ITM submits drug master file to FDA for GeGant

AuntMinnie.com staff writers
Jul 12, 2020
2019 12 17 23 59 6699 News Ball 400

German radiopharmaceutical group ITM Isotopen Technologien MĂĽnchen 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.

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