Drugmaker Lupin said the United States Food and Drug Administration (USFDA) had completed certain inspections at its Vishakapatnam facility, with no regulatory observations.
The USFDA completed a pre-approval and GMP (good manufacturing practices) inspection of its Active Pharmaceutical Ingredients (API) manufacturing facility at Visakhapatnam (Vizag). “The inspection was conducted from March 6 to March 10, 2023 and concluded with no observations.” the company said.
Indian drugmakers have been seeing a spate of regulatory observations as the USFDA resumed its physical inspection of manufacturing facilities, as global travel resumed following the decline in Covid-19 cases.