China NMPA Drug Inspection - Shaanxi Xiyue Pharmaceutical Co., Ltd. - Isosorbide dinitrate tablets

This document, the "Ningxia Drug Sampling Inspection Information Announcement (No. 11, 2018)," was issued by the Ningxia Food and Drug Administration on October 10, 2018. It presents the outcomes of a regional drug sampling inspection conducted in accordance with the "Drug Administration Law of the People's Republic of China" and the "Regulations on the Administration of Drug Quality Sampling Inspection." The inspection covered 109 batches of 55 different drug varieties, including chemical drugs, traditional Chinese medicine, and traditional Chinese medicine decoction pieces. Products from numerous manufacturers, such as Ningxia Yongshoutang Traditional Chinese Medicine Pieces Co., Ltd., Chengdu Jinhua Pharmaceutical Co., Ltd., and Shandong Xinhua Pharmaceutical Co., Ltd., were evaluated. The primary regulatory standard for these assessments was predominantly the "Chinese Pharmacopoeia 2015 Edition" (Parts I or II), alongside other relevant national drug standards. A key finding of the announcement is that all inspected drugs fully complied with the established regulations. As a result, no violations or non-compliant items were identified across any of the sampled batches, meaning no specific corrective actions were required from the involved companies.