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

 
• By Derrick Gingery

Agency officials don't care if DMF holder doesn't give access to its entire facility list; FDA says industry is responsible for listing all facilities that could be used as part of ANDA.

FDA entrance sign 2016

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.

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