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INTRODUCTION TO

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Incorporated in 1978 and headquartered in New Delhi - India ... Lamotrigine, Risperidone, Tramadol, Esomeprazole, Losartan, Pantoprazole, Olanzapine... – PowerPoint PPT presentation

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Title: INTRODUCTION TO


1
INTRODUCTION TO JUBILANT FULLY INTEGRATED
SOLUTIONS IN GENERICS
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 RD
  • Subsidiaries in Europe (Jubilant Europe), USA
    China
  • Global positions in key products, exported to
    over 120 countries

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 MAs, MRPs and DCP procedures

4
Moving up the Pharmaceutical Value Chain
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.

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.
7
Benefits of backward integration
OUT-LICENSING
  • strong RD 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

8
Jubilants facilities
  • API In-house API formulation production
  • RD 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

9
Jubilant Life Sciences API
  • Jubilant develops a range of
  • APIs and intermediates in therapeutic
  • categories of the central nervous
  • system, cardiovascular system, gastro-
  • intestinal and anti-infectives.
  • These APIs 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...

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

11
RD 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.

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

13
Jubilants 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
Providing integrated offers for licensing and
supply of finished dosage forms to clients in
Europe
One stop solution
Cost
Significant cost saving through full integration
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

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.
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