R&D Presentation .PPT
- 1. Partnering Healthcare Globally Ipca Laboratories Limited Ipca Greetings from
- 2. Formulations 66% APIs / Intermediates 34% Company Overview Incorporation 1949 2005-06 Total Income US$ 167 Mln CAGR (last 5 years) 16% Exports : Total Income 53% Formulation : Total Income 66% Number of Employees Over 4,500
- 3. • Exports to over 100 countries. • 9th largest pharma exporter from India. • Forbes “Best under a Billion” outside USA award in 2003, 2004 and 2005 • One of the largest manufacturer of APIs, viz. Atenolol, Amodiaquine, Artemisinin derivatives, Chloroquine, Furosemide, HCQS, Propranolol • Approved API suppliers to MNCs like AstraZeneca, BASF, GSK, Merck, Pfizer, and Sanofi-Aventis • Contract manufacturing of formulations for EU customers, viz. Almus ,Crescent, Hexal, Stada, Ranbaxy UK, and others Highlights 2003 2004 2005 Forbes Global - Best Under a Billion
- 4. We aspire to be US$ 400 Mln Company by 2010 by • Becoming world leaders in 25 APIs • Consolidating our global leadership in Antimalarial therapies • Establishing key partnerships with innovator companies & MNCs • Being a competent and competitive supplier of generic formulations • Expanding presence to 170 countries Aspirations
- 5. 48, Kandivili Industrial Estate Kandivili (West), Mumbai – 400 067 All markets, all divisions. Area: 10,000 sq feet. Research & Development (Formulations)
- 6. • Good knowledge skills • Experienced scientists • Multidimensional exposure Developm ent Analytical Regulatory Total Ph.D 2 4 0 6 M.Pharm 16 0 3 19 M.Sc 6 20 4 30 B.Pharm 19 4 13 36 B.Sc 3 17 0 20 Others 23 2 2 27 Total 69 47 22 138 Research & Development (Formulations) Personnel strength
- 7. Major Equipment at R&D facility Activity Major equipments Granulation • Fluid Bed Processor- Single pot operation • High Shear Granulators • Extruder & Spheroniser- pellet technology • Roll Compactor-dry granulation • Tray dryers, Fluidized Bed Dryers • Low RH- effervescent tablets (< 20% RH) Compression • Double layered compression machine • Press cota • Double rotary/ Single rotary compression machine Coating • Auto Coater- Sugar, Film & Pellet coating. • Manually operated conventional coating pan. Packing • Blister Packing machine- with Alu Alu packing facility • Strip packing machine. Capsules • Manually operated Capsule Filling Machines- Tab-IN-Cap / Pellets, all sizes Liquids/ Ointments/ Creams • Suitable equipments for liquids, ointments & creams (Planned in future for Regulated Markets) Stability study • Walk-in stability chambers (ICH guidelines) Fluid Bed Processor Autocoater
- 8. Analytical Instruments Instruments Nos Nuclear Magnetic Resonance Spectrometer (NMR) 1 Liquid Chromatograph Mass Spectrometer (LCMS) 1 Gas Chromatograph Mass Spectrometer (GCMS) 1 X – Ray Diffraction (XRD) 1 HPLC with PDA and UV – VIS Detector 21 Head Space Gas Chromatography 2 Dissolution Tester with UV Visible Spectrophotometer 1 UV Visible Spectrophotometer 1 Dissolution Tester 8 FTIR 1 High Performance Thin Layer Chromatography 1 Particle Size Analyzer (Malvern) 1 Autotitrator 1 Differential Scanning Calorimeter 1
- 9. Dosage Forms Expertise Solid Oral Dosage Forms • Tablets • Capsules Liquid Formulations • Syrups, Suspensions • Emulsions & Dry Syrups Semisolid Formulations • Ointments, Gels & Creams (Planned in future for regulated markets) Sterile Dosage Forms • Liquid Injectables • Dry Powder Vials Novel Drug Delivery Systems • Microemulsions • Geomatrix Systems • Bilayer Systems • Tab-in-Tab technology
- 10. • Stability Indicating Assay • Related Compounds • Dissolution Profile • Content Uniformity • OVI / Residual Solvents • Impurity profile study • Drug : Excipients compatibility study • Characterization of impurities Analytical Expertise
- 11. In-House Regulatory Expertise • Advises Ipca’s scientists on legislations, pharmaceutical law frames and developing regulatory strategies • Preparation and filing of dossiers • Liaisoning with different regulatory bodies DESIGN ANALYTICAL PKG. DESIGN TECHNOLOGY STABILITY STUDIES PROCESS / SCALE UP NEW PRODUCT Administrative 1 3 4 5 CTD 2 Quality Non Clinical Clinical Quality Summary
- 12. Validation Identification Technology Transfer Regulatory Evaluation Development Research & Development (Formulations) New products introduction
- 13. Pre-formulation Establish Drug : Excipients compatibility. Development lots Mini experimental trials to decide the formula / process. Process optimization Fine tuning to avoid scale-up problem. Process qualification To define critical processing steps (Scale-up batch) and test parameters usually mimics production conditions. Pivotal batch Samples are used to perform the bio- equivalence study / clinical trials. Product development For PAI visit. report & Submission Development Program Timelines 3 4 2 4 2 Stability Studies Around 15 Months for Product Development, by Following ICH Guidelines Months Stages Activities
- 14. The starting formulation may be based on INTUITION but the ending formulation must be based on SCIENCE
- 15. • Dedicated areas attached to manufacturing sites Two at Athal for EU generics One at Piparia for ANDAs (US) • cGMP compliance • Flexibility 6.5 Kg – 50 Kg • Equipment with similar principle • Technology transfer team on-site Applications : • Manufacturing pivotal/clinical batches • Stability batches (100,000 minimum) • Scaling up 10 x Pilot Plant Capabilities for Oral Solids:
- 16. Technology Transfer R&D Development More effective as we move point of intersection to the left Manufacturing & Quality 0 100 Launch / Commercialization Early Development • Master Manufacturing Document • Development Report • Specifications • Validation Protocols/SOPs • Onsite training & technical Presentation
- 17. METHOD DEVELOPMENT METHOD VALIDATION METHOD TRANSFER Approved “The process of providing documented evidence that Something does what it is intended to do”. Analytical Method Flow
- 18. EU Generics Generic Products US ANDAs Status EU US Approvals 23 2 Submissions 15 6 Pivotal Batches 9 9 Under Development 21 19 Total 68 36 23 15 9 21 2 6 9 19
- 19. Research & Development (Formulations) Summary of generic fillings # Country Cumulative dossier approvals recd. Dossier filed- awaiting approvals Total dossiers 1 UK 23 15 38 2 New Zealand 5 14 19 3 Australia 5 - 5 4 US 2 6 8 5 Portugal 12 7 19 6 South Africa 27 19 46 7 Hungary 5 - 5 Grand Total 79 61 140
- 20. Product development since last 3 years Research & Development (Formulations) Dosage form No. of products Tablets IR 119 NDDS 24 Bilayered 08 Matrix based 11 Delayed release 05 Hard gelatin Caps 10 Liquid orals 10 Dry powder for reconstitution 06 Sterile preparation 10 Liquid injs. 05 Dry powder for inj. 05 Semi solids 02 Total Domestic 108 162 Products ANDA 20 EU 34
- 21. Top 100 drugs - U.S. market value Orals 76% Non - orals 24% Technology and product focus drug delivery systems Source: IMS America - products Oral CR 60% Inhalation 27% Tablet in tablet Bi-layer tablet
- 22. Bilayered approach – why? • Release of both drugs starts immediately • Ease of manufacturing • Elegance to the product A + L = A L Technology & product focus
- 23. A’sunate A’quine Why? • Elegance to the product • Improved product stability • Minimal incompatibility Tab in tab technology Technology & product focus
- 24. Unique Products* Physical and /or chemical incompatible drugs • Cefadroxil + Lactobacillus • Artesunate + Amodiaquine Drugs with different biological half lives • Loratidine + Pseudoephedrine Dual release formulations • Antidiabetic drug combinations To prevent side effects • Lamotrigene MR tablets Mumps – multiple unit particulate system • Filled in hard gelatin capsule • Compressed within a tablet (Diameter about 800 - 1000µ) (Metoprolol Succinate XL) *For Indian Market
- 25. Protocol design/approval Preliminary data review Final Report • • • Smooth project flow Project management • Bioequivalence studies Co-ordination with CRO
- 26. Formulation patents Formulation Patents Patents Filed Patent Type 5(NDDS) 4 (Combination) 2 (Formulation/ Composition) (Process) 9 1(US) 20(Indian) 4(PCTs) Patent Cell: 7 Persons (API & Formulations)
- 27. Eminent Indian Academic Institutes BITS, Pilani, Rajasthan Central Drug Research Institute (CDRI), Lucknow (UP) Bombay College of Pharmacy (BCP), Mumbai PERD Center, Ahmedabad Bombay University, Mumbai Sponsored Ph.D fellowship R & D Partnerships: Industry & Academia Interface Tapping into India’s best & brightest technical pool for collaborative research Working together to achieve our goals.
- 28. • Pharmacopoeias • Freedom of Information (FOI) • Orange Book/BNF • Physicians Desk Reference (PDR) • Generally Recognized Safe Excipients (GRSE) • ICH Guidelines • CDER Guidelines • Literature Search Sources of Information
- 29. Project Management • We offer dedicated project managers • Periodic status reports – as per client requirements • Regular conference calls • Meetings (at least twice a year or more as needed)
- 30. R&D investment (% to sales) Year % To sales 1.87% 2.80% 4.40% 4.97% 5.05% 5.52% Research & Development (Formulations) Both formulation & chemical R&D 0 1 2 3 4 5 6 2001-02 2002-03 2003-04 2004-05 2005-06 2006-07
- 31. Increased Customer Satisfaction Both internal & external customers Principal thrust Research & Development (Formulations)
- 32. • Our aim is to develop stable, safe & efficacious products • Optimal utilization of resources • State of the art latest equipments and instruments • Infrastructure & technical capabilities for first mover advantage • Multi-dimensional dosage formulations NDDS/CR & SR innovative approach to have USP over the competitors • Analytical competency inline with International regulatory requirements • Accrediation -- ISO 9000 and DST (Dept. of Science & Technology, Govt. of India) In Summary
- 33. Locations Activities Approvals / Certifications Constructed Area (sq. mt) Tableting Capacity (p.a.) Athal Tablets Capsules UK-MHRA TGA-Australia MCC-S.Africa ANVISA-Brazil ISO-9001 23,000 8 Bn Ratlam Tablets Liquids Injectables MCC-S.Africa WHO-Geneva 5,500 1.40 Bn Kandla (Beta-lactum – Penicillin products) Tablets Capsules Dry Syrups MHRA-UK MCC-S.Africa TGA-Australia 3,026 0.12Bn- Tabs 0.7Bn- Caps Piparia (proposed site for US FDA) Tablets WHO 6,143 1.20 Bn Indore (Proposed) Solid Dosage - 10,000 - Formulation Manufacturing Facilities
- 34. Dr. V. K. Jadhav Vice President – Analytical Development & Regulatory Affairs Phone : + 91 22 6647 4406 Mobile : + 91 93241 15111 E-mail : vivek@ipca.co.in Mr. Hasit Bhatt President, Ipca Pharmaceuticals, Inc. Phone : 908-412-6561 Mobile : 908-432-3028 E-mail : hasit@ipcausa.com Mr. Y. K. Bansal President – R & D (F) Phone : + 91 22 6647 4450 Mobile : + 91 98211 33026 E-mail : ykbansal@ipca.co.in Ipca India Contacts Ipca US Contact Mrs. Kavita Sehwani General Manager – Regulatory Affairs Phone : + 91 22 66474344 Mobile : + 91 93231 91467 E-mail : kavita@ipca.co.in