Your selection

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.
Contributing to saving lives.

Overview News

News Buch Berlin

Reorganization in the Executive Board of Eckert & Ziegler

The Supervisory Board of Eckert & Ziegler AG has now formally approved the reorganization of the Executive Board already announced in December 2022. Accordingly, the founder and Chairman of the Execut...

more ...

Recognized Australian Endocrine & Hypertension Center Joins International Groups with a Clinical Trial of PentixaPharm’s Primary Aldosteronism Lead Candidate

Following clinical investigations of hypertension specialists in the Netherlands, France, the United States, and China, the Monash Medical Center (Monash Health) and Hudson Institute in Melbourne, Aus...

more ...

Interview about Berlin-Buch – A Location for Future Innovation

The BerlinBioCube incubator is currently being built on Campus Berlin-Buch. The new five-story building provides a total of 8,000 m² of space for state-of-the-art laboratories, offices, and shared spa...

more ...

Events Buch Berlin

02.06.2023, 19:00
Rainer Kirchmann & Florian Galow im Trichter

Kultur im Trichter

more ...

03.06.2023, 12:00
artspring in Buch: Rudolf J. Kaltenbach und Silvia Fohrer zeigen Skulpturen aus Stein und Zeichnungen

Das Künstlerpaar öffnet sein Atelier im alten E-Werk auf dem Gelände von Vattenfall zum artspring Kunstfestival

more ...

03.06.2023, 14:00
„Umzug der Tiere“

Demonstration und Kundgebung für die Anpassung der Bebauungsplanung beim Senatsvorhaben „Neues Stadtquartier Buch Am Sandhaus“

more ...

This website is supported by: