“On February 26, 2025, the US FDA issued a Warning Letter to Granules’ Gagillapur facility based on its inspection conducted in August 2024. The FDA has not indicated any further escalation,” Granules India said in a regulatory filing
The classification of “Official Action Indicated” (OAI) remains, but the regulator has not signaled any further escalation. The company stated that it will respond within the stipulated timeframe and seek a meeting with the FDA to demonstrate its ongoing compliance efforts.
“We will respond within the stipulated timeframe and seek a meeting with the FDA to demonstrate ongoing progress towards compliance. We remain confident that this matter will be resolved satisfactorily within a reasonable timeframe,” the company said.
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Back in December 2024, Granules India had informed that the company’s Gagillapur facility in Telangana had been classified as Official Action Indicated (OAI) by the US FDA. In September 2024, the USFDA issued a form 483 with six observations for the Gagillapur facility.
The warning letter may temporarily impact the FDA review of pending product submissions from the Gagillapur facility. However, the manufacturing and distribution of existing products from the site remain unaffected.
Granules has implemented a comprehensive remediation plan following the FDA audit and six Form 483 observations. The company voluntarily paused manufacturing and dispatches in September 2024 to conduct a risk assessment, ensuring no product contamination or safety concerns before resuming operations.
The remediation efforts include corrective and preventive actions (CAPAs), oversight by three independent consulting firms, continuous product testing, and monthly updates to the FDA.
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The Warning Letter highlights four key areas previously outlined in the Form 483 observations. Granules stated that significant progress has been made in addressing these concerns, with most corrective actions completed and the remaining ones progressing as scheduled.
“Granules has been providing regular updates to the FDA on the progress and effectiveness of these remediation measures through regular monthly updates. A key focus of these efforts remains risk mitigation, ensuring that there is no adverse impact on the safety or quality of products manufactured and distributed from the Gagillapur facility,” it said.
Despite regulatory challenges at Gagillapur, Granules remains confident in its long-term growth, driven by new launches from its GPI facility in the US, capacity expansion at Genome Valley, increased production in Europe, and an expanding oncology pipeline from Unit V.
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Shares of Granules India Ltd ended at ₹502.00, down by ₹11.75, or 2.29%, on the BSE.
First Published: Feb 27, 2025 4:29 PM IST
