Tsis ntev los no, Zhejiang Jiuzhou Pharmaceutical Co., Ltd.Tuam txhab) tau txais lubDaim Ntawv Ceeb Toom Pom Zoo rau Kev Lag Luam Daim Ntawv Thov Kev Siv Tshuaj Siv Tshuaj Muaj Tshuaj(Daim Ntawv Ceeb Toom No.: 2023YS00457) rau Sitagliptin Phosphate, tawm los ntawm National Medical Products Administration (tom qab no hu uaNMPA). Cov ntsiab lus yog raws li nram no:
I. Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Lub Npe Tshuaj: Sitagliptin PhosphateRegistration Standard No.: YBY63092023Packaging Specifications: 1kg/nruas, 2kg/drum, 5kg/drum, 10kg/drum, 15kg/drum, 20kg/drum, 25kg/drumApplication khoom siv tshuaj: Kev lag luam tshuaj ingredientManufacturer: Zhejiang Jiuzhou Pharmaceutical Co., Ltd., Waisha Industrial Zone, Jiaojiang District, Taizhou City, Zhejiang Province (Tsis yog. 99 Waisha Road) Kev Pom Zoo Pom Zoo: Raws li covTxoj Cai Tswj Tshuaj Txhaum Cai ntawm Tuam Txhab Tuam Txhab Suav, raws li kev tshuaj xyuas, cov khoom no ua raws li cov kev cai ntawm kev pom zoo ntawm cov tshuaj generic, thiab kev tsim cov khoom no tau pom zoo. Cov txheej txheem zoo, cov ntawv ntim khoom thiab cov txheej txheem tsim khoom yuav tsum tau ua raws li cov ntaub ntawv txuas nrog.
II. Lwm Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Sitagliptin Phosphate yog ib qho tshuaj tiv thaiv hyperglycemic, feem ntau qhia rau kev kho mob ntawm hom 2 mob ntshav qab zib mellitus. Lub Tuam Txhab xa daim ntawv thov kev lag luam rau API no mus rau Lub Chaw rau Kev Ntsuas Tshuaj Tshuaj ntawm NMPA (tom qab no hu uaCDE) thaum Lub Ob Hlis 2020, thiab tsis ntev los no tau dhau los ntawm CDE kev tshuaj xyuas, thiab tau txais Daim Ntawv Pom Zoo Pom Zoo rau Kev Lag Luam Daim Ntawv Thov Kev Siv Tshuaj Siv Tshuaj Siv Tshuaj los ntawm NMPA. Cov xwm txheej ntawm API no yog tso tawm raws liAntawm CDE's Registration Information Platform for Excipients, Packaging Materials thiab APIs.
