Ngomhla ziyi-12 kuMfumfu, 2024, i-JYMed's Liraglutide API yathola isitifiketi Sokuqinisekisa Okubhaliwe (WC), okumaka isinyathelo esibalulekile sokuthunyelwa ngempumelelo kwe-API emakethe ye-EU.
II-WC (Isiqinisekiso Esibhaliwe)kuyimfuneko eyisibopho yokuthunyelwa kwama-API ukusuka emazweni angewona awe-EU ukuya emakethe ye-EU. Sikhishwe isiphathimandla esilawulayo sezwe elithumelayo, lesi sitifiketi siqinisekisa ukuthi i-API ethunyelwe ithobelanaUmkhuba Omuhle Wokukhiqiza (GMP)amazinga abekwe yi-EU. Idlala indima ebalulekile ekuqinisekiseni ikhwalithi nokuphepha kwama-API futhi ibalulekile emazweni angewona awe-EU afuna ukufinyelela emakethe yemithi ye-EU.
Ukwamukelwa kwesitifiketi se-WC se-Liraglutide API akubonisi nje kuphela ukuqashelwa okusemthethweni kwekhwalithi nokuphepha kwemikhiqizo ye-JYMed kodwa futhi kuthuthukisa amandla enkampani okwandisa ubukhona bayo emakethe ye-EU API. Le mpumelelo iqinisa isikhundla se-JYMed embonini yezemithi yomhlaba wonke, ihlinzeka ngamathuba amakhulu entuthuko futhi yandise isithunzi sayo samazwe ngamazwe.
Mayelana ne-JYMed
I-Shenzhen JYMed Technology Co., Ltd. (ngemuva kwalokhu ebizwa ngokuthi i-JYMed) yasungulwa ngo-2009, igxile ocwaningweni, ekuthuthukisweni, ekukhiqizeni nasekuthengisweni kwama-peptide nemikhiqizo ehlobene ne-peptide. Ngesikhungo esisodwa socwaningo kanye nezisekelo zokukhiqiza ezintathu ezinkulu, i-JYMed ingomunye wabakhiqizi abakhulu bama-API e-peptide ahlanganiswe ngamakhemikhali e-China. Ithimba eliyinhloko lenkampani le-R&D liziqhayisa iminyaka engaphezu kwengu-20 yesipiliyoni embonini ye-peptide futhi seliphumelele ukuhlolwa kwe-FDA kabili. Uhlelo lwe-JYMed lwezimboni ze-peptide olubanzi futhi olusebenzayo lunikeza amakhasimende uhla olugcwele lwezinsizakalo, okuhlanganisa ukuthuthukiswa nokukhiqizwa kwama-peptide okwelapha, ama-peptide ezilwane, ama-antimicrobial peptides, nama-cosmetic peptides, kanye nokubhaliswa nokusekelwa kokulawula.
Imisebenzi Yebhizinisi Eyinhloko
1.Ukubhaliswa kwasekhaya nokwamazwe ngamazwe kwe-peptide APIs
2.Amapeptide ezilwane nezimonyo
3.Ama-peptide angokwezifiso kanye nezinsizakalo ze-CRO, CMO, OEM
Izidakamizwa ze-4.PDC (i-peptide-radionuclide, i-molecule ye-peptide-encane, i-peptide-protein, i-peptide-RNA)
Ngokungeziwe ku-Tirzepatide, i-JYMed ithumele imibhalo yokubhalisa ne-FDA kanye ne-CDE kweminye imikhiqizo embalwa ye-API, okuhlanganisa nezidakamizwa ezidumile njengamanje zekilasi le-GLP-1RA njenge-Semaglutide ne-Liraglutide. Amakhasimende azayo asebenzisa imikhiqizo ye-JYMed azokwazi ukubhekisela ngokuqondile inombolo yokubhalisa ye-CDE noma inombolo yefayela le-DMF lapho ethumela izicelo zokubhalisa ku-FDA noma ku-CDE. Lokhu kuzonciphisa kakhulu isikhathi esidingekayo sokulungiselela imibhalo yesicelo, kanye nesikhathi sokuhlola kanye nezindleko zokubuyekezwa komkhiqizo.
Xhumana nathi
I-Shenzhen JYMed Technology Co., Ltd.
Ikheli: 8th & 9th Floors, Building 1, Shenzhen Biomedical Innovation Industrial Park, No. 14 Jinhui Road, Kengzi Subdistrict, Pingshan District, Shenzhen
Ucingo: +86 755-26612112
Iwebhusayithi:http://www.jymedtech.com/
Isikhathi sokuthumela: Oct-17-2024