Izindaba Ezijabulisayo | Isikhungo Sokukhiqiza esikhulu saseSemaglutide API esikhulu kunazo zonke sidlula ukuhlolwa kwe-US FDA

Kusukela ngo-Agasti 26 kuya ku-Agasti 30, 2024, indawo yokukhiqiza i-jymed's Peptide, i-Hubei Jx Bio-Pharmaceutical Co, Ltd. Lezi zindawo ezihlongozwayo eziwukhiye ongezansi njengohlelo lwekhwalithi, uhlelo lokukhiqiza, uhlelo lwe-Equipment kanye neSikhungo Sendawo, Izilawuli Zelebhu, kanye noHlelo Lokuphathwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezinto Zokwenziwa Kwezezimali.

Lokhu kubhala ukuhlolwa kwe-FDA lokuqala okuqedwe ngempumelelo yiHubei Jx Peptide Production Center. Ngokombiko wokuhlola, ikhwalithi yekhwalithi kanye nezinhlelo zokukhiqiza ihlangabezana naka-FDA amazinga e-FDA.

UJymed udlulisa ukubonga kwawo okuqotho kumlingani wayo onamasu, iRochem, ngokusekelwa kwawo okuqhubekayo ngokuhlolwa kwayo okwedlule nokwethulwa kwe-FDA.

Lokhu kufinyelelwa kukhombisa ukuthi lesi sikhungo sokukhiqiza se-Hubei Jx's Peptide sinamathela kwizidingo ze-FDA zekhwalithi yekhwalithi nezinhlelo zokukhiqiza, zikufanelekele ukungena emakethe yase-US.

Mayelana noJymed

Yasungulwa ngonyaka ka-2009, iShenzhen Jment Technology Co, Ltd. iyinkampani ye-biotechnology egxile ocwaningweni oluzimele, ukuthuthukiswa, ukukhiqizwa kanye nokuthengiswa kwemikhiqizo ye-peptide, kanye nezinsizakalo zokukhiqiza. Le nkampani inikezela ngama-apis ama-peptide angaphezu kwama-20, anemikhiqizo emihlanu, kufaka phakathi i-semaglutide ne-tirezepatide, ekuqedeni ngempumelelo ukugcwaliswa kwe-FDA DMF.

I-Hubei JX Facility ifaka imigqa engu-10 yokukhiqiza ama-peptide APIs (kufaka phakathi imigqa yezindiza yezindiza) ehambisana namazinga we-CGMP we-US, eU, neChina. Lesi sikhungo sisebenza uhlelo lokuphathwa kwekhwalithi oluphelele lwekhwalithi kanye ne-EHS (Ezemvelo, Ezempilo, kanye nezokuphepha). Idlulise ukuhlolwa kwe-NMPA GMP esemthethweni kanye nokucwaningwa kwamabhuku kwe-EHS okwenziwe ngamakhasimende omhlaba aholayo.

Izinsizakalo Eziyisisekelo

Ukubhaliswa kwe-ONEPTIDE ye-OnePherdom
Ama-ceptides angama-2.vetetic kanye nama-cosmetic
3.Custom Peptide Synthesis, Cro, CMO, kanye nezinsizakalo ze-OEM
I-4.PDC (izimboni zezidakamizwa ze-peptide), kufaka phakathi i-peptide-radionuclide, i-peptide-molecuclide, i-molecule encane, amaprotheni we-peptide-rna, kanye nama-peptide-rna ahlangana