We particularly wish to express appreciation to our manufacturing partner, MURR. “This is one component of our efforts to increase dependable, domestically produced radioisotope supply for the United States. facility means an immediate increase in Mo-99 production efficiencies in Columbia,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “FDA’s expedited review and approval of the additional filling lines in our Columbia, Mo. Since commercial availability nearly 16 months ago, RadioGenix ® Systems have provided customers with reliable Tc-99m supply for tens of thousands of patients’ diagnostic imaging studies, despite ongoing shortages from suppliers using legacy, uranium-based production methods. The RadioGenix System is an innovative, high tech radioisotope separation platform for use in producing Tc-99m from non-uranium based Mo-99. FDA approval of the filling lines was made through expedited review of a Prior Approval Supplement to the original RadioGenix ® System (technetium Tc 99m generator) New Drug Application, which was approved in 2018. Mo-99 is a medical radioisotope used to produce technetium-99m (Tc-99m), the most widely used diagnostic imaging radioisotope and of critical importance for patient healthcare.
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Addition of the filling lines is part of NorthStar’s ongoing expansion plans to increase production and capacity of domestic, non-uranium based Mo-99 for the U.S. Food and Drug Administration (FDA) has approved the addition of two molybdenum-99 (Mo-99) filling lines at its facility in Columbia, Mo. NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, today announced that the U.S.