of alternate sites considered and the basis of selecting the proposed
site, particularly the environmental considerations gone into should be
highlighted
Particulars Details
Corners Latitude Longitude
Plant site co-ordinates A 16°31'0.80"N 77°18'53.81"E
(Latitude & Longitude) B 16°30'58.88"N 77°18'53.76"E
C 16°30'58.92"N 77°18'49.38"E
D 16°31'0.89"N 77°18'49.44"E
Temperature Max. 42ºC, Min. 26ºC
Present land-use KIADB land (Industrial area)
Average rainfall 850 mm per year
Nearest Highway NH:167/SH-51 (Yadgir - Raichur Road) – 0.9 km (SW)
Nearest Railway station Chegunta Railway Station – 3.6 km (SW)
Rajiv Gandhi International Airport, Shamshabad – 140.9 Km
Nearest Airport
(NE)
Bhima river at 8.6 km (SW)
Nearest Water body Krishna river at 12.2 km (SW)
Kadechur lake at 1.5 km (NE)
Nearest Village Kadechur – 1.2 Km (E)
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
The total production capacity of the proposed project is 40 TPM. The list of the
proposed products is given in below table.
TABLE 3.2: LIST OF PROPOSED API’S
Sl. No. Product Name Qty. in TPM Therapeutic use
1. Aatorvastatin calcium 5 To treat cholesterol
2. Albendazole 8 Anti-worm medication
To treat the symptoms of acute
3. Clopidogrel Bisulphate 5
coronary syndrome
4. Dapoxetine Hydrochloride 2 Inhibitor
Darunavir amorphous &
5. 1 To treat HIV-1 infection
ethanolate
6. Domperidone 3 Anti-sickness
7. Etodolac 1 To reduce the pain and swelling
8. Etoricoxib 2 To reduce pain and swelling
9. Famotidine 3 To treat gastritis
10. Fenbendazole 3 Treatment of parasites
11. Fluconazole 8 Azole antifungals
12. Gefitnib 1 To treat lung cancer
13. Levocetirizine Dihydrochloride 3 To relieve runny nose
14. Metronidazole 8 Antibiotic
15. Montelukast Sodium 2 To prevent wheezing
16. Moxifloxacin 2 To treat pneumonia
17. Olmesartan 5 To treat high blood pressure
18. Omeprazole 8 To treat gastritis
19. Pantoprazole Sodium 8 To treat gastritis
20. Praziquantel 1 Anthelmintics
21. Rabeprazole Sodium 3 To treat gastritis
22. Rosuvastatin calcium 3 To treat cholesterol
To treat male sexual function
23. Sildenafil citrate 5
problems
24. Sitagliptin Phosphate 1 To control high blood sugar
25. Tadalafil 2 To treat erection problems
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
Tapentadol Hydrochloride
26. 3 Pain relieve
Telmisartan
27. 5 To treat high blood pressure
Terbinafine Hydrochloride
28. 2 Antifungal
Triclabendazole
29. 3 Anthelmintics
Vildagliptin
30. 2 Treatment of type 2 diabetes
Total (5 products) 40 TPM
Note: From the above list of products, any 5 products will be manufactured at a given
point of time.
The process description for the proposed products along with route of synthesis, flow
diagram, material balances are attached as ANNEXURE - 2.
v. Raw material required along with estimated quantity likely source marketing
area of final product/s, mode of transport of raw material and finished product
The list of raw materials along with quantities are attached as ANNEXURE –3. The raw
materials will be sourced from local market and also from the different suppliers across
the world. The raw materials and finished products will be transported through road.
After the reaction is complete the solvents are recovered in a distillation unit. The
residue from the distillation unit is collected in a container and sent co processing. The
recovered solvents are collected in drums, labeled and analyzed. Then they are reused
(recycled) for the process.
In the proposed project, conservation has adequately addressed and hence, water
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
consumption is optimized. All process effluent and domestic sewage will be sent to
CETP.
vii. Availability of water its source, energy/power requirement and source should
be given.
TABLE 3.3: WATER CONSUMPTION DETAILS
Water requirement Effluent
Sl. No. Purpose
in KLD Generation in KLD
1 Process Water 66.0 48.2
2 Scrubbing 3.0 4.0
3 RO Reject - 19.8
4 Cooling Tower 55.4 5.5
5 Boiler 23.5 3.4
6 Washing 3.0 3.0
8 Domestic Usage 2.0 1.7
9 Gardening 10.7 -
Total 163.6 85.6
The max water demand for proposed project is 163.6 KLD, which will be met by KIADB.
Power demand is 500 KVA which will be met by GESCOM.
viii. Quantity of wastes to be generated (liquid & solid) and scheme for
management/disposal
The various types of waste from different units of the proposed plant are described
underneath:
a) Liquid Waste
All the products require water during the process. The wastewater generated from the
plant is 85.6 KLD will be sent to CETP
TABLE 3.4: EFFLUENT DETAILS
Sl. Unit HTDS LTDS Waste-water Treatment Method
No. KLD KLD Generation in
KLD
1 Process 31.8 16.4 48.2 Sent to CETP,
2 Scrubber System 4.0 - 4.0 Kadechur
3 RO Reject - 19.8 19.8
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
The details of solid and hazardous waste generated along with the mode of disposal is
detailed in below table.
TABLE 3.5: HAZARDOUS & SOLID WASTE DETAILS.
Category Name of the
S. No of the Hazardous Quantity Disposal Method
HW Waste
Hazardous waste generation from plant
Waste oils &
1 5.1 Grease/ Used 0.5 KL/Annum Agencies authorized by KSPCB
Mineral oil
Oil Soaked
2 5.2 2 Kgs/month KSPCB authorized Vendor
Cotton
Store in secured manner and
Distillation
3 20.3 250 kgs/day hand over to authorized
Residue
incinerator /
Co-processing in cement kiln
Process Store in secured manner and
4 28.1 Organic Solid 2404 kg/day hand over to authorized
Waste incinerator /
Co-processing in cement kiln
Store in secured manner and
6 28.3 Spent Carbon 124.3 Kgs/Day hand over to authorized Co-
processing
in cement kiln
Off Store in secured manner and
7 28.4 Specification 1 ton/month hand over to authorized
Products incinerator /
Co-processing in cement kiln
Store in secured manner and
Date expired 500
8 28.5 hand over to authorized
products Kgs/Month
incinerator /
Coprocessing in cement kiln
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
Detoxified-
After complete detoxification,
Container & 300
9 33.1 shall be disposed to the outside
Container No’s/Month
agencies.
Liners of
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
Hazardous
Chemicals and
Wastes
Contaminated
cotton rags or Store in secured manner and hand
10 33.2 3 Kgs/month
other cleaning over to KSPCB Authorized Vendor
materials
Used Lead
11 A1160 2No’s/Annum Returned back to dealer/ Supplier
Acid batteries
Other & Miscellaneous Solid Wastes
12 -- Coal ash 2800 Kg/day Sent to Brick Manufacturers
Shall be stored in secured manner
In organic & handed over to KSPCB
13 -- 359.23 kg/day
Solid Waste authorized co-processing in
cement kiln /TSDF.
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
Flue
Emission of Emission Emission of Stack Stack Flue gas
Gas
Capacity SPM in of SO2 in NOx in dia. in Height in Velocity
Temp.
In KVA mg/Nm3 mg/Nm3 mg/Nm3 m (m) in m/sec
in ˚C
250 KVA 40 60 70 0.25 140 4m AGL 21
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
4. SITE ANALYSIS
i. Connectivity:
The plant site is well connected by road to the major national and state highway
network. The approach road to the site would have to be suitably laid by making it a
two-lane road suitable for movement of heavy loads involved including the
construction materials.
The Project site is close to Yadagir Raichur road which is at a distance of 0.9 Km towards
South West side and the nearest railway station is Chegunta railway station at 3.6 km
towards SW. The nearest airport is Rajiv Gandhi International Airport located at a
distance of 140.9 km from the site towards North East.
M/s. Mansfield Pharma Pvt. Ltd. acquired 2 acres of land at KIADB notified industrial
area.
Topographically, the site is plain and devoid of rocky outcrops and does not have any
forests. No significant cutting or filling activities are required for land development
activities. Entire site area is under industrial occupation and no cultivation land exists.
No clearance of existing land, vegetation or buildings is involved. The project site is
located at the Northern part of Karnataka. The elevation in the project site is 363
meter above mean sea level. An area covering 10 km radius, with project site as centre,
topo sheet has been prepared and shown subsequently.
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
FIGURE: 3.4 TOPOMAP COVERING 5 KM & 10 KM RADIUS FORM THE PROJECT SITE
iv. Existing land use pattern (agriculture, non-agriculture, forest, water bodies
(including area under CRZ)), shortest distances from the periphery of the
project to periphery of the forests, national park, wild life sanctuary, eco
sensitive areas, water bodies (distance from the HFL of the river), CRZ, In case
of notified industrial area, a copy of the gazette.
The district is bounded by Gulbarga district in the north, Bijapur district in west,
Raichur district in south and Telangana in the east. The existing land use patter is
industrial and the project site is in the KIADB notified industrial area. There are no
reserved forests, national parks, wild life sanctuary and CRZ regions within 10 km
radius. There is no HFL from the periphery of the project site. There are no eco-
sensitive locations within 10 Km from the site.
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
v. Existing Infrastructure:
Soils: The vast stretch of fertile black soil of the district is known for bumper red gram
and jowar Crops and the district is also referred to as the “Daal bowl” of the state. The
soil types in the taluk are deep black, medium black soil, shallow soil and lateritic soil.
The thickness of deep & medium black soil varies from 0.5 to 3.6 m. Infiltration rate of
shallow, medium and deep black soil is moderate to poor. Infiltration rate of medium
black soil recorded in the district is 2.5 cm/hr.
For transportation, the project site is well connected to Raichur-Yadgir road at a distance
of 0.9 km & Chenguta railway station at a distance of 3.6 km. The nearest village is
Kadechur at a distance of 1.2 km. Other basic infrastructures like primary, secondary and
higher schools, colleges, Community and primary health care centres banks, temples, are
located at Yadgiri district which is at 33.7 km from the project site.
The impact of human settlement is expected to be positive, as apart from some people
being directly employed, many others will get indirect employment.
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
5. PLANNING BRIEF
The proposed API manufacturing unit is located within the Kadechur Industrial Area,
Yadagir Taluk & district of Karnataka State. The proposed site is earmarked by KIADB.
No buildings or infrastructure is existing in proposed land. There is internal KAIDB
road which is approach road to the project site. Approval from appropriate competent
authority will be obtained.
ii. Population Projection:
Not Applicable
iii. Land use planning (breakup along with green belt etc):
Area in percentage
Sl no Description Area (Sqmt)
(%)
1 Ground coverage area 2725.5 33.7
2 Green belt area 2694.3 33.3
3 Roads area 2670.0 33.0
Total 8089.8 100
vi. Amenities/Facilities:
M/s. Mansfield Pharma Pvt. Ltd. proposed to establish API manufacturing unit at
Kadechur industrial area, Yadgiri Taluk and District. The project facility includes
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
building blocks of production, raw material storage, office building and finished
product storage area and other facilities.
6. PROPOSED INFRASTRUCTURE
i. Industrial Area: The proposed project is manufacturing of API’s and will takes place
in KIADB Industrial area.
ii. Residential Area: Not Applicable.
iii. Greenbelt: 2694.3 Sqmt (33.3%)
iv. Social Infrastructure: Necessary support infrastructure will be provided as per the
requirement of the project.
v. Connectivity: Project site is well connected by an asphalted road and near state
highway SH-51 (Raichur-Yadagir Road) just 0.9 Km away from the Factory entrance.
vi. Drinking Water Management: The water demand is met from KIADB (Karnataka
Industrial Areas Development Board) water supply. The requirement of water for
the unit is for domestic, industrial purposes and landscape development.
vii. Sewerage system: The wastewater generated from Boiler blow down, cooling tower
blow down and domestic sewage will be sent to CETP.
viii. Industrial waste management:
a) Air Environment:
The major air pollution sources from the industry are DG sets, boilers, scrubber stack
connected to process sections. These sources will be provided with control systems with
stacks of adequate height so as to disperse the emanating flue gases containing SPM,
oxides of sulfur, nitrogen and process emissions free from acid/alkali and Volatile
organic carbons without affecting the ground level concentrations and also dedicated
scrubbers will be provided exclusively to the process section with adequate stack height
as per the regulatory requirements.
i. Sources:
Boilers: The industry is proposing for Briquettes/Coal fired Boilers of capacity 1X4TPH.
D.G. sets: Diesel generators of 1X 250 KVA capacity will be installed to serve as an
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
alternative source of power supply to this unit.
ii. Mitigative measures:
1. Process emission will be connected to scrubber with a stack attached.
2. The vapours will be collected through exhaust system consisting of hood, duct
and vacuum fan and then vented out.
3. Stack will be provided to D.G. sets.
b) Noise Environment:
i. Sources:
Generators, Reactors, Compressors, Fans
c) Water Environment:
The water demand is met from KIADB (Karnataka Industrial Areas Development
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
Board). The requirement of water for the unit is for domestic, industrial purposes
and landscape development. The total water requirement for the industry is 163.6
KLD.
i. Sources:
Process water
Cooling tower blow down
Floor wash
Boiler blow down
1. Rain water harvesting plan will be executed effectively & a storage reservoir of
adequate capacity will be provided to hold rainwater.
2. Recycle of process water including steam condensate.
3. Control of water taps, washings, leakages from pump glands and flanged joints.
4. Floor cleaning with water will be replaced with dry cleaning.
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
x. Power Requirements and Supply and Source:
The total power requirement of the proposed plant is about 500 KVA, which will
be met from GESCOM.
There is no human settlement or structures at the project site. Thus no R & R issue
is involved.
i. Likely date of start of construction and likely date of completion (Time schedule
for the project to be given)
The industry will take necessary approvals from the consented authority and start
the construction immediately after obtaining Environmental Clearance and Consent
For Establishment.
TABLE 8.1: TIME FRAME FOR COMPLETION OF THE PROJECT
Dec 2021 to April
Details of work Aug 2021 to July 2022
2022
Building and construction work 8 months
Erection of reactors and service facilities 5 months
Total 13 months
ii. Estimated project cost along with analysis in terms of economic viability of the
project.
The overall project cost for the proposed API manufacturing unit is 4.8 Crores. The
breakup is given below.
BREAKUP OF THE PROJECT COST
Particulars Amount (Rs. Crores)
Land 0.4
Building, civil work 1.4
Plant & Machinery -Mechanical, Utilities, etc. 1.6
Furniture, Fixtures and other assets 0.4
Electrical & Utilities & Miscellaneous 1.0
Total 4.8
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Pre-Feasibility Report M/s. Mansfield Pharma Pvt. Ltd
9. ANALYSIS OF PROPOSAL
i. Financial and social benefits with special emphasis on the benefit to the local
people including tribal population, if any, in the area
The proposal will bring employment opportunities. It will also bring trade
opportunities to the country.
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