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INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS. 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

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INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS

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  1. INTRODUCTION TO JUBILANT FULLY INTEGRATED SOLUTIONS IN GENERICS Jan 2009

  2. 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

  3. 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

  4. Generic Products Regulatory Services Discovery Services APIs CRAMS Performance Chemicals Organic Intermediates 1985-90 1990-95 1980-85 1995-2000 2000-2003 2004 Moving up the Pharmaceutical Value Chain Jan 2009

  5. 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

  6. Backward integration OUT-LICENSING RA SUPPLY Perfect synergism from API development up to supply of the finished dosage form, guaranteeing reliability in quality and timing. Jan 2009

  7. 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

  8. 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

  9. Jubilant Life Sciences API Jubilant develops a range of API’s and intermediates in therapeutic categories of the central nervous system, 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

  10. 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

  11. 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

  12. 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

  13. 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 • Highly qualified and experienced scientists • Novel, patented and non-infringing technologies Skill / Technologies One stop solution Providing integrated offers for licensing and supply of finished dosage forms to clients in Europe Cost Significant cost saving through full integration Jan 2009

  14. 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

  15. 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

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