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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/03/2025 | Amphastar Pharmaceuticals |
U.S.A |
AMPHASTAR NANJING PHARMACEUTICALS INC | 32700 | INSULIN ASPART USP | 2018-05-16 | Active | II | N/A | ||
28/03/2025 | Novo Excipients |
India |
NOVO EXCIPIENTS PVT LTD | 27184 | NOVOMIX | 2013-05-15 | Active | IV | N/A |