Natco Pharma's Mekaguda API Plant Receives US FDA Establishment Inspection Report (EIR)
The clearance from the US FDA for an API manufacturing facility is crucial for Natco Pharma to maintain its ability to supply products to the US market, ensuring regulatory compliance and business continuity for a key operational site.
The receipt of an Establishment Inspection Report (EIR) from the US FDA signifies the successful closure of the inspection, and the initial observation was classified as 'Voluntary Action Indicated' (VAI), which is the least severe classification, indicating no major compliance issues.
* NATCO Pharma Limited announced that its Active Pharmaceutical Ingredient (API) manufacturing plant located in Mekaguda, Hyderabad, India, has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) on July 24, 2025. * The FDA had conducted an inspection at this facility from June 9 to June 13, 2025. * During the inspection, the company received one (1) observation in Form -483, which was classified as “Voluntary Action Indicated” (VAI).
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