Granules India has received one observation from the US Food and Drug Administration (USFDA) following a pre-approval inspection at its oral solid manufacturing facility located in Shamirpet, Hyderabad.

The inspection, conducted between July 22 and July 26, 2025, concluded with the regulator issuing a Form 483, which includes a single observation. The company clarified that the issue was procedural in nature and does not relate to data integrity.

“We are preparing our response to address the USFDA’s observation and will submit it within the stipulated timeline,” Granules India said in a regulatory filing.

The Shamirpet facility plays a key role in Granules’ manufacturing operations, particularly in supplying oral solid dosage forms for regulated markets such as the United States.

The company has been expanding its footprint globally and continues to maintain a strong compliance track record across its facilities.