NATCO Pharma’s API Facility Cleared by U.S.FDA in Mekaguda Inspection

PharmaGenDRx News Bureau, – July 25, 2025

09:30 AM IST

Natco Pharma Limited, known for its role in supplying generic medicines in critical and underserved areas announced that they have been issued Establishment Inspection Report (EIR) for its Active Pharmaceutical Ingredient facility in Hyderabad.

The U.S. FDA had conducted inspection from June 9 to 13,2025. The company claims that they received 1 (One) observation in the Form-483 which was classified as “Voluntary Action Indicated” (VAI). The VAI and EIR confirms successful closure of the inspection. This also proves Natco Pharma’s commitment towards maintaining quality abiding by global regulatory standards.

By Subhajit Mishra