Positron ($POSC.OB) has gotten approval from the Nuclear Regulatory Commission to manufacture and distribute radiopharmaceuticals at its plant in Crown Point, IN.
The maker of molecular imaging products received a pharmacy license from the Indiana Board of Pharmacy last December. The dual authorizations set the stage for the company to sell radiochemicals and radiopharmaceuticals in the U.S.
The company is currently producing indium 111 oxyquinoline for customer evaluation and commercial sale with plans to process additional radioisotopes for medical use. With the NRC approval, Positron plans to begin selling indium oxyquinoline in the next quarter, says Scott Stiffler, VP of pharmaceuticals.
"This NRC approval completes the mandatory requirements qualifying our Crown Point site as a fully licensed and operational radiochemical manufacturing facility," Stiffler said in a statement.
The Positron manufacturing facility is designed to do both proprietary and third-party manufacturing of small to medium batches of radioactive products.
The company also sells PET scanners manufactured through a joint venture, Neusoft Positron Medical Systems, which has a facility in Shenyang, China. It manufactures a line of radiopharmaceutical compounding equipment at a plant in Fishers, IN. That 10,000-sq.-ft. facility opened in August 2010.
- here's the release
- read the SEC filing
Contractor Positron opens radioactive-drug plant