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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