Navcure ( A Division of Stellar- Bio Labs), Chandigarh, Antacid Medicine
Company Overview - Sharon Bio-Medicine Ltd.
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Transcript of Company Overview - Sharon Bio-Medicine Ltd.
BUILDING AN INTEGRATED COMPANY
Research Manufacturing Packaging• Pre-clinical studies• API • Formulation
g• Intermediates• Actives• Finished dosage
g g• Finished
Pharmaceuticals
Developments e osage
… Caring for Relationships
Vision:
• We aim at earning the reputation of being a reliable manufacturer and a force to reckon with in the area 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 • 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 advantageoutcome that gives us the competitive 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”
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 Main focus on Strategy and Commercial Operations
Lalit Misra - Director • Over 14 years in Operations, Projects & Business Development y p , j p• Responsible for Operations, Business Development and New Projects.
M h K l Di tMohan Kala - Director• 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
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.
2011 GLP OECD received for Sa-FordCanadian Approval received for Formulation Unit 1.Finished Product Supplies to Australia started
2009
2010 Certification for Formulation Unit & API- GMP accreditation by UKMHRA for Formulation Unit 1.-WHO GMP certified for API Unit 2.
2007Commissioned Formulation Unit at Dehradun.
2009Foray in Animal ToxicologyCommissioned API Unit – 2 with focus on regulated markets.
2005Awarded ISO 9001-2000 accreditation by BVQI UKAS –API Unit-I.
2000
1995Foray into API’s with Launch of Trimetazidine Di HCl
Went public with 25% offering focus on R&D in API / Int.19971989
Incorporation of Company.
Current Management took over.
2014 Proposed Formulation Facility in SEZ Vizag, India. Projected Investment 50 m USD
2013 P d API F ilit i Sh l M h ht
Projected Investment 50 m USD
2013 Proposed API Facility in Sholapur, Maharashtra. Projected Investment 30 m USD
2012US FDA MCC S h Af A l f F l U 1
EMEA & US FDA Approvals for API Unit 22012
Joint Venture Project for API Manufacturing in Uzbekistan
2012
US FDA & MCC South Africa Approvals for Formulation Unit 1
7594
111
133Turnover in USD millions
17.62 17.73
29.64
EPS
07-08 08-09 09-10 10-11 08-09 09-10 10-1107 08 08 09 09 10 10 11
Sharon Vs Sensex SensexSharon
Share Holder
160170180190200
185001900019500200002050021000
Sharon
120130140150
1600016500170001750018000
10 10 10 10 10 10 11 11 11 11 11 11
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Location: Taloja, Mumbaij , Separate High pressure reaction zone.
Specialization of handling 5 to 6 development projects simultaneously.
Focused on De elopment of cost effecti e ualit products Focused on Development of cost effective, quality products,
Process Improvement & simplification.
cGMP – Kilo Lab Facility
Analytical Method Development team
well supported by:
HPLC’s, UV visible spectrophotometer, GC HPLC s, UV visible spectrophotometer, GC
FTIR
Purified water generator
3 S bili Ch b 3 Stability Chambers
Misc testing instruments / apparatus
Research & Development : FormulationResearch & Development : Formulation
Location: Dehradun & MumbaiLocation: 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.
Location: Taloja, Mumbai.j , Certification: WHO GMP, ISO 9001-2008, GMP Countries for which approval is proposed: South Korea, Europe, GCC Countries, USA, Mexico.
Manufacturing: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 U it 1 f d M f t i f I t di tAPI Unit 1 focused on Manufacturing of Intermediates.
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.
Fluid Bed Dryer
Reaction area
BlenderVacuum Tray Dryer
Isolation Vessel
FTIR
Wet LabGC Room
HPLC Chemical & Reagent Store
Wet Lab
Location: Dehradun, near Delhi, Certification / Approvals:
UKMHRA, WHO GMP , INVIMA, (Colombia), Namibia, Uganda, TGA, Canada.
Proposed Certification USFDA & ANVISA Proposed Certification: USFDA & ANVISA
Manufacturing:
Capacity Tablets & Capsules 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 The plant has capability to manufacture Solid oral dosage forms, Aqueous, Non-aqueous as well 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.p , , p g g .
GranulationGranulation
Pelletisation
Tablet CompressionTablet Compression
Tablet Coating
Blister Packaging
Bulk Packaging
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 Cephalosporin range: Capable of manufacturing Tablets, Capsules & Injectable including Dry 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
L ti T l j M b i Location: Taloja, Mumbai. 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 y pinitiative towards building a Contract Research Organization of high repute.
SA-FORD offers short & long term studies on mice, rodents , guinea pigs and g g grabbits.
Studies offered include Inhalation, Reproductive Toxicology & Genotox
Expansion is underway to add a dog facility
Double Door lAutoclaves
Animal Cage
Clinical Chemistry Histopathology y p gy
CQA: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 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 With over 10 people the RA team has sufficient expertise to handle and manage all queries from Customers and Regulatory Authorities worldwide.
ADD SUSTAINABILITY TO YOUR SUPPLY CHAIN THROUGH INTEGRATED » ADD SUSTAINABILITY TO YOUR SUPPLY CHAIN THROUGH INTEGRATED INTERMEDIATE, ACTIVE & FINSIHED DOSAGE MANUFACTURING.
BENEFIT FROM OUR EXPERIENCE IN PRODUCTION PROJECT MANAGEMENT » BENEFIT FROM OUR EXPERIENCE IN PRODUCTION, PROJECT MANAGEMENT AND PRODUCT LIFE CYCLE MANAGEMENT
BENEFIT FROM OUR HIGH LEVEL OF ‘COMMITMENTS » BENEFIT FROM OUR HIGH LEVEL OF ‘COMMITMENTS
WITH REGARDS TO QUALITY & DELIVERY