China NMPA Drug Inspection - Dandong Yichuang Pharmaceutical Co., Ltd. - Injectable Yanhuning

On January 23, 2025, the National Medical Products Administration (NMPA) issued Announcement No. 7 of 2025, identifying 13 batches of drugs from 10 companies that failed to meet national quality standards. Key companies cited include Shijiazhuang Green Pharmaceutical Co., Ltd., Tonghua Renmin Pharmaceutical Co., Ltd., Hunan Yige Pharmaceutical Co., Ltd., and several traditional Chinese medicine producers such as Anhui Kanghe and Anguo Jiuwang Pharmaceutical. The inspections, conducted by various provincial institutes, revealed several critical quality issues. Notable violations included the presence of visible foreign matter in eye drops, incorrect chemical potency or activity levels in injections and tablets, and excessive moisture or impurities in herbal materials. Additionally, one batch of Carthamus tinctorius was found to contain unauthorized coloring agents, including Acid Red 73 and Tartrazine. These failures constitute a violation of the Drug Administration Law of the People’s Republic of China. Under this regulatory framework, the NMPA has ordered the affected enterprises to implement immediate risk control measures, including the suspension of sales and the recall of all non-compliant products. The companies are required to conduct thorough internal investigations to identify the root causes of these failures and implement corrective actions. Furthermore, provincial regulatory departments have been directed to pursue legal investigations into the suspected illegal activities and publicly disclose their findings to ensure pharmaceutical safety and compliance.