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.

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