Hebei Changshan Biochemical Pharmaceutical (300255.SZ) announced on September 20th that the company recently received the "Certificate Of GMP Compliance Of A Manufacturer" issued by the Republic of Croatia Agency For Medicinal Products And Medical Devices, based on the relevant regulations of the European Medicines Agency.

Enokidusan Sodium Injection is used to prevent thromboembolic diseases (prevention of intravenous thrombosis formation), especially thrombus formation related to orthopedic or general surgery; treatment of established deep venous thrombosis with or without pulmonary embolism, with mild clinical symptoms, excluding pulmonary embolism requiring surgical treatment or thrombolytic therapy; in combination with aspirin, it is used to treat unstable angina and non-Q wave myocardial infarction; used in blood dialysis extracorporeal circulation to prevent thrombosis formation.

This is the first time that the company's production facility for Enoxaparin Sodium Injection has passed the EU GMP certification. According to the mutual recognition system of GMP among EU member states, passing the GMP certification this time indicates that the certified production line now complies with EU GMP standards, and the Enoxaparin Sodium Injection product meets the requirements for entering the EU market. After passing the GMP certification this time, Enoxaparin Sodium Injection still needs to obtain EU marketing authorization before being marketed in the EU.