白云山分公司获得药品补充申请批件

Core Viewpoint - The company has received approval for its injectable Cefuroxime Sodium from the National Medical Products Administration, enhancing its market competitiveness in the pharmaceutical sector [1] Group 1: Product Approval - The Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. has received the "Drug Supplement Application Approval Notice" for its injectable Cefuroxime Sodium [1] - The injectable Cefuroxime Sodium was officially launched in China in May 2006 and submitted for consistency evaluation on April 3, 2025, with acceptance received on April 11, 2025 [1] Group 2: Product Characteristics - Cefuroxime Sodium is a second-generation cephalosporin effective against most Gram-negative and Gram-positive bacteria, known for its broad antibacterial spectrum, low renal toxicity, and stability against β-lactamase [1] - The drug is widely used in clinical settings for treating respiratory infections, urinary tract infections, and surgical infections [1] Group 3: Market Position - Injectable Cefuroxime Sodium is included in the National Essential Medicines List (2018) and classified as a Category B drug under the National Medical Insurance (2025) [1] - The successful completion of the generic drug consistency evaluation is expected to enhance the market competitiveness of the product [1]