GRANULES INDIA IN FOCUS AFTER USFDA ISSUES 11 OBSERVATIONS

Shares of Granules India Ltd. will remain in focus on November 2 after the company disclosed that the US Food and Drug Administration issued 11 observations following an inspection of its finished dosage manufacturing facility at Gagillapur, Hyderabad. The USFDA conducted a Current Good Manufacturing Practice inspection at the facility between October 19 and October 30, 2026. The inspection concluded with the issuance of a Form FDA 483 containing 11 observations. This was the first USFDA inspection of the facility since the Warning Letter issued on February 26, 2025, following an earlier inspection conducted in August-September 2024. According to the company, none of the observations were related to data integrity or cross-contamination. Instead, they primarily concerned improvements in investigations, change control, process and equipment qualification, visual inspection controls and documentation practices. Granules India clarified that the observations have no impact on the manufacturing or distribution of products from the facility. The company will submit a comprehensive response to the USFDA within the stipulated 15 business days. Commenting on the inspection, the company said the process progressed constructively and that the observations could be addressed through appropriate responses and corrective and preventive actions (CAPA). It reiterated that quality remains a key priority and that it will continue to engage transparently with the regulatory agency. Meanwhile, the company's board of directors is scheduled to meet on Monday, November 2, 2026, to consider and approve the unaudited financial results for the second quarter and half-year ended September 30, 2026.