Eckert & Ziegler Receives Japanese Approval for GalliaPharm® Generator, Expanding Gallium-68 Diagnostics for Prostate Cancer
核心洞察
Eckert & Ziegler (搜索) Radiopharma GmbH has received marketing authorization from Japan's Ministry of Health, Labour and Welfare for its GalliaPharm® (搜索) 68Ge/68Ga Radionuclide Generator through Novartis Pharma K.K.
The approval enables broader use of Gallium-68-based diagnostics in Japan, specifically for the clinical use of Novartis kit Locametz® (搜索) for 68Ga-PSMA-11 preparation in prostate cancer imaging.
GalliaPharm® (搜索) is an established GMP-grade generator used internationally for positron emission tomography (PET) imaging, particularly enabling PSMA (搜索) imaging for prostate cancer detection.
Eckert & Ziegler (搜索) Radiopharma GmbH has secured a significant regulatory milestone in Japan with the approval of its GalliaPharm® (搜索) 68Ge/68Ga Radionuclide Generator from Japan's Ministry of Health, Labour and Welfare (MHLW). The authorization, announced on September 19, 2025, was facilitated through Novartis Pharma K.K., which will serve as the Designated Marketing Authorization Holder for GalliaPharm® in Japan, overseeing product distribution and safety information management.
Expanding Gallium-68 Diagnostics in Japan
The approval represents a major advancement in the availability of Gallium-68 diagnostics in Japan, particularly for PET imaging related to prostate cancer. The authorization specifically enables the clinical use of the Novartis kit Locametz® (搜索) for radiopharmaceutical preparation of 68Ga-PSMA-11, which has also received approval alongside the generator.
GalliaPharm® (搜索) is an established GMP-grade generator for Gallium-68, used internationally in the preparation of radiopharmaceuticals for positron emission tomography (PET) imaging. The technology is particularly valuable for enabling PSMA (搜索) imaging for prostate cancer detection, supporting more precise imaging capabilities and potentially facilitating earlier diagnosis.
Clinical Impact and Market Access
With the approval now in place, healthcare providers in Japan will gain access to a dependable and proven tool for producing Gallium-68 radiopharmaceuticals. This development is expected to enhance diagnostic capabilities within Japanese healthcare systems, providing nuclear medicine specialists with the same high-quality generator technology that has supported diagnostic imaging advancements in many other regions.
"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 (搜索) SE. "Introducing GalliaPharm® (搜索) 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."
Strategic Expansion
The entry of GalliaPharm® (搜索) into Japan reflects Eckert & Ziegler (搜索)'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. This move signals the company's dedication to broadening access to reliable isotope technologies and fostering global innovation in molecular imaging.
Eckert & Ziegler (搜索) SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution.