Granules India on Wednesday said its wholly-owned subsidiary, Granules Pharmaceuticals Inc., located in Chantilly, Virginia, United States, has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA).

The EIR followed a Pre-Approval Inspection (PAI) conducted by the USFDA in June 2025 for a first-to-file controlled substance Abbreviated New Drug Application (ANDA), the company said in a stock exchange filing. The USFDA inspection report carried one observation.

“There was one observation during the inspection, and it has been resolved,” the Hyderabad-based company informed the bourses.

Receipt of the EIR indicates the successful closure of the inspection, according to the company.

In June, Granules India informed the stock exchanges that the

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