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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 05/02/2026 | CURIUM US LLC |
U.S.A |
CURIUM US LLC | 42956 | LUTETIUM LU 177 PSMA I&T INJECTION | 2025-12-13 | Active | II | N/A | ||
| 29/01/2026 | Isotope Technologies Munich |
Germany |
ITM MEDICAL ISOTOPES GMBH | 35008 | LU-177 N.C.A. PRECURSOR RADIOPHARMACEUTICAL PRECURSOR SOLUTION | 2020-09-21 | Active | II | Complete | 2023-06-23 | 2023-06-20 |
