China NMPA Drug Inspection - Hainan Huanglong Pharmaceutical Co., Ltd. - Sodium cytidine triphosphate for injection

The State Food and Drug Administration (SFDA) announced on May 11, 2017, findings from drug testing that identified 11 batches of substandard drugs from seven pharmaceutical companies. These companies include Mayinglong Pharmaceutical Group Co., Ltd., CR Double-Crane Pharmaceutical Co., Ltd., Chengdu Better Pharmaceutical Co., Ltd., Chifeng Weikang Biochemical Pharmaceutical Co., Ltd., Chenxin Pharmaceutical Co., Ltd., Hainan Huanglong Pharmaceutical Co., Ltd., and Gansu Dadeli Pharmaceutical Co., Ltd. The identified issues across various drug products, such as Diosmin tablets and Enalapril-Hydrochlorothiazide tablets, primarily involved critical quality parameters including content determination, dissolution rate, content uniformity, and related substances. In response, provincial food and drug administrations initiated immediate control measures, including product seizures, suspension of sales and use, and mandatory product recalls, along with directives for rectification. The SFDA further mandated comprehensive investigations into these companies for violations related to the production and sale of substandard drugs, specifically referencing Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China. Provincial authorities are required to publicly release the outcomes of these investigations within three months and report findings to the SFDA promptly. This enforcement action underscores the regulatory commitment to ensuring drug quality and patient safety.