克拉霉素干混悬剂

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新华制药:关于子公司获得克拉霉素干混悬剂《药品注册证书》的公告
Zheng Quan Ri Bao· 2025-08-26 13:59
Group 1 - The core point of the article is that Xinhua Pharmaceutical announced the approval of its subsidiary's drug registration for Clarithromycin suspension by the National Medical Products Administration [2] Group 2 - The drug registration certificate for Clarithromycin suspension has been officially issued, indicating regulatory approval for the product [2]
新华制药:公司及子公司获得药品注册证书
Zheng Quan Shi Bao Wang· 2025-08-26 11:12
Core Viewpoint - Recently, Xinhua Pharmaceutical (000756) announced the approval of several drug registration certificates by the National Medical Products Administration, indicating a positive development for the company's product portfolio [1] Group 1 - Xinhua Pharmaceutical received the drug registration certificate for Sacubitril/Valsartan Sodium Tablets and Minoxidil Lotion [1] - The wholly-owned subsidiary, Xinda Pharmaceutical, received the drug registration certificate for Clarithromycin Dry Suspension [1]
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》
Zhi Tong Cai Jing· 2025-08-26 09:41
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(00719.HK):子公司获得克拉霉素干混悬剂《药品注册证书》
Ge Long Hui· 2025-08-26 09:35
Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval for the registration of Clarithromycin Dry Suspension from the National Medical Products Administration [1] Company Summary - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., is responsible for the newly approved product [1] - The approval of the drug registration certificate signifies a potential expansion in the company's product offerings and market presence [1] Industry Summary - The approval of Clarithromycin Dry Suspension aligns with the ongoing trends in the pharmaceutical industry towards expanding antibiotic options [1] - Regulatory approvals such as this are crucial for companies in the pharmaceutical sector to enhance their competitive edge and meet market demands [1]
山东新华制药股份(00719)子公司获得克拉霉素干混悬剂《药品注册证书》
智通财经网· 2025-08-26 09:35
Group 1 - Shandong Xinhua Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has received the drug registration certificate for Clarithromycin suspension from the National Medical Products Administration [1] - The application for the marketing authorization of Clarithromycin suspension was submitted in December 2023 and accepted, with the registration certificate granted in August 2025 [1] - The approval of Clarithromycin suspension will enhance the company's portfolio of anti-infective drugs and improve its overall competitiveness [2] Group 2 - 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 of Clarithromycin in public medical institutions in China for 2024 is approximately RMB 1.123 billion [2]
新华制药:子公司获得克拉霉素干混悬剂《药品注册证书》
Xin Lang Cai Jing· 2025-08-26 09:32
Core Viewpoint - The announcement indicates that the company's subsidiary has received regulatory approval for a new drug, which is expected to enhance its product portfolio and market presence in the pharmaceutical industry [1] Group 1 - The full subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has been granted a drug registration certificate for Clarithromycin dry suspension by the National Medical Products Administration [1] - Clarithromycin is indicated for the treatment of infections caused by pathogens sensitive to the drug, including upper respiratory infections, lower respiratory infections, skin and soft tissue infections, and acute otitis media [1]