Cadila Corporate

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  • 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