China NMPA Drug Inspection - Yantai Dongcheng Dayang Pharmaceutical Co., Ltd. - Ambroxol Hydrochloride Dispersible Tablets

This document, the "Ningxia Drug Quality Sampling Inspection Information Announcement (No. 14, 2017)," was published by the Ningxia Food and Drug Administration on December 1, 2017. It details the results of a region-wide drug sampling inspection conducted in accordance with the "2017 Regional Drug Sampling Inspection Work Plan." The inspection involved drug regulatory departments and testing institutions across Ningxia. The comprehensive sampling covered 50 distinct drug varieties, totaling 135 batches, which included chemical drugs, antibiotics, traditional Chinese medicines, and traditional Chinese medicine decoction pieces. Products from various manufacturers, such as Ningxia Yongshoutang Traditional Chinese Medicine Pieces Co., Ltd. and Pfizer Pharmaceutical Co., Ltd., were evaluated. The regulatory framework for these inspections primarily utilized the Chinese Pharmacopoeia (2015 Edition, Parts I and II), alongside various National Drug Standards and Ministry of Health Drug Standards. A key finding of this announcement is that all inspection results met the established requirements. Consequently, no violations or issues were identified across any of the sampled batches, and therefore, no specific corrective actions were required for non-compliance.