Nuclear medicine solutions company Curium announced Tuesday that it has submitted and filed regulatory documents in the United States and in Europe for its PET imaging agent germanium-68.
The St. Louis-based firm, which calls itself the largest vertically integrated radiopharmaceutical manufacturer in the industry, submitted a stand-alone Drug Master File (DMF) with the U.S. Food and Drug Administration along with an Active Substance Master File (AMSF) with the European Medicines Agency for its radiopharmaceutical.
The filings provide both the FDA and EMA with detailed information about the group's facilities, processes, and other confidential subject matter related to its germanium-68 agent.
“The investment to secure the DMF and AMSF was significant, and positions Curium as the only manufacturer offering germanium-68 that meets these increased control standards sought by regulators,” said Dan Brague, CEO of Curium’s North American location. “We look forward to partnering with current and new customers to provide high quality products for patients in need.”
Curium produces germanium-68 for calibrated sources used in PET scanners and as a positron source for radiopharmaceuticals used during molecular imaging.
According to the announcement, Curium’s products—which include SPECT, PET, and therapeutic radiopharmaceuticals—support more than 14 million patients around the world.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.