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TirzepatideDMF TirzepatideGLP-1/GIPDMF Type IICMCANDANDA FDADMF5 Type I Type IIAPI Type III Type IV Type VFDA DMF 1.Mounjaro 2.DMFType II 3.FDAPre-Submission MeetingFDA CMCCTD 3.2.S 1. /FmocHPLC 2. 39 3. / FDA 20230.03 ppm ICH Q3D10 ppm 4. 25/60%RH40/75%RH 3.2.R 1. HPLC/UPLC UV 2.3 3. FDA 1.eCTDESGFDA 2.IRFDA QDMF AANDAMounjaro QFDA A2024Type II DMF8-14ANDA 1

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