DULLES, VIRGINIA, 4 September 2015 – IBA Molecular North America, Inc. (IBA), a leader in the manufacture and distribution of radiopharmaceuticals, announced today approval by the United States Food and Drug Administration (FDA) of abbreviated new drug applications (ANDAs) for Fludeoxyglucose F 18 Injection, USP (FDG) and Sodium Fluoride F 18 Injection, USP (NaF). These two radiopharmaceuticals are employed in positron emission tomography (PET) scans.
IBA had already completed a significant investment in its radiopharmaceutical facilities, including installation of new production cells and synthesis modules, QA/QC equipment, automated dose-drawing stations and improved environmental systems, completing the transition of its manufacturing and distribution network to achieve compliance with 21 CFR Part 212 CGMP requirements.
“For IBA, this transformation and the FDA approvals are much more than just meeting current regulations,” noted Ken Smithmier, President and CEO of IBA. “It is our pathway to the future of molecular imaging. We elected to put in place equipment and procedures that meet the very rigorous requirements (EC GMP standards) of our worldwide institutional and biotechnology associates, making IBA the premier partner in developing and introducing new, targeted radiopharmaceutical products. We are leading the industry toward improvements in healthcare through the broader application of molecular imaging.”
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IBA had earlier received FDA approval of its ANDA for Ammonia N 13 Injection, USP.
About IBA Molecular North America, Inc.
IBA Molecular North America, Inc. (IBA) is a leading developer, manufacturer and distributor of radiopharmaceutical products and supporting services used in molecular imaging in the USA. The company has a unique product portfolio and pipeline of diagnostic tracers aimed at advancing the development of the global movement towards personalized medicine and making molecular imaging/therapy a major discipline in healthcare. IBA, headquartered in Dulles, Virginia, also provides educational, technical and marketing support to medical specialists to help better respond to patient needs. IBA’s parent company is Illinois Health and Science (IHS), a non-profit healthcare system that specializes in enhancing patient care by making strategic investments in healthcare related opportunities. IHS also owns Decatur (IL) Memorial Hospital, Integrated Health Network and Zevacor Molecular.
