China NMPA Drug Inspection - Xian Lijun Pharmaceutical Co., Ltd - Sodium citicoline injection

The Ningxia Food and Drug Administration (NMPA) released its Drug Quality Sampling Inspection Information Announcement (No. 05, 2018) on June 29, 2018. This regional oversight program involved the inspection of 119 batches across 41 drug varieties, encompassing chemical drugs, traditional Chinese medicines (TCM), and TCM decoction pieces. The inspections revealed 11 non-compliant batches originating from 8 distinct varieties, all of which were traditional Chinese medicine products.

Key quality issues identified included "Sulfur Dioxide Residue" in Bletilla striata, deviations in "Properties" and "Content Determination" for various Schisandra chinensis products, and "Appearance" defects in Clematis chinensis. Additionally, Rubia cordifolia showed multiple failures across its properties, identification, inspection, and content determination, while Piper longum failed on "Total Ash" and Citrus medica on "Content Determination." These findings indicated a failure to adhere to the quality standards primarily specified in the Chinese Pharmacopoeia (2015 Edition) and the Ningxia Traditional Chinese Medicine Processing Standards (1997 Edition).

Manufacturers whose products were implicated included Ningxia Mingde Traditional Chinese Medicine Pieces Co., Ltd., Ningxia Northwest Medicinal Materials Technology Co., Ltd., Ningxia Baicaowang Pharmaceutical Co., Ltd., Anguo Juyitang Pharmaceutical Co., Ltd., Baoji Kexing Pharmaceutical Co., Ltd., Pingliang Xinyuan Traditional Chinese Medicine Prepared Slices Co., Ltd., and Ningxia Wuma Tianqi Traditional Chinese Medicine Slices Co., Ltd. The regulatory directive mandates that relevant municipal and county market supervision administrations investigate and address these non-compliant drugs in accordance with applicable legal provisions.