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Prabhakar R. Gruddanti, MS, PhD (he/him/his)

Director
United States Pharmacopeia
Rockville

Prabhakar has joined USP in January of 2020 and he is currently the Director of Pharmaceutical Sciences, General Chapters, and works with Microbiology, Dosage Forms and Packaging & Distribution Expert Committee related activities. He is also the scientific lead for the Complex Generics initiatives at USP, including developing standards for Extractables & Leachables, as well as other complex products such as Complex Injectables, Ophthalmics, Topical & Transdermal, Nasal & Inhalation products.

Prior to joining USP, Prabhakar worked in the pharmaceutical industry for more than 27 years at various small and large pharmaceutical companies in the field of analytical and bio-analytical chemistry. His expertise includes analytical and bioanalytical method development and validations, use of modern analytical technologies such as HPLC/UPLC and LC-MS/MS for characterization of both small and large molecules, use of automated instrumentation (TPW, and Sotax AT MD) for assay and dissolution testing, ICH stability testing, and preparation of regulatory documentation for IND/ANDA/NDA submissions.

Prabhakar has BS and MS degrees in chemistry and PhD degree in bioanalytical chemistry.

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