Granules Pharmaceuticals clears US FDA audit

Granules India today announced that Granules Pharmaceuticals, Inc (GPI), a wholly-owned foreign subsidiary of the company, located in Chantilly, Virginia, the US, received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA).

The GPI facility was inspected by the FDA from 24th to 28th January, 2022 for two of its product applications filed. There were three minor observations during the inspection and GPI had addressed the observations in the stipulated time period.

Commenting on the audit, Priyanka Chigurupati, Executive Director, GPI, said, “We are glad to have completed yet another audit after successfully addressing minor observations. This is the sixth successful US FDA audit for this facility.”