Recently, Borui Biopharmaceuticals (Suzhou) Co., Ltd. (hereinafter referred to as "the Company") has received the Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) for its oseltamivir phosphate active pharmaceutical ingredient (API).
The relevant information is hereby announced as follows:
I. Basic Information of the Drug
Name of the Chemical Active Pharmaceutical Ingredient: Oseltamivir Phosphate
Manufacturer/Holder of the Drug: Borui Biopharmaceuticals (Suzhou) Co., Ltd.
Certificate Number: No. CEP 2022-488-Rev 00
Issuing Authority: European Directorate for the Quality of Medicines & HealthCare (EDQM)
Validity Period: Valid for five years starting from March 7, 2024
II. Other Relevant Information of the Drug
Oseltamivir phosphate is indicated for the treatment and prevention of influenza A and B virus infections. The Company submitted the CEP application for its oseltamivir phosphate API to EDQM in December 2022, and obtained the CEP certificate in March 2024.
