August 27, 2012 — Positron Corp., a molecular imaging healthcare company, announced the submission of a drug master file (DMF) with the U.S. Food and Drug Administration (FDA) for the production of active pharmaceutical ingredient (API)-grade strontium-82 (Sr-82) through its wholly owned subsidiary, Manhattan Isotope Technology LLC (MIT). This will offer a second source for the nuclear myocardial perfusion cardiac imaging agent.
A DMF is a document submitted to the FDA that contains complete information on an API or finished drug dosage form. 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 main objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product.
Manhattan Isotope’s DMF submission initiates the protocol, procedures and compliance required to produce Sr-82 for radiopharmaceutical applications, specifically for commercial use in Sr-82/Rubidium (Rb)-82 generators. Sr-82/Rb-82 generator manufacturers may now qualify MIT as a supply source and vendor for API grade Sr-82.
Manhattan Isotope’s DMF positions the company as the only commercial entity in the United States in the Sr-82 processing and production arena. Currently, the U.S. Department of Energy (DOE) is the only domestic supplier for many of the more than 300 different isotopes, which are critical in medical, commercial, research and national security applications. Recent shortages have emphasized the importance of managing the demand for critical isotopes.
“Our submission of the DMF is a very significant milestone, as it signifies Positron’s evolution towards a vertically integrated nuclear medicine healthcare company," said Jason Kitten, president of MIT. "Positron, through MIT, is the first private entity to demonstrate the expertise and ability to enter the market as a processor and supplier of API-grade strontium-82. Proficiencies in this segment are key to our end-to-end solution strategy. 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 positron emission tomography (PET) market as a whole.”
For more information: www.positron.com