China NMPA Drug Inspection - Jilin Shuangxing Pharmaceutical Co., Ltd. - Acanthopanax senticosus tablets
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The National Medical Products Administration (NMPA) of China issued Announcement No. 89 of 2018 on September 18, 2018, detailing that 13 batches of drugs from eight pharmaceutical companies failed to meet regulatory standards. Inspections conducted by various drug testing institutions, including the Shanghai Municipal Institute for Food and Drug Control, identified critical quality deficiencies. Hubei Dongxin Pharmaceutical Co., Ltd. had six batches of Valacyclovir Hydrochloride Capsules fail the dissolution rate test, affecting drug absorption. Jilin Shuangxing Pharmaceutical Co., Ltd., Yichun Jinbei Pharmaceutical Co., Ltd., and Harbin Huayu Pharmaceutical Group Co., Ltd. produced Acanthopanax senticosus tablets with non-compliant content determination, impacting their efficacy. Additionally, Zhejiang Proconyu Natural Medicine Co., Ltd.'s Maiwei Dihuang oral liquid, and products from Anhui Daxibei Traditional Chinese Medicine Pieces Co., Ltd., Anhui Zehua Traditional Chinese Medicine Pieces Co., Ltd., and Shaohuatang Traditional Chinese Medicine Co., Ltd., exhibited appearance issues, indicating potential quality problems. In response, the NMPA mandated immediate control measures, including product sealing, seizure, sales suspension, recalls, and rectification. Furthermore, relevant provincial drug regulatory authorities were directed to investigate these companies for illegal activities under Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*, requiring public disclosure of investigation results within three months.
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