国家药监局：暂停进口、销售和使用Sun Pharmaceutical Industries Limited重酒石酸卡巴拉汀胶囊

Core Viewpoint - The National Medical Products Administration (NMPA) has suspended the import, sale, and use of the cabozantinib capsules produced by Sun Pharmaceutical Industries Limited due to quality management deficiencies and non-compliance with production standards [1] Group 1: Regulatory Actions - NMPA conducted a remote inspection of Sun Pharmaceutical Industries Limited regarding the cabozantinib capsules [1] - The inspection revealed that the company's quality management department lacked sufficient capability, leading to inadequate risk assessment for certain batches of marketed products [1] - As a result, NMPA has decided to halt the importation, sale, and usage of the cabozantinib capsules immediately [1] Group 2: Compliance Issues - The inspection found defects in the production process related to contamination prevention and adherence to the Chinese Pharmacopoeia [1] - Sun Pharmaceutical Industries Limited's practices were deemed non-compliant with the Drug Production Quality Management Standards (2010 revision) of China [1] - The drug supervision departments at various import ports have been instructed to suspend the issuance of import clearance documents for the affected product [1]