Curium has filed a drug master file (DMF) with the U.S. Food and Drug Administration (FDA) and an active substance master file with the European Medicines Agency (EMA) for germanium-68.
Curium produces Germanium-68 Ultra at a facility in St. Louis for two main applications -- calibration sources for PET scanners and as a positron source for PET imaging radiopharmaceuticals.
Curium has been producing and selling germanium-68 to U.S. and international customers for the past six years. Receiving regulatory approvals in the U.S. and Europe will help the company meet growing demand for germanium-68 in both finished dosage form and in generators while also meeting demand for radiopharmaceuticals produced in compliance with current good manufacturing practice (cGMP) rules.
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