Hubei Yinuorui Heparin Sodium Active Pharmaceutical Ingredient Obtains Turkey’s GMP Re-certification Certificate.

Hubei Enoray Biopharmaceutical Co., Ltd.'s active pharmaceutical ingredient, enoxaparin sodium, has obtained the Turkish GMP Re-certification Certificate after passing the initial Turkish GMP certification in 2018 and undergoing re-certification in April 2021.

Given that the global COVID-19 pandemic remains uncontrolled, GMP on-site inspections have become difficult to carry out due to health risks. Therefore, for this Turkish GMP re-certification, a new document-based inspection approach has been adopted, in accordance with Turkish official regulations and customer requirements.
According to the inspection requirements, Hubei Yinuorui’s quality department has compiled a report on the operation of the company’s quality system, submitted the required documentation on schedule, and ultimately passed the re-inspection.
This GMP re-certification was successfully completed as scheduled, providing ongoing regulatory compliance support for the sale of our enoxaparin sodium product in the Turkish market.
At the same time, this certification was obtained despite the fact that GMP on-site inspections could not be carried out due to a sudden public emergency. Hubei Yinuorui actively adjusted its approach to preparing for GMP inspections, in close cooperation with pharmaceutical regulatory authorities and its clients, and successfully secured the official GMP certification. This certification lays a solid foundation for future non-standard GMP inspections and preparations.