China NMPA Drug Inspection - Jiangsu Heshengtang Pharmaceutical Co., Ltd. - Gentian

On August 27, 2025, the National Medical Products Administration (NMPA) issued Announcement No. 30, reporting that 28 batches of drugs from 17 companies failed to meet quality standards. Key companies cited for non-compliance include Aomei Pharmaceutical Factory, Wante Pharmaceutical (Hainan) Co., Ltd., Shaanxi Xiyue Pharmaceutical Co., Ltd., and several traditional Chinese medicine (TCM) producers such as Hebei Kangshenghua Pharmaceutical and Sichuan Jinke Pharmaceutical. The findings resulted from rigorous testing conducted by various provincial institutes for drug control.

The main violations identified include physical and chemical defects such as incorrect particle size in creams, excessive impurities in syrups, and poor dissolution rates in capsules, all of which can compromise drug efficacy and absorption. Furthermore, several TCM products failed identification tests or were found to contain pesticide residues and excessive moisture, suggesting issues with adulteration, processing, or storage conditions.

Under the regulatory framework of the Drug Administration Law of the People's Republic of China and the 2020 Chinese Pharmacopoeia, the NMPA has mandated immediate enforcement actions. These include the suspension of sales and use, comprehensive product recalls, and internal investigations by the manufacturers to rectify the causes of failure. Additionally, provincial authorities are required to investigate potential illegal activities and publicly disclose their findings to ensure industry-wide accountability and public safety.