Granules India subsidiary clears USFDA audit

Hyderabad: The drug maker Granules India on Wednesday announced that its US-based subsidiary cleared a pre-approval inspection (PAI) audit by the US drug regulator.

“Granules India Limited 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 (FDA) from June 21-June 25.

“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”, read an official release.

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“The observations were responded to within the stipulated time, and we are happy to inform that the FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on July 20, 2021. This is the fifth US FDA audit for this facility,” said Priyanka Chigurupati, Executive Director, GPI.

Granules India is a growing pharmaceutical manufacturing company with best-in-class facilities and is committed to operational excellence, quality and customer service.

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