Companies

Granules Pharmaceuticals concludes FDA audit with two minor observations

Our Bureau Hyderabad | Updated on June 28, 2021

The audit is a pre-approval inspection for three products filed from this facility

Granules, a vertically integrated pharmaceutical company headquartered in Hyderabad, has announced that Granules Pharmaceuticals Inc. (GPI), its wholly owned subsidiary in Chantilly, Virginia has completed an audit by the US Food and Drug Administration (USFDA) with two minor observations.

Also read: Granules India earmarks capex of Rs 1,000 crore till FY24

This facility was inspected by the USFDA from June 21-25. The audit is a pre-approval inspection for three products filed from this facility. “We will be responding to the two observations within the stipulated time period,” said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals Inc.

GPI is a USFDA & DEA approved facility spread over 1,00,000 sq ft area, with established R&D & Manufacturing capabilities for low volume, oral solid dosage forms, according to a company statement.

Published on June 28, 2021

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