Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval for the registration of Clarithromycin suspension, which is expected to enhance the company's product offerings in the anti-infection drug category and improve its overall competitiveness [1][2]. Group 1: Product Approval - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has been granted a drug registration certificate for Clarithromycin suspension by the National Medical Products Administration [1]. - The application for the marketing authorization of Clarithromycin suspension was submitted in December 2023 and was accepted, with the registration certificate obtained in August 2025 [1]. Group 2: Indications and Market Potential - Clarithromycin is indicated for treating infections caused by pathogens sensitive to it, including upper respiratory infections, lower respiratory infections, skin and soft tissue infections, and acute otitis media [2]. - The estimated sales revenue for Clarithromycin in public medical institutions in China is approximately RMB 1.123 billion in 2024 [2]. - The approval of Clarithromycin suspension will enrich the company's anti-infection drug portfolio [2].
山东新华制药股份子公司获得克拉霉素干混悬剂《药品注册证书》