Core Viewpoint - The National Medical Products Administration (NMPA) of China has suspended the import, sale, and use of certain pharmaceutical products from Sun Pharmaceutical Industries Limited and Supriya Lifescience Ltd. due to quality control issues and non-compliance with regulations [1][3][5]. Group 1: Sun Pharmaceutical Industries Limited - Sun Pharmaceutical's Rivastigmine Hydrogen Tartrate Capsules have been suspended due to inadequate risk assessment of batches exceeding standards and deficiencies in quality management during production [1][3]. - The company, established in 1983, was once the highest-valued and largest pharmaceutical firm in India, with Rivastigmine being a first-line treatment for mild to moderate Alzheimer's disease [4]. - The domestic market for Rivastigmine capsules was previously dominated by Novartis until 2018, when Jingxin Pharmaceutical obtained the first generic approval, with the market size estimated at nearly 200 million yuan [4]. Group 2: Supriya Lifescience Ltd. - Supriya Lifescience's Chlorpheniramine Maleate active pharmaceutical ingredient has been suspended due to failure to ensure compliance with production and inspection regulations, as well as inadequate facility management [5][6]. - This is not the first instance of suspension; the same product was previously halted in 2020 for similar quality management issues [2][6]. - Chlorpheniramine Maleate is widely used in over 2,000 cold and allergy medications, and its production has been linked to significant price increases in the past due to market manipulation [7][8].
生产过程不规范,两款印度产药物被暂停进口
Bei Ke Cai Jing·2026-01-26 13:09