2. BUILDING AN INTEGRATED COMPANY
Research Manufacturing
g Packaging
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• Pre-clinical studies • Intermediates • Finished
• API • Actives Pharmaceuticals
• Formulation • Finished dosage
s e osage
Development
… Caring for Relationships
3. Vision:
• We aim at earning the reputation of being a reliable manufacturer and a force to reckon with in the area
of Production of Chemical Intermediates, Bulk Actives and Pharmaceutical Formulations.
• We aim at being considered a benchmark when it comes to Production efficiency & excellence across
the Globe
• We see ourselves in the future as having a diverse portfolio of customers and contributing to their
success
Mission:
• While Aligning all short and long term strategies with our ‘vision’ we shall :
• Put our best foot forward in our R&D efforts to develop important generic alternatives for new drugs.
• Create an operations environment that balances key objectives, quality and costs with a resultant
outcome that gives us the competitive advantage.
advantage
• Delivering superior customer service and shareholder value.
• “We dedicate ourselves to the pursuit of: “Providing a respectful and rewarding work environment for
our employees”
4. Savita Gowda - Managing Director
• Over 18 years experience in manufacturing and marketing & SCM
• Overseas overall operations of the Company
• Main focus on Strategy and Commercial Operations
Lalit Misra - Director
• Over 14 years in Operations, Projects & Business Development
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• Responsible for Operations, Business Development and New Projects.
Mohan K l Director
M h Kala - Di t
• 28 years of financial operations in Pharma Industry
• Responsible for the Finance, Costing and Taxation matters
Vijay Kriplani – Director
· 29 years of experience in Designing, Executing & Engineering of Projects, Product
Development, Technology development, Feasibility Study of the Projects.
Responsible for Executing of Projects, Technology Development
5. Established in 1989. Current management took over in 1995.
Public Listed, with shares traded at the Bombay Stock Exchange.
Annual turnover of over $130 mn
Operations spanning across 7 locations in India
Market Presence in more than 40 countries.
Facilities are approved by Several International Health Authority.
6. 2011 GLP OECD received for Sa-Ford
Canadian Approval received for Formulation Unit 1.
Finished Product Supplies to Australia started
2010 Certification for Formulation Unit & API
- GMP accreditation by UKMHRA for Formulation Unit 1.
-WHO GMP certified for API Unit 2.
2009
Foray in Animal Toxicology
Commissioned API Unit – 2 with focus on regulated markets.
2007 Commissioned Formulation Unit at Dehradun.
2005
Awarded ISO 9001-2000 accreditation by BVQI UKAS –API Unit-I.
2000
1997 Went public with 25% offering focus on R&D in API / Int.
1989 1995
Foray into API’s with Launch of Trimetazidine Di HCl
Current Management took over.
Incorporation of Company.
7. 2014 Proposed Formulation Facility in SEZ Vizag, India.
Projected Investment 50 m USD
2013 Proposed API Facility in Sh l
P d F ilit i Sholapur, M h ht
Maharashtra.
Projected Investment 30 m USD
2012 EMEA & US FDA Approvals for API Unit 2
2012
US FDA & MCC S h Af A
South Africa Approvals f F
l for Formulation U 1
l Unit
2012
Joint Venture Project for API Manufacturing in Uzbekistan
9. Location: Taloja, Mumbai
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Separate High pressure reaction zone.
Specialization of handling 5 to 6 development projects simultaneously.
Focused on Development of cost effective, quality products
De elopment effecti e ualit products,
Process Improvement & simplification.
cGMP – Kilo Lab Facility
Analytical Method Development team
well supported by:
HPLC’s, UV visible spectrophotometer, GC
HPLC s,
FTIR
Purified water generator
3 Stability Ch b
S bili Chambers
Misc testing instruments / apparatus
10. Research & Development : Formulation
Location: Dehradun & Mumbai
Two separate development sites at Dehradun & Mumbai.
Focused on development of Oral solid dosage; Tablet & Capsules.
Specialization in development of Sustained Release & Bi-layered products.
In house analytical laboratory to support Method Development, Validation & Stability Analysis.
Tie-ups with External Labs for performing of Clinical studies.
11. Location: Taloja, Mumbai.
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Certification: WHO GMP, ISO 9001-2008, GMP
Countries for which approval is proposed: South Korea, Europe, GCC Countries, USA, Mexico.
Manufacturing:
Over 60 Reaction/processing vessels with total capacity over 1 Lakh ltrs.
Powder handling Capacity up to 4 MT finished product per day.
API Unit 1 f
U it focused on M f t i of I t
d Manufacturing f Intermediates.
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API Unit 2 is a Start-of-Art cGMP Facility commissioned in 2009 mainly focused on API’s.
API Unit 2 has 3 Manufacturing lines & Packaging lines capable of handling 1Kg to 500Kg batch sizes.
12. Fluid Bed Dryer
Reaction area
Isolation Vessel
Blender
Vacuum Tray Dryer
13. FTIR
Wet Lab
HPLC
GC Room Chemical & Reagent Store
14. Location: Dehradun, near Delhi
,
Certification / Approvals:
UKMHRA, WHO GMP , INVIMA, (Colombia), Namibia, Uganda, TGA, Canada.
Proposed Certification: USFDA & ANVISA
Certification
Manufacturing:
Capacity Tablets & Capsules
CURRENT : 2500 million
POST EXPANSION : 4500 million
The plant has capability to manufacture Solid oral dosage forms Aqueous Non aqueous as well
forms, Aqueous, Non-aqueous
as temperature/humidity sensitive products .
Plant is well equipped with 5 Wet Granulation Suites, 2 Dry Granulation suite, 6
Compression, suites, 2 Capsulation suites and 9 Packaging Suites.
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16. Sharon has strategically tied up with third party Manufacturing sites for the below mentioned
Categories. All these sites have WHO GMP Certification.
Oncology : Capable of handling cytotoxic & Non- cytotoxic products. Also
capable of manufacturing Lyophilized products.
Cephalosporin range: Capable of manufacturing Tablets, Capsules & Injectable including Dry
Tablets
powder injection
Injectable: Capable of handling Non B-lactum & Non-cephalosporin Injectable.
Also capable of manufacturing Ophthalmic range of products.
Ointments & Creams: Capable of handling a wide range of products.
Soft Gel: Capable of handling a wide range of herbal products
17. Location: Taloja, Mumbai.
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Quality Standards: OECD GLP (Certificate No.: GLP/C 0033), EPA, ICH, ISO
10993
Operating as SA-FORD, which is a division of Sharon Bio Medicine Ltd.
SA-FORD stands for SAnctuary FOr Research & Development and is Sharon’s
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initiative towards building a Contract Research Organization of high repute.
SA-FORD offers short & long term studies on mice, rodents , g
g guinea pigs and
g
rabbits.
Studies offered include Inhalation, Reproductive Toxicology & Genotox
Expansion is underway to add a dog facility
18. Double Door
Autoclaves
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Animal Cage
Clinical Chemistry
y Histopathology
p gy
19. CQA:
The Corporate Quality Assurance (CQA) team based at the Vashi office, keeps an overview on
ensures that high levels of Quality standards are followed at all manufacturing sites.
With over 12 personnel the team is well equipped and directly controls the various Site specific
Quality Teams.
The CQA reports directly to the Management.
The CQA has its own quality audit systems whereby it is able to determine any compliances at
manufacturing site.
RA:
The Regulatory Affairs (RA) team based at the Vashi office, coordinates with all sites for
Technical Documents to ensure that all Drug Master Files & Dossiers are processed as per the
requirement.
With over 10 people the RA team has sufficient expertise to handle and manage all queries
from Customers and Regulatory Authorities worldwide.
20. » ADD SUSTAINABILITY TO YOUR SUPPLY CHAIN THROUGH INTEGRATED
INTERMEDIATE, ACTIVE & FINSIHED DOSAGE MANUFACTURING.
» BENEFIT FROM OUR EXPERIENCE IN PRODUCTION PROJECT MANAGEMENT
PRODUCTION,
AND PRODUCT LIFE CYCLE MANAGEMENT
» BENEFIT FROM OUR HIGH LEVEL OF ‘COMMITMENTS
WITH REGARDS TO QUALITY & DELIVERY