Granules India Ltd has announced that it received a Warning Letter from the US Food and Drug Administration (FDA) on February 26, 2025, regarding its Gagillapur facility. The letter follows an inspection conducted in August 2024, which resulted in an "Official Action Indicated" (OAI) classification.
Key points:
1. Manufacturing and distribution of existing products from the Gagillapur facility continue unaffected.
2. The Warning Letter may temporarily impact FDA review of pending product submissions from this site.
3. The FDA has not indicated any further escalation.
4. Granules has implemented a comprehensive remediation plan, including corrective and preventive actions (CAPAs).
5. The company voluntarily paused manufacturing and dispatches in September 2024 for a risk assessment but has since resumed operations.
Granules remains confident in resolving the matter satisfactorily within a reasonable timeframe. The company's growth strategy remains robust, with ongoing expansion through its US-based GPI facility, increased market presence in the US and Europe, and advancements in its Genome Valley site.
Source: Granules India Ltd regulatory filing, February 27, 2025