Manufacturing of Pharma Intermediates and APIs

174 Pages·2016·3.04 MB·English

ON

THE PROPOSEDEXPANSION PROJECT

(BY ADDITION OF NEW PRODUCTS)
(Manufacturing of Pharma Intermediates and APIs)

Under Activity: 5(f)
(Synthetic Organic Chemical Manufacturing Industry)

OF

Located at:
Plot No. 911-912-922, Phase-III,
GIDC Vapi,Tal-Vapi, Dist-Valsad
Pin- 396195, Gujarat-India
Prefeasibility Report Megafine Pharma(P)Ltd.

INDEX
1. E xecutive Summary……………………………………………………………………………………….……………… 01
2. I ntroduction……………………………………………………………………………………..………….………………. 03
i. Identification of the Project and Proponent. 03
ii. Brief Description of the project 04
iii. Need of the project and its importance to the country and or region 04
iv. Demand –Supply Gap 04
v. Imports vs. Indigenous production 04
vi. Export Possibility / Domestic / export Markets 04
v ii. Employment Generation (Direct and Indirect) due to the project. 04
3. P roject Description………………………………………………………………………………………………………… 05
i. Type of Project including interlinked and interdependent projects, If any 05
ii. Location (map showing general location, Specific location, and project boundary 05
& project site layout)with coordinates
iii. Profile of Project site 06
iv. Site Layout Plan 08
v. Details of alternate sites considered and the basis of selecting the proposed site, 10
particularly the environmental considerations gone into should be highlighted
vi. Size or magnitude of operation 11
vii. Project description with process details (a schematic diagram/ flow chart 11
showing the project layout components of the project etc. should be given)
viii. Raw material required along with estimated quantity, likely source, marketing 18
area of final products/s, mode of transport of raw Material and finished product
ix. Resource optimization/ recycling and reuse envisaged in the project, 33
x. Availability of water its source, Energy/power requirement and source 33
xi. Quantity of waste to be generated (liquid and solid) and scheme for their 34
Management/disposal
xii. Schematic representations of the feasibility drawing which give information of 41
EIA purpose
4. Site Analyses………………………………………………………………………………………………………………… 42
i. Connectivity 42
ii. Land Form, land Use and Land Ownership 42
iii. Existing Infrastructure/ land use pattern 42
iv. Soil Classification and Land Use Classification 42
v. Climate Data from secondary source 42
vi. Social Infrastructure 42
5. P lanning Description……………………………………………………………………………………………………… 43
i. Planning Concept (Type of industries, facilities, transportation, etc.) 43
ii. Population Projection 43
iii. Land use planning (breakup along with green belt etc. 43
iv. Assessment of Infrastructure demand (Physical & Social) 43
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Prefeasibility Report Megafine Pharma(P)Ltd.

v. Amenities/ Facilities 43
6. P roposed Infrastructure ……………………………………………………………………………………………….. 44
i. Industrial Area (Processing Area) 44
ii. Residential Area (Non Processing Area). 44
iii. Green belt 44
iv. Connectivity 44
v. Drinking Water management (Source& Supply of water) 44
vi. Sewage System 44
vii. Industrial Waste Management 44
7. R ehabilitation and Resettlement (R&R) Plan…………………………………………………………………. 44
I. Policy to be adopted (Central/ State) in respect of the project affected persons
including home oustees, land oustees and landless laborers (a brief outline to be 44
given):
8. P roject Schedule & Cost Estimates…………………………………………………………………….............. 44
i. Likely date of start of construction and likely date of completion 44
Estimated project cost along with analysis in terms of economic viability of the
ii. 44
project
9. A nalysis of Proposal (Final Recommendations)…………………………………………………............. 45
i. Financial and social benefits with special emphasis on the benefit to the local 45
people including tribal population, if any, in the area
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Prefeasibility Report Megafine Pharma(P)Ltd.

1. EXECUTIVE SUMMARY

1.0 About Project:
M/s. Megafine Pharma(P)Ltd is an existing Company having its unit located at Plot no. 911-912, 922
G.I.D.C., Phase-III, Vapi,Dist.-Valsad,Gujarat-396195 manufacturing syntheticorganic compound as
Advance Drug Intermediates and Bulk Drugs / APIs for Pharma Industry @ 8.71MT/Month.The unit is
involved in Multimilling, Blending, Packing, Labeling of Bulk Drugs and Intermediates @
50MT/Month.
Now, the Company propose to manufacture additional new products within its existing premises
asAdvanceDrug Intermediates and Bulk Drugs / APIs @ 26MT/Month at Plot no. 911-912,922 G.I.D.C.,
Phase-III, Vapi,Dist.-Valsad,Gujarat-396195.
2.0 Highlights of the Project:
Sr. No. Particulates Description
1. Project Location Megafine Pharma (P) Ltd.
Plot no. 911, 912&922 G.I.D.C., Phase-III, Tal.-Vapi,Dist.-
Valsad,Gujarat-396195
2. Project Activity, Category as Project Activity:-5(f)- Synthetic Organic Chemicals,
per amendments Category:-B
3. Project Cost Phase-I15.00Crores& Phase-II 9.00 Crores (Includes
Modification, Modernization & Automation to comply better
R&D, EHS & cGMP)
4. Total area of Project Abt. 4000 sq.mt
5. Products with capacity A. Manufacturing:
Existing:
Pharma Intermediates&Bulk Drugs/APIs: 8.71 MT /M
Proposed:
Pharma Intermediates & Bulk Drugs/APIs:17.29 MT /M
Total after proposed :
Pharma Intermediates &Bulk Drugs / APIs@ 26 MT/M
B. Milling Blending Activity:
Existing: 50 MT/Month
6. Power Requirement 475 HP
7. Utilities (D.G. Sets, Boilers, D.G. Set : Three(Capacity:250+25KVA(Existent) and 250 KVA
Thermopack, etc...) (Proposed)
Boiler IBR: 1120kgs/day, Thermopack: 4Lac Kcal/hr, Boiler
Non-IBR: 800 kgs/day,Boiler IBR: 1120 kgs/day (proposed)
8. Fuel Requirements HSD : 60 Lit./hr.& Natural Gas: 1700 SCM/day, LDO- 75 Lit/hr
9. Man Power 150 persons
10. Air pollution Control All equipment and centrifuges are connected to scrubbers,
Measures LDAR program implemented, Dust collector will be attached
to pulverizer.
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Prefeasibility Report Megafine Pharma(P)Ltd.

11. Water requirement & waste Water Consumption: 89.00 KL/day, Sourced from GIDC water
water generation with mode supply.
of disposal Domestic waste water –12 KLD disposed off through
adequate soak pit and septic tank.
Industrial waste water- Will be segregated as diluted and
concentrated streams.
The diluted stream: 8.15 KL/day, being treated using existing
adequate ETP to meet GPCB norms for further treatment by
CETP through underground drainage of GIDC, Vapi
The concentrated stream: Sent to CETP for CMEE, being
approved member, through tankers with required manifest.
12. Solid / Hazardous waste Managed as per Hazardous Waste (Management, Handling
Generation And Transboundary Movement) Rules-2008.
13. Nearest Highway NH-8: 5.0 Km (Approx.)
14. Nearest Railway Station Vapi- 6.0 Km (Approx.)
15. Nearest Airport Daman 16 Km NW (Approx.) and Surat :125 Km NW
(Approx.)
16. Nearest Forest/ None
Sanctuary/Eco-sensitive zone.
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Prefeasibility Report Megafine Pharma(P)Ltd.

2. INTRODUCTION

I. Identification of Project and Proponent:
Name of the Project Proponent: M/s. Megafine Pharma(P)Ltd
• Unit is established in 1980 as M/s Fine Chemicals then became Superfine Labs P. Ltd. and today it
is Megafine Pharma(P) Ltd.
• Unit is manufacturing various synthetic organic compounds as pharma intermediates & bulk drugs
for pharma industries.
• M/s Megafine Pharma(P) Ltd. achieved milestone in business journey.
1993 : Global pioneer in manufacturing advance macrolides.
o
1994 : Visiting & Exhibiting in overseas market initiated
o
2000 : Achieved almost 100% export oriented unit
o
2006 : Gujarat State FDA approval for GMP as Schedule-M
o
2008 : US-FDA Inspected without any Deficiency; This was First of its kind in Gujarat, US-
o
FDA approved Unit.
2010 : ISO 9001:2008 Certification.
o
2011 : SME Award of “Business Gaurav” as Best Performing Medium Scale Pharma Co.
o
2012 – ISO 14001-18000 OHSAS Certification(Environment, Health & Safety)
o
2013 –Audited by MNC for EHS&Surveillance audit by US-FDA
o
• Unit has obtained Consent to Establish and has obtained valid CCA of the board No.AWH-58429
dated 18-11-2013 valid up 30-09-2018 for manufacturing of existing products.
• The unit is member of CETP, Vapi Green Enviro Ltd.(VGEL) for discharge of treated waste water.
And solid waste at TSDF site
• The unit is member of SEPPL through Vapi Green Enviro Ltd. (VGEL) for incineration of
combustible residual waste. Member of Cement industries for co-processing of combustible
waste
• The unit is member of FACCO and CMEE, Vapi Green Enviro Ltd. (VGEL) for segregated
concentrated waste water treatment.

The company is a registered Private Limited company and is promoted by three Directors. Details
related to them are given below:
Sr. No. Name of Directors Residential Address Background
190-B, Heera Panna Co-op.Hsg. B. Tech. (Chem.)
Mr. Ashok K. Jhaveri Soc., Bhulabhai Desai Road, Haji Ali, I.I.T.-Delhi having 39
1.
Mumbai. years of experience
A/ 7&8, Ashoka Residency, B. Sc. having 35 years
Mr. Hasmukh P.
Tilakwadi, B/H Rajiv Gandhi Bhavan of experience
2.
Gandhi
Marg, Nasik - 422 002.
801-JoganiAppartment, 29-B B. Com. Having 25
Mr. Shailesh J.
Dongarsi Road, Walkeshwar, years of experience
3.
Sanghvi
Mumbai – 400 006.

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Prefeasibility Report Megafine Pharma(P)Ltd.

II. Brief description of nature of the Project:
M/s. Megafine Pharma(P)Ltd is an existing Company having its unit located at Plot no. 911-912, 922
G.I.D.C., Phase-III,Vapi,Dist.-Valsad,Gujarat-396195 manufacturing synthetic organic compound as
Advance Drug Intermediates and Bulk Drugs / APIs for Pharma Industry @ 8.71MT/Month. The unit
is involved in Multimilling, Blending, Packing, Labelling of Bulk Drugs and Intermediates@
50MT/Month.
Now, the Company propose to manufacture additional new products within its existing unit &
proposed new block for PharmaIntermediates and bulk drugs/APIs @ 26 MT/Month which are
synthetic organic chemicals, at Plot no., 911-912,922 G.I.D.C, Phase-III, Vapi, Dist.-Valsad, Gujarat-
396195. For the proposed expansion project, the company propose to use in-house developed ready
technology and intends to procure the available latest technology for manufacturing the proposed
products.
The pharma / health industrial sector in the past many years has seen a consistent growth and also
keeping in mind our strong presence in the local & globalmarket.Hence we have identified the
demand for the proposed products which are meant for very new medicines meant for fast growing
therapeutic segments like Cardiac, Neuro, Pulmonary, Diabetic, etc.with R&D developed our own
process patents we can take a lead & produce commercially in bulk for domestic market as well as
with strong presence in export markets.
As per the EIA notification- 2006 as amended the proposed new project involves the production of
“Pharma Intermediates and APIs” which falls under item no. “5(f) – Synthetics Organic Chemical
Industries“as per the EIA notification- 2006, hence required prior Environmental Clearance.
III. Need for the project and its importance to the country and or region:
The proposed expansion project will provide a potential & required growth opportunity for the
already running business of the company. The company is US FDA approved facility since 2008.
Moreover company has strong presence with leading pharma cos. locally as-well-as internationally;
mainly in regulated market. The company & the products are well approved & registered with the
leading regulatory authorities & the pharma customers’ in local &international markets.
IV. Demand–Supply Gap:
The products have very good demand & high potential asPharma Intermediates and bulk drugs/APIs
for PharmaceuticalIndustries.
V. Imports vs. Indigenous production:
Proposed products manufacturing in the country will be very much viable &acceptable compare to
importsdue to our grass-root technology, efficient productivity and EHS-GMP compliances. Our
products approval & DMF filing for leading overseas customers gives tremendous boost to our
export; whichearns valued forex revenue generation for our county.
VI. Export Possibility / Domestic / export Markets:
There is a fast growing demand of the proposed products in the export & our local market. Our
products are widely used and are in huge demand in the domestic pharma/health industry.
VII. Employment Generation (Direct and Indirect) due to the project:
There will be very good opportunity of employment generation of additional qualified staff
&unqualified workers directly for100 nos.and indirectly for 50 nos.) Due to proposed expansion
project.

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Prefeasibility Report Megafine Pharma(P)Ltd.

3. PROJECT DISCRIPTION

I. Type of Project including interlinked and interdependent projects, If any :
The proposed project is not interlinkedand interdependentproject of the company.

II. Location (map showing general location, specific location, and project boundary & project site
layout) with coordinates:
The map showing general location, specific location and project boundary and project site layout of
M/s. Megafine Pharma(P)Ltd unit located at Plot no. 911-912,922 G.I.D.C, Phase-III, Tal.-Vapi,Dist.-
Valsad,Gujarat-396195.The latitude and longitude of the project site is20.21’58°N and72.56’43°E.

Fig. 3.1: Location map showing the Project site in Notified Industrial area of GIDC Vapi

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Prefeasibility Report Megafine Pharma(P)Ltd.

III. Profile of Project Site:

Sr. No. Nearest Infrastructure Feature Distance from Project Site
1 Geographical Position 20°.21’58 N and 72°.56’43E.
2 Elevation above Sea Level 32 Meters (Approx.)
3 Nearest Village Chhiri- Chharwada (5.0 kmNE)
4 Nearest Town Vapi(5.0 km W)
5 Nearest National Highway NH 8 (5.0 Km W)
6 Nearest State Highway GJ SH 5 (5 Km SW)
8 Nearer RW Station Vapi (6 Km)
Daman (17KmsW)
9 Nearest Airport
Surat (125 Kms NW)
Arabian Sea (18 Km W)
10 Nearest Surface water Resource/Reservoir
DamangangaRiver (7 Km SW)
No patches of Reserve Forest within the study
11 Forest Patches
area of project site.
Location of Archaeologically /Historically
12 --
important places
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Prefeasibility Report Megafine Pharma(P)Ltd.

National Park/Sanctuary or Ecologically Dadra& Nagar Haveli Wild Life Sanctuary
13
sensitive Area Approx. 20 km E
Dadra & Nagar Haveli – 7 Km E
14 National or State Boundary
Daman – 15 km W
Dadra & Nagar Haveli – 7 Km E
15 Tourist Places
Daman – 15 km W
Proposed project is in the GIDC Notified
Selection of project Site and Detail of Industrial area having proper industrial
16
alternate Site. infrastructure hence alternate site
consideration is not envisaged.
17 Size or Magnitude of Operation Small Medium Scale (SME)

Plot site Area Statement:

Area Statement Area After Proposed Expansion (in m2)
Total Area 3992.00
Construction Area 2076.24
Open Land Area 1316.90
Greenbelt Area 598.80

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