China NMPA Drug Inspection - Wuhan Taifu Pharmaceutical Co., Ltd. - Isatis root granules

The Ningxia Food and Drug Administration published its Drug Quality Sampling Inspection Information Announcement (No. 06, 2017) on July 21, 2017. This regional initiative, conducted under the "2017 Regional Drug Sampling Inspection Work Plan," involved comprehensive testing across the Ningxia region. The inspection encompassed 81 varieties of drugs, totaling 152 batches. These included 17 varieties of chemical drugs (49 batches), 3 varieties of antibiotics (10 batches), 8 varieties of traditional Chinese medicine (26 batches), and 53 varieties of traditional Chinese medicine decoction pieces (67 batches). A diverse range of manufacturers supplied these products, including Ningxia Mingde Traditional Chinese Medicine Pieces Co., Ltd., CSPC Ouyi Pharmaceutical Co., Ltd., Jiangsu Hansoh Pharmaceutical Group Co., Ltd., and numerous others across China. The primary regulatory frameworks referenced for these inspections included the Chinese Pharmacopoeia (2010 and 2015 Editions), National Drug Standards, Ministry of Health Drug Standards, and specific Ningxia medical institution preparation standards. Significantly, all 152 batches of drugs inspected were found to be compliant with the established quality requirements. Therefore, no violations or specific required actions were issued against any of the sampled products or their manufacturers in this report.