Ipca Laboratories Ltd receives 3 observations from USFDA for API facility at Tarapur

Ipca Laboratories Limited has announced that the US FDA conducted the inspection of the Company's Active Pharmaceutical Ingredients (APIs) manufacturing facility situated at Tarapur (PalgharMaharashtra) from 1st December, 2025 to 5th December, 2025. At the conclusion of the inspection, US FDA has issued a Form 483 with 3 (three) observations.

The Company will submit its comprehensive response on these observations to the US FDA within the stipulated time and shall work closely with the agency to resolve these issues at the earliest.

The Company takes the quality and compliance issues with utmost importance and remains committed to maintain the highest standards of quality and compliance across all its manufacturing facilities.

Source : Equity Bulls

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IPCALaboratories USFDA Inspection APIFacility Tarapur 3Observations