健友股份:子公司获得美国FDA盐酸伊达比星注射液药品转移生产场地注册批件
NKFNKF(SH:603707) news flash·2025-05-19 09:38

Core Viewpoint - The company announced that its subsidiary, Meitheal Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for the production site transfer of Idarubicin Hydrochloride Injection in various dosages [1] Group 1 - The approved dosages include 5mg/5mL, 10mg/10mL, and 20mg/20mL [1] - The approval is for the production at the company's subsidiary, Jianjin Pharmaceutical Co., Ltd. [1] - The ANDA number for the product is 065036 [1]