Abhilash Reddy Email & Phone Number

1. Proven track record of successful formulation development and technology transfer of following generic Injectable products for Global Markets (US and Europe)• Non aqueous liquid injections of Oncology injectables • Lyophilized products of Oncology injectables and antibiotics• Peptide injectables in prefilled syringes • Drug device combination products in pens and auto injectors• Hormonal injectable suspensions • Aseptic products• Terminal Sterilization cycles for temperature sensitive products2. Development of 505(b)(2) formulations from Lyo to liquid3. Coordinating and providing R&D Support to MS&T and Production for site transfer activities include scale up and exhibit batches and support to RA team for filing4. Respond to agency queries by coordinating with regulatory team in addressing deficiencies and/or regulatory queries 5. Expertise in managing entire breadth of development activities inclusive of project identification, manpower management, system implementation, materials management, project execution etc.

Listed skills include Hplc, Regulatory Affairs, Formulation Development, Pharmacokinetics, and 16 others.