NorthStar Medical Radioisotopes, LLC (NorthStar), a company involved in the production and distribution of radioisotopes used for medical imaging, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Beloit, Wis. cGMP facility to manufacture the RadioGenix System and associated materials. Approval of the Beloit manufacturing facility follows FDA’s recent approval of the RadioGenix System for producing the medically important radioisotope technetium-99m (Tc-99m) using domestically sourced, non-uranium based molybdenum-99 (Mo-99). The approval was made through a Prior Approval Supplement to the recently approved RadioGenix System New Drug Application 202158 and is the first step for NorthStar in expanding its manufacturing capacity. In addition to this manufacturing approval, NorthStar has initiated the RadioGenix System commercial launch.
“NorthStar has quickly achieved several key milestones in advancing our strategically planned RadioGenix System roll-out,” said George P. Messina, Chairman and CEO of NorthStar. “First, the FDA approval of our Beloit manufacturing facility enables us to scale up production and expand capacity to meet anticipated customer demand. The approval came well in advance of the anticipated FDA action date. Second, we are also very pleased to announce that the commercial launch of the RadioGenix System has commenced, with the first contract signed and the first installation scheduled at a customer site. 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. We anticipate shipping additional RadioGenix Systems as potential customers receive licensing amendments for their sites, and look forward to sharing our progress.”
“FDA approval for manufacturing in Beloit, Wis., means that NorthStar now has the capability to scale up and expand our RadioGenix manufacturing volume four-fold,” said Stephen Merrick, President and Chief Operating Officer of NorthStar. “The cGMP facility houses the manufacturing and quality control operations required to produce RadioGenix Systems, consumable kits and spare parts. Also, as recently announced, we have begun construction of additional manufacturing space for activities related to the processing of Mo-99, the material used by the RadioGenix System to generate the medically important isotope Tc-99m.”
The 50,000 square foot facility at 1800 Gateway Boulevard, Beloit, Wis. includes NorthStar corporate headquarters, development, manufacturing and quality control operations. NorthStar has additional expansion activities underway and planned in Beloit on its 33-acre campus that will support the continued scale-up of production.
