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Eckert & Ziegler Strahlen- und Medizintechnik AG
Regulatory Filings • Mar 3, 2023
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Corporate | 3 March 2023 10:15
Eckert & Ziegler Submits Drug Master File for Lu-177 n.c.a.
EQS-News: Eckert & Ziegler Strahlen- und Medizintechnik AG / Key word(s): Miscellaneous
Eckert & Ziegler Submits Drug Master File for Lu-177 n.c.a.
03.03.2023 / 10:15 CET/CEST
The issuer is solely responsible for the content of this announcement.
Berlin, 3 March 2023. 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 ( 177 Lu) 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 ( 177 Lu) 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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Your contact:
Eckert & Ziegler AG, Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Tel.: +49 (0) 30 / 94 10 84-138, [email protected] , www.ezag.com
03.03.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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| Language: | English |
| Company: | Eckert & Ziegler Strahlen- und Medizintechnik AG |
| Robert-Rössle-Str.10 | |
| 13125 Berlin | |
| Germany | |
| Phone: | +49 30 941084-138 |
| Fax: | +49 30 941084-112 |
| E-mail: | [email protected] |
| Internet: | www.ezag.de |
| ISIN: | DE0005659700 |
| WKN: | 565970 |
| Indices: | SDAX |
| Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange |
| EQS News ID: | 1574365 |
| End of News | EQS News Service |