LUBBOCK, Texas, Aug. 22, 2012 /PRNewswire/ -- Positron Corporation, (OTCBB:POSC) a leading molecular imaging healthcare company, is pleased to announce the submission of a Drug Master File (DMF), with the Federal Drug Administration (FDA), for the production of Active Pharmaceutical Ingredient (API) grade strontium-82, through its wholly owned subsidiary Manhattan Isotope Technology, LLC.
A Drug Master File (DMF) is a document submitted to the FDA, which contains complete information on an Active Pharmaceutical Ingredient (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/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 over 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, substantiating Positron's timely entrance into this market.
Jason Kitten, President of Manhattan Isotope Technology stated, "Our submission of the DMF is a very significant milestone, as it signifies Positron's evolution towards a vertically integrated nuclear medicine healthcare company. 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 PET market as a whole."
About Positron: Positron Corporation is a leading molecular imaging healthcare company vertically integrating all the segments of nuclear cardiology—providing an end-to-end solution for cardiac PET. Through proprietary PET imaging systems, radiopharmaceuticals and radioisotopes solutions, Positron enables healthcare providers to more accurately diagnose disease and improve patient outcomes, while practicing cost effective medicine. Positron's unique products, market position and approach in securing the supply chain are substantial advantages, further accelerating the adoption of cardiac PET and growth of nuclear cardiology. Positron is redefining the industry. More information about Positron is available at www.positron.com.
Forward Looking Statements: Statements in this document contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based on many assumptions and estimates and are not guarantees of future performance. These statements may involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Positron Corporation to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Positron assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Our actual results may differ materially from the results anticipated in these forward-looking statements due to a variety of factors, including, without limitation those set forth as "Risk Factors" in our filings with the Securities and Exchange Commission.
|SOURCE Positron Corporation|
Copyright©2012 PR Newswire.
All rights reserved