两款印度药物被暂停进口到中国 一些中国药企或受波及

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, which do not comply with China's drug production quality management standards [1][2]. Group 1: Sun Pharmaceutical Industries Limited - The drug in question is the Cabergoline capsule, used as a first-line treatment for mild to moderate Alzheimer's disease, and is a generic product from Sun Pharmaceutical Industries Limited [1]. - The suspension was due to inadequate quality management capabilities in the production process, insufficient risk assessment for batches exceeding standards, and defects in preventing contamination and compliance with the Chinese Pharmacopoeia [1]. Group 2: Supriya Lifescience Ltd. - Supriya Lifescience Ltd. is one of the top five global manufacturers of Chlorpheniramine Maleate raw materials [2]. - The suspension of Chlorpheniramine Maleate raw materials was due to the company's failure to ensure that each batch of released products met regulatory and registration requirements, along with poor site management and ineffective measures to prevent pests [2]. - This is not the first instance of Supriya Lifescience Ltd.'s raw materials being suspended; a similar suspension occurred in March 2020 due to non-compliance with production quality management standards [2]. Group 3: Regulatory Actions and Implications - The NMPA has mandated that the Chlorpheniramine Maleate raw materials from Supriya Lifescience Ltd. cannot be sold or used for drug formulation in China, and any formulations already produced with these raw materials cannot be released [3]. - The holders of drug marketing licenses for products already on the market must conduct investigations and evaluations immediately and take necessary risk control measures based on the findings [3].