NKF's subsidiary has obtained the production site transfer registration approval for Idarubicin Hydrochloride 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, allowing Jianjin Pharmaceutical Co., Ltd. to produce idarubicin hydrochloride injection (5mg/5mL, 10mg/10mL, and 20mg/20mL). This drug is used for the treatment of adult acute myeloid leukemia and is expected to be launched in the U.S. soon, which is anticipated to have a positive impact on the company's performance
According to the Zhitong Finance APP, NKF (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 Dactinomycin Injection, 5mg/5mL, 10mg/10mL, and 20mg/20mL, single dose (ANDA No.: 065036), approving production at the site of the company's subsidiary Jianjin Pharmaceutical Co., Ltd.
Dactinomycin Injection is used in combination with other anti-leukemia drugs for the treatment of adult acute myeloid leukemia (AML) and is a product that the U.S. FDA has recently focused on due to market shortages. The newly approved product is expected to be launched in the U.S. soon, which is likely to have a positive impact on the company's operating performance