Granules India Limited submitted a press release to the National Stock Exchange of India Limited and BSE Limited regarding a regulatory inspection of its manufacturing facility.
The United States Food and Drug Administration (USFDA) concluded a current Good Manufacturing Practice (cGMP) inspection of the company's finished dosage facility located at Gagillapur, Hyderabad. The inspection period was from October 19, 2026, to October 30, 2026.
The inspection concluded with the issuance of a Form FDA 483 containing eleven observations. The company specifically noted that none of these observations were related to data integrity or cross-contamination. The observations pertain to areas requiring enhancement, including investigations, change control, process and equipment qualification, visual-inspection controls, and documentation practices.
The company stated there is no impact on the manufacturing or distribution of products from the site as a result of these observations. Granules India will submit a comprehensive response to the USFDA within the stipulated timeframe of 15 business days.
This inspection was significant as it was the first USFDA inspection of the Gagillapur facility since the company received a Warning Letter on February 26, 2025. That Warning Letter was itself a follow-up to an inspection conducted in August-September 2024.
Management Commentary: Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, commented that the inspection progressed constructively. He stated the observations are of a nature that the company believes can be fully addressed through their responses and corrective and preventive actions (CAPA). He reiterated that quality is the foundation of the company's operations and committed to continued transparent engagement with the agency.
The disclosure was signed and submitted by Chaitanya Tummala, Company Secretary & Compliance Officer.