Natco Pharma Mekaguda API unit gets USFDA EIR
Hyderabad: NATCO Pharma Limited has announced that the U.S. Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for the Active Pharmaceutical Ingredient (API) facility located in Mekaguda.
The inspection was conducted by the USFDA from June 9th – June 13th, 2025.
Read also: USFDA issues one observation for Natco Pharma Mekaguda unit
Following the inspection, the company received one observation in the Form-483, which was classified as “Voluntary Action Indicated” (VAI).
NATCO Pharma Limited, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The Company is a R&D oriented, and a science driven company in the targeted therapies of domestic market and focuses on limited competition molecule in the US. The Company has 9 manufacturing sites and 2 R&D facilities in India. The Company’s different manufacturing facilities are approved by several leading regulatory authorities like US FDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets.
