Granules India’s Gagillapur Facility Receives US FDA’s OAI Status

Granules India Ltd provided an update to the stock exchanges about its Gagillapur facility in Hyderabad, Telangana, which was classified as “Official Action Indicated” (OAI) by the US FDA. This classification stems from an inspection conducted in September 2024, during which the FDA issued Form 483 with 6 observations.

OAI Impact

The company clarified that the OAI status does not affect ongoing manufacturing, distribution, or sales of existing products from the Gagillapur site. However, it may delay the review and approval of pending submissions for new products until the OAI status is resolved.

Granules India has proactively undertaken a comprehensive remediation plan to address the six observations. In September 2024, the company voluntarily paused manufacturing and dispatches to conduct a detailed risk assessment. This assessment confirmed there were no product contamination or patient safety concerns, allowing operations and dispatches to resume.

The remediation plan includes robust corrective and preventive actions (CAPAs), oversight by an independent third party, and ongoing product testing for risk assessment. To date, over 80% of the CAPAs have been completed, with the remaining tasks scheduled for closure by March 2025. The company is also maintaining regular communication with the FDA and providing monthly progress updates. Granules India plans to request a meeting with the US FDA to present its progress and seek a potential reinspection of the facility.

Diversified Growth Strategy

Despite the OAI status, Granules India emphasised its strong and diversified growth strategy, which is not entirely dependent on the Gagillapur facility. Key growth drivers include new product launches from its GPI facility in the US, growth from large-volume products in the US and Europe, expansion of its greenfield formulation facility at Genome Valley, advancements in its European value chain and an expanding oncology pipeline from Unit V.

Granules India remains confident that its proactive measures and commitment to compliance will result in resolving the OAI status and ensuring continued progress across its global operations.

On December 4, 2024, Granules India share price opened at ₹536.10, slightly up from its previous close of ₹534.15. At 9:34 AM, the share price of Granules India was trading at ₹537.25, up by 0.58% on the NSE.

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