Transcript PPT - Jubilant Pharmaceuticals

INTRODUCTION TO
JUBILANT
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
Generic
Products
Regulatory
Services
Discovery
Services
APIs
CRAMS
Performance
Chemicals
Organic
Intermediates
1980-85
1985-90
1990-95
Jan 2009
1995-2000
2000-2003
2004
Core business
Jubilant Pharmaceuticals is a totally backward integrated service and
product 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
RA
OUTLICENSING
Perfect synergism from API development up to supply of the
finished dosage form, guaranteeing reliability in quality and
timing.
Jan 2009
SUPPLY
Benefits of backward integration
 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
OUTLICENSING
Jubilant’s facilities
 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
Jan 2009
Jubilant Life Sciences API
Jubilant develops a range of
API’s and intermediates in therapeutic
categories of the central nervous
system, cardiovascular system, gastrointestinal 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
Quality & Reliability
• 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
Skill / Technologies
One stop solution
Cost
• 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
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
TURNKEY
MANUFACTURING
SITE 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.
Jan 2009