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Mr. Madhu Kothapalli is a Founding Partner of CorePharma LLC. He has 12 years of experience in managing the Quality Control and Analytical R&D labs. His expertise includes developing and validation of HPLC, GC, UV, FT-IR and other Spectroscopic analytical methods for testing API and Finished Products. He has thorough knowledge of characterization of drug substances, impurities and metabolites using NMR, MS, FTIR, DSC, Elemental Analysis, etc. He has in depth knowledge of cGMP, GLP and ICH guidelines. He is actively involved in training, out of specification (OOS), out of trend (OOT), and change control documentation. He has thorough knowledge of OGD/FDA requirements for analytical portion of ANDA submission. Mr. Kothapalli worked at Invamed, Inc. from 1993 to 1998 as a Laboratory Supervisor and Laboratory Chemist. Mr. Kothapalli received a Master’s Degree in Industrial Pharmacy from the University of Toledo in Ohio, and a Bachelor’s Degree in Pharmacy from Annamalai University in India. | 