Innovation / 03.03.2023
Eckert & Ziegler Submits Drug Master File for Lu-177 n.c.a.

Eckert & Ziegler (ISIN DE0005659700, SDAX) has successfully submitted a Type II Drug Master File (DMF) with the U.S. Food and Drug Administration for lutetium (¹⁷⁷Lu) chloride solution (containing no-carrier-added radioisotope Lutetium-177), an active pharmaceutical ingredient and received DMF registration number 038043.

Drug manufacturers can now refer to this DMF when developing new radiopharmaceuticals for the U.S. market and use the lutetium (¹⁷⁷Lu) chloride solution in clinical trials of drugs, for example. A large number of tumor-specific drugs can be labeled with the beta emitter lutetium-177, which brings the radiating effect of the isotope directly to the tumor cell.

"We are excited about the access to the U.S. market for lutetium-177 based radiotherapeutics," explains Dr. Lutz Helmke, member of the Executive Board and responsible for the Medical segment at Eckert & Ziegler. "Thanks to our joint venture with Atom Mines LLC, we have excellent access to the scarce and indispensable precursor ytterbium-176 and thus the possibility to supply no-carrier-added lutetium-177 in highest purity and reliably to pharmaceutical customers worldwide."

Radionuclide therapy with lutetium-177, is becoming well established as a valuable treatment option within precision oncology for various indications. Eckert & Ziegler is one of the leading partners for the radiopharmaceutical industry, offering complete early development services in addition to the supply of isotopes, including process development and scale-up, CMC development, manufacturing and packaging, product release and stability programs.

About Eckert & Ziegler.
Eckert & Ziegler Strahlen- und Medizintechnik AG with nearly 1.000 employees is a leading specialist for isotope-related components in 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 shares (ISIN DE0005659700) are listed in the SDAX index of Deutsche Börse.
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