Dr Reddy’s has been given the all-clear for its Indian formulations manufacturing facility in Duvvada, Visakhapatnam, after obtaining an establishment inspection report (EIR) from the US Food and Drug Administration (FDA) for the site that has been dealing with manufacturing setbacks since a 2015 warning letter.
The Duvvada site was included in an FDA warning letter issued to Reddy’s in November 2015 that also highlighted issues with the Indian firm’s local active pharmaceutical ingredient (API)