Uday Rangole
Sr. General Manager at Macleods Pharmaceuticals Ltd
- Role
- Sr General Manager at Macleods Pharmaceuticals Ltd
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Uday Rangole
Proven track record of Successful Formulation development (ANDAs and NDAs) of Injectable products for Global Markets (US, Europe, AUS, JAPAN, ROW and Domestic) Expertise in developing Generic formulations, in Onco and non-Onco injectables (including lyophilized, Extended Release Suspension, nanoparticles formulation), Nasal formulations. Lyo cycle development, QbD implementation, L&E, Reduced exposure Terminal Sterilization. Para IV and 505(b)2 formulations development Technology transfer and scale up: Planning and managing technology transfer, scale up batches of developed projects. Troubleshooting support for commercial products: Coordinating investigations and providing technical inputs to Production team for trouble shooting commercial projects. Site transfer support for commercial products: Coordinating and providing R&D Support for products site transfer, manufacturing characterization and process validation batches and supporting RA team for filing SUPAC to different agencies Queries Response: Coordinating with Regulatory team in addressing deficiencies or regulatory queries Expertise in managing entire breadth of development activities inclusive of project identification, manpower management, system implementation, materials management & project execution etc.
Experience
Sr General Manager
Apr 2025 — Present
Education
Amravati University
M.Pharm
2006 — 2008
Savitribai Phule Pune University
B.Pharm
2001 — 2005
Skills
- Pharmaceutics
- V&V
- Formulation
- Generic Programming
- Regulatory Submissions
- Pharmaceutical Industry
- Hplc
- Gmp
- Ectd
- Regulatory Affairs
- Validation
- Technology Transfer
- Anda
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