药品上市审批
Search documents
联邦制药(03933.HK):盐酸莫西沙星滴眼液(规格:0.5%(3ml:15mg)、0.5%(5ml:25mg))通过国家药监局上市审批
Ge Long Hui· 2025-12-09 10:08
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-infective treatments [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Zhuhai United Pharmaceutical Co., Ltd., received approval for Moxifloxacin Hydrochloride Eye Drops in two specifications: 0.5% (3ml: 15mg) and 0.5% (5ml: 25mg) [1] - The drug is classified as a fourth-generation fluoroquinolone with broad-spectrum antibacterial activity, effective against bacteria such as Staphylococcus aureus and Haemophilus influenzae [1] Group 2: Market Position and Future Plans - The product is included in the National Medical Insurance Directory (2024 edition) as a Class B drug, indicating its importance in the healthcare system [1] - The approval is expected to expand the company's ophthalmic product portfolio and strengthen its position in the anti-infective treatment market [1] - The company aims to continue advancing new product development to provide comprehensive and high-quality medication solutions, which is anticipated to generate greater returns for the company and its shareholders [1]
葵花药业:双醋瑞因胶囊获上市许可受理
news flash· 2025-05-08 08:26
Core Viewpoint - Kweichow Moutai has received a notice of acceptance for the registration application of Duzhuaiyin capsules from the National Medical Products Administration, indicating progress in the approval process for a new product aimed at treating osteoarthritis in hip and knee joints [1] Group 1 - The product is classified as a chemical drug of category 4 and is in capsule form, targeting osteoarthritis treatment [1] - The company plans to actively promote the product's licensing work and will continue to monitor the approval status [1]