两款印度药物被暂停进口到中国,一些中国药企或受波及
Di Yi Cai Jing·2026-01-26 12:01

Core Viewpoint - The National Medical Products Administration (NMPA) of China has suspended the import, sale, and use of two drugs produced by Indian manufacturers due to quality management issues during production [1][3]. Group 1: Company-Specific Information - Sun Pharmaceutical Industries Limited's drug, the racemic carbamazepine capsule, is a first-line treatment for mild to moderate Alzheimer's disease and is a generic product [1][3]. - The suspension of Sun Pharmaceutical's product is attributed to inadequate quality management, insufficient risk assessment of certain batches, and failure to comply with China's Good Manufacturing Practice (GMP) standards [3]. - Supriya Lifescience Ltd. is recognized as one of the top five global manufacturers of chlorpheniramine maleate raw materials, which is commonly used in combination cold medications [3]. Group 2: Regulatory Actions and Implications - The NMPA's suspension of Supriya Lifescience Ltd.'s chlorpheniramine maleate raw material is due to the company's failure to ensure compliance with regulatory and registration requirements during production [3][5]. - This is not the first instance of Supriya Lifescience Ltd.'s chlorpheniramine maleate being suspended; a similar suspension occurred in March 2020 due to non-compliance with GMP standards [4]. - The suspension will not only affect Supriya Lifescience Ltd. but also Chinese pharmaceutical companies that utilize this raw material for their cold medications, requiring immediate investigation and risk control measures for already released products [5].