by
Thomas Dworetzky, Contributing Reporter | October 12, 2018
In late July, NorthStar booked its first order for the RadioGenix System. The installation comes alongside the FDA’s clearance for its cGMP facility, the Beloit-based manufacturing site of the the system.
“The Beloit facility gives us all our capacity for RadioGenix System manufacture, with more Mo-99 infrastructure in process and planned for the future," Stephen Merrick, president and COO of NorthStar,
told HCB News. "By the fourth quarter of 2018, NorthStar will have the ability to supply approximately 10 percent of the U.S. market, which would significantly mitigate the impact of the type of shortages we have been seeing recently.”
The 50,000-square-foot facility houses the manufacturing, development, and quality control operations necessary for the production of RadioGenix Systems as well as consumable kits, spare parts and other associated materials; and includes the corporate headquarters of the nuclear medicine technology enterprise.
Its clearance enables NorthStar to scale production and expand manufacturing capacity faster, to further meet the demands of its customers.
The green light from the FDA comes earlier than expected and is part of a Prior Approval Supplement granted for the New Drug Application 202158 of its RadioGenix System.
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