He has rich professional experience of 26+ years in development and filing of different dosage forms. Filed about 250 ANDAs and 505(b)(2) NDAs with US FDA and 50+ generic products in Europe and 25+ in Australia. Experience of developing and filing various dosage forms including Solid Orals, Liquid Orals, Sterile dosage forms (Injectable and Ophthalmic), Topical and Transdermal Delivery system. Extensive experience on development of Modified Release dosage forms. He is very well versed with regulatory requirement of various countries. He has granted 29 patents in US and 150+ patents in Europe.
He was the member of team involved in development and scale up of Cipro OD in Ranbaxy which was out licensed to Bayer (US).
Development, scale up and launch of Metoprolol XL tablets in Wockhardt. It was second generic approved against Toprol XL in 2010. I was awarded Chairman’s Trophy for approval and launch of the product. Was involved in filing and approval of multiple FTFs
Since Sep 2020 Onwards he has started on his own Cochlea Pharma, they work as CRO for product development and also provide retainer services for a particular product (or set of products) and R&D.
He last worked in Slayback Pharmaceuticals Inc.as Senior Vice President and Head – Global R&D and Head – Indian Operations,
His responsibilities included guiding the team in development of various dosage forms; setting up various development and quality systems. Also coordinating with CROs and CMOs for various activities including costing.
He also worked in Alkem Laboratories Ltd, Taloja, Maharashtra as President R&D (Team size: 400+) The responsibilities included leading R&D at Taloja, Raigad, Maharashtra and R&D team at St. Louis, Missouri, USA.
Guiding all teams (formulation, analytical, packaging, process development, BE centre, regulatory affairs) in development, filing and launch of products for domestic, ROW and Regulatory markets (especially US, Australia and EU). The various dosage form includes Solid dosage forms (tablets, capsules, sachets, powder, dry suspensions) (Immediate release, delayed release, modified release, dual release etc.), liquid dosage forms (solutions/ suspensions), topical products, nasal solution, sublingual and buccal film and transdermal delivery system. Also involved in development of device for topical application.
Involved in evaluation and due diligence for acquiring a facility in US.
Filed 60+ ANDAs with USFDA and 25+ products each in Australia and EU. The products include FTF products and NCE-1 products.
35+ products approved by US FDA including topical products and nasal solution.
Preparing R&D budget and getting approval from management.
He also worked with organisations like Wockhardt Limited, Aurangabad, Maharashtra as Senior Vice President – Pharma Research He handled team size of 200+
He was the Head – Formulation Development and Analytical Research (formulation)
His responsibilities included
Teams at Aurangabad, Maharashtra and MGP – Chicago, Illinois, USA.
Guiding team of scientists for development of various dosage forms for ROW and Regulated markets. The various dosage forms included Solid dosage forms (tablets, capsules, sachets, powder, dry suspensions) (Immediate release, delayed release, modified release, dual release etc.), liquid dosage forms (solutions/ suspensions, Modified Release liquids) and sterile products (solution and lyophilised injections, depot injections and Ophthalmic products) Also involved in development of pen device.
Involved in development of formulations for NCEs (Solid orals and large volume injections).
More than 150 ANDAs filed with US FDA and more than 30 generic products in Europe.
Involved in due diligence for acquisition of overseas companies.
I was involved in planning of budget and taking necessary approvals from Chairman.
He also worked for Ranbaxy Research Laboratories, Gurgaon as Associate Director – NDDS
He handled responsibilities like Project conceptualization, Strategizing Formulation Development Plan, Project Management and timely delivery of products for various countries (especially advanced countries) by co-ordinating activities Development, Analytical, Clinical, Packaging and manufacturing groups. Filed many NDDS ANDAs including FTF with USFDA and generic products in Europe.
Assisting Vice President –NDDS in group activities including budgeting and planning.
Development of MR formulations of NCEs and filing INDs of NCEs
He was also senior Research Fellow, CSIR, New Delhi. Teaching of undergraduate classes along with Research Project.Lecturer, in different colleges including College of Pharmacy, Delhi
Examiner for M.Pharm (Part 1) Pharmaceutics, Univ. of Delhi (Session 2003-2004)
Dissertation (25+) submitted to various Universities including BITS Pilani, Manipal Academy of Higher Education, Tamilnadu MGR Medical University, Panjab University Patiala, RVS College of Pharmaceutical Sciences Sulur, RC Patel College of Pharmacy, under my supervision leading to award of M.Pharm degree.
His other extra-Curricular activities include
Member, Local Organizing Committee, 37th IPC, New Delhi, Dec 1985
Co-Chairman, Accommodation Committee, Local Organizing Committee, 45th IPC, Dec 1993
Joint Secretary, IPGA, 1992-1996
Educational Qualifications:
April, 1996: Ph.D. in Pharmacy, Univ. of Delhi. Thesis entitled “Development of Transdermal Drug Delivery System for Vasoactive Drugs” (thesis submitted in 1994)
He has ten Publications in various National and International Journals
Eight presentations in various National and International conferences and Seminars
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