China Isotope & Radiation (01763): CNNC High Tech's Lu-177 DMF successfully passes U.S. FDA filing.

Zhitong Finance APP News, China Isotope & Radiation Corporation (01763) announced that recently, Chengdu Nuclear Gaotong Isotope Co., Ltd. (Nuclear Gaotong), a subsidiary of China Isotope & Radiation Corporation, received a confirmation letter from the U.S. Food and Drug Administration (FDA). The previously submitted DMF file for Lu-177 API successfully passed review, marking that Nuclear Gaotong's Lu-177 API DMF file has been recognized by the FDA, the DMF number has been successfully activated, and it is qualified to be referenced by downstream formulation manufacturers. This is an important step for Nuclear Gaotong in advancing its international layout in the field of key raw materials for nuclear medicine.