Nuclear medicine firm Curium has filed regulatory applications in the U.S. and Europe for germanium-68, a radiopharmaceutical used in PET imaging.
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.
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
