China NMPA Drug Inspection - Anhui Jiezhong Biochemical Co., Ltd. - Rehmannia

On June 22, 2018, the National Medical Products Administration (NMPA) of China issued an announcement detailing the non-compliance of 10 batches of drugs produced by nine enterprises. Following tests by various provincial drug control institutes, companies such as Tonghua Xinghua Pharmaceutical Co., Ltd., Yantai Juxian Pharmaceutical Co., Ltd., and Bozhou Jingwan Traditional Chinese Medicine Pieces Factory were identified for significant quality control deficiencies. Main issues included substandard active ingredient content, inadequate dissolution rates, inconsistent fill weight uniformity, and unacceptable levels of ash content or appearance defects in products like Acanthopanax senticosus granules, Metoprolol tartrate tablets, and traditional Chinese medicine pieces.

In response to these findings, regulatory authorities implemented immediate control measures, including sealing and seizing the affected products. The implicated companies were mandated to cease sales, recall the non-compliant drugs, and rectify the identified issues. Operating under the Drug Administration Law of the People's Republic of China, the NMPA directed provincial drug regulatory bodies to conduct thorough investigations into the illegal activities of these manufacturers. These investigations were required to be completed, and their results publicly disclosed, within three months, ensuring accountability and adherence to national drug quality standards.