Guang'an Kate Pharmaceutical Co., Ltd. (tom qab no hu ua "Guang'an Kate"), ib qho tag nrho -tus tswv lag luam ntawm Fuan Pharmaceutical (Group) Co., Ltd. (tom qab no hu ua "Lub Tuam Txhab"), tsis ntev los no tau txais Daim Ntawv Ceeb Toom Pom Zoo rau Kev Lag Luam Kev Tso Cai Ua Lag Luam Hauv Tebchaws Cov Khoom Siv Tshuaj Siv Tshuaj Administration.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 |
|---|---|---|---|---|
| Lipoic acid | Y20210000898 | Guang'an Kate | 15kg / nruas | Tom qab kev tshuaj xyuas, cov khoom no ua raws li cov kev cai rau kev sau npe tshuaj, thiab daim ntawv thov kev tsim khoom thiab kev tso npe rau cov khoom no tau pom zoo. |
| Palonosetron Hydrochloride | Y20210000631 | Guang'an Kate | 500g / nruas | Tom qab kev tshuaj xyuas, cov khoom no ua raws li cov kev cai rau kev sau npe tshuaj, thiab daim ntawv thov kev tsim khoom thiab kev tso npe rau cov khoom no tau pom zoo. |
Lipoic acid feem ntau yog siv rau kev kho mob ntawm kev hnov mob txawv txav los ntawm ntshav qab zib peripheral neuropathy. Palonosetron hydrochloride yog tshuaj antiemetic.
Raws li cov ntaub ntawv platform ntawm National Medical Products Administration (NMPA), txog rau tam sim no, tag nrho ntawm 14 lub tuam txhab tau txais kev pom zoo rau kev lag luam tso cai daim ntawv thov lipoic acid ua cov khoom siv tshuaj nquag (API), thiab 20 lub tuam txhab tau txais kev pom zoo rau palonosetron hydrochloride ua API.
Qhov kev pom zoo ntawm cov saum toj no -hais APIs yuav tso cai rau lawv siv rau hauv kev npaj ua lag luam hauv tsev thiab ntxiv dag zog rau cov khoom lag luam ntawm lub tuam txhab.
Txawm li cas los xij, cuam tshuam los ntawm cov xwm txheej xws li kev nce qib ntawm kev soj ntsuam kev ua raws li GMP, lub teb chaws cov cai, thiab kev hloov pauv hauv kev lag luam ib puag ncig, kev tsim khoom thiab kev muag khoom raws li kev muag khoom tshwj xeeb ntawm cov saum toj no - APIs tau hais txog yuav raug tsis paub meej.
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.
