USFDA action on Granules does not affect existing products, but new approvals may be impacted

Granules India

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26 Aug, 2025 12:21

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USFDA's classification of Granules India's Gagillapur facility in Hyderabad as 'Official Action Indicated' (OAI) does not impact the ongoing manufacturing, distribution, or sale of existing products from the site, the company clarified on December 4. Granules added that it has sought a meeting with the USFDA to present the progress, and seek a potential re-inspection of the facility.

However, the regulator rap may impact the process of review of pending submissions from the facility for approval of new products, till the time the OAI status is not resolved, the company added. Shares of Granules India has taken a severe knock of 10% on December 3 after US drug regulator's actions were informed.

The pharma company has already said that it intends to work with the US drug regulator and is confident of securing compliance for the facility soon.

Granules India said it has undertaken a 'proactive, voluntary and comprehensive' remedial plan to address the six form 483 observations that have been raised by the USFDA. The company said it had voluntarily paused manufacturing and dispatches in September, in order to conduct a thorough risk assessment. Operations and dispatches have since resumed following this assurance, Granules added.

"Our voluntary remediation plan includes robust corrective and preventive actions (CAPAs), oversight by an independent third party, continued product testing for risk assessment, and regular monthly progress updates to the USFDA," Granules India said.

The pharma company informed that so far, over 80% of the CAPAs have been completed, and the remainder are on track for closure by March next year.

The USFDA had conducted an inspection at the Gagillapur finished dosage facility from
August 26-September 6, 2024. Granules India had earlier said that the impact on the facility will have a 'small spillover' into Q3FY25 as well but the impact on lost sales will be less than what was seen in Q2FY25.