In which document does one designate the API starting material, the drug master file or some other filing application? 1.45K viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K January 8, 2021 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted January 8, 2021 0 Comments Spread the loveAt least here in the states, a DMF or the NDA/ANDA could be used. However, it may vary in the other ICH regions. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login