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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
January 2, 2013
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names of suppliers in a Type II active pharmaceutical ingredient (API) drug master file (DMF), as urged in recent FDA draft guidance, would be duplicative and significantly increase generic-drug makers’ workload, a coalition of API and excipient manufacturers says.