Tushar Mahajan
Associate Vice President - Inhalation R & D
- Role
- Associate Vice President at Aurobindo Pharma Ltd
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Tushar Mahajan
Over 20 years of Rich experience in field of Inhalation R&D. Successfully delivered number of Nasal Spray, Injectable, Ophthalmic and Topical products for regulatory Markets.Product commercial evaluation, Strategic development planning, execution of stepwise development ensuring robust product performance, project management, Technology transfer, dossier build up, regulatory submission, query response for successful approval and commercialisation of products.Worked with CMO’s and CDMO’ across the globe for Product Development, dossier preparation and submissions and successful product launch for Regulated markets.Leading the team for successful submissions to Regulated authorities such as Canada, EU, US etc.Successfully developed, tech transferred and submitted Generic Albuterol Sulfate MDI to USFDA in Dec 2016. Product received approved in Aug 2020.Developed of Nasal Sprays, pMDI’s and DPI products for regulatory markets.Developed and commercilaised number of Ophthalmic, Injection and Topical products for regulatory markets.Specialized in Formulation development, Device development, process optimisation and technology transfer and device development and Project management of anti asthmatic formulations for IRF, ROW, US, Canada and EU markets.· Leading the project on Qbd based product development, starting from strategic planning till development and commercialisation of product. • developing blueprints of timelines for execution of each milestone, product characterization studies required for finalization of formulation and submission, particle size engineering, planning and execution of lab scale stability batches and finally installation and qualification of lab scale as well as plant scale equipments for batch execution.· Responsible for troubleshooting of issues related to formulation development of Inhalation dosage forms by meticulous reviewing and interpreting each issue and deliver solutions to each one.· Preparation of IND document for USFDA and developing presentation slide packs for inhalation projects. · Through in Concepts of Quality by design and Design of Experiment, and also in 505 (b) 2 NDA and 505 j ANDA for MDIs as per requirement of ICH, CMC and EMEA.· Finalizing master manufacturing formulas for trials batches (during development phase), as well as for commercial batches.
Experience
Associate Vice President
Feb 2025 — Present · Hyderabad, IN
Education
North Maharashtra University
Bachelor of Pharmacy - BPharm
Dr. D. Y. Patil Vidyapeeth
Master of Business Administration - MBA, Project Management
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