German radiopharmaceutical firm ITM Isotopen Technologien has been granted a drug master file by the U.S. Food and Drug Administration (FDA) for its GeGant germanium-68/gallium-68 generator.
As a result, those who are interested in developing new drugs for the U.S. market can refer to the drug master file and use GeGant in clinical tests for radiopharmaceuticals and in other settings, ITM said. GeGant will be produced and distributed for the U.S. market by ITM's longtime partner RadioMedix.
