No More 'Hidden' Facilities, US FDA Tells Generic Sponsors

The US FDA appears unwavering in its requirement that sponsor list all relevant manufacturing facilities at the top of each ANDA submitted. There will be no exceptions, even if the sponsor does not have access to the drug master file (DMF) holder's complete facility list, agency officials emphasized recently.

A common problem plaguing generic drug applications during their review is the emergence of manufacturing centers deep within the application that were not been identified by the sponsor