China NMPA Drug Inspection - SHANDONG LUYE PHARMACEUTICAL CO., LTD - Ganoderma lucidum capsules

The National Medical Products Administration (NMPA) issued Announcement No. 73 of 2018 on August 17, 2018, detailing non-compliance across 12 batches of drugs from 11 companies. Inspections conducted by provincial drug testing institutions identified significant quality control deficiencies. Key violations included: Peppermint (six batches from companies like Bozhou Boyaotang Pharmaceutical Co., Ltd.) had issues with appearance, microscopic characteristics, and thin-layer chromatography. Angelica pubescens (three batches, e.g., from Chengdu Hexiangtian Pharmaceutical Co., Ltd.) failed on appearance, thin-layer chromatography, and content determination. Ganoderma lucidum capsules from Shandong Luyao Pharmaceutical Co., Ltd. were substandard in moisture content and fill weight variation. Folic acid tablets from Yantai Zhongzhou Pharmaceutical Co., Ltd. showed non-compliance with related substances and dissolution rate. These deficiencies fall under the regulatory framework of the *Drug Administration Law of the People's Republic of China* and relevant Pharmacopoeia standards. In response, regulatory authorities initiated immediate control measures, including product sealing, seizure, suspension of sales, recalls, and required rectification. Provincial drug authorities are mandated to investigate these companies for illegal activities related to producing and selling substandard drugs, with findings to be completed and publicly disclosed within three months. This action underscores NMPA's commitment to ensuring drug quality and patient safety.