01 1CordenPharma
01 1LUTETIUM (177LU) CHLORIDE SOLUTION FOR RADIOLABELING (NO-CARRIER-ADDED)
01 1Germany
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-07-31
Pay. Date : 2025-05-30
DMF Number : 38043
Submission : 2023-02-27
Status : Active
Type : II
20
Eckert And Ziegler Radiopharma Gmbh, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is LUTETIUM (177LU) CHLORIDE SOLUTION FOR RADIOLABELING (NO-CARRIER-ADDED), with a corresponding US DMF Number 38043.
Remarkably, this DMF maintains an Active status since its submission on February 27, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 31, 2025, and payment made on May 30, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
