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Zhejiang Xianju Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") has recently received the Drug Registration Certificate (Certificate No.: 2025S00441) for Beraprost Sodium Tablets issued and approved by the National Medical Products Administration. The registration of the Company's Beraprost Sodium Tablets has been approved. The relevant information is hereby announced as follows:

Drug Basic Information

·             Drug Name: Beraprost Sodium Tablets

·             Dosage Form: Tablet

·             Specification: 20μg (calculated as Beraprost Sodium)

·             Drug Registration Standard Number: YBH01802025

·             Drug Approval Number: National Drug Approval No. H20253372

·             Registration Category: Chemical Drug Category 4

·             Marketing Authorization Holder/Manufacturer: Zhejiang Xianju Pharmaceutical Co., Ltd.

Application Contents: Application for domestic production drug registration and marketing authorization.

Approval Conclusion: In accordance with the "Drug Administration Law of the People's Republic of China" and relevant regulations, after being reviewed, this product meets the relevant requirements for drug registration. The registration is approved, and the Drug Registration Certificate is issued.

Other Relevant Information about the Drug

Beraprost Sodium Tablets, with a strength of 20μg (calculated as Beraprost Sodium), are referenced to the original imported Beraprost Sodium Tablets, marketed under the brand name Dorner®. The Reference Listed Drug (RLD) of Beraprost Sodium Tablets was developed by Toray Industries, Inc. and was approved for marketing in Japan in January 1992. Dorner® was approved for import in China in August 2003. The indication for Beraprost Sodium Tablets is to improve symptoms such as ulcers, intermittent claudication, pain, and cold sensation caused by chronic arterial occlusive disease.

The strength of Beraprost Sodium Tablets applied for by the Company this time is consistent with that of the originator’s that has been approved for marketing. The application was made under Chemical Drug Category 4.

The domestic production drug registration certificate for Beraprost Sodium Tablets is conducive to enriching the Company's product portfolio and enhancing market competitiveness.