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names of suppliers in a Type II active pharmaceutical ingredient (API) drug master file (DMF), as urged in recent FDA draft guidance, would be duplicative and significantly increase generic-drug makers’ workload, a coalition of API and excipient manufacturers says.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.
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