Comments
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.
Comments
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.