Granules India provides an update regarding the US FDA’s classification of its Gagillapur facility under “Official Action Initiated” (OAI), as per the recent communication on December 3, 2024.
This classification does not affect ongoing manufacturing, distribution, or sales of existing products from the facility. However, it may delay the review and approval of pending submissions for new products until the OAI status is resolved.
To address six Form 483 observations raised by the US FDA, Granules India has initiated a robust and voluntary remediation plan. This includes corrective and preventive actions (CAPAs), independent oversight, and regular updates to the US FDA. Operations and dispatches, which were voluntarily paused in September for risk assessment, have resumed. To date, over 80% of CAPAs are completed, with the remainder set to close by March 2025. A meeting with the US FDA has been requested to present progress and seek a reinspection.
Granules’ growth remains strong, driven by new launches from its GPI facility in the US, high-volume products in the US and Europe, a greenfield formulation facility at Genome Valley, and advancements in Europe and oncology from Unit V.
These initiatives ensure sustained business performance while reinforcing Granules’ commitment to compliance and quality.
