Ngomhla we-12 ku-Okthobha, ngo-2024, i-JYMed's Liraglutide API yafumana isatifikethi esiBhaliweyo sokuQinisekisa (WC), esiphawula inyathelo elibalulekileyo ekuthumeleni ngempumelelo i-API kwimarike ye-EU.
II-WC (isiqinisekiso esibhaliweyo)yimfuneko enyanzelekileyo yokuthunyelwa ngaphandle kwee-API ukusuka kumazwe angengawo awe-EU ukuya kwimarike ye-EU. Ikhutshwe ngugunyaziwe olawulayo welizwe elithumela ngaphandle, esi satifikethi siqinisekisa ukuba i-API ethunyelwa ngaphandle ithobelaUqheliselo oluLungileyo lokuVelisa (GMP)imigangatho esekwe yi-EU. Idlala indima ebalulekileyo ekuqinisekiseni umgangatho kunye nokhuseleko lwe-APIs kwaye ibalulekile kumazwe angengawo e-EU afuna ukufikelela kwimarike ye-EU yamayeza.
Ukwamkelwa kwesatifikethi seWC seLiraglutide API akubonisi nje kuphela ukuvunywa ngokusemthethweni komgangatho kunye nokhuseleko lweemveliso ze-JYMed kodwa ikwanyusa amandla enkampani ekwandiseni ubukho bayo kwimarike ye-EU API. Le mpumelelo yomeleza indawo ye-JYMed kushishino lwamayeza ehlabathi, ibonelela ngamathuba amakhulu ophuhliso kunye nokwandisa isidima sayo kumazwe ngamazwe.
Malunga JYMed
I-Shenzhen JYMed Technology Co., Ltd. (emva koku ebizwa ngokuba yi-JYMed) yasekwa ngo-2009, igxile kuphando, uphuhliso, imveliso, kunye nokuthengiswa kweepeptides kunye neemveliso ezinxulumene ne-peptide. Ngeziko elinye lophando kunye neziseko ezintathu eziphambili zemveliso, i-JYMed yenye yabavelisi abakhulu bee-APIs ze-peptide ezenziwe ngamachiza e-China. Iqela eliphambili lenkampani le-R&D liqhayisa ngaphezulu kweminyaka engama-20 yamava kwishishini le-peptide kwaye liphumelele ngempumelelo uhlolo lwe-FDA kabini. Inkqubo yoshishino ye-peptide ebanzi kunye nesebenzayo ye-JYMed inikezela abathengi uluhlu olupheleleyo lweenkonzo, kubandakanywa uphuhliso kunye nokuveliswa kweepeptide zonyango, iipeptide zezilwanyana, i-antimicrobial peptides, kunye ne-cosmetic peptides, kunye nokubhaliswa kunye nenkxaso yokulawula.
Imisebenzi yoShishino oluPhambili
1.Ubhaliso lwasekhaya kunye nolwamazwe ngamazwe lwe-peptide APIs
2.Izilwanyana zezilwanyana kunye ne-cosmetic peptides
3.Custom peptides kunye CRO, CMO, OEM iinkonzo
Amachiza e-4.PDC (i-peptide-radionuclide, i-peptide-imolekyuli encinci, i-peptide-protein, i-peptide-RNA)
Ukongeza kwi-Tirzepatide, i-JYMed ingenise iifayili zobhaliso kunye ne-FDA kunye ne-CDE kwezinye iimveliso ze-API, kubandakanywa amachiza aziwayo eklasi ye-GLP-1RA njengeSemaglutide kunye neLiraglutide. Abathengi bexesha elizayo abasebenzisa iimveliso ze-JYMed baya kukwazi ukubhekisela ngokuthe ngqo kwinombolo yobhaliso ye-CDE okanye inombolo yefayile ye-DMF xa befaka izicelo zokubhalisa kwi-FDA okanye kwi-CDE. Oku kuya kunciphisa kakhulu ixesha elifunekayo ukulungiselela amaxwebhu ezicelo, kunye nexesha lokuvavanya kunye neendleko zokuphononongwa kwemveliso.
Qhagamshelana nathi
IShenzhen JYMed Technology Co., Ltd.
Idilesi: 8th & 9th Floors, Building 1, Shenzhen Biomedical Innovation Industrial Park, No. 14 Jinhui Road, Kengzi Subdistrict, Pingshan District, Shenzhen
Ifowuni: +86 755-26612112
Iwebhusayithi:http://www.jymedtech.com/
Ixesha lokuposa: Oct-17-2024