PET vendor Positron has submitted a drug master file (DMF) to the U.S. Food and Drug Administration (FDA) for the production of active pharmaceutical ingredient (API)-grade strontium-82 through its Manhattan Isotope Technology subsidiary.
A DMF is a document submitted to the FDA that contains information on API, or finished drug dosage form. The submission initiates the protocol, procedures, and compliance required to produce strontium-82 for radiopharmaceutical applications, such as strontium-82 and rubidium-82 generators.
Manufacturers of such generators may now qualify Manhattan Isotope as a supplier for API-grade strontium-82 and rubidium-82, which would make the company the only commercial U.S. supplier for the isotopes, according to Positron.
