恩华药业：子公司召回重酒石酸卡巴拉汀胶囊

Core Viewpoint - The National Medical Products Administration (NMPA) of China has decided to suspend the import, sale, and use of the Cabalitin capsules produced by Sun Pharmaceutical Industries Limited due to quality management deficiencies identified during a remote inspection [1][2]. Group 1: Regulatory Actions - The NMPA found that Sun Pharmaceutical's quality management department was inadequate and failed to conduct sufficient risk assessments for certain batches of products that exceeded standards [1] - The suspension will take effect from January 23, 2026, as per relevant regulations [1] - Jiangsu Enhua Hexin Pharmaceutical Marketing Co., Ltd., a wholly-owned subsidiary of Enhua Pharmaceutical, will initiate a three-level recall of the affected Cabalitin capsules to ensure medication safety [1] Group 2: Financial Impact - For the fiscal year 2025, the sales revenue from the recalled product is approximately 40 million yuan, accounting for less than 1% of the company's total revenue [2] - The estimated sales amount involved in the recall is around 9 million yuan, with the actual quantity and amount of recalled products yet to be determined [2] - The company anticipates that the recall will not have a significant impact on its production operations or annual financial status, and it will take legal measures to address any economic losses due to supplier issues [2] Group 3: Future Measures - The company plans to enhance supplier management and improve its quality management system to ensure product quality and maintain patient safety [2]