Kusukela ngomhla ka-Agasti 26 kuya ku-Agasti 30, 2024, indawo yokukhiqiza i-peptide ye-JYMed, i-Hubei JX Bio-Pharmaceutical Co., Ltd., iphumelele ngempumelelo ukuhlolwa kwendawo okwenziwa yi-US Food and Drug Administration (FDA). Ukuhlola kuhlanganisa izindawo ezibalulekile njengohlelo lwekhwalithi, uhlelo lokukhiqiza, uhlelo lwemishini kanye nendawo, izilawuli zaselabhorethri, kanye nohlelo lokuphatha izinto.
Lokhu kuphawula ukuhlolwa kokuqala kwe-FDA okuphothulwe ngempumelelo yisikhungo sokukhiqiza i-peptide i-Hubei JX. Ngokombiko wokuhlola, ikhwalithi yesikhungo nezinhlelo zokukhiqiza zihlangabezana ngokugcwele namazinga e-FDA.
I-JYMed idlulisa ukubonga kwayo okuqotho kumlingani wayo onamasu, i-Rochem, ngokusekela kwabo okuqhubekayo phakathi nokuhlolwa kwe-FDA okwedlule nokwamanje.
Le mpumelelo isho ukuthi indawo yokukhiqiza i-peptide yakwa-Hubei JX ithobela izidingo ze-FDA zekhwalithi nezinhlelo zokukhiqiza, okuyenza ifanelekele ukungena emakethe yase-US.
Mayelana ne-JYMed
Yasungulwa ngo-2009, i-Shenzhen JYMed Technology Co., Ltd. yinkampani ye-biotechnology egxile ocwaningweni oluzimele, ukuthuthukiswa, ukukhiqizwa, nokudayiswa kwemikhiqizo ye-peptide, kanye ne-peptide yangokwezifiso R&D kanye nezinsizakalo zokukhiqiza. Le nkampani inikeza ama-API we-peptide angaphezu kuka-20, anemikhiqizo emihlanu, kuhlanganise ne-Semaglutide ne-Tirzepatide, eqede ngempumelelo ukufakwa kwe-US FDA DMF.
Isikhungo se-Hubei JX sinemigqa yokukhiqiza eyi-10 yama-peptide API (okuhlanganisa nemigqa yesikali somshayeli) ethobela amazinga e-cGMP ase-US, EU, nase-China. Lesi sikhungo sisebenza ngohlelo olubanzi lokuphatha ikhwalithi yezemithi kanye nohlelo lokuphatha lwe-EHS (Environmental, Health, and Safety). Iphumelele ukuhlolwa okusemthethweni kwe-NMPA kwe-GMP kanye nokuhlolwa kwe-EHS okwenziwa amakhasimende ahamba phambili emhlabeni jikelele.
Amasevisi Abalulekile
1.Ukubhaliswa kwe-API ye-peptide yasekhaya neyamazwe ngamazwe
2.Amapeptide ezilwane nezimonyo
3.Ukwenziwa kwe-peptide yangokwezifiso, i-CRO, i-CMO, nezinsizakalo ze-OEM
4.PDC (Peptide Drug Conjugates), okuhlanganisa i-peptide-radionuclide, i-peptide-molecule encane, i-peptide-protein, kanye ne-peptide-RNA conjugates
Ulwazi lokuxhumana
Ikheli: 8th & 9th Floors, Building 1, Shenzhen Biomedical Innovation Industrial Park, Jin Hui Road 14, Kengzi Street, Pingshan District, Shenzhen, China
Ngemibuzo ye-API yamazwe ngamazwe:
+86-755-26612112 | +86-15013529272
Okwezinto Ezingavuthiwe ze-Domestic Cosmetic Peptide:
+86-755-26612112 | +86-15013529272
Nge-Domestic API Registration kanye ne-CDMO Services:
+86-15818682250
Iwebhusayithi:www.jymedtech.com
Isikhathi sokuthumela: Dec-11-2024