China NMPA Drug Inspection - Hainan General Kangli Pharmaceutical Co., Ltd. - Ozagrel sodium for injection

In July 2020, the National Medical Products Administration (NMPA) of China issued Announcement No. 50, identifying 25 batches of drugs from 14 pharmaceutical companies that failed to meet national quality standards. Key manufacturers cited in the report include Suzhou Pharmaceutical Factory (of Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.), Hainan General Kangli Pharmaceutical Co., Ltd., Hunan Huana Pharmaceutical Co., Ltd., and several traditional Chinese medicine producers.

The inspections revealed various quality violations across multiple product categories. Major issues included failures in solution clarity and color for Amikacin Sulfate injections, the presence of visible foreign matter in Sodium Ozagrel injections, and poor dissolution rates in Lansoprazole tablets. Furthermore, some analgesic tablets were found to contain Auramine O, an unauthorized dye, while other products failed tests for fill volume, particle size, and active ingredient content.

These findings were documented based on the Drug Administration Law of the People's Republic of China and the 2015 edition of the Chinese Pharmacopoeia. In response to these violations, the NMPA has mandated immediate risk control actions, requiring the affected companies to suspend sales, halt use, and initiate product recalls. Additionally, the companies must conduct internal investigations to identify the root causes of these failures and implement corrective measures. Local regulatory authorities are tasked with overseeing these rectifications and pursuing legal investigations into the production of substandard drugs, with all final outcomes to be disclosed to the public.