China NMPA Drug Inspection - Jiuzhou Hengyuan (Anguo) Pharmaceutical Co., Ltd. - Privet

On July 17, 2023, the National Medical Products Administration (NMPA) issued Announcement No. 30, reporting that 49 batches of drugs failed to meet quality standards during recent testing. A significant number of violations were attributed to Beijing Langdi Pharmaceutical Co., Ltd. and its contract manufacturer, Shanxi Zhendong Pharmaceutical Co., Ltd., particularly regarding Calcium Carbonate D3 granules and tablets that failed 'content determination' tests for Vitamin D3 levels. Other cited companies include Hebei Jinniu Yuanda Pharmaceutical, Changchun Xin’an Pharmaceutical, and several Traditional Chinese Medicine suppliers such as Anguo Runde Pharmaceutical. The inspections identified various quality issues, including inaccurate ingredient concentrations, poor dissolution rates, excessive moisture content, and failures in physical adhesion and weight consistency. These findings were evaluated against the regulatory framework of the Drug Administration Law of the People's Republic of China and the 2020 edition of the Chinese Pharmacopoeia. In response, the NMPA has ordered immediate risk control measures, including the suspension of sales and use, alongside a total recall of the non-compliant batches. The involved enterprises must investigate the root causes of these failures and implement corrective actions, while provincial authorities conduct further legal investigations into the suspected misconduct.