Generic drugmaker Natco Pharma has received an establishment inspection report from the U.S. Food and Drug Administration for its active pharmaceutical ingredient manufacturing facility in Hyderabad.
The U.S. FDA had inspected the API facility, in Mekaguda here, from June 9-13 and issued Form 483 with one observation. The regulator had classified it as “voluntary action indicated” (VAI), the company said on Thursday, announcing issue of the EIR.
Natco Pharma shares closed 3.58% lower at ₹997.70 each on the BSE.
Published – July 24, 2025 09:20 pm IST
Source: https://www.thehindu.com/business/natco-pharmas-hyderabad-api-plant-receives-eir-from-us-fda/article69850841.ece
