13.12.2024 / Eckert & Ziegler Radiopharma GmbH (Eckert & Ziegler), a leading provider of isotope technology for nuclear medicine and radiopharmaceutical applications, announces the submission of its GalliaPharm® 68Ge/68Ga Radionuclide Generator for approval in Japan. This will pave the way for broader access to cutting-edge diagnostic tools including 68Ga-PSMA-11 in Japan. For GalliaPharm®, Novartis Pharma K.K., will manage safety information and distribution of the product in Japan.

GalliaPharm® is widely used as a high-quality GMP grade generator for Gallium-68, supporting the production of radiopharmaceuticals for positron emission tomography (PET) imaging, particularly in oncology including the diagnosis of prostate cancer through PSMA imaging. An approval in Japan will provide the local healthcare community with an accessible and reliable tool to label Gallium-68 radiopharmaceuticals, offering new precision in diagnostic imaging that may improve early disease detection and patient outcomes.

“This step with the MHLW for us is a critical one,” stated Dr. Deljana Werner, Head of QA and Regulatory Affairs for the Medical Division of Eckert & Ziegler SE. “As a company committed to advancing nuclear medicine globally, we see GalliaPharm®’s entry into the Japanese market as a pivotal opportunity to support medical professionals in enhancing patient care through precise and innovative imaging solutions.”

By seeking approval in Japan, Eckert & Ziegler reinforces its commitment to meeting the specific needs of diverse healthcare markets, tailoring its innovations to support local advancements in nuclear medicine. This step not only underscores the company’s dedication to providing advanced radioisotopes for medical applications worldwide, but also strengthens its position as a trusted partner in the evolving landscape of radiopharmaceuticals.

About Eckert & Ziegler SE
Eckert & Ziegler 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. Eckert & Ziegler SE shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
 

Source :Press Release Eckert & Ziegler
Eckert & Ziegler Submits GalliaPharm® for Approval by Japan’s Health Authority MHLW