German radiopharmaceutical group ITM Isotopen Technologien München said it has submitted a drug master file (DMF) to the U.S. Food and Drug Administration (FDA) for its GeGant germanium-68/gallium-68 generator.
GeGant will be produced and distributed for the U.S. market by ITM's longtime partner RadioMedix. The generator enables onsite production of gallium-68 for radiolabeling and is available in the sizes of 1 GBq (30 mCi), 2 GBq (50 mCi), and 4 GBq (100 mCi), according to the vendor.
ITM said that thousands of the generators can be produced each year at the RadioMedix Spica Center in Houston, TX.
![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)
