On October 12, 2024, JYMed's Liraglutide API obtained the Written Confirmation (WC) certificate, marking a critical step toward the successful export of the API to the EU market.
II-WC (isiqinisekiso esibhaliweyo)yimfuno enyanzelekileyo yokuthumela ngaphandle i-APIs kumazwe angenzi ntengiso kwintengiso ye-EU. Ikhutshwe nguMlawuli oLungelelanisa ilizwe elithumela ngaphandle, esi siqinisekiso siqinisekisa ukuba i-API yathunyelwa i-API ihambelana neIntshukumo yeMveliso elungileyo (GMP)Imigangatho ebekiweyo yi-EU. Idlala indima ebalulekileyo ekuqinisekiseni umgangatho kunye nokhuseleko lwe-APIs kwaye kubalulekile kumazwe angenzi-e-EU efuna ukufikelela kwimarike ye-EU.
Ukufunyanwa kwesiqinisekiso se-WC se-Liraglutide API kungekuphela nje kubonakalisa ukwamkelwa ngokusesikweni komgangatho kunye nokhuseleko lweemveliso ze-JYMED kodwa ukwandisa amandla enkampani ukwandisa ubukho bentengiso ye-EU API. Le mpumelelo yomeleza isikhundla se-jymed kumzi-mveliso wamachiza wehlabathi, ukubonelela ngamathuba okuphuhlisa kunye nokwandisa udumo lwayo lwamazwe aphesheya.
Malunga neJymed
Itekhnoloji ye-Shenzhen Jymed Co., Ltd. (i-LTD. (i-LTD. Ngeziko elinye lophando kunye neziseko ezintathu eziphambili zokuvelisa, i-JYMED yenye yezona ziphambili ze-chepthedles zepeptrides e-China. Iqela leNkampani ye-R & D ineqela elingaphezulu kweminyaka engama-20 kumava kwishishini le-Peptide kwaye iphumelele ngempumelelo uhlolo lwe-FDA kabini. Inkqubo ye-JYmed ye-jipteed elungelelanisiweyo nefanelekileyo ye-Piptide ibonelela ngoluhlu olupheleleyo lweenkonzo, kubandakanya ukuphuhliswa nokuveliswa kwemveliso yonyango, i-Heeterial Poptiides, i-vetronial peptides, kunye nenkxaso kunye nenkxaso yomthetho.
Eyona misebenzi iphambili yeshishini
I-1.OMORECT ITYWARY KUNYE NOBUCHULE BENKONZO
2. I-Pepeties yeZilwanyana yeZilwanyana
3.Cwangcisa isikhuselo kunye ne-cmo, iinkonzo ze-OEM
I-4.PPDC yamachiza (Peptide-Radionuclide, iMolecule encinci, iPiptide-protein, i-Peptide-RNA)
Ukongeza kwi-tirzepatide, i-JYMED ingenise iFilimu yobhaliso nge-FDA kunye neCDDE kwiimveliso ze-API ezininzi, kubandakanya amachiza adumileyo e-GLP-1 nxaxheba ngoku njenge-semaglutide neliraglutide. Abathengi kwixesha elizayo besebenzisa iimveliso zikaJymed baya kuba nakho ukuthengisa ngqo inombolo yobhaliso lwe-CDE okanye inombolo yefayile ye-DMF xa ungenisa izicelo zobhaliso kwi-FDA okanye kwi-CDE. Oku kuya kulinciphisa kakhulu ixesha elifunekayo lokulungiselela amaxwebhu esicelo, kunye nexesha lovavanyo kunye neendleko zoqwalaselo lwemveliso.
Qhagamshelana nathi
Itekhnoloji ye-Shenzhen Jymed Co., Ltd.
Idilesi: I-8th kunye ne-9th Likar, isakhiwo 1, i-shenzhen binzmedical park park, i-14 jinhui yendlela, i-kengmbi subsist, pingshan
Ifowuni: +86501212112
Iwebhusayithi:http://www.jymedtech.com/
IXESHA LOKUQALA: I-OCT-17 ukuya kwi-1724
