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FDA has issued Drug Master File for ITM’s Gallium Generator GeGant®

ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and RadioMedix Inc., a clinical stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has issued the Drug Master File (DMF no. 34938) for ITM’s next generation Germanium-68/Gallium-68 (68Ge/68Ga) Generator, distributed under the brand name GeGant®. The DMF will allow parties interested in developing new drugs for the U.S. market to refer to the DMF and use GeGant® in clinical tests for radiopharmaceuticals and in other settings.


The GeGant® Generators will be manufactured at the RadioMedix Spica Center in Houston, Texas, U.S., a GMP radiopharmaceutical manufacturing facility that is dedicated to advanced investigational and commercial stage radiopharmaceutical manufacturing and distribution. At this center, thousands of 68Ge/68Ga generators can be produced annually. This high production capacity enables ITM and RadioMedix to meet the rapidly increasing demand for Gallium-68 in the United States and across the world.


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Source: Businesswire