jan 2009 introduction to jubilant fully integrated solutions in generics

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Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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Page 1: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

Jan 2009

INTRODUCTION TOJUBILANT

FULLY INTEGRATED SOLUTIONS IN GENERICS

Page 2: Jan 2009 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

Page 3: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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

Page 4: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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

Page 5: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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.

Page 6: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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.

Page 7: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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

Page 8: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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

Page 9: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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...

Page 10: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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

Page 11: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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.

Page 12: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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

Page 13: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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

Page 14: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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

Page 15: Jan 2009 INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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.