China NMPA Drug Inspection - Gansu Shenyuantang Pharmaceutical Co., Ltd. - Bupleurum

On July 16, 2021, the Gansu Provincial Drug Administration released findings from a drug sampling inspection conducted by the Lanzhou Municipal Institute for Food and Drug Control. The inspection identified three batches of traditional Chinese medicine pieces that failed to meet established quality standards. The manufacturers cited in the report include Beijing Qiancao Traditional Chinese Medicine Pieces Co., Ltd., Gansu Fuxinghou Biomedical Technology Co., Ltd., and Gansu Shenyuantang Pharmaceutical Co., Ltd.

The main violations identified involved failures in 'content determination' (active ingredient levels) and 'physical properties' or 'appearance.' Specifically, samples of Raspberry, Eriocaulon, and Bupleurum were found to be non-compliant with the technical requirements outlined in the 2015 and 2020 editions of the Chinese Pharmacopoeia.

Following these results, regulatory authorities seized the substandard products and initiated legal investigations into the companies involved. Required actions include a thorough investigation by the manufacturers into the root causes of the quality failures, the implementation of formal rectification measures to resolve the issues, and the mitigation of any potential public health risks. The results of the ongoing investigations are scheduled to be made public within three months.