NorthStar Medical Radioisotopes announced recently that it earned approval from the U.S. FDA for a facility in Beloit, Wis., to manufacture its RadioGenix System and associated materials.
According to a release, the RadioGenix System produces radioisotope technetium-99m (Tc-99m) using domestically sourced, non-uranium based molybdenum-99 (Mo-99).
“The FDA approval of our Beloit manufacturing facility enables us to scale up production and expand capacity to meet anticipated customer demand,” NorthStar Chairman and CEO George P. Messina said in a statement. “This important event marks another milestone in NorthStar’s commitment to provide the United States healthcare system with a reliable, domestic non-uranium based Mo-99 supply for production of the important medical diagnostic imaging radioisotope, technetium-99m.”
The 50,000-square foot facility includes NorthStar’s corporate headquarters and its development, manufacturing and quality control operations.