Cadila Pharmaceuticals is an Indian pharmaceutical company established in 1951. Their vision is to be a leading global pharmaceutical player by 2010. They have over 3,500 employees including 1,300 in marketing and 400 scientists. Cadila has manufacturing facilities in India and an overseas joint venture in Ethiopia. They focus on key therapeutic areas and have developed several novel products, including the world's first parenteral formulation of Rabeprazole. Cadila aims to provide integrated healthcare solutions and be a one-stop global outsourcing partner through contract manufacturing, research, licensing, and marketing services.

1. Corporate Presentation
1
October 2005

2. Cadila Pharmaceuticals, Gujarat, India
The spirit of innovation
in Indian Pharmaceuticals Business.
2
Dedicated to Human Healthcare – Since 1951.
October 2005

3. Our Mission Our Vision
“Our vision is to be a leading
pharmaceutical company in India
and to become a significant
global player by the year 2010.”
“We shall provide total
customer satisfaction and
achieve leadership in chosen
markets, products and services
across the globe, through
excellence in technology,
based on world-class research
and development.”
3
October 2005

4. Our Values
• Provide total customer satisfaction.
• Make available products and services of
highest quality at affordable prices.
• Enrich our human resources asset to become
highly competent professionals and
technology based.
• Foster mutually rewarding relations with all
our business partners.
• Manage and maintain our operations with
utmost concern for ‘Environment, Health
and Safety’.
• Be a good corporate citizen, driven by high
ethical standards in our practices.
4
October 2005

5. Overview
• Amongst the largest healthcare manufacturing
groups in India (Global Sales: 150 Mio US$) with
five decades (since 1951) of equity in providing
affordable healthcare.
• Integrated Operations in Life Sciences from APIs
to intermediates to finished formulations,
biotechnology, contract research, clinical
research, hospital products,
herbal / natural products and pharmaceutical
machinery.
• Strategic collaboration and operations spanning
over 90 countries across the globe in USA, Japan,
Europe, CIS, South East Asia, Africa and Middle
East.
5
October 2005

6. Overview (Contd.)
• A human capital of 3500 employees including
1300 in marketing and 400 highly qualified
scientists engaged in contract and collaborative
research projects.
• Very strong marketing network across India,
serviced by 25 Consignment & Supply agents and
2,300 stockists.
• Five manufacturing locations in India conforming
to cGMP standards and an overseas Joint Venture
in Ethiopia.
6
October 2005

7. Integrated Healthcare Solutions Provider
Formulations Clinical Research (CRO)
(Human & Vet)
Biotechnology Herbal
Bulk Actives Hospital Disposables
Specialty Chemicals Diagnostics
7
October 2005

8. Our State-of-the-art Manufacturing Facilities
• International approvals : WHO-Geneva, UK MHRA, TGA Australia,
MCC South Africa, ISO 9001, ISO 14001 and ANVISA -Brazil.
• Ability to manufacture complex molecules and multiple dosage forms.
• 55 Mn US$ earmarked for expansion / upgradation during 2005-06.
• High degree of backward integration.
• Stringent quality control and cost leadership.
• Successful partnership with vendors for quality compliances.
8
October 2005

9. Research & Development
• Dedicated facilities for :
- Innovative Research
- Generics Research
• Formulation Pharmacology
New Drug Delivery, Clinical Pharmacology, Pharmaco-
kinetics, Toxicity,Bio Equivalence.
• Biotechnology
Vaccines, Diagnostics, Bio Therapeutics
• Chemical Research (API)
Histaminic, Antiseptic, Anti -TB, Anti Diabetic, Anti
Ulcer, Cardiovascular, Anti Depressant, Anti Acne.
• CRO
Innovative Clinical Research Organization (CRO)
Conforming to International Regulatory Framework.
9 • 400 R&D Scientists – Separate 70,000 sq. ft. facility.
October 2005

10. Intellectual Property Based Approach
• Development of non-infringing process thorough
understanding of patents / intellectual property.
• A dedicated Intellectual Property Cell for worldwide patent
filing and evaluation.
• API Patent Applications filed in 2004:
– Anti convulsant
– Anti diabetic
– Sedative
– Hypnotic [TWO APPLICATIONS]
– Anti hypertensives: THREE APPLICATIONS]
– Anti depressant
10
October 2005

11. Contract Research Organization (CRO)
• Compliance with GCP, GLP, cGMP.
• Expertise in Following Areas:
– Formulation Development [EU CTD /ANDA]
– Bio-Equivalence / Bio-Analytical Studies
– Clinical Research - Phase II to Phase IV
• Strengths and Skills:
– Extensive network of hospitals and medical institutes throughout India
– GCP trained clinical trial monitoring team
– Well-defined SOPs to comply with GCP
– Database of investigators in diversified therapeutic area
– Collaborative work with the prestigious Research Institutes for NCEs
11
October 2005

12. CRO: Services
• Formulation Development:
– Formulation / Dossier development [CTD/ANDA]
– Expertise in oral and parenteral formulations
– Novel Drug delivery System
• Bio-equivalence / Bio-analytical Study:
– Manned by GCP trained professionals adhering to ICH-GCP compliant
SOPs
– Analysis using automated HPLCs, LC-MS and LC-MS/MS procedures
– Equipped with a 38-bed clinical facility with an ICU and separate
screening, phlebotomy, drug storage
• Clinical Research:
– All aspects of Phase II, III and IV
– Protocol writing and Expert report generation
12
October 2005

13. Contract Manufacturing
• Reliable supply of quality products - Validated
and approved processes and in compliance with
the registration file.
• Minimize investments in capital-intensive facilities.
• Improve net earning and cash flow.
• Divert resources to focus on their core competencies –
R&D and marketing.
• All products are analyzed and released by our
quality control staff before shipment.
• Monitor and optimize the timeliness of our delivery
and keep it up to our customer’s utmost satisfaction.
13
October 2005

14. Bulk Actives
Dedicated site currently manufacturing over 30 bulk actives for captive
consumption for domestic and international markets.
Two USFDA approved plants for Fluoxetine and Ethambutol.
14
October 2005

15. DMFs for USA / EUROPE
• Active US DMF :
– Ethambutol HCl
– Fluoxetine HCl
• Products filed for US DMF and European DMF :
– Amlodipine Besylate
– Lacidipine
– Loratadine
– Fluconazole
– Glibenclamide
– Ondansetron HCl
– Carvedilol
Products currently covered by valid patents are offered for R&D
use in accordance with 35 USC 271 (e)+ (A13(1)
15
October 2005

16. Patents Granted
• The process for the preparation of a fixed dose pharmaceutical composition of
anti infective agent/s and micro-organisms as active ingredients (Patents
granted in India, USA, UK, Sri Lanka, Ukraine, Eurasia, Australia).
• The process for manufacturing Topical Ophthalmic preparations without
systemic effects (Patent granted in S.Africa).
• Methods for producing Recombinant Insulin from fusion proteins (Patents
granted in S. Africa, Australia).
• The process for manufacturing formulation of Topical Beta Blockers with
improved efficacy (Patents granted in India, Eurasia, Russia).
• Ophthalmic formulation comprising a Beta Blocker and Carbopol (Patent
granted in Europe).
• Use of an Immunomodulator for the management of HIV disease / infection
(Patent granted in UK).
• Method of treating cancer (Patent granted in UK).
• Use of MW in the treatment of obstructive lung disease (Patent granted in
UK).
• Method of Treating Human Immunodeficiency Virus (HIV)
disease / infection (Patent granted in New Zealand).
16
October 2005

17. Major Therapeutic Areas
Cardiovascular Anti-infective
• Anti-hypertensives • Anti-bacterials
• Anti-anginals • Anti-virals
• Anti-arrythmics • Anti-fungals
Neuropsychiatric Other Segments
• Anti-depressants • Anti-TB
• Anxiolytics • Anti-diabetics
Gastrointestinal • Lipid Lowering
• Anti-ulcerants • NSAIDs
• Anti-spasmodics • Anti-histaminics / Cough
• Gastrointestinal anti-infectives • Cortico-steroids
• Anti-emetics • Vitamins / Haematinics
• Anthelmintics
500+ products covering 25 therapeutic groups in human &
10 in animal health care.
17
October 2005

18. Novel Products from Cadila-First Time in the World
Scat Eye Drops
• World’s First & Most potent ophthalmic anti-bacterial
(Highest Therapeutic Index).
18
October 2005

19. Probiotic with Anti-infective Agent
• World’s First Probiotic combined with anti-infective
agent preserving efficacy of both.
• Drastically reduces Gastrointestinal side effects.
- SYMBIOTIK
Patented
- LMX
- CLAX
19
October 2005

20. Neva HIV
• World’s First, whole -blood
based rapid, simple field test
(agglutination test) kit for
HIV-1 & 2 using recombinant
reagents.
• Specificity and Sensitivity
matching ELISA based tests.
20
October 2005

21. Rabeloc I.V.
• World’s First Parentral Formulation of Rabeprazole surpassing the
ingenuity of originators and their world-wide collaborators.
• The only drug available which raises pH above 6 and maintains it
consistently.
• Provides medical therapy for upper GI bleed for the first time.
• Provides cure for resistant Acid – peptic diseases.
Patent Pending
21
October 2005

22. Immuvac – Unique Poly-antigenic Vaccine
• In Leprosy :
Therapeutic Vaccine which reduces duration of therapy by 50% as it hastens
bacterial killing & bacterial clearance.
• Now being developed for management of TB :
Early data shows significant improvement in sputum conversion, cure rate and
relapse rate.
• Future :
Multi-centric large trails initiated under IND, USFDA.
22
October 2005

23. International Marketing
• Over 900 products registrations in 45 countries.
• International Distribution Network of 65
distributors
• Multinational, multicultural and multilingual work
force of over 150 sales personnel Internationally.
23
October 2005

24. CPL’s International Network Of Operations
AMERICAS & CARRIBEAN AFRICA
CIS & EUROPE • USA • West Indies • South Africa
• Canada • Brazil • Kenya
• Bulgaria
• Nigeria
• Latvia
• Tanzania
• Russia
• Zambia
• Ukraine
• Uganda
• Kazakh
• RD Congo
• Belarus
• Mauritius
• Azerbaijan
• Ethiopia
• Georgia
• Zimbabwe
• Armenia
• Ivory Coast
• Moldova
• Cameroon
• Senegal
MIDDLE EAST SOUTH EAST ASIA & OCEANIA
• Yemen
• Bahrain • Sri Lanka • Thailand • Singapore
• Oman • Australia • Vietnam • Malaysia
• Iran • New Zealand • Myanmar • Philippines
24
October 2005

25. Subsidiaries and Partner Companies
Subsidiaries Marketing Joint
• USA Offices Ventures
• Japan • Russia • South Africa
• Kenya • Kazakhstan • Ethiopia
• Nigeria • Vietnam
25
October 2005

26. One Stop Global Outsourcing
• Contract Manufacturing
– Injectables (including Cephalosporins)
– Oral Solids and Liquids
– Lyophillization facilities
– API and intermediates Synthesis
• Contract Research Services [CRO]
– Formulation Development
– Bioequivalence and Bioanalytical Studies
– Clinical Research
• Licensing and Supply [EU CTD / ANDA]
– Pharmaceuticals
– Biogenerics
– OTC and Herbal
– Diagnostics and Disposables
• Marketing and Distribution Services
– India
– Our operational markets in Africa, CIS, SE Asia etc.
26
October 2005

27. THANK YOU
27
October 2005