Tsis ntev los no, Shandong Xinhua Pharmaceutical Co., Ltd. (tom qab no hu ua "Xinhua Pharmaceutical" los yog "Lub Tuam Txhab") tau txais FDA Registration Approval Letter for Sevelamer Carbonate Active Pharmaceutical Ingredient (tom qab no hu ua "cov khoom"), uas tau raug lees paub los ntawm USF thiab kev lees paub los ntawm Kev Tswj Xyuas Khoom Noj thiab Dr. Cov ntsiab lus tseem ceeb tau tshaj tawm hauv qab no:
I. Cov ntaub ntawv yooj yim
Tshuaj npeTom ntej: Sevelamer Carbonate
Yam tshuaj: Active Pharmaceutical Ingredient (API)
Sau npe Classification: Tshuaj Tshuaj
Tus neeg thov: Shandong Xinhua Pharmaceutical Co., Ltd.
Cov khoom siv: Daim Ntawv Tso Cai Ua Lag Luam rau Cov Tshuaj Synthesized API Ua Hauv Tebchaws
Drug Master File (DMF) Number: 035326
Kev pom zoo xaus: Kev tshuaj xyuas ntawm Drug Master File rau Sevelamer Carbonate API tau ua tiav nrog tsis muaj teeb meem ntxiv, thiab cov khoom raug pom zoo rau kev lag luam.
II. Lwm cov ntaub ntawv ntsig txog
Thaum lub Kaum Ib Hlis 2020, Xinhua Pharmaceutical tau xa DMF ntawm cov khoom mus rau US Food and Drug Administration (FDA) thiab tau txais tus lej sau npe. Thaum Lub Kaum Ib Hlis 2024, Lub Tuam Txhab tau txais tsab ntawv pom zoo sau npe tshuaj, nrog rau kev tshuaj xyuas cov lus pom zoo tias DMF tau pom zoo thiab siv tau.
Sevelamer Carbonate yog qhia rau kev tswj ntawm hyperphosphatemia hauv cov neeg laus cov neeg mob uas muaj kab mob raum ntev (CKD) tab tom lim ntshav. Nws yog ib qho uas tsis yog-absorbable phosphate-binding cross-linked polymer uas tsis muaj calcium lossis lwm yam hlau. Nws adsorbs phosphate nyob rau hauv lub plab zom mov los ntawm kev sib pauv ion, thiab cov complexes tau tawm ntawm cov quav uas tsis muaj kev nqus dej, ua kom muaj kev nyab xeeb siab.
Sevelamer Carbonate Tablets, Ameslikas tsim los ntawm Sanofi Genzyme, tau ua lag luam thiab siv dav hauv ntau tshaj 40 lub teb chaws suav nrog Tebchaws Meskas, Nyiv, Canada thiab cov tebchaws nyob sab Europe. Sevelamer Carbonate tam sim no tsuas yog tom ntej no xwb - tiam phosphate binder tau pom zoo los ntawm US Food and Drug Administration (FDA) uas tsis muaj calcium los yog lwm yam hlau, thiab nws tau pom zoo tsis tu ncua raws li thawj - kab tus neeg sawv cev rau txo phosphate hauv cov txheej txheem kho mob thiab cov qauv hauv tsev thiab txawv teb chaws. Raws li cov ntaub ntawv txheeb cais, qhov ntim thoob ntiaj teb ntawm Sevelamer Carbonate API tau mus txog ntau dua 600 metric tons hauv 12 lub hlis xaus rau lub Peb Hlis 31, 2024.
