Granules Pharmaceuticals clears US FDA audit

Granules India yesterday announced that Granules Pharmaceuticals, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, USA, has cleared a pre-approval inspection (PAI) for three of its applications filed from this facility.

The company, had undergone the PAI audit by the US Food and Drug Administration (FDA) from 21st June, 2021 to 25th June, 2021. The FDA has issued two minor observations during the audit.

Speaking in this regard, Priyanka Chigurupati, Executive Director, GPI, said, “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 the 20th July, 2021. This is the fifth US FDA audit for this facility.”