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October 2005 1 Corporate Presentation

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Page 1: Cadila Corporate

October 2005

1

Corporate Presentation

Page 2: Cadila Corporate

October 2005

2

Cadila Pharmaceuticals, Gujarat, India

The spirit of innovationin Indian Pharmaceuticals Business.

Dedicated to Human Healthcare – Since 1951.

Page 3: Cadila Corporate

October 2005

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Our Mission

“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.”

Our Vision

“Our vision is to be a leading pharmaceutical company in India

and to become a significant global player by the year 2010.”

Page 4: Cadila Corporate

October 2005

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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.

Page 5: Cadila Corporate

October 2005

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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.

Page 6: Cadila Corporate

October 2005

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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.

Page 7: Cadila Corporate

October 2005

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Integrated Healthcare Solutions Provider

Specialty Chemicals

Formulations (Human & Vet)

Biotechnology

Bulk Actives

Herbal

Clinical Research (CRO)

Hospital Disposables

Diagnostics

Page 8: Cadila Corporate

October 2005

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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.

Page 9: Cadila Corporate

October 2005

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Research & Development

• Chemical Research (API)

Histaminic, Antiseptic, Anti -TB, Anti Diabetic, Anti Ulcer, Cardiovascular, Anti Depressant, Anti Acne.

• Formulation Pharmacology

New Drug Delivery, Clinical Pharmacology, Pharmaco-kinetics, Toxicity,Bio Equivalence.

• Biotechnology

Vaccines, Diagnostics, Bio Therapeutics

• Dedicated facilities for :- Innovative Research- Generics Research

Innovative Clinical Research Organization (CRO)Conforming to International Regulatory Framework.

• 400 R&D Scientists – Separate 70,000 sq. ft. facility.

• CRO

Page 10: Cadila Corporate

October 2005

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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

Page 11: Cadila Corporate

October 2005

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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

Page 12: Cadila Corporate

October 2005

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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

Page 13: Cadila Corporate

October 2005

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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.

Page 14: Cadila Corporate

October 2005

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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.

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October 2005

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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)

Page 16: Cadila Corporate

October 2005

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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).

Page 17: Cadila Corporate

October 2005

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Cardiovascular

• Anti-hypertensives

• Anti-anginals

• Anti-arrythmics

Neuropsychiatric

• Anti-depressants

• Anxiolytics

Gastrointestinal

• Anti-ulcerants

• Anti-spasmodics

• Gastrointestinal anti-infectives

• Anti-emetics

• Anthelmintics

Anti-infective

• Anti-bacterials

• Anti-virals

• Anti-fungals

Other Segments

• Anti-TB

• Anti-diabetics

• Lipid Lowering

• NSAIDs

• Anti-histaminics / Cough

• Cortico-steroids

• Vitamins / Haematinics

500+ products covering 25 therapeutic groups in human &10 in animal health care.

Major Therapeutic Areas

Page 18: Cadila Corporate

October 2005

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Novel Products from Cadila-First Time in the World

Scat Eye Drops

• World’s First & Most potent ophthalmic anti-bacterial (Highest Therapeutic Index).

Page 19: Cadila Corporate

October 2005

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Probiotic with Anti-infective Agent

- SYMBIOTIK

- LMX

- CLAX

• World’s First Probiotic combined with anti-infective agent preserving efficacy of both.

• Drastically reduces Gastrointestinal side effects.

Patented

Page 20: Cadila Corporate

October 2005

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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.

Page 21: Cadila Corporate

October 2005

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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 itconsistently.

• Provides medical therapy for upper GI bleed for the first time.

• Provides cure for resistant Acid – peptic diseases.

Patent Pending

Page 22: Cadila Corporate

October 2005

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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.

Page 23: Cadila Corporate

October 2005

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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.

Page 24: Cadila Corporate

October 2005

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CPL’s International Network Of Operations

CIS & EUROPE• Bulgaria• Latvia• Russia• Ukraine• Kazakh• Belarus• Azerbaijan• Georgia• Armenia• Moldova

MIDDLE EAST• Yemen• Bahrain• Oman• Iran

• USA• Canada

AFRICA• South Africa• Kenya• Nigeria• Tanzania• Zambia• Uganda• RD Congo• Mauritius• Ethiopia• Zimbabwe• Ivory Coast• Cameroon• Senegal

• Sri Lanka• Australia• New Zealand

SOUTH EAST ASIA & OCEANIA

AMERICAS & CARRIBEAN

• West Indies• Brazil

• Thailand• Vietnam• Myanmar

• Singapore• Malaysia• Philippines

Page 25: Cadila Corporate

October 2005

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Subsidiaries and Partner Companies

Subsidiaries• USA • Japan• Kenya• Nigeria

MarketingOffices• Russia• Kazakhstan• Vietnam

JointVentures• South Africa• Ethiopia

Page 26: Cadila Corporate

October 2005

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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.

Page 27: Cadila Corporate

October 2005

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THANK YOU