Anurag Trivedi
Vice President, API Analytical at Lupin Limited
- Role
- Vice President, Api Analytical at Lupin
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
Experience
Vice President, Api Analytical
Jul 2019 — Present · Pune, IN
Have been at Lupin since 1989, having held multiple positions of responsibility-Currently spearheading a team of 100+ professionals-Led the development of robust analytical methods for APIs, ensuring seamless DMF filing and regulatory compliance-Delivered prompt and comprehensive responses to DMF/ANDA queries, enabling swift approvals and market readiness-Conducted advanced genotoxic and nitrosamine evaluation and established innovative methodologies for risk mitigation-Led impurity synthesis initiatives for in-house APIs and drug products-Executed solid-state characterization, including polymorph identification, leveraging advanced tools like pXRD, DSC, TGA, DVS and Raman spectroscopy-Provided strategic guidance on reverse engineering for innovator samples-Enabled thorough OOS investigations at plant-level using LCMS and GCMS-Orchestrated cross-functional coordination, fostering collaboration across departments for seamless project execution-Championed specification finalization processes-Evaluated and finalized the right instrument and induction of new techniques
Education
Barkatullah Vishwavidyalaya
Master of Science - MS
Bundelkhand University, Jhansi
Doctor of Philosophy - PhD
2004
Skills
- Chemistry
- Analytical Chemistry
- Pharmaceutics
- Chromatography
- Technology Transfer
- Validation
- Gmp
- Pharmaceutical Industry
- Sop
- Fda
- Hplc
- Glp
- Lc-Ms
- Dissolution
- Regulatory Affairs
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