Baiyunshan Chemical Pharmaceutical Factory, ib ceg ntawm Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd. (tom qab hu ua "Lub Tuam Txhab"), tau txais covCefixime Chemical Active Pharmaceutical Ingredient (API) Daim Ntawv Pom Zoo Kev Lag Luamtau tshaj tawm thiab pom zoo los ntawm National Medical Products Administration (NMPA) thaum Lub Peb Hlis 20, 2024. Cov ntsiab lus tseem ceeb tau tshaj tawm raws li hauv qab no:
I. Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Lub Npe Tshuaj API: Cefixime
Ntim Cov Lus Qhia: 25 kg / nruas
Daim ntawv ceeb toom: 2024YS00226
Txais No.: CYHS2260303
Kev Sau Npe Tus Qauv No. ntawm Tshuaj API: YBY61512024
Lub Sijhawm Siv Tau: 24 lub hlis
Chaw tsim tshuaj paus: Baiyunshan Chemical Pharmaceutical Factory ntawm Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd.
Chaw Nyob Chaw Tsim Khoom: Tsis yog . 78 Tongbao Road, Tonghe Street, Baiyun District, Guangzhou
Lub Sijhawm siv tau ntawm Daim Ntawv Ceeb Toom: Tshaj tawm rau lub Peb Hlis 18, 2029
Daim ntawv thov khoom: Daim ntawv thov kev lag luam rau hauv teb chaws - tsim cov tshuaj API
Kev Pom Zoo Cov Lus Nug: Raws li covTxoj Cai Tswj Tshuaj Txhaum Cai ntawm Tuam Txhab Tuam Txhab Suavthiab cov kev cai cuam tshuam, thaum tshuaj xyuas, cov khoom no ua raws li cov kev cai rau kev sau npe tshuaj, thiab daim ntawv thov rau npe rau cov khoom no tau pom zoo los ntawm no.
II. Lwm Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Cefixime yog ib qho kev hais lus -tswj thib peb- tiam cephalosporin tshuaj tua kab mob, qhia rau kev kho mob ntawm cov kab mob ua pa, kab mob urinary, kab mob biliary thiab lwm qhov chaw uas tshwm sim los ntawm cov kab mob uas raug kab mob.
Baiyunshan Chemical Pharmaceutical Factory tau txais Daim Ntawv Pov Thawj Tshuaj Tshiab thiab Daim Ntawv Pom Zoo Ntau Lawm rau Cefixime chemical API hauv 2003 (pom zoo No.: H20030043; Sau Npe No.: Y20190005402). Cov khoom no yog cefixime npaj los ntawm Baiyunshan Chemical Pharmaceutical Factory nrog cov txheej txheem tshiab. Tom qab ua tiav cov kev tshawb fawb cuam tshuam thiab txhim kho tus qauv zoo, lub Hoobkas tau xa daim ntawv sau npe nrog tus lej sau npe cais mus rau Lub Xeev Lub Chaw Tswj Xyuas Khoom Noj thiab Tshuaj Hauv Lub Rau Hli 2022, uas tau txais tom qab ntawd.
