China NMPA Drug Inspection - Jilin City Luwang Pharmaceutical Co., Ltd. - Compound Gentian Sodium Bicarbonate Tablets

The National Medical Products Administration (NMPA) announced on June 28, 2018, findings from various provincial drug control institutes detailing multiple instances of drug non-compliance. Several pharmaceutical companies were identified for producing substandard products.

Key violations included Jilin Luwang Pharmaceutical Co., Ltd. for Compound Gentian Sodium Bicarbonate Tablets failing disintegration tests. Hebei Quantai Pharmaceutical Co., Ltd., Shandong Shengyin Duobao Traditional Chinese Medicine Pieces Technology Co., Ltd., and Hainan Shounanshan Ginseng Industry Co., Ltd. were cited for Chicken Gizzard Lining products not meeting appearance and extractive standards. Hubei Xianglian Pharmaceutical Co., Ltd. and Shaanxi Hanwang Pharmaceutical Co., Ltd. had Muxiang Shunqi Pills with appearance issues. Sanmenxia Sainov Pharmaceutical Co., Ltd.'s Xiaoshuan Enteric-coated Capsules exceeded microbial limits, while Tonghua Yisheng Pharmaceutical Co., Ltd.'s Yanlixiao Capsules showed fill weight variation. Additionally, Fuzhou Haiwang Fuyao Pharmaceutical Co., Ltd. produced Folic Acid Tablets with non-compliant related substances.

In response, regulatory authorities initiated immediate control measures including sealing and seizing products, and ordered companies to suspend sales, recall affected batches, and implement corrective actions. Operating under the *Drug Administration Law of the People's Republic of China*, specifically Articles 73, 74, and 75, the NMPA mandated provincial authorities to investigate these companies for illegal activities related to substandard drug production and sale. Investigations, encompassing production verification and product tracing, are to be finalized within three months, with results publicly disclosed.