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October 2005
1
Corporate Presentation
October 2005
2
Cadila Pharmaceuticals, Gujarat, India
The spirit of innovationin Indian Pharmaceuticals Business.
Dedicated to Human Healthcare – Since 1951.
October 2005
3
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.”
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.
October 2005
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Overview
• Amongst the largest healthcare manufacturing groups in India (Global Sales: 150 Mio US$) with five decades (since 1951) of equity in providing affordable healthcare.
• Integrated Operations in Life Sciences from APIs to intermediates to finished formulations, biotechnology, contract research, clinical research, hospital products,herbal / natural products and pharmaceutical machinery.
• Strategic collaboration and operations spanning over 90 countries across the globe in USA, Japan, Europe, CIS, South East Asia, Africa and Middle East.
October 2005
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Overview (Contd.)
• A human capital of 3500 employees including 1300 in marketing and 400 highly qualified scientists engaged in contract and collaborative research projects.
• Very strong marketing network across India, serviced by 25 Consignment & Supply agents and 2,300 stockists.
• Five manufacturing locations in India conforming to cGMP standards and an overseas Joint Venture in Ethiopia.
October 2005
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Integrated Healthcare Solutions Provider
Specialty Chemicals
Formulations (Human & Vet)
Biotechnology
Bulk Actives
Herbal
Clinical Research (CRO)
Hospital Disposables
Diagnostics
October 2005
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Our State-of-the-art Manufacturing Facilities
• International approvals : WHO-Geneva, UK MHRA, TGA Australia, MCC South Africa, ISO 9001, ISO 14001 and ANVISA-Brazil.
• Ability to manufacture complex molecules and multiple dosage forms.
• 55 Mn US$ 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.
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
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
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
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
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.
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.
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)
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).
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
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).
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
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.
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
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.
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.
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
October 2005
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Subsidiaries and Partner Companies
Subsidiaries• USA • Japan• Kenya• Nigeria
MarketingOffices• Russia• Kazakhstan• Vietnam
JointVentures• South Africa• Ethiopia
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.
October 2005
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THANK YOU