Ipca Laboratories Ltd on Friday (December 5) announced that the US Food and Drug Administration (US FDA) has issued a Form 483 with three observations following its inspection of the company's Active Pharmaceutical Ingredients (APIs) manufacturing facility at Tarapur in Palghar, Maharashtra.

The inspection was carried out from December 1, 2025, to December 5, 2025.

According to the company, the observations were shared at the conclusion of the inspection. Ipca Laboratories stated that it will submit a comprehensive response to the US FDA within the stipulated timeline. The company added that it will work closely with the agency to address and resolve the issues raised.

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Ipca Laboratories said i

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