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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 | Axplora |
Germany |
FARMABIOS SPA | 25791 | MELPHALAN HYDROCHLORIDE | 2012-02-14 | Active | II | Complete | 2014-02-21 | 2013-09-05 |
| 28/03/2025 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 25644 | MELPHALAN HCL, NON-STERILE, BULK DRUG SUBSTANCE | 2011-12-29 | Active | II | Complete | 2013-06-21 | 2012-11-21 |
