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

SUPPLY

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

OUTLICENSING

 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

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 DCGI-India, Bfarm (DE) and MEB (NL) certified by

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 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

One stop solution

Cost

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