NATCO Pharma Limited has informed that the U.S. Food and Drug Administration (FDA) had conducted an inspection at the Active Pharmaceutical Ingredient Division located in Mekaguda, Hyderabad, India, from June 9th - 13th, 2025.

The company received one observation in the Form-483 which was classified as “Voluntary Action Indicated” (VAI). In connection with the above, the company has now informed that the U.S. FDA has now issued Establishment Inspection Report (EIR) for the API facility located in Mekaguda on July 24th 2025. 

NATCO Pharma Limited headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients, and crop protection products.