Granules India share price will remain in focus on November 2 following the company eleven observations from the United States Food and Drug Administration (USFDA).
The USFDA was conducted a current Good Manufacturing Practice inspection from October 19 to October 30, 2026, at finished dosage facility at Gagillapur, Hyderabad. and concluded with the issuance of a Form FDA 483 containing eleven observations.
This was the first USFDA inspection of the facility since the Warning Letter of February 26, 2025, which followed an inspection in August - September 2024.
None of the observations were related to data integrity or cross-contamination, while related to enhancements in investigations, change control, process and equipment qualification, visual-inspection controls and documentation practices, company said.
There is no impact on manufacturing or distribution of products from the site and will submit a comprehensive response to the USFDA within the stipulated 15 business days, company added.