China NMPA Drug Inspection - Zhejiang Lepu Pharmaceutical Co., Ltd. - Coenzyme Q10 capsules

On February 17, 2017, the State Administration for Market Regulation issued an announcement regarding 15 batches of substandard drugs identified through testing by various drug institutions. Eight pharmaceutical companies were implicated, including Gansu Huangfumi Pharmaceutical Co., Ltd., Chengdu Mingri Pharmaceutical Co., Ltd., Shanxi Taiyuan Pharmaceutical Co., Ltd., Kunming Zhenhua Pharmaceutical Factory Co., Ltd., Zhejiang Yake Pharmaceutical Co., Ltd., Inner Mongolia Mongolian Medicine Co., Ltd., Shanxi Yunpeng Pharmaceutical Co., Ltd., and Hulunbuir Songlu Pharmaceutical Co., Ltd. The violations encompassed critical quality attributes such as bacterial count, related substances, weight variation, content determination, appearance, and identification. Specific examples included bacterial count issues for Gansu Huangfumi's Baotailing and related substance problems for Chengdu Mingri's Desloratadine tablets. In response, provincial food and drug administrations implemented immediate control measures, including product sealing and seizure. The affected companies were mandated to suspend sales, recall the substandard batches, and initiate rectification. Furthermore, provincial authorities were instructed to investigate the illegal activities, issue penalty decisions within one month in accordance with Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*, and publicly report these findings to the State Food and Drug Administration. Penalties were also to be applied to the responsible individuals.