Home » Suppliers Oppose FDA Proposal to Have Contact Info in Type II API DMFs
Suppliers Oppose FDA Proposal to Have Contact Info in Type II API DMFs
Listing the names of suppliers in a Type II active pharmaceutical ingredient (API) drug master file (DMF), as urged in recent FDA draft guidance, would be duplicative and significantly increase generic-drug makers’ workload, a coalition of API and excipient manufacturers says. The agency has not historically required that the names of material suppliers be listed in a DMF because such information has been considered irrelevant to the chemistry, manufacturing and controls assessment, the Bulk Pharmaceuticals Task Force said in recent comments on the draft.
Generic Line
Generic Line
Upcoming Events
-
04Apr
-
11Apr
-
14Apr
-
25Apr
-
14May