Granules’ US arm concludes FDA Audit with three minor observations

Hyderabad: Hyderabad-based Granules India said that Granules Pharmaceuticals, a wholly owned foreign subsidiary of the company, located in Chantilly, Virginia, USA had undergone a Pre-approval Inspection (PAI) by the US Food and Drug Administration (US FDA) from 24th to 28th January 2022. The audit is a PAI for two of its product applications filed from […]

Hyderabad: Hyderabad-based Granules India said that Granules Pharmaceuticals, a wholly owned foreign subsidiary of the company, located in Chantilly, Virginia, USA had undergone a Pre-approval Inspection (PAI) by the US Food and Drug Administration (US FDA) from 24th to 28th January 2022.

The audit is a PAI for two of its product applications filed from this facility. The US FDA issued three minor observations during the audit conducted at the facility.

Granules India is involved in manufacturing of entire value chain – from active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs) and finished dosages (FDs).