Core Viewpoint - The approval of Moxifloxacin Hydrochloride Eye Drops by the National Medical Products Administration of China marks a significant advancement for the company in the ophthalmic product sector, enhancing its competitive position in the field of anti-infection treatments [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Zhuhai United Pharmaceutical Co., Ltd., has received approval for Moxifloxacin Hydrochloride Eye Drops in two specifications: 0.5% (3ml: 15mg) and 0.5% (5ml: 25mg) [1] - The drug approval numbers are: National Drug Approval Code H20256128 and H20256129 [1] Group 2: Product Characteristics - Moxifloxacin Hydrochloride is classified as a fourth-generation fluoroquinolone with broad-spectrum antibacterial activity [1] - The eye drops are indicated for the treatment of bacterial conjunctivitis caused by sensitive microorganisms such as Staphylococcus aureus, Haemophilus influenzae, and Chlamydia trachomatis [1] - The product is preservative-free, minimizing the toxic effects of preservatives on ocular tissues, making it suitable for a wide range of patients [1] Group 3: Market Position and Future Outlook - The eye drops are included in the National Medical Insurance Directory (2024 version) as a Class B drug, which may enhance market access and reimbursement potential [1] - This approval is expected to further expand the company's ophthalmic product portfolio and strengthen its position in the anti-infection treatment sector [1] - The company is committed to advancing new product development to provide comprehensive and high-quality medication solutions for clinical use, which is anticipated to generate greater returns for the company and its shareholders [1]
联邦制药:盐酸莫西沙星滴眼液通过国家药品监督管理局上市审批