Granules India arm receives USFDA inspection report for Virginia facility, single observation resolved

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 USFDA completed an inspection of its API Unit-I facility located at Bonthapally, Telangana, which concluded with one Form 483 observation.The Bonthapally site is among the world’s largest single-location Paracetamol API manufacturing facilities by volume and also includes production units for Metformin and Guaifenesin APIs.

In February, the drugmaker stated it received a warning letter from the USFDA for its Gagillapur facility, following an inspection conducted in August 2024.

In a regulatory filing, the company had stated, “On February 26, 2025, the US FDA issued a warning letter to Granules’ Gagillapur facility based on its inspection conducted in August 2024. The FDA has not indicated any further escalation.”

The inspection classification was ‘Official Action Indicated (OAI)’, though the regulator did not signal any additional enforcement action.

Shares of Granules India ended the previous session 1.3% lower at ₹566 apiece.