China NMPA Drug Inspection - Hunan Dino Pharmaceutical Co., Ltd. - Orlistat capsules

In October 2021, the National Medical Products Administration (NMPA) released an announcement detailing seven batches of medications that failed to meet quality standards. The five pharmaceutical companies involved include Zhongshan Wanhan Pharmaceutical Co., Ltd., Hunan Dino Pharmaceutical Co., Ltd., Sancai Shiqi Pharmaceutical Co., Ltd., Qinghai Baojiantang Guoyao Co., Ltd., and Wuhu Zhang Hengchun Pharmaceutical Co., Ltd. The primary violations involved failures in product identification, dissolution rates, and content determination. Specifically, Orlistat Capsules from Zhongshan Wanhan failed identification and dissolution tests, which can hinder how the medication is absorbed by the body. Other products, such as Pediatric Cough Syrup and Compound Licorice Oral Solution, failed content determination tests, indicating that the active ingredient levels did not meet specified requirements. Following the regulatory framework of the Drug Administration Law of the People's Republic of China, the NMPA has ordered the manufacturers to immediately suspend sales and usage of the affected batches and initiate product recalls. Furthermore, the companies must investigate the root causes of these failures and implement corrective actions. Provincial regulatory authorities have been directed to investigate the potential production and sale of counterfeit or substandard drugs and to publicly disclose the results of their investigations.