Formulation

WANBURY LIMITED : 

WANBURY LIMITED Research & Development (Formulations) & Manufacturing.

Slide 2: 

Overview Research and Development (Formulations) R&D Centre located in Central Mumbai about 30 min drive from Airport. Established in 2001. Area - 6000 sq.ft. Approved by Indian Federal Authority (DSIR). A talent pool of about 10 Scientists. Supporting staff for Documentation, Purchase & Commercial functions. Analytical Development Lab. and Stability Lab. In-house QA presence. Product is delivered as a complete package.

Overview ….contd. : 

Overview ….contd. Manufacturing (Finished Dosage) -Manufacturing status - - In-house mfg. plant (for exports). - Outsourcing (for local market). - Commercial operations in Spain (outsourced). Dosage Forms being marketed: - Tablets. - Capsules (hard and soft gelatin). - Oral liquids. - Small volume Parenterals. Presence in Neutraceuticals, Hematinics, GI products, Cough & Cold prep., Anti-inflammatory and antibiotics. More than 20 products in local market; 10 M tabs and capsules sold annually.

Overview …contd. : 

Overview …contd. In-house Manufacturing Plant A WHO certified GMP facility for tablets and capsules. USFDA approvable – ready for inspection by end 2008. 60 miles south-east of Mumbai airport. 25,000 sq. ft. area. Another 20,000 sq ft available for expansion. Capacity ~ 50 M tablets per month on two shift operation. Export to non-regulated and semi-regulated markets. USFDA approved facility for manufacture of Compression Grade API in Navi Mumbai.

R & D – Capabilities : 

R & D – Capabilities A talent pool of 10 Scientists with exposure to all facets of product development. Available know-how and expertise for more than 100 single and combination products. Exposure to ~ 300 exhibit batches and over 50 ANDA submissions. Product Development equipment up-to bench level ( ~ 5 kg). Scale-up facility at the mfg plant. Analytical method development and Validation. Stability studies as per ICH and Regulatory requirements. Intellectual property management. Regulatory support documentation.

R&D – Capabilities. …contd. : 

R&D – Capabilities. …contd. Analgesics/Anti-inflammatory - Sulpha/Trimethoprim tabs, Ibuprofen Tabs. Paracetamol combinations with Ibuprofen, Phenylpropanolamine and caffeine, Mefenamic Acid, Indomethacin Capsules, Piroxicam Capsules, Tramadol Tablets. etc. Antibiotics - Ciprofloxacin, Ofloxacin, Norfloxacin Tabs. Antimalarials - Sulphadoxine, Pyremethamine and its combination, Quinine. Cardiac – Amplodipine, Atenolol, Metoprolol Tablets. Anti-diabetic - Metformin and its combinations. Antiamoebics - Metronidazole and its combinations. Anti ulcers - Ranitidine, Cimetidine, Rabeprazole, etc. Cough and cold preparations of all types. Miscellaneous - Bisacodyl Tablets, Promethazine Tablets, Glucosamine - Chondroitin Tablets. Vitamin/Mineral combinations of all types. Oral Liquids – cough/cold, fever and pain management. Soft gelatin Capsules – vitamin-mineral combinations.

R & D (Formulations) – Future Plans : 

R & D (Formulations) – Future Plans State-of-art R&D Centre by Dec 2009. Location – Mazgaon (about 50 miles from Mumbai) – Greenfield project over 18 acre land. 30,000 sq ft area. Potential for over 70 Scientists. Development, scale-up and exhibit batch mfg. Focus on NDDS projects and projects for regulated markets. Increased focus on CRAMS.

Technical Capabilities : 

Technical Capabilities Capability to develop stable and robust products: - Solid dosage forms (tablets, capsules) - Novel Drug Delivery Systems - SR/ER/MR dosage forms. - Off patent Generics for regulated markets (US and EU). - Platform technologies (taste masking, Fluid bed processing). - Compression grade API’s. - CRAMS. - Value added generics. - Other dosage forms like oral liquids, Dry Syrups, semi- solids, etc. Regulatory support.

Slide 9: 

Representative Product Development Scenario. STAGE-1 Phase – 1 Phase - 2 Phase - 3 Phase - 4 Project Kick-off Prototype Dev. Scale-up & Stability Exhibit Batch Validation Inquiry by Customer upto 1 kg 10-60 kg min 100,000 10 X exhibit CDA Formulation Formula opt. Approved Process Validation Development Feasibility Studies Reverse Eng. Process Opt. Cleaning Ver. Cleaning Validation Technical Literature and ICH stability BE Study Commerce Interaction Patent search Commercial Analytical dev. Method validation Reg. submission Post-mkting surv. Pilot BE Study Customer Advantage Price Idea Phase 1 report Prod. Dev. Report ANDA submission Commercial pdt. Feasibility Sight samples Stability Data Time varies depending on the type of project and intended market. Schedule