China NMPA Drug Inspection - Xinxiang Pharmaceutical Co. Ltd. - Ribavirin Injection

The State Food and Drug Administration (SFDA) issued its National Drug Quality Bulletin on August 13, 2009, following national evaluation and sampling inspections. Conducted under the National Drug Evaluation and Sampling Plan, the inspections aimed to bolster drug supervision and public safety by ensuring compliance with the Chinese Pharmacopoeia 2005 Edition. The overall quality of the inspected drugs – Ribavirin, Salbutamol Sulfate, and Chlorpheniramine Maleate preparations – was generally good, but several manufacturers were cited for deficiencies. Seven batches of Ribavirin preparations from companies including Changzhi Sanbao Biochemical Pharmaceutical, Queshan Longyuan Pharmaceutical, Xinxiang Changle Pharmaceutical, Guizhou Tiandi Pharmaceutical, Jiangsu Lianshui Pharmaceutical, and Henan Huali Pharmaceutical failed due to issues such as incorrect fill volume and visible foreign matter. Jiangsu Yongda Pharmaceutical Co., Ltd. had two non-compliant batches of Salbutamol Sulfate tablets, failing content uniformity and content determination tests. For Chlorpheniramine Maleate tablets, nine batches from firms such as Datong Yungang Pharmaceutical, Datong Weihua Pharmaceutical, Shandong Junan Pharmaceutical Factory, Shanxi Fenhe Pharmaceutical, Liaoyuan Yulong Yadong Pharmaceutical, and Jilin Xianfeng Technology Pharmaceutical exhibited failures in dissolution, content determination, and content uniformity. All provincial food and drug administrations are required to investigate these substandard drugs and implicated entities according to legal provisions, reporting their findings to the SFDA Inspection Bureau by September 15, 2009.