Striving to excellence in API manufacturing Sound R & D for product development and Crams Striving towards excellence in API manufacturing

Transcription

1 Striving to excellence in API manufacturing Sound R & D for product development and Crams Striving towards excellence in API manufacturing

2 The Mission The Mission Mission Be a facility capable of providing highest standards of API for regulated and developing markets Focus on product development from lab to kilo lab. Scale up through pilot plant to commercial production batch and to be a responsible CRAMs partner Provide Quick and Appropriate response to the needs of all stakeholders Be a Preferred and Reliable Partner through commitment to Intellectual Property and Integrity Vision To excel as research based, technology driven API manufacturing and development organisation

3 History & Milestones 1984: Incorporated for the manufacture of Pharmaceuticals as Curekraft Chemicals 1991: 2005: Acquired by the Chemcrown group Change in management control Renamed as ProVentus Life Sciences 2006: Manufacture of generic APIs for human consumption Commencement of CRAMS activities 2007: Inauguration of R&D and cgmp Kilo-lab 2008: Inauguration of new cgmp manufacturing facilities 2009: Revamp and relocation of intermediates manufacturing facility to make the facility fully cgmp compliant

4 Location Maraimalai Nagar, Chennai, Tamil Nadu - In a leading industrial belt - 30 Km from Chennai airport - 40 Km from Chennai sea port - Just off an arterial highway - NH45 - Land area: 5.3 Acres (3 acres is unutilized)

5 Site Plan WARE HOUSE UTILITIES VACANT EMPTY BLDG. VACANT B L SOLVENT O STORAGE C VACANT VACANT K 1 ENTRY ENTRY EMPTY BLDG. V A C A N T ANALYTICAL R&D, KILO-LAB

6 Activities Process Research Generic API Manufacture Scale up : Kilo Lab & Pilot Plant Large scale manufacture of Generic APIs, NCEs & Intermediates Future Emerging Technologies High Potency Compunds- Research & Scale up Future

7 Span of Activities To be provide integrated drug discovery programs of high quality Pre- Pilot API Drug Med Scale Animal Clinic Biology Manufac- Design formulation Manufac- Chem up Tox Trial development turing turing Long-term strategy; partnership based Current Not planned as a core-competency; to offer through partners

8 Core Competencies Process research: Produce high quality of API in cgmp compliance plant Scale-up process developed by customer; Develop process and scale-up to provide multi-kilo material Route selection Process optimization - Reaction conditions, Solvent optimization, cycletime optimization Contract manufacturing Custom synthesis

9 APIs in manufacturing Primidone Oxybutynin hydrochloride Isopropamide Iodine Tropicamide Trospium chloride Raloxifene hydrochloride Modafinil Propatyl Nitrate Gabapentin APIs under development Olmesartan Brinzolamide Chlorthalidone APIs ready for production Calcium Dobesilate Biperiden hydrochloride Ambroxol Veterinary APIs in manufacturing Febantel Oxyclozanide Quinapyramine salts

10 INFRASTRUCTURE & CAPABILITIES

11 Manufacturing - Bay 1 Capacity MOC Pressure Temperature Range 1. 3,000 L Stainless Steel FV to 4 atm C 2. 2,000 L Stainless Steel FV to 4 atm C 3. 2,000 L Stainless Steel FV to 6 atm C 4. 2,000 L Glassed steel FV to 4 atm C 5. 2,000 L Glassed steel FV to 4 atm C 6. 2,500 L PP FRP Centrifuge SS Centrifuge SS Tray Dryer SS Tray

12 Manufacturing - Bay 2 Capacity MOC Pressure Temperature L C Glassed steel, FV to 6 atm -15 to C L Glassed steel FV to 6 atm -15 to C L Glassed steel FV to 6 atm -15 to C L Stainless Steel FV to 6 atm -15 to C 1. Centrifuge SS Centrifuge SS Vacuum Tray Dryer SS Tray 4. Multi-mill SS Kg / hr 5. Sieve-shaker SS dia 6. Octagonal blender SS L 7. Rotary vacuum dryer (to be installed) SS 316 1,000 L

13 Manufacturing - Bay 2 Capacity MOC Pressure Temperature L C Glassed steel, FV to 6 atm -15 to C L Glassed steel FV to 6 atm -15 to C L Glassed steel FV to 6 atm -15 to C L Stainless Steel FV to 6 atm -15 to C 1. Centrifuge SS Centrifuge SS Vacuum Tray Dryer SS Tray 4. Multi-mill SS Kg / hr 5. Sieve-shaker SS dia 6. Octagonal blender SS L 7. Rotary vacuum dryer (to be installed) SS 316 1,000 L

14 Kilo Lab Capacity MOC Temperature L Suite 1 All glass Atm to FV -78 to +250 C L Suite 1 All glass Atm to FV -78 to +250 C L Suite 2 All glass Atm to FV -78 to +250 C Class 100, Nutsche filter SS L 2. Nutsche filter PP FRP 50 L 3. Vacuum Tray Dryer SS Tray 4. Vacuum Tray Dryer SS Tray 5. Multi-mill SS Kg / hr 6. Sieve-shaker SS dia

15 Utilities Steam Kg / hr Chilled Brine deg. C Cooling water TR Hot Oil - 200, deg. C High vacuum - 1 mm Hg House 720 mm Hg Nitrogen - Cylinder bank

16 Analytical HPLC Shimadzu Prominence PDA, ELS detectors Shimadzu Prominence UV, ELS detectors, Auto sampler GC Perkin Elmer UV Shimadzu Auto Titrator Head Space Sampler Metrohm 794 Titration capabilities - Non-aqueous, acid-base, redox, argentometric & KF The following analysis are currently outsourced: 1H & 13-C-NMR, Elemental analysis, Mass spectra (LC-MS / GC-MS / EI / CI), Particle Size Analysis (Laser based with long bench), X-Ray diffraction (single / powder), Infrared

17 Regulatory Status Kilo-lab & Manufacturing facilities conform to cgmp requirement US-FDA inspection expected in 2011 Regulatory support can be provided with all products Audited by our customers which include Big Pharmaceutical companies from USA and Europe

18 Looking ahead.. Pilot Plant (4Q 2010) High-end Fluorination capabilities (2Q 2011) At laboratory and kilo scale Containment facility(1q 2012) Research, Scale-up & Manufacture of high potency compounds Large scale Manufacturing of APIs and Intermediates (3Q 2011) Manufacture of NCEs

19 Why ProVentus? 1. Strategic location - Chennai, South India; a prime location Insulated from major pharmaceutical companies Availability of talent-pool 2. Established track record with leading pharma-majors across the globe 3. Management & operations expertise available 4. Proposed growth plans encompasses the entire spectrum of chemistry related pharmaceutical services

20 Contact Information ProVentus Life Sciences Private Limited C-9, Industrial Estate Maraimalainagar Chennai Tamil Nadu India Tel: manoj@proventuslife.com Web:

21 THANK YOU WE LOOK FORWARD TO ASSOCIATING WITH YOU