China NMPA Drug Inspection - Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. - Cefuroxime axetil tablets

The Ningxia Drug Administration in China published the findings of its 2018 drug sampling inspections on January 22, 2020. This comprehensive review assessed 156 batches across 59 drug varieties, including chemical drugs, traditional Chinese medicine preparations, and traditional Chinese medicine decoction pieces. Four specific drug varieties, totaling five batches, were found to be non-compliant with quality requirements.

Key violations included products from Ningxia Jintaiyang Pharmaceutical Co., Ltd., with "Typha pollen" failing on total ash and insoluble ash content, and "Pulsatilla chinensis" showing deficiencies in total ash and extractives. Ningxia Mingde Traditional Chinese Medicine Slices Co., Ltd. had two batches of "Lysimachia christinae" that did not meet content determination standards, while Anhui Yaozhiyuan Traditional Chinese Medicine Slices Co., Ltd.'s "Peucedanum praeruptorum" also failed content determination.

These inspections were carried out in accordance with the "Drug Administration Law of the People's Republic of China," "Regulations on the Administration of Drug Quality Sampling Inspection," and standards such as the "Chinese Pharmacopoeia 2015 Edition." The relevant local market supervision administrations have initiated investigations and are taking legal actions against the manufacturers of the non-compliant drugs to uphold drug quality and safeguard public health.