China NMPA Drug Inspection - Yuzhou Tianyuan Pharmaceutical Co., Ltd. - Danshen Formula Granules

On July 17, 2023, China’s National Medical Products Administration (NMPA) published Announcement No. 30, revealing that 49 batches of drugs from 16 manufacturers failed to meet national quality standards. A significant portion of the non-compliant products involved calcium carbonate D3 granules and tablets produced or commissioned by Beijing Zhendong Langdi Pharmaceutical Co., Ltd. and Shanxi Zhendong Pharmaceutical Co., Ltd. Main violations across the identified batches included failures in content determination—particularly regarding vitamin D3 levels—as well as issues with drug dissolution, weight variation, and excessive moisture or ash content in traditional Chinese medicine components. Other notable companies cited include Changchun Xin'an Pharmaceutical and Shandong Yikang Pharmaceutical. Operating under the framework of the Drug Administration Law of the People's Republic of China and the 2020 Chinese Pharmacopoeia, the NMPA has ordered immediate regulatory actions. Impacted enterprises must suspend the sale and use of these drugs, initiate product recalls, and conduct thorough internal investigations to rectify the causes of non-compliance. Additionally, provincial regulatory authorities have been directed to investigate potential illegal activities and publicly report their findings to ensure consumer safety and industry accountability.