Tsis ntev los no, Zhejiang Anglikang Pharmaceutical Co., Ltd. (tom qab no hu ua "Lub Tuam Txhab") tau txaisDaim Ntawv Ceeb Toom Pom Zoo rau Kev Siv Tshuaj Ntxiv Tshuaj Muaj Tshuaj Muaj Tshuajmuab los ntawm National Medical Products Administration (tom qab no hu ua "NMPA"). Cov ntsiab lus tseem ceeb tau tshaj tawm hauv qab no:
I. Cov Ntaub Ntawv Tseem Ceeb ntawm Daim Ntawv Pom Zoo
Lub npe ntawm cov tshuaj active tshuaj khoom xyawCov tshuaj: Cefadroxil
Tus lej sau npe: Y20190007306
Tus neeg tsim khoom npe: Zhejiang Anglikang Pharmaceutical Co., Ltd.
Chaw Nyob Chaw Tsim Khoom: Tsis yog. 1000 North Shengzhou Avenue, Shengzhou City, Shaoxing
Cov ntsiab lus ntawm daim ntawv thov: Kev hloov kho ntawm API ntau lawm txheej txheem; Hloov kho cov qauv sau npe
Kev pom zoo xaus: Raws li covTxoj Cai Tswj Tshuaj Txhaum Cai ntawm Cov Neeg Sawv Cev ntawm Tuam Tshojthiab cov kev cai cuam tshuam, thaum tshuaj xyuas, cov khoom siv ntawm cov khoom no ua tau raws li cov kev cai rau kev sau npe tshuaj. Cov khoom siv ntxiv hauv qab no ntawm cov khoom no tau pom zoo: 1. Kev hloov kho ntawm API ntau lawm txheej txheem (hloov los ntawm cov txheej txheem chemical synthesis rau cov txheej txheem enzymatic); 2. Kev hloov kho cov qauv zoo.
II. Cov ntaub ntawv tseem ceeb ntawm cov khoom
Lub Tuam Txhab tau txais daim ntawv pov thawj kev tso npe (Kev Pom Zoo No. H20093188) rau cov tshuaj API Cefadroxil (tsim los ntawm cov txheej txheem chemical synthesis) thaum Lub Ob Hlis 2009. Cov khoom no yog cov tshuaj API Cefadroxil npaj los ntawm Lub Tuam Txhab nrog cov txheej txheem tshiab. Tom qab ua tiav cov kev tshawb fawb thiab kev txhim kho cov qauv zoo, Lub Tuam Txhab tau xa daim ntawv thov hloov kho rau NMPA thaum Lub Rau Hli 2023, uas tau txais.
Cov khoom no yog qhia rau cov kab mob sib kis los ntawm Cefadroxil- cov kab mob rhiab heev xws li staphylococci, streptococci thiab pneumococci, nrog rau cov kab mob ua pa, kab mob ntawm daim tawv nqaij thiab cov nqaij mos, kab mob hauv qhov ncauj, kab mob hauv plab, nrog rau otitis media thiab lwm yam mob.
