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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
31/10/2025 Amphastar Pharmaceuticals
U.S.A
AMPHASTAR NANJING PHARMACEUTICALS INC 32700 INSULIN ASPART USP 2018-05-16 Active II N/A
31/10/2025 Novo Excipients
India
NOVO EXCIPIENTS PVT LTD 27184 NOVOMIX 2013-05-15 Active IV N/A