Dr Reddy’s receives USFDA post-application action letter for Bachupally facility

Dr Reddy’s Laboratories said it has received a post-application action letter from the US Food and Drug Administration following the pre-approval inspection conducted at its biologics manufacturing facility in Bachupally, Hyderabad.

The company said the letter relates to responses submitted to the US regulator after the inspection carried out in September 2025.Dr Reddy’s said it will continue to work closely with the USFDA and is committed to addressing the observations outlined in the letter.