Shares of Granules India declined over 3% after the company received a Warning Letter from the US Food and Drug Administration (FDA) regarding its Gagillapur facility. The letter follows an inspection conducted in August 2024, which resulted in an “Official Action Indicated” (OAI) classification. While the FDA has not recommended further escalation, Granules India remains committed to addressing regulatory concerns and ensuring full compliance.
To strengthen quality and regulatory standards, Granules India has implemented a comprehensive remediation plan. This includes corrective and preventive actions (CAPAs), oversight from independent consulting firms, continuous product testing, and regular updates to the FDA. In September 2024, the company voluntarily paused manufacturing and dispatches for a thorough risk assessment, ensuring there were no patient safety concerns before resuming operations.
The Warning Letter primarily highlights four key areas that were previously identified in the FDA Form 483 observations. Granules India has made significant progress in resolving these issues, with most corrective actions already completed and the remaining ones progressing as scheduled. The company continues to provide monthly updates to the FDA, focusing on risk mitigation and product safety.
Granules India shares opened at ₹489.45, reaching a high of ₹494.75 and a low of ₹478.05. The stock’s 52-week high stands at ₹721.00, while the 52-week low is ₹389.35.
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