jan 2009 introduction to jubilant fully integrated solutions in generics
TRANSCRIPT
Jan 2009
INTRODUCTION TOJUBILANT
FULLY INTEGRATED SOLUTIONS IN GENERICS
Jan 2009
Jubilant fact sheet Incorporated in 1978 and headquartered in New Delhi - India
Ownership of the company 52% with founders, 30% with PE and institutions and 18% with public
Over 25 years of experience in Chemical & Knowledge-based industry
Strong Financials: Net sales of 416 million $ in FY 2007, PAT of $ 52 million
Employs 4,466 people including about 1,050 in R&D
Subsidiaries in Europe (Jubilant Europe), USA & China Global positions in key products, exported to over 120
countries
Jan 2009
Jubilant Pharmaceuticals fact sheet
Incorporated in 1993
Based in Gent – Belgium
Subsidiary of Jubilant Life Sciences since 2004
Broad-spectrum services and products provider to pharmaceutical marketing companies in Europe
Knowledge-based company with excellent track record in national MA’s, MRP’s and DCP procedures
Jan 2009
Moving up the Pharmaceutical Value Chain
1980-85 1985-90 1990-95 1995-2000 2000-2003 2004
Generic Generic ProductsProducts
Organic Organic IntermediatIntermediat
eses
PerformancPerformance Chemicalse Chemicals
CRAMSCRAMS
APIsAPIs
Discovery Discovery ServicesServices
Regulatory Regulatory ServicesServices
Jan 2009
Core businessJubilant Pharmaceuticals is a totally backward integrated
service andproduct provider for generic pharmaceutical companies.
Our core business and competences are:
Out-licensing with supply of fully in-house developed generics.
Manufacturing site transfers with production at the in-house facility.
Regulatory Services Clinical research at the in-house facility in Delhi, India.
Jan 2009
Backward integration
OUT-LICENSING
SUPPLYRA
Perfect synergism from API development up to supply of the finished dosage form, guaranteeing reliability in
quality and timing.
Jan 2009
Benefits of backward integration
OUT-LICENSING strong R&D and
manufacturing capacities at Jubilant India
Jubilant Pharmaceuticals as the single contact point in Europe for licensing, registration and supply
Qualitative supply of dosage form products
Competitive pricing throughout the entire supply term
Jan 2009
API : In-house API formulation & production
R&D Formulation :
Plain dosage forms Added-value Controlled and sustained release
BE studies : In-house Clinical center
In-house Regulatory Affairs expertise
In-house production of pharmaceutical dosage forms
In-house GDP logistics with GMP certification :
EU release
Jubilant’s facilities
Jan 2009
Jubilant Life Sciences API
Jubilant develops a range of API’s and intermediates in therapeuticcategories of the central nervoussystem, cardiovascular system, gastro-intestinal and anti-infectives.
These API’s are the core of the finished dosage form developments.
Commercially available molecules with DMF/
CoS include: Carbamazepine, Oxcarbazepine,
Citalopram, Lamotrigine, Risperidone, Tramadol,Esomeprazole, Losartan, Pantoprazole, Olanzapine...
Jan 2009
Jubilant Clinsys Clinical Research
Wholly owned subsidiaries based in Delhi, India and Philadelphia, US
Bioavailability, bioequivalence, pharmacokinetic and phase 1 clinical studies
46 bed facility spread in ~35,000 sq. ft. area in Delhi – certified by DCGI-India, Bfarm (DE) and MEB (NL)
Own Bio-analytical, PK, Clinical Lab, Statistical and quality assurance under one roof
Clinical research started in June 2005
Jan 2009
R&D Formulation Center
The development work on dosage forms has a
therapeutic focus on
Central Nervous System
Cardiovascular System
Anti-infective
Respiratory System
Anti-diabetic treatment
A dedicated team of more than 100 scientists is working in laboratories equipped with
the latest scientific instruments.
Jan 2009
Dosage form manufacturing
Jubilant owns a finished dosage forms c-GMP compliant manufacturing facility at Roorkee, India.
The facility was set up in July 2007 and EU-GMP approved by the UK-MHRA in record time.
Current annual production capacity is 1.2 billion tablets and 330 million capsules with expansion foreseen in the near future.
Production capabilities span across various IR, NDDS and taste masked oral solids through:
wet and dry granulation direct compression encapsulation spheronisation extrusion
Jan 2009
Jubilant’s strengths
•Complete project management in-house
•Availability of large number of qualified experts
•Strict adherence to EU/US FDA guidelines
•High quality Drug Master Files and CoS•Highly qualified and experienced
scientists
•Novel, patented and non-infringing technologies
Providing integrated offers for licensing and supply of finished dosage forms to clients in Europe
Skill / Technologies
Quality & Reliability
One stop solution
Cost Significant cost saving through full integration
Jan 2009
Main Focus
Jubilant understands the outsourcing requirements of its customers and transforms their needs into solutions.
Long-term supply of finished dosage forms following either :
OUT-LICENSING
OR
TURNKEYMANUFACTURINGSITE TRANSFERS
Jan 2009
One stop solution
Our customers are companies which :
market & sell medicinal products
are eager to expand their product portfolio/geographic territory and want to be first to the market
wish to upgrade to state-of-the-art active substances and finished dosage form manufacturing
prefer to concentrate their resources on marketing and choose Jubilant as one stop solution for research, development, RA and supply.