Granules India has issued an update regarding the US FDA’s classification of its Gagillapur facility under “Official Action Initiated” (OAI), following six observations outlined in a Form 483 report. The company clarified that this classification does not affect the ongoing manufacturing, distribution, or sale of existing products from the site. However, it may delay the review and approval of pending submissions for new products until the OAI status is resolved.
In response, Granules India has implemented a voluntary and comprehensive remediation plan to address the concerns. As part of this initiative, the company paused manufacturing and dispatches in September to conduct a thorough risk assessment. After ensuring there were no risks of product contamination or patient safety concerns, operations and dispatches resumed.
The remediation plan includes corrective and preventive actions (CAPAs), oversight by an independent third party, regular product testing, and monthly updates to the US FDA. Granules reported that over 80 per cent of the CAPAs have been completed, with full implementation expected by March 2025. The company is seeking a meeting with the US FDA to present its progress and request a potential reinspection.
Despite the OAI status, Granules highlighted its diversified growth strategy. Key contributors include new product launches from the GPI facility in the US, growth in large-volume products in the US and Europe, capacity expansion at its Genome Valley greenfield formulation facility, advancements in the European value chain, and an expanding oncology pipeline from Unit V.
Granules reiterated its commitment to compliance and sustained performance while working towards resolving the OAI status. The company stated that these initiatives ensure a stable growth trajectory independent of new product approvals from the Gagillapur site.
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