China NMPA Drug Inspection - Nanjing Baijingyu Pharmaceutical Co., Ltd. - Aminophylline tablets

This document, the Jiangsu Province 2018 Issue 4 Drug Quality Bulletin, released on December 17, 2018, details findings from drug inspections conducted across various pharmaceutical and traditional Chinese medicine manufacturers. The inspections, covering batches produced between 2016 and 2018, identified numerous non-compliant drug products and medicinal materials.

For finished chemical drugs, antibiotics, and biochemical drugs, several companies, including Shanghai Qingdao Guofeng Pharmaceutical Co., Ltd., Jilin Kuahai Biochemical Pharmaceutical Manufacturing Co., Ltd., Hebei Yinengpu Pharmaceutical Co., Ltd., Hubei Ji'antang Pharmaceutical Co., Ltd., and Nanjing Baijingyu Pharmaceutical Co., Ltd., were cited. Common violations involved critical quality attributes such as weight discrepancies, dissolution rates, incorrect content determination of active ingredients (e.g., Danshensu B), and particle size issues.

Regarding traditional Chinese medicinal materials and prepared slices, a broader range of companies, including Xuzhou Pengzu Traditional Chinese Medicine Pieces Co., Ltd., Anhui Xinxing Traditional Chinese Medicine Pieces Co., Ltd., Anhui Shangde Traditional Chinese Medicine Pieces Co., Ltd., and Anhui Yaozhiyuan Chinese Herbal Pieces Co., Ltd., faced scrutiny. Issues included failures in content determination (e.g., volatile oil), excessive moisture, incorrect total ash content, and misidentification or deviations in physical properties.

The regulatory framework for these assessments primarily referenced the Chinese Pharmacopoeia (2010 and 2015 Editions) and specific Ministry of Health Drug Standards for Traditional Chinese Medicine. The identification of these significant quality deficiencies necessitates immediate regulatory actions, including potential market withdrawals, recalls, and corrective measures by the implicated manufacturers to ensure product quality and public safety.