Fuan Pharmaceutical (Group) Co., Ltd. (tom qab no hu ua "Lub Tuam Txhab") ntawm no tshaj tawm tias nws tag nrho -tus tswv lag luam, Fuan Pharmaceutical Group Ningbo Tianheng Pharmaceutical Co., Ltd. (tom qab no hu ua "Tianheng Pharmaceutical" tsis ntev los no tau txais daim ntawv thov API los ntawm National Medical Products Administration (NMPA). Cov ntsiab lus tseem ceeb tau tshaj tawm raws li hauv qab no:
| API npe | Sau npe No. | Chaw tsim tshuaj paus | Ntim Specification | Kev pom zoo xaus |
|---|---|---|---|---|
| Regoraphenib | Y20210000852 | Tianheng Pharmaceutical | 2kg / lub thawv | Tom qab kev tshuaj xyuas, cov khoom no ua raws li cov kev cai rau kev sau npe tshuaj, thiab daim ntawv thov kev tso npe ntawm cov khoom no tau pom zoo. |
Regorafenib yog qhia rau kev kho mob ntawm cov neeg mob uas muaj mob qog noj ntshav metastatic, qog nqaij hlav plab, thiab cov kab mob hepatocellular carcinoma uas tau txais kev kho mob sorafenib ua ntej. Raws li cov ntaub ntawv platform ntawm National Medical Products Administration, raws li niaj hnub no, tsib lub lag luam (xws li Tianheng Pharmaceutical) tau txais kev pom zoo rau kev lag luam daim ntawv thov ntawm regorafenib API.
Kev pom zoo ntawm cov khoom API tau hais los saum toj no yuav ua rau nws siv hauv kev tsim khoom lag luam hauv tsev thiab ntxiv dag zog rau cov khoom lag luam ntawm cov chaw muag khoom. Txawm li cas los xij, lub sijhawm tsim khoom thiab muag khoom thiab kev muag khoom tshwj xeeb ntawm API cov khoom lag luam raug cuam tshuam los ntawm cov yam ntxwv xws li kev nce qib ntawm GMP kev soj ntsuam xyuas, lub teb chaws cov cai, thiab kev hloov pauv hauv kev lag luam ib puag ncig. Cov neeg ua lag luam raug qhia kom txiav txim siab ua tib zoo thiab ua tib zoo saib xyuas kev pheej hmoo ntawm peev.
