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news.Positron has submitted a drug master file (DMF) for the production of active pharmaceutical ingredient (API) grade strontium-82, through its subsidiary, Manhattan Isotope Technology, to the Federal Drug Administration (FDA).
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The DMF contains factual and complete information on a drug product’s chemistry, manufacturer, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product.
The DMF submission includes the protocol, procedures, and compliance required to produce Sr-82 for radiopharmaceutical applications, including for commercial use in Sr-82/Rb-82 generators.
Manhattan Isotope Technology president Jason Kitten said the submission of the DMF signifies Positron’s evolution towards a vertically integrated nuclear medicine healthcare company.
"Positron’s ability to supply strontium and support production needs will not only stabilize the source supply of strontium-82, but will also lend growth to and strengthen the cardiac PET market as a whole," Kitten added.