Hubei JXBio Pharmaceutical Co., Ltd., malo opangira ma peptide odzipatulira a JYMed, adamaliza kuyenderanso pamalopo ndi US Food and Drug Administration (FDA) kuyambira pa Marichi 10-14. Kuyang'aniraku, komwe ndi gawo la kafukufuku wa Drug Quality Assurance, kudawunikira machitidwe akuluakulu kuphatikiza mtundu, kupanga, zida ndi zida, zowongolera ma lab, ndi kasamalidwe ka zinthu. Ma API omwe adawunikira adaphatikizapo Liraglutide, Semaglutide, Tirzepatide, ndi Oxytocin.

Kutsatira kuwunikaku, a FDA adapereka lipoti lovomerezeka la Establishment Inspection Report (EIR), kutsimikizira kuti ntchito za Hubei JXBio zimakwaniritsa miyezo yapamwamba ya bungweli pazabwino komanso kutsata.

Ichi ndi kuyendera kwachiwiri motsatizana kwa FDA komwe kunachitika ndi malo athu a Hubei, kutsimikiziranso kudzipereka kwathu pakupanga makina apamwamba kwambiri padziko lonse lapansi. Imatseguliranso njira yolembetsa bwino zinthu padziko lonse lapansi ndikulimbitsa malo athu pamsika wapadziko lonse wa peptide.

Za JYMed

JYMed ndi kampani yapamwamba kwambiri yopanga mankhwala yomwe imagwira ntchito pa kafukufuku, chitukuko, kupanga, ndi malonda a zinthu zopangidwa ndi peptide. Timaperekanso ntchito zomaliza mpaka-mapeto za CDMO, zopereka mayankho ogwirizana a peptide kwa makasitomala amankhwala, zodzoladzola, ndi azanyama padziko lonse lapansi.

Zogulitsa zathu zili ndi ma peptide API ambiri. Zogulitsa zamtundu wamtundu monga Semaglutide ndi Terlipressin zakwaniritsa bwino US FDA DMF file.

Wothandizira wathu wathunthu, Hubei JXBio, amagwiritsa ntchito mizere yopangira peptide API yopangidwa kuti ikwaniritse miyezo ya cGMP yokhazikitsidwa ndi US FDA ndi NMPA yaku China. Malowa ali ndi mizere yopangira 10 yayikulu komanso yoyendetsa ndege, mothandizidwa ndi dongosolo lokhazikika lazamankhwala (QMS) komanso pulogalamu yolimba yaumoyo ndi chitetezo (EHS).

JXBio yadutsa kuwunika kwa GMP ndi US FDA ndi NMPA yaku China ndipo imadziwika ndi makampani opanga mankhwala padziko lonse lapansi chifukwa chochita bwino mu kasamalidwe ka EHS, kuwonetsa kudzipereka kwathu kosasunthika pazabwino, chitetezo, komanso kusunga chilengedwe.

Magawo a Bizinesi Yapakati

• Kulembetsa padziko lonse lapansi ndi kutsata malamulo a peptide API

• Zanyama ndi zodzikongoletsera peptide mankhwala

• Kupanga ndi kupanga ma peptide (CRO, CMO, OEM)

• Peptide-drug conjugates (PDCs), kuphatikizapo:

• Peptide-radionuclide conjugates

• Peptide-mamolekyu ang'onoang'ono

• Peptide-protein conjugates

• Peptide-RNA Therapeutics

ZOPHUNZITSA ZABWINO

Kuti mudziwe zambiri za malonda athu, chonde titumizireni:

Mafunso a Global API ndi Zodzikongoletsera: +86-150-1352-9272

Kulembetsa kwa API & Ntchito za CDMO (misika yaku US ndi EU): +86-158-1868-2250

Imelo:jymed@jymedtech.com

Address: Pansi 8 & 9, Nyumba 1, Shenzhen Biomedical Innovation Industrial Park,

14 Jinhui Road, Kengzi Subdistrict, Pingshan District, Shenzhen, China