China NMPA Drug Inspection - Disa Pharmaceutical Group Co., Ltd. - Roxithromycin Dispersible Tablets

On August 27, 2020, the Shaanxi Provincial Drug Administration published a drug quality announcement detailing results from provincial sampling inspections. The inspection identified 11 batches of non-compliant products from several manufacturers, including Disa Pharmaceutical Group Co., Ltd., Shaanxi Yishengtang Pharmaceutical Co., Ltd., and Anhui Xintai Pharmaceutical Co., Ltd., as well as various traditional Chinese medicine providers. The primary violations involved failures in physical appearance (properties), identification testing, and content determination, meaning the drugs did not meet the required chemical or physical specifications. These assessments were conducted under the regulatory framework of the Chinese Pharmacopoeia (primarily the 2015 Edition) and the Ministry of Health Drug Standards. In response to these findings, the Shaanxi Provincial Drug Administration mandated that local regulatory authorities implement immediate control measures on the affected units. Required actions include the seizure of non-compliant products and the initiation of formal legal investigations and handling procedures against the involved companies to ensure public medication safety.