The generators allow Gallium-68 radionuclide production for use in Positron Emission Tomography.
Eckert & Ziegler radiopharma segment head and board member Andre Heß said having enabled the availability of Ga-68 labelled diagnostics for clinical use the company would like to encourage academic research, as well as research and development in the departments of international pharmaceutical corporations.
"The potential for theranostics is also highly promising. The theranostic approach entails initial diagnosis using a Ga-68 labeled molecule in a PET scan followed by therapy where Yttrium-90 is coupled with the same carrier molecule," Heß added.
"The newly-obtained manufacturing authorization will encourage and enable clinical studies for Ga-68 diagnostics. We have also applied for marketing authorization to sell the 68Ge/68Ga generators."
The radionuclide can be coupled with a multipurpose diagnostic biomolecule to create ready-for-use pharmaceuticals used in PET scan diagnoses.
Gallium-68-based technology reducing costs as it does not require the use of expensive cyclotrons.