Title: INTRODUCTION TO
1 INTRODUCTION TO JUBILANT FULLY INTEGRATED
SOLUTIONS IN GENERICS
2Jubilant 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
3Jubilant 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
4Moving up the Pharmaceutical Value Chain
5Core 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.
6Backward integration
OUT-LICENSING
RA
SUPPLY
Perfect synergism from API development up to
supply of the finished dosage form, guaranteeing
reliability in quality and timing.
7Benefits 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
8Jubilants 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
9Jubilant 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...
10Jubilant 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
11RD 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.
12Dosage 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
13Jubilants 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
14Main 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
15One 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.