Core Viewpoint - The company, Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited, announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the injection of Cefotaxime (0.5g, 1.0g) after passing the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The approval pertains to the injection of Cefotaxime, a third-generation cephalosporin antibiotic, which is used to treat infections caused by sensitive microorganisms, including severe systemic infections and various types of infections such as respiratory, urinary, skin, and central nervous system infections [1] - Tianxin Pharmaceutical obtained the registration certificate for the injection of Cefotaxime in September 2002 and submitted the consistency evaluation application to the National Medical Products Administration in December 2023, which has been accepted [1] - The approval is significant as it enhances the company's product portfolio in the antibiotic segment, potentially increasing its market competitiveness and addressing various infection treatments [1]
白云山:注射用头孢他啶(0.5g、1.0g)通过仿制药质量和疗效一致性评价