Granules India announced that the US Food and Drug Administration (USFDA) has successfully completed a Pre-Approval Inspection (PAI) at the manufacturing facility of its wholly-owned subsidiary, Granules Pharmaceuticals, Inc., located in Chantilly, Virginia, USA. The inspection was carried out between June 23 and June 27, 2025.
The inspection was related to a first-to-file Abbreviated New Drug Application (ANDA) for a controlled substance. At the end of the process, the USFDA issued one Form 483 observation. The company confirmed that the observation was addressed and resolved during the course of the inspection itself.
Granules Pharmaceuticals is a key part of Granules India’s US operations, and the PAI marks an important step forward in its regulatory pipeline. The resolution of the observation during the inspection reflects the company’s preparedness and responsiveness to regulatory standards.