Brief: Eckert & Ziegler Submits Drug Master File For Lu-177 N.C.A.

Eckert & Ziegler SE

03/03/2023 09:19

March 3 (Reuters) - ECKERT & ZIEGLER  EUZG.DE :
    * SUBMITS DRUG MASTER FILE FOR LU-177 N.C.A.
    * HAS SUCCESSFULLY SUBMITTED A TYPE II DRUG MASTER FILE
(DMF) WITH
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 U.S. MARKET AND USE LUTETIUM (177LU)
CHLORIDE SOLUTION IN CLINICAL TRIALS OF DRUGS

Further company coverage:  EUZG.DE 

 (Gdansk Newsroom)
 ((gdansk.newsroom@thomsonreuters.com; +48 58 7696600;))