Indiana-based radiopharmaceutical developer and manufacturer completes FDA inspection on behalf of the European Medicines Agency (EMA)
Indiana-based radiopharmaceutical developer and manufacturer completes FDA inspection on behalf of the European Medicines Agency (EMA)
SpectronRx, a leading radiopharmaceutical contract development and manufacturing organization (CDMO), today announced that the United States Food and Drug Administration (FDA) has completed its inspection of the company’s South Bend, Indiana facility on behalf of the European Medicines Agency (EMA). The news comes as SpectronRx works to quickly scale its operations to meet the European Union’s (EU) growing demand for radiopharmaceutical compounds that can be used in the treatment and detection of certain cancers and other diseases. The inspections, which are part of a Mutual Recognition Agreement between the FDA and EMA, are a critical step in the drug approval process for both regulatory agencies.
“European health leaders have expressed concerns about the future availability of medical isotopes for their patients,” said John Zehner, CEO of SpectronRx. “We understand this concern and are working hard to have all the necessary approvals in place by 2023. At that time, SpectronRx’s South Bend facility will serve as an important hub for supplying the European Union with much-needed diagnostic and therapeutic medical isotopes.”
Under the Mutual Recognition Agreement between the FDA and EMA, each agency fully recognizes the other’s inspections of manufacturing sites for human medicines. Ultimately, the agreement helps companies avoid duplicate drug inspections and enables regulators to devote more time and resources to other parts of the world where there is a greater risk. Furthermore, the agreement allows easier importation into the EU for both commercial and investigational medicinal products from the U.S., eliminating the requirement for review of the drug product manufacturing information, including the batch record, testing, and GMP compliance review by an EU-qualified person (QP). However, when needed, both agencies have the right to independently inspect facilities within each other’s territory at any time.
“We are pleased by the mutual agreement inspection process and believe that it serves regulators, companies and patients within the U.S. and EU well,” added Anwer Rizvi, President of SpectronRx. “It’s refreshing to see regulators from different countries working together in the interest of patients. And because of this, SpectronRx can more easily operate as a global developer, manufacturer and nuclear pharmacy, bringing life-changing drugs to those in need.”
SpectronRx is also in the process of expanding its U.S. Nuclear Regulatory Commission (NRC) Materials License to include the handling of Radium-226, which is essential for developing the rare but promising isotope Actinium-225. SpectronRx’s NRC materials license authorizes the company to receive, acquire, possess and transfer byproduct, source, and special nuclear material in any chemical and/or physical form. The current license lists more than 25 different isotopes, ranging from Lutetium-177 to Molybdenum-99 and Iodine-123. Authorized uses include the preparation and distribution of radioactive drugs and radiochemicals for medical use to authorized recipients, including chemical synthesis, radioiodination and redistribution of used and unused generators.
SpectronRx has over 100 employees across four locations and provides services to organizations on six continents. The company works routinely with pharmaceutical and healthcare organizations throughout the U.S., in select European countries and in Asia, where it supplies isotopes to Japan. SpectronRx’s domestic operations include four locations, a 36,000 Sq. Ft. facility in South Bend, Indiana, a 60,000 Sq. Ft. facility in Indianapolis, Indiana, a soon-to-be-announced location in Connecticut and more than 10 acres in Bunker Hill, Indiana, where it will produce Actinium-225.
To learn more, visit SpectronRx.com.