ITM submits drug master file to FDA for GeGant

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.