浙江仙琚制药股份有限公司关于盐酸尼卡地平注射液通过一致性评价的公告

Core Viewpoint - Zhejiang Xianju Pharmaceutical Co., Ltd. has successfully passed the consistency evaluation for the quality and efficacy of Nicardipine Hydrochloride Injection, which is expected to enhance the product's market competitiveness and accumulate experience for future evaluations [1][4]. Group 1: Drug Information - The drug Nicardipine Hydrochloride Injection is a calcium channel blocker primarily used for rapid blood pressure reduction and managing acute hypertension situations, such as during surgery or in emergency settings [3]. - The approved specifications for Nicardipine Hydrochloride Injection are 10ml:10mg (approval number H20258264) and 5ml:5mg (approval number H20258265), with the product adhering to the national drug registration standard YBH32372025 [3]. Group 2: Approval Details - The approval for the drug was granted based on the regulations outlined in the Drug Administration Law of the People's Republic of China and related announcements, allowing the addition of 5ml:5mg and 10ml:10mg specifications [2].