Vericiguat

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API lub npe Qhov taw qhia Innovator Patent Expiry Date (Tebchaws Asmeskas)
Vericiguat Lub plawv tsis ua hauj lwm Bayer thiab MSD Tsib.Peb 24, 2031


Product Detail

Khoom cim npe

KHOOM PLIG

Vericiguat yog ibpyrazolopyridineuas yog5-fluoro-1H-pyrazolo[3,4-b]pyridinenyob rau hauv uas cov amino hydrogen ntawm txoj hauj lwm 1 tau hloov los ntawm ib pawg 2-fluorobenzyl thiab covhydrogenntawm txoj hauj lwm 3 tau raug hloov los ntawm 4,6-diamino-5-[(methoxycarbonyl)amino] pyrimidin-2-yl pawg.Nws yog solubleguanylatecyclase stimulator uas yog siv rau kev kho mob plawv tsis ua hauj lwm.Nws muaj lub luag hauj lwm raws li ib tug solubleguanylatecyclase activator, tus neeg sawv cev vasodilator thiab cov tshuaj tiv thaiv kab mob.Nws yog ib qhoaminopyrimidine, apyrazolopyridine, carbamate ester thiab organofluorine compound.

Vericiguat tab tom tshawb nrhiav hauv kev sim tshuaj NCT02861534 (A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)).

Vericiguat yog SolubleGuanylateCyclase Stimulator.Lub mechanism ntawm kev txiav txim ntawm vericiguat yog raws li ib tugGuanylateCyclase Stimulator.

Vericiguat yog ib hom tshuaj siv los tswj thiab kho lub plawv tsis ua hauj lwm nrog txo ejection feem (HFrEF).Nws yog pab tau rau mob plawv tsis ua hauj lwm, tsis ntev los no decompensated plawv tsis ua hauj lwm.Vericiguat tsis ua kom muaj sia nyob ntev tab sis tiv thaiv kev kho mob.Qhov kev ua no qhia txog cov kev qhia, cov txheej txheem ntawm kev ua, koob tshuaj, thiab hom kev tswj hwm los ntawm pab pawg neeg sib koom tes, kev cuam tshuam tsis zoo, contraindications, thiab ntau qhov kev sim los txhawb cov pov thawj ntawm cov tshuaj muaj txiaj ntsig hauv HFrEF.

CERTIFICATE

2018 GMP-2
原料药GMP证书201811(captopril ,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

QUALITY MANAGEMENT

Quality management1

Tswv yim18Quality Consistency Evaluation tej yaam num uas tau pom zoo4, thiab6tej yaam num raug tso cai.

Quality management2

Advanced thoob ntiaj teb kev tswj hwm qhov system tau tso lub hauv paus ruaj khov rau kev muag khoom.

Quality management3

Kev saib xyuas zoo ua haujlwm los ntawm tag nrho lub neej voj voog ntawm cov khoom kom ntseeg tau tias qhov zoo thiab kho cov nyhuv.

Quality management4

Pab Pawg Kev Tswj Xyuas Kev Tswj Xyuas Kev Ua Haujlwm txhawb nqa qhov kev xav tau zoo thaum lub sijhawm thov thiab tso npe.

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