Posachedwapa, Shenzhen JYMed Technology Co., Ltd. (pambuyo pake amatchedwa "JYMed") yamaliza bwino mafayilo a Drug Master File (DMF) pazinthu zina zisanu ndi bungwe la US Food and Drug Administration (FDA), likukulitsanso mbiri yake ya mankhwala.
ZA JYMED
JYMed ndi kampani yaukadaulo yaukadaulo ya biopharmaceutical yomwe imagwira ntchito pa kafukufuku wodziyimira pawokha, chitukuko, kupanga, ndi kugulitsa zinthu zopangidwa ndi peptide, komanso ntchito zopanga makontrakiti ndi mabungwe opanga (CDMO). Kampaniyo yadzipereka kupereka ma API apamwamba kwambiri a peptide ndi mayankho makonda kwa makasitomala apadziko lonse lapansi. Zogulitsa zake zimaphatikizapo ma API angapo a peptide, okhala ndi zinthu zoyambira monga Semaglutide ndi Terlipressin atamaliza kale zolemba za US FDA DMF.
Kampani yake yocheperapo, Hubei JXBio Pharmaceutical Co., Ltd., imagwiritsa ntchito mizere yopangira peptide API yotsogola yomwe imagwirizana ndi mfundo za cGMP zokhazikitsidwa ndi US FDA, European EMA, ndi NMPA yaku China. Malowa ali ndi mizere 10 yayikulu komanso yoyendetsa ndege ndipo yakhazikitsa dongosolo lokhazikika lazamankhwala (QMS) komanso dongosolo loyang'anira zaumoyo ndi chitetezo (EHS). Izi zimawonetsetsa kuti ntchito yonse, kuyambira pa R&D mpaka kupanga, ikukwaniritsa miyezo yapamwamba kwambiri padziko lonse lapansi. Kampaniyo yadutsa bwino pakuwunika kwa GMP kochitidwa ndi US FDA ndi NMPA yaku China ndipo yadziwika ndi makampani otsogola padziko lonse lapansi chifukwa cha kayendetsedwe kabwino ka EHS, kuwonetsa kudzipereka kwake pakusamalira bwino, chitetezo, komanso udindo wa chilengedwe.
Magawo Amabizinesi Akuluakulu:Kulembetsa ndi kutsatira API ya peptide yapadziko lonse lapansi,Zowona Zanyama ndi zodzikongoletsera,Mapulogalamu amtundu wa peptide, kuphatikiza CRO, CMO, ndi OEM mayankho,Peptide-drug conjugates (PDCs), kuphatikiza peptide-radionuclide, peptide-yaing'ono molekyulu, peptide-mapuloteni RNA, ndi peptide-protein RNA.
ZOPHUNZITSA ZABWINO
Kuti mumve zambiri pazogulitsa zathu, lemberani.
Mafunso a Global API ndi Zodzikongoletsera: Tel No.: +86-15013529272;
Kulembetsa kwa API & Ntchito za CDMO (msika wa USA EU): +86-15818682250
Imelo:jymed@jymedtech.com
Address: Pansi 8 & 9, Building 1, Shenzhen Biomedical Innovation Industrial Park, 14 Jinhui Road, Kengzi Subdistrict, Pingshan District, Shenzhen
Nthawi yotumiza: Mar-25-2025




