PET vendor Positron said that its Manhattan Isotope Technology (MIT) subsidiary officially entered the radiopharmaceutical production business with final sign-off on the project from the U.S. Food and Drug Administration (FDA).
Positron reported that MIT received a drug master file (DMF) acknowledgment letter from the FDA for its strontium-82 (Sr-82) drug substance.
With its assignment of DMF No. 26411, MIT joins the U.S. Department of Energy and Nordion as DMF holders for Sr-82 active pharmaceutical ingredient (API), Positron said. The company is now permitted to submit letters of authorization with companies supplying Sr-82/Rb-82 generators, according to Positron.
