头孢丙烯干混悬剂

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ST葫芦娃: 海南葫芦娃药业集团股份有限公司关于获得头孢丙烯干混悬剂药品注册证书的公告
Zheng Quan Zhi Xing· 2025-07-10 16:22
Core Viewpoint - The company has received the drug registration certificate for Cefprozil Dry Suspension from the National Medical Products Administration, which will enhance its product line and positively impact its development [1][2]. Drug Information - Drug Name: Cefprozil Dry Suspension - Dosage Form: Oral Suspension - Registration Category: Chemical Drug Class 3 - Specification: 2.5g (based on C??H??N?O?S) - License Holder: Hainan Huluwa Pharmaceutical Group Co., Ltd. - Acceptance Number: CYHS2302198 - Drug Approval Number: National Drug Approval H20254800 - Approval Conclusion: The drug meets the registration requirements and has been granted a registration certificate, pending compliance inspection for production quality management [1][2]. R&D and Related Information - Cefprozil is a cephalosporin antibiotic originally developed by Bristol-Myers Squibb Company, indicated for mild to moderate infections caused by sensitive bacteria, including: 1. Streptococcal pharyngitis/tonsillitis 2. Otitis media and acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains), and Moraxella catarrhalis (including beta-lactamase producing strains) 3. Acute bronchitis secondary bacterial infections and acute exacerbations of chronic bronchitis caused by Moraxella catarrhalis (including beta-lactamase producing strains) 4. Non-complex skin and soft tissue infections caused by bacteria, although abscesses typically require surgical drainage [2]. - The company has invested a total of RMB 4.9474 million (approximately 0.49474 million) in the R&D of this product [2]. - As of the announcement date, eight other companies in China have also been approved to produce Cefprozil Dry Suspension, with a total of 13 specifications approved [2].