Cadila Pharmaceuticals R&D Presentation
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Spread over more than 1,05,000 sq. ft. area, Cadila Pharmaceuticalsβ R & D facilities, recognized by the Department of Science & Technology, Government of India, are manned by more than 300 scientists. A centralized Quality Control & Analytical Research Laboratory has been set up to meet the domestic and international quality standards. The Company has expanded operations by building further on already existing set-up by investing in new premises, to include modern, state-of-the-art amenities. One of the few companies in the country carrying out collaborative research, Cadila Pharmaceuticals taps the best scientific talent in the country and has collaborations with more than 30 leading Research and Development centers in India. To know more about Cadila Pharmaceuticals visit: http://cadilapharma.com/
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Cadila Pharmaceuticals R&D Presentation
- 2. β’ USP Products β’ Niche Technologies β’ Affordable Price Focus Since inception in 1951
- 3. Formulation Development Pre-Clinical & Clinical Research Biotechnology R&D Divisions Chemical SBU - API Herbal Product Development
- 4. 1 2 3 4 Rugged new product Identification process Integration with API / Chemical SBU Niche Generic / Innovative dosage forms (NDDS) Strong IP portfolio Domestic β Generics (Me-too) Export for Me-Too & Value-added Generics Exports & Domestic NDDS NDDS, US ANDA & ROW Dossier 2010 2015 New Drug Products / NDDS β First-time launch in India Generic opportunities in Regulated Export markets R&D Model Growth Drivers
- 5. Research & Development Intellectual Property Phyto- chemistry Pharma Development Pre Clinical Clinical Research Chemical SBU Biotechnology Regulatory RQA R&D Framework
- 6. Divisions 1. PROCESS CHEMISTRY 2. ANALYTICAL DEVELOPMENT 3. REGULATORY AFFAIRS 4. INTELLECTUAL PROPERTY CELL 5. PROCESS SCALE-UP β’ Development of Non- Infringing Process β’ Multi-scale synthesis - from gm to kilo level β’ Eco-friendly and cost effective process Capabilities β’ Gastroenterology β’ Cardiovascular System β’ Central Nervous System β’ Antiemetic β’ Anti-allergic Focus Areas Chemical R&D
- 7. Pharma Formulation Development Formulation Development Packaging Development Technology Transfer Analytical Research Stability Intellectual Property β’ Research-friendly environment β’ Participative leadership β’ Range of product formulations covering therapeutic groups in human & animal healthcare
- 8. Novel Drug Delivery System THERAPY 1. Gastroenterology 2. Cardiovascular System 3. Diabetic 4. Anti-viral & Ant-Tubercular Fixed Dose Combinations Biotechnology Formulations Herbal Products Liquid OralsOphthalmic Topical Soft Gelatin Capsules Solid Orals Parenteral Research Pipeline Dosage Forms Markets β’ India-Domestic β’ International β’ Semi-regulated (Latin America, SE Asia, CIS region) β’ Regulated Markets ( USA-EU ) Formulation: Scope
- 9. Novel & Innovative Dosage Forms Capabilities β’ Liposome-based drug delivery system β’ Oral controlled release formulations β’ Improved Bioavailability: Anti Viral, Paclitaxel, Cur cumin o Micro emulsions, o Nano-emulsions o SMEDDS o Bio-enhancer β’ Nano-crystal dispersions β’ Lyophilized formulations β’ Taste Masking
- 10. Define Research Design Develop Implement IPM / Literature Search Pre β Formulations Bench Scale Lab Scale PE Batch Exhibit Batch Stability / BioStudies Stage 0 Stage 1 Stage 2 Stage 3 Stage 4 β’ Product identified β’ Bulk supplier identified & committed β’ Literature search β’ IPM strategy finalization β’ Packaging development initiated β’ Development strategy finalization β’ Analytical method development started β’ Prototype developed and stability study β’ AR&D Methods developed β’ In Vitro Dissolution profiling β’ Formulation / process finalized β’ Taste / Trade Dress approval for Market Launch β’ Prototype scaled up to Lab scale β’ AR&D methods firmed up and validated β’ Pre-Exhibit batch execution β’ Pilot BE studies β’ Exhibit batch execution β’ Stability study as per ICH requirement. β’ Pivotal BE studies β’ Technical Dossier compilation β’ Commercial scale Process Validation post Regulatory approval Drug Development Process
- 11. EQUIPMENT β’ HPLC β’ UPLC β’ GC β’ DS β’ Dissolution Testing Apparatus β’ USP Type I and II β’ USP Type III β’ UV-Visible Spectrometer β’ Franz diffusion cell Analytical Research Lab
- 12. ACTIVITIES β’ API Characterization β’ Pre-formulation studies β’ Forced degradation studies β’ Analytical method development validation & transfer to QC β’ Stability studies as per ICH guidelines β’ Specialized analytical tools to support biotech formulations, NDDS products Analytical Research Lab
- 13. β’ Selection and testing of primary / secondary / tertiary packaging materials β’ Innovative packaging solutions β’ Art work development β’ Master Manufacturing Docket, Specifications, Standard Testing Procedures β’ Review of Technology Transfer Docket, Product Development Report β’ Process optimization and scale-up β’ Integration of Formulation Development with Production, QA, QC etc. β’ Trouble-shooting at manufacturing Packaging Development Technology Transfer
- 14. Pre-Clinical β’ Experimental Pharmacology β’ Regulatory Toxicology - US FDA also Clinical Pharmacology β’ Two separate identical 46 bedded units (total 92 beds) β’ Data pool of approx. 6,000 healthy volunteers. (500 female volunteers and 400 geriatric volunteers ) Clinical Research β’ Clinical Trials Submission for o DCGI o US FDA Clinical Research Organization
- 15. Africa FW Africa SE Asia CIS Latin MENA EU/Aus/NZ/WHO USA Global Registrations: An Update A total of 1223 Registrations Globally
- 16. Thank you