Shares of Granules India Ltd crashed 8% on Friday, 28 February, after the US Food and Drug Administration (US FDA) issued a warning notice to the company’s Gagillapur factory.
In its regulatory filing, the company said, “On 26 February 2025, the US FDA issued a Warning Letter to Granules’ Gagillapur facility based on its inspection conducted in August 2024.”
The warning letter focuses on four significant issues that were previously noted in the FDA Form 483 findings. In addressing all of the FDA’s conclusions in these four areas, Granules has made significant progress; most of the corrective actions have been completed, and the remainder are on track.
Although manufacturing and delivery of existing goods from the Gagillapur site are unaffected, the company said in a filing that the warning letter may have a short-term impact on the FDA’s review of pending product applications from this location until the issue is resolved.
Additionally, the FDA has not signalled any future increase. The company agreed to respond within the specified time frame and to ask for a meeting with the FDA to demonstrate ongoing progress toward compliance.
Following the FDA audit and six Form 483 observations, Granules has implemented a comprehensive and proactive corrective strategy to enhance compliance and support product quality and safety at the Gagillapur facility.
Granules India is a well-known pharmaceutical company in India that produces active pharmaceutical ingredients (APIs), intermediates, and pharmaceutical formulations. The company manufactures both prescription and over-the-counter (OTC) generic pharmaceutical products. By offering products in several therapeutic areas, including diabetes, cardiovascular disease, and disorders of the central nervous system, it caters to global markets.
At 12:32 pm, the shares of Granules India were trading 7.54% lower at Rs 468.75 on NSE.
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