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Ngo-Okthoba 12, 2024, i-Liraglutide's Liraglutide API yathola isitifiketi esibhaliwe (WC), ukumaka igxathu elibucayi ekuthekelweni okuphumelelayo kwe-API kuya emakethe ye-EU.

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Le khasiI-WC (isiqinisekiso esibhaliwe)Ingabe imfuneko eyisibopho yokuthumela ngaphandle kwama-API avela emazweni angewona ama-EU aya emakethe ye-EU. Ekhishwe yigunya elilawulayo lezwe elithumela ngaphandle, lesi sitifiketi siqinisekisa ukuthi i-API ethunyelwayo ihambisana neUkusebenza okuhle kokukhiqiza (GMP)amazinga abekwe yi-EU. Idlala indima ebalulekile ekuqinisekiseni ikhwalithi nokuphepha kwama-API futhi kubalulekile emazweni angewona ama-EU afuna ukufinyelela emakethe yemithi ye-EU.

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Ukutholwa kwesitifiketi se-WC seLiraglutide API kungakhombisi ukuqashelwa okusemthethweni kwekhwalithi nokuphepha kwemikhiqizo yeJymed kodwa futhi kuthuthukisa amandla enkampani yokwandisa ubukhona bayo eMakethe ye-EU API. Lokhu kufinyelelwa kuqinisa isikhundla sikaJyme embonini yezemithi yomhlaba, ukuhlinzeka ngamathuba amaningi entuthuko futhi kwandise idumela laso laphesheya.

Mayelana noJymed

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I-Shenzhen jymed Technology Co, Ltd. (Laqishefethi okukhulunywa ngayo njengoba uJymed) yasungulwa ngo-2009, enakekela ocwaningweni, ekuthuthukisweni, ekukhiqizeni nasekuthengisweni kwemikhiqizo ehlobene ne-pepttide. Ngama-One Research Center kanye nezisekelo ezintathu ezinkulu zokukhiqiza, i-jymed ingenye yezisebenzi ezinkulu kakhulu zamakhemikhali enzelwe amakhemikhali we-peptide apes in China. Iqembu le-Core R & D liqhosha iminyaka engaphezu kwengu-20 yesipiliyoni embonini ye-pepttide futhi selidlule ngempumelelo ukuhlolwa kwe-FDA kabili. Uhlelo oluphelele lwe-Pepment oluphelele nolusebenzayo lwe-Peptide lwe-Weeptide lunikeza amakhasimende uhla oluphelele lwezinsizakalo, kufaka phakathi ukuthuthukiswa kwama-peptides zokwelapha, ama-peptides wezilwane, ama-antimicrobial ama-peptides, kanye nokubhalisa kanye nokusekelwa kokubhaliswa.

Imisebenzi Eyinhloko Yebhizinisi

Ukubhaliswa kwe-1.domatoristic kanye namazwe aphesheya kwama-peptide apis

Ama-ceptides angama-2.vetetic kanye nama-cosmetic

3.Custom Peptides kanye ne-CRO, CMO, OEM Services

Izidakamizwa ze-4.PDC (i-peptide-radionuclide, i-pottide-molecule-molecule encane, i-peptide-protein, i-peptide-rna)

Ngaphezu kwe-TirzePatide, uJymed uhambise imidwebo yokubhalisa nge-FDA ne-CDE ngeminye imikhiqizo eminingana ye-API, kufaka phakathi izidakamizwa ezithandwayo ze-API ezithandwayo njengamanje njenge-semaglutide ne-liraglutide. Amakhasimende esikhathi esizayo asebenzisa imikhiqizo kaJymed's azokwazi ukubheka ngqo inombolo yokubhaliswa kwe-CDE noma inombolo yefayela le-DMF lapho uhambisa izinhlelo zokubhalisa ku-FDA noma i-CDE. Lokhu kuzonciphisa kakhulu isikhathi esidingekayo sokulungiselela amadokhumenti okusebenzisa, kanye nesikhathi sokuhlola kanye nezindleko zokubuyekezwa komkhiqizo.

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Xhumana nathi

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I-Shenzhen jymed Technology Co, Ltd.

Ikheli: Izitezi ze-8 & 9th, zokwakha 1, iShenzhen Biomedical Innovation Industrial Park, No. 14 Jinhui Road, Kengzi Subribistre, Pingzhen
Ucingo: +86 755-26612112
Iwebhusayithi:http://www.jymedtech.com/


Isikhathi Sokuthumela: Oct-17-2024
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