Kutshanje, i-Shenzhen JYMed Technology Co., Ltd. (emva koku ebizwa ngokuba yi-"JYMed") igqibe ngempumelelo iifayili zeDrug Master File (DMF) kwiimveliso ezongezelelweyo ezintlanu kunye noLawulo lwezoKutya kunye neziyobisi lwase-US (FDA), yandisa ngakumbi ipotifoliyo yayo yemveliso.
NGOJYMED
I-JYMed yinkampani ye-biopharmaceutical yobuchwepheshe obuphezulu obukhethekileyo kuphando oluzimeleyo, uphuhliso, ukuveliswa, kunye nokuthengiswa kweemveliso ezisekelwe kwi-peptide, kunye nophuhliso lwekhontrakthi kunye neenkonzo zentlangano yokuvelisa (CDMO). Inkampani izimisele ukubonelela nge-peptide APIs ezikumgangatho ophezulu kunye nezisombululo ezilungiselelwe abathengi behlabathi. Ipotfoliyo yayo yemveliso ibandakanya uninzi lwee-APIs ze-peptide, kunye neemveliso eziphambili ezifana ne-Semaglutide kunye ne-Terlipressin sele zigqibile ukufakwa kwe-US FDA DMF.
I-subsidiary yayo, i-Hubei JXBio Pharmaceutical Co., Ltd., isebenzisa imizila yemveliso ye-peptide ye-API ehambelana nemigangatho ye-cGMP ebekwe yi-US FDA, i-EMA yaseYurophu, kunye ne-NMPA yaseTshayina. Eli ziko libandakanya i-10 enkulu kunye nemigca yemveliso eyi-pilot kwaye iseke inkqubo engqongqo yolawulo lomgangatho wamachiza (QMS) kunye nenkqubo yokulawula impilo yendalo kunye nokhuseleko (EHS). Ezi ziqinisekisa ukuba yonke inkqubo, ukusuka kwi-R&D ukuya kwimveliso, ihlangabezana neyona migangatho iphezulu yamazwe ngamazwe. Inkampani iphumelele ngempumelelo uhlolo lokuthotyelwa kwe-GMP yi-FDA yase-US kunye ne-NMPA yase-China kwaye yamkelwe ziinkampani ezikhokela amayeza zehlabathi ngokugqwesa kolawulo lwe-EHS, ebonisa ukuzinikela kwayo okubalaseleyo kumgangatho, ukhuseleko, kunye noxanduva lokusingqongileyo.
IiNdawo zoShishino ezingundoqo:Ubhaliso kunye nokuthotyelwa kwe-API yeepeptide zasekhaya nezamazwe ngamazwe, iipeptide zezilwanyana nezokuthambisa,Iinkonzo ze-peptide zesiko, kuquka izisombululo ze-CRO, i-CMO, kunye ne-OEM,i-Peptide-drug conjugates (PDCs), kuquka i-peptide-radionuclide, i-peptide-encinci imolekyuli, i-peptide-protein ye-RNA, kunye ne-peptide-protein RNA.
IIMVELISO EZIPHAMBILI
Ukuze ufumane iinkcukacha ezithe vetshe kwiimveliso zethu, nceda uqhagamshelane nathi.
I-Global API kunye nemibuzo ye-Cosmetic: Inombolo yomnxeba: + 86-15013529272;
Ubhaliso lwe-API kunye neeNkonzo ze-CDMO (imarike yase-USA EU): +86-15818682250
I-imeyile:jymed@jymedtech.com
Idilesi: Umgangatho 8 & 9, isakhiwo 1, Shenzhen Biomedical Innovation Industrial Park, 14 Jinhui Road, Kengzi Subdistrict, Pingshan District, Shenzhen
Ixesha lokuposa: Mar-25-2025




