Tsis ntev los no, Borui Biopharmaceuticals (Suzhou) Co., Ltd. (tom qab no hu ua "Lub Tuam Txhab") tau txais daim ntawv pov thawj ntawm kev tsim nyog rau Monographs ntawm European Pharmacopoeia (CEP) tawm los ntawm European Directorate rau Cov Tshuaj Zoo & Kev Noj Qab Haus Huv (EDQM) rau nws cov tshuaj oseltamivir PIactive phosphatetical.
Cov ntaub ntawv cuam tshuam tau tshaj tawm hauv qab no:
I. Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Lub npe ntawm cov tshuaj active tshuaj khoom xyawTom ntej: Oseltamivir Phosphate
Chaw tsim tshuaj paus / Tus tuav ntawm TshuajTom ntej: Borui Biopharmaceuticals (Suzhou) Co., Ltd.
Certificate Number: No. CEP 2022-488-Rev 00
Tso Cai: European Directorate for the Quality of Medicines & HealthCare (EDQM)
Lub Sijhawm siv tau: Siv tau rau tsib xyoos pib txij lub Peb Hlis 7, 2024
II. Lwm Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Oseltamivir phosphate yog qhia rau kev kho thiab tiv thaiv kab mob khaub thuas A thiab B. Lub Tuam Txhab tau xa daim ntawv thov CEP rau nws cov oseltamivir phosphate API rau EDQM thaum Lub Kaum Ob Hlis 2022, thiab tau txais daim ntawv pov thawj CEP thaum Lub Peb Hlis 2024.
