Hubei Yinuorui Sodium Heparin and Nadroparin Calcium APIs have been granted domestic marketing approval.

   2022 On March 31, Hubei Enoray Biopharmaceutical Co., Ltd. received the Notification of Pre-Marketing GMP Compliance Inspection Results for its heparin sodium and nadroparin calcium APIs, issued by the Hubei Provincial Drug Administration.

The sodium heparin active pharmaceutical ingredient passed the on-site registration inspection in September 2021, and the final review of the registration documentation was completed on March 16, 2022. The registration status on the CDE Excipient and Raw Material Registration Platform was changed from “I” to “A.” On March 31, 2022, the company received a notification of passing the GMP compliance inspection.

The nadroparin calcium passed the on-site verification for registration in September 2021, and the final review of the registration documents was completed on March 25, 2022. The registration status on the CDE raw material and excipient registration platform changed from “I” to “A.” On March 31, 2022, the company received a notification of passing the GMP compliance inspection.

Thus, Hubei Yinuorui’s heparin-based active pharmaceutical ingredients—including enoxaparin sodium, low-molecular-weight heparin calcium, heparin sodium, and nadroparin calcium—have all completed registration filings in China, passed GMP inspections, and obtained marketing authorization. This will play a crucial role in promoting the company’s expansion and development in the domestic market.

In the daily quality management process of pharmaceutical production, YinoRui will actively carry out self-inspections and optimization activities for its quality systems. By aligning with both domestic and international regulatory requirements, we will continuously enhance our quality management standards to ensure that our product quality consistently meets registration and customer requirements.