China NMPA Drug Inspection - Henan Tianzhi Pharmaceutical Co., Ltd. - Ozagrel sodium injection

On November 30, 2020, the Yunnan Provincial Drug Administration, operating under the National Medical Products Administration (NMPA) framework, published its second Drug Quality Bulletin for the year. This announcement follows comprehensive province-wide sampling and inspections aimed at ensuring public medication safety. The report identifies several pharmaceutical companies whose products failed to meet the standards established by various editions of the Chinese Pharmacopoeia and other state-level regulations. Key violations include the presence of visible foreign matter in Ozagrel Sodium Injection produced by Henan Tianzhi Pharmaceutical Co., Ltd., and excessive sulfur dioxide levels in Kudzu root from Yunnan Dongrong Dianxi Traditional Chinese Medicine Logistics Management Co., Ltd. Other issues identified include failures in microscopic identification, thin-layer chromatography testing, and excessive ash content among products from manufacturers such as Yunnan Meikang Chinese Herbal Pieces Co., Ltd., Kunming Hehe Traditional Chinese Medicine Slices Co., Ltd., and Jiangxi Kangqile Traditional Chinese Medicine Co., Ltd. By publishing these non-compliant results, the administration facilitates regulatory enforcement and public transparency. Required actions involve heightened supervision by regional drug regulatory departments and ensuring that substandard batches are handled according to safety protocols to mitigate risks to public health.