September 19, 2025 | Berlin, Germany
Eckert & Ziegler Radiopharma GmbH (Eckert & Ziegler), a leading provider of isotope technology for nuclear medicine and radiopharmaceutical applications, has received marketing authorization in Japan from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its GalliaPharm® 68Ge/68Ga Radionuclide Generator, through Novartis Pharma K.K. which will oversee product distribution and safety information management as the Designated Marketing Authorization Holder for GalliaPharm® in Japan.
This authorization opens the door for broader use of Gallium-68–based diagnostics in Japan through the clinical use of the Novartis kit Locametz® for radiopharmaceutical preparation of 68Ga-PSMA-11, which has also been granted approval.
GalliaPharm® is an established GMP-grade generator for Gallium-68, used internationally in the preparation of radiopharmaceuticals for positron emission tomography (PET) imaging, particularly in enabling PSMA imaging for prostate cancer detection. With the approval now in place, healthcare providers in Japan will be able to access a dependable and proven tool for producing Gallium-68 radiopharmaceuticals, supporting more precise imaging and potentially facilitating earlier diagnosis.
“This regulatory clearance marks a significant step for our medical division,” said Dr. Deljana Werner, Global Director Quality and Regulatory Affairs for the Medical Division of Eckert & Ziegler SE. “Introducing GalliaPharm® to Japan means we can equip local nuclear medicine specialists with the same high-quality generator technology that has supported diagnostic imaging advancements in many other regions.”
The entry of GalliaPharm® into Japan reflects Eckert & Ziegler’s ongoing commitment to expanding access to reliable isotope technologies, tailored to the requirements of local markets, and to fostering innovation in molecular imaging worldwide.
