Eckert & Ziegler Strahlen-und-Medizintechnik AG (EZAG), through its wholly owned subsidiary Eckert & Ziegler Radiopharma GmbH (EZR), recently submitted to the U.S. Food and Drug Administration (U.S. FDA) an amendment of its Drug Master File (DMF) for its pharmaceutical grade Germanium-68/Gallium-68 generator, GalliaPharm®. If found acceptable, the amendment will allow nuclear pharmacists to achieve a significantly higher number of elutions per generator and thereby increase the average availability of Gallium-68 in U.S. hospitals by about 40%.
EZAG is a world market leader for pharmaceutical grade Germanium-68/Gallium-68 generators and has recently seen a significant increase in the United States of the use of Gallium-68 labeled diagnostics for the detection of neuroendocrine tumors.
This increase in demand led to longer GalliaPharm® delivery times to radiopharmacies and raised concern among U.S. industry participants regarding the sufficient supply of these radioisotopes. EZAG has addressed these concerns by submitting extended stability data to the U.S. FDA, which reveal continuing safe use of EZAG’s GalliaPharm® generator at even higher number of elutions. If approved, the increased number of elutions per generator would in turn allow radiopharmacies and hospitals, to benefit from increased Gallium-68 supply for radiopharmaceutical application.
In addition to the increase of permitted elutions per GalliaPharm® generator, EZAG will also increase its overall production of GalliaPharm® generators beginning January 2019.
About Eckert & Ziegler.
Eckert & Ziegler Eckert & Ziegler Strahlen- und Medizintechnik AG (ISIN DE0005659700), with around 800 employees, is one of the world’s largest providers of isotope-related components for radiation therapy and nuclear medicine.
Contributing to saving lives.
Eckert & Ziegler AG, Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Tel.: +49 (0) 30 / 94 10 84-138, email@example.com, www.ezag.com