Core Viewpoint - Ningbo Meinuohua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the raw material drug Atorvastatin Calcium, which will enhance the company's product line and business scope [1][3]. Group 1: Registration Information - The registration number for Atorvastatin Calcium is Y20240000440, and it is produced by Xuancheng Meinuohua Pharmaceutical Co., Ltd. in Anhui [1]. - The product is available in various packaging specifications: 5kg, 10kg, 15kg, 20kg, and 25kg [1]. - The approval indicates that the product meets the requirements for drug registration under the Drug Administration Law of the People's Republic of China [1]. Group 2: Indications and Pharmacological Action - Atorvastatin Calcium is indicated for the treatment of hypercholesterolemia and mixed hyperlipidemia, as well as for the prevention and treatment of coronary heart disease [2]. - The drug functions as a statin, primarily acting in the liver to reduce cholesterol synthesis, increase low-density lipoprotein receptor synthesis, lower blood cholesterol and low-density lipoprotein cholesterol levels, moderately decrease serum triglyceride levels, and increase high-density lipoprotein levels [2]. Group 3: Impact on the Company - Xuancheng Meinuohua submitted the review application for Atorvastatin Calcium on May 16, 2024, and it passed the review on December 17, 2025, with a cumulative R&D investment of 14.9496 million yuan [3]. - The approval of Atorvastatin Calcium demonstrates compliance with national drug review technical standards, allowing the product to be sold in the domestic market, which will enrich the subsidiary's product line and help expand the company's business scope [3].
宁波美诺华药业股份有限公司 关于控股子公司阿托伐他汀钙原料药通过CDE技术审评的公告