Granules India Limited announced that its wholly owned subsidiary, Granules Pharmaceuticals, Inc., based in Chantilly, Virginia, USA, has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (US FDA). The report pertains to the Pre-Approval Inspection (PAI) conducted in June 2025 for a first-to-file controlled substance Abbreviated New Drug Application (ANDA).
The company confirmed that the inspection concluded with a single observation, which has since been resolved to the satisfaction of the regulator. The receipt of the EIR signifies that the US FDA has closed the inspection process for the facility.
This development marks an important step for Granules India in expanding its U.S. market portfolio, especially in the controlled substances segment. The company continues to strengthen its global compliance standards and maintain the highest levels of quality across its manufacturing operations.
