China NMPA Drug Inspection - Changchun Dazheng Pharmaceutical Technology Co., Ltd. - Compound Glycyrrhiza Tablets

The State Food and Drug Administration (SFDA) of China issued its National Drug Quality Bulletin (2010, Issue 2) on August 24, 2010, announcing results from a nationwide drug quality sampling inspection. Conducted to enhance drug supervision and safeguard public health, the inspection covered 2415 batches across 12 pharmaceutical preparations, including the essential medicine Sanqi Capsules and 11 other varieties. While Sanqi Capsules batches met standards, 28 batches from the other 11 preparations were found to be non-compliant.

Key manufacturers identified with violations included Sichuan Daqian Pharmaceutical Co., Ltd., Hainan Lingkang Pharmaceutical Co., Ltd., Guangxi Guangming Pharmaceutical Co., Ltd., Beijing Saisheng Pharmaceutical Co., Ltd., and Liaoning Tianlong Pharmaceutical Co., Ltd. The issues spanned critical quality attributes such as content uniformity, pH value, fill volume, ingredient identification, content determination, sterility, loss on drying, and potency assay. These non-conformities indicate deviations from established drug standards, primarily the Chinese Pharmacopoeia and Ministry of Health Drug Standards.

In response, the SFDA mandated that provincial food and drug administration departments conduct thorough investigations into the non-compliant products and associated entities. These authorities are required to take appropriate legal actions and submit their investigation results to the SFDA's Inspection Bureau and Drug Market Supervision Office by the end of October 2010. This bulletin underscores the SFDA's commitment to maintaining stringent drug quality oversight within the national regulatory framework.