Granules India arm clears USFDA audit
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Hyderabad: Granules India Limited has announced that Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the Company located in Chantilly, Virginia, USA had undergone a Pre-Approval Inspection (PAI) audit by the U.S. Food and Drug Administration (USFDA) from 21st June 2021 to 25th June 2021.
The audit is a pre-approval inspection for three of its applications filed from this facility. The FDA issued two minor observations during the audit.
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