China NMPA Drug Inspection - Jilin Shuangshi Pharmaceutical Co., Ltd. - Dendrobium Nobile Pills

On September 9, 2020, the National Medical Products Administration (NMPA) issued Announcement No. 57, identifying 20 batches of drugs from 10 pharmaceutical companies that failed to meet national quality standards. Key manufacturers cited include Jilin Tonghua Boxiang Pharmaceutical, Hainan Puli Pharmaceutical, Shanxi Qianyuan Pharmaceutical Group, and Guangzhou Huacheng Pharmaceutical. The violations were discovered during inspections by various regional drug institutes and primarily concerned failures in identification tests, specifically for Dendrobium Nobile Night-Shining Pills. Other issues included excessive moisture levels (loss on drying) in Clarithromycin tablets, poor clarity in Sodium Aloxicillin solutions, and inconsistent content uniformity in herbal granules. Additionally, several traditional medicine products failed to meet standards for physical appearance and properties. These enforcement actions were conducted under the regulatory framework of the Drug Administration Law of the People's Republic of China and the 2015 Chinese Pharmacopoeia. In response, the NMPA has ordered the immediate suspension of sales and use of the affected batches, alongside mandatory product recalls. The involved companies must investigate the root causes of these failures and implement corrective actions. Provincial authorities are further tasked with investigating potential illegal manufacturing practices and publicly disclosing the results.