PhanikumarReddy Satti
Also known as: Phani Satti, Phanikumar Reddy Satti, Phani Kumar Reddy Satti
Veranova, Acharya Nagarjuna University, Andhra University
About
Dr. Phanikumar Reddy Satti is a distinguished analytical scientist with over 20 years of experience in pharmaceutical research and development, specializing in analytical method development, validation, and lifecycle management for both innovator and generic drug products. He currently serves as Director and Senior Principal Scientist of Analytical Development at Veranova L.P. (formerly Johnson Matthey Health) in West Deptford, New Jersey, USA.
Dr. Satti has extensive expertise in analytical characterization of drug substances, solid orals, oral suspensions, sterile formulations, and topical products, utilizing advanced instrumentation such as HPLC, UPLC, GC, LC-MS/MS, GC-MS, ICP-MS/OES, and UV-Vis spectroscopy. He is also well-versed in impurity profiling, degradation pathway elucidation, and regulatory submissions (DMF, ANDA, IND, NDA) in compliance with ICH, FDA, and global regulatory guidelines.
Throughout his career, Dr. Satti has successfully built and led high-performing analytical teams, established GMP-compliant laboratories, and driven numerous projects through clinical and commercial phases. His leadership extends to mentoring scientists, fostering innovation, and ensuring scientific excellence in analytical R&D.
Dr. Satti’s scholarly contributions include peer-reviewed publications in Separation Science Plus, Pure and Applied Chemistry, Chirality, and Nanotheranostics, as well as co-authored book chapters on Pharmaceutical Validation and Advanced Pharmaceutical Analysis. He is also a named inventor on the global patent WO2010127205A3 (Fixed-Dose Combination Drug Formulation).
His current research interests focus on stability-indicating method development, impurity characterization using hyphenated techniques (LC-MS/NMR), and nitrosamine impurity assessment and control. Dr. Satti is pursuing his Ph.D. in Analytical Chemistry from Acharya Nagarjuna University, India, and continues to contribute actively to advancing pharmaceutical analytical science and regulatory compliance worldwide.
Employment
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Veranova Director2021 - Present
Education
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Acharya Nagarjuna University Ph.D2023 - Present
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Andhra University Masters in Science2000 - 2002
Projects & Funding
Projects & funding information is unavailable.
Publications (9)
- Isolation and Structural Elucidation of Oxidative Degradation Products of Bosutinib by Preparative HPLC, LC–MS, and NMR Spectroscopy Save
- Quantitative analysis of nitrosamine impurities using liquid chromatography tandem mass spectrometry Save
- A Comprehensive Development and Validation of a Stability‐Indicating High‐Performance Liquid Chromatographic Method for Adagrasib Drug Substance With Degradation Product Characterization by Liquid Chromatography‐Tandem Mass Spectrophotometry Save
- Enantiomeric Analysis of Chiral Drugs Using Mass Spectrometric Methods: A Comprehensive Review Save
- Enantiomeric resolution of three profen drugs using direct thin-layer chromatographic method Save
- Nanomedicine And Nanotheranostics: Special Focus on Imaging of Anticancer Drugs Induced Cardiac Toxicity Save
- FORCED DEGRADATION STUDIES: PRACTICAL APPROACH - OVERVIEW OF REGULATORY GUIDANCE AND LITERATURE FOR THE DRUG PRODUCTS AND DRUG SUBSTANCES Save
- Fixed dose drug combination formulations Save
- The combination drugs debate: Incompatibility problems can be overcome Save