Hubei Yinuorui Heparin Sodium Active Pharmaceutical Ingredient Passes China’s GMP Compliance Inspection.

        2020 Year 07 Moon 20 day ~2020 Year 07 Moon 22 Day, Hubei Provincial Drug Administration Technical Review and Verification Center Conduct a study on the active pharmaceutical ingredient enoxaparin sodium from Hubei Enoray Biopharmaceutical Co., Ltd. for a period of 3 sky GMP Compliance on-site inspection.

During this inspection, the inspector examined Hubei Yinuorui. GMP A professional and rigorous audit was conducted on-site, covering the quality management system, the production and inspection of enoxaparin sodium products, and ultimately, a recommendation was made to YinoRui. 7 General defect items. After the inspection is completed. 10 Within three days, YinoRui organized the rectification of the identified defects and prepared a rectification report to be submitted to the Hubei Drug Administration. After the rectification report was reviewed and approved by the Hubei Drug Administration, it was... 2020 Year 09 Moon 07 Received from the Hubei Provincial Drug Administration. GMP Compliance check passed via notification.

Continue 2019 Year 5 Following the on-site verification of the registration for the active pharmaceutical ingredient enoxaparin sodium, this time... GMP Having successfully passed the inspection, this signifies that Hubei Yinuorui Sodium Heparin API can now be legally sold in the Chinese market. In line with our company’s goal of building an international heparin industry platform, we have integrated high-quality upstream and downstream resources, establishing a complete heparin industrial chain—from pig small intestine processing and mucosal heparin extraction to the production of graded low-molecular-weight heparin APIs—and have thus secured another regulatory clearance.