Granules India Ltd has 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 suggested further escalation, the company is committed to addressing the concerns and ensuring compliance.
Granules India has already implemented a robust remediation plan to strengthen quality and regulatory standards at the facility. The plan includes corrective and preventive actions (CAPAs), oversight from independent consulting firms, continuous product testing, and regular updates to the FDA. The company voluntarily paused manufacturing and dispatches in September 2024 for a comprehensive risk assessment, confirming that there were no patient safety concerns before resuming operations.
The Warning Letter primarily highlights four key areas that were previously addressed in the FDA Form 483 observations. Granules India has made substantial progress in resolving these issues, with most corrective actions completed and the remaining ones on schedule. The company continues to provide monthly updates to the FDA, focusing on risk mitigation and ensuring product safety.
Despite this temporary regulatory challenge, Granules India’s growth strategy remains strong. The company continues to expand through its US-based GPI facility, increasing market presence in the US and Europe, and advancing its greenfield formulation site at Genome Valley. Additionally, value chain enhancements in Europe and a growing oncology pipeline from Unit V further reinforce its market position.
While the Warning Letter may temporarily impact the review of pending product approvals from the Gagillapur site, existing manufacturing and distribution remain unaffected.
