Ulwazi ngeMveliso
Igama:Cabazitaxel
Inombolo yeCAS:183133-96-2
Ifomula yemichiza:C45H57NO14
Iinkcukacha:99%
Umbala:umgubo omhlophe okanye omhlophe
Umthombo:ISemi-synthesized nge-10-DAB
Uhlobo:APIs
Imbali ye-Hande GMP
1. Kwi-1996, inkqubo yomgangatho yasekwa kwaye yafunyanwa i-DMF.
2. Kwi-2004, i-FDA yokuhlola indawo ifumene isatifikethi seCGMP.
3. Ngo-2009, i-semi-synthetic paclitaxel DMF kunye ne-natural paclitaxel CEP yafunyanwa.
4. Ngo-2011, i-semi-synthetic paclitaxel CEP yafunyanwa.
5. Kwi-2012, idlulise ukuhlolwa kwe-TGA kwi-site, yafumana isatifikethi se-GMP, kwaye yadlula i-FDA yokuhlola indawo.
6. Kwi-2013, idlulise indawo yeCGMP.
7. Kwi-2015, i-Indiya yabhaliswa kwaye iJapan yabhaliswa.
Umthamo wemveliso yesandla
Umjikelo wemveliso:30-45 iintsuku.
Ibhetshi yemveliso:ibhetshi enye inokuvelisa malunga ne-15kg.
Umthamo wemveliso yesandla:kukho uluhlu lwempahla kwaye lunokuveliswa ngobuninzi.
Amandla Esandla
Inkampani yeHande ineqela lophando kunye nophuhliso iminyaka emininzi.Iqela lenze isicelo seqela lezinto eziqanjiweyo ezinelungelo elilodwa lomenzi wechiza kwaye lafumana uqhagamshelo lwenkqubo engenamthungo ukusuka elabhoratri ukuya kwimveliso yorhwebo ngobuninzi.Isiseko semveliso ye-GMP esakhiweyo siye saphumelela ngokulandelelana uphononongo lolawulo lwe-US FDA, EU EDQM, China GMP, Japan PMDA, Australia TGA, South Korea, India, Taiwan, China, Türkiye, Russia, SGS, Dun&Bradstreet, njl. kwangelo xesha, inkampani ixhotyiswe ngeqela lophando kunye nophuhliso kwaye ifumene amalungelo awodwa abenzi ngokulandelelanayo.Igumbi lokuvavanya i-QC, ukuqonda kakhulu uvavanyo lweprojekthi yemveliso.
Iinkonzo zethu
1.Iimveliso:Ukubonelela ngomgangatho ophezulu, izicatshulwa zezityalo ezisulungekileyo, imathiriyeli ekrwada yamayeza, kunye nabaphakathi bamayeza.
2.Iinkonzo zobugcisa:Izicatshulwa ezenziwe ngokwezifiso ezineenkcazo ezizodwa ngokweemfuno zabathengi.
Yiba ngoyena mthengisi ubalaseleyo wezinto ezikrwada kunye namashishini anentembeko!
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