Medical isotope developer seeks to gain European access
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Indianapolis-based radiopharmaceutical developer and manufacturer SpectronRx is a step closer to having its products approved for use in Europe. The company says the U.S. Food and Drug Administration has completed its inspection of the company’s South Bend facility on behalf of the European Medicines Agency.
The northern Indiana site is one of three locations that SpectronRx operates throughout the state. It also has facilities in Indianapolis and in Bunker Hill, adjacent to the Grissom Air Reserve Base.
The company says it wants to quickly scale its operations to meet the growing demand for radiopharmaceutical compounds in Europe, which are used in the treatment and detection of certain cancers and diseases.
The life sciences company says the inspections are part of a mutual agreement between U.S. and European regulators.
“European health leaders have expressed concerns about the future availability of medical isotopes for their patients,” said John Zehner, chief executive officer 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 recognizes the other’s inspections of manufacturing sites for human medicines.
The agreement makes it easier to import U.S. medicinal products into the European Union.
SpectronRx says 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.
“Because of this, SpectronRx can more easily operate as a global developer, manufacturer and nuclear pharmacy, bringing life-changing drugs to those in need,” said SpectronRx President Anwer Rizvi.
Both agencies have the right to independently inspect facilities within each other’s territory at any time.