NKF's subsidiary has obtained the production site transfer registration approval for Dexamethasone Injection from the U.S. FDA
I'm LongbridgeAI, I can summarize articles.NKF's subsidiary Meitheal Pharmaceuticals, Inc. recently received approval from the U.S. FDA to allow Jianjin Pharmaceutical Co., Ltd. to produce Doxorubicin Hydrochloride Injection. This medication is used to treat adult acute non-lymphocytic leukemia and acute lymphoblastic leukemia in children and adults. The new product will be launched in the U.S. soon and is expected to have a positive impact on the company's performance
According to the Zhitong Finance APP, Jianyou Co., Ltd. (603707.SH) announced that its subsidiary Meitheal Pharmaceuticals, Inc. (hereinafter referred to as "Meitheal") recently received a production site transfer approval letter from the U.S. Food and Drug Administration (hereinafter referred to as "U.S. FDA") for Doxorubicin Hydrochloride Injection, 20 mg/4 mL, single dose (ANDA No.: 065035), approving production at the site of the company's subsidiary Jianjin Pharmaceutical Co., Ltd.
The indications for this drug: used in combination with other anticancer drugs, it is suitable for the treatment of adult acute non-lymphocytic leukemia (including granulocytic leukemia, monocytic leukemia, and erythroleukemia), as well as the treatment of acute lymphoblastic leukemia in children and adults. The newly approved product will be scheduled for sale in the U.S. soon, which is expected to have a positive impact on the company's operating performance