About
Monik Gohil is the API CMC Professional Lead at Apicore Pharmaceuticals with extensive experience in API research and development, including technology transfer, scale-up, DMF filling, and control strategy development. Previously, he has held significant roles at Sun Pharmaceutical Industries Ltd. and Zydus Group. His expertise covers API synthesis and quality control, ensuring regulatory compliance and product safety. Monik holds a Master’s in Organic Chemistry from The Maharaja Sayajirao University of Baroda and is pursuing a PhD in Heterocyclic Organic Chemistry. His recent work includes a published article on chalcone-based triazolo pyrimidine compounds in Current Organic Chemistry.
Skills & Expertise
SAP BO XI
MS Office
Minitab
Organic Synthesis
Sci-Fiender
ACD-Chemsketch
LIMS
Stereoisomerism
Project Management
Project Coordination
Research Interests
Organic Chemistry
Chemistry
Connect With Me
Experience
- • Lead for development of project and synthesize impurities. • To discuss, understand and design overall API control Strategy and specification with respect to finalized Route of Synthesis at R & D as per Regulatory requirement. Specification approval. • Technical review of process input before plant validation and ensure smooth implementation at plant level. • Technical review of Characterization report of standards. • Stereoisomerism statement and Polymorphism statement • Technically review and Approval of Process Development Report (PDR). • Effective review and assist Drug Master file, Query response, Response to Customer query. • Responsible to involve and review Investigation report, Justification report, Nitrosamine impurities report, Genotoxic evaluation.
Education
RK UNIVERSITY
Publications (1)
An improved method has been developed for photocyclization of stilbene to construct phenanthrenes and benzo[c]phenanthrenes. This reaction is promoted by iodine while tetrahydrofuran is used as an eff...
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