1. Kufambira mberi kwebasa kwazvino:
Regulatory declaration of natural paclitaxel:
● China CDE:
Musi waZvita 13, 2021, iyo CDE yekuwedzera application yakapedzwa (iyo yazvino CDE chimiro inoratidzwa mupikicha).uye Hande akagamuchira GMP pa-site yekuteerera kuongororwa kweYunnan Provincial Food and Drug Administration muna Ndira 18-20, 2022. Sezvo CDE isingachabudisi chero magwaro emvumo yekunyoresa API uye shanduko yekuongorora, haizobudisi chero magwaro anotsigira eiyo nguva iripo, asi inogona kutotaridzirwa nekugadzirira uye zvishandiso.Zvinoenderana nemvumo yeCDE, ndapota tarisa kune iyo shanduko yekuzivisa email kune yakabatana maitiro uye yakajairwa shanduko..
Mushure mekuongororwa kwepa-saiti, Yunnan Hande anotangazve kutengesa zvekutengesa mumusika weChinese.Kambani yako inogona kushandisa zvigadzirwa zveHande kutsvagisa nekusimudzira, bvunzo diki, bvunzo yekutyaira uye kushandiswa kwekiriniki zvinoenderana nezvaunoda.Zvishandiso zvekushandisa zvinogona kutora zvakananga Hande CDE zvinhu.
● EU EDQM:
Hande atora chitupa cheCEP uye “Chitupa Chekuburitsa MaAPI kuEU” (“WC”), uye musika weEU watangazve kutengesa zviri pamutemo.Kana kambani yako ichida CEP chitupa uye mvumo tsamba kana zvigadzirwa, ndapota taura nesu nenguva.
● US FDA:
Iyo DMF shanduko yeruzivo yaendeswa.
● Dzimwe nyika kana matunhu:
Russia: Vatengi varipo vatanga kumisa kunyoreswa;
India: DMF data yakatumirwa;
Brazil: DMF data kugadzirira;
Japan: Zvinyorwa zvekunyoresa zvakaendeswa;
TGA yeAustralia: Mukugadzirira;
EU GMP: mukugadzirira;
Dzimwe nyika dzese dzichashanda panguva imwe chete.Mune ramangwana, Hande ichabatsira kambani yako kuwedzera musika wepasi rose.
2. 10-DAB semi-synthetic paclitaxel mutsara wekugadzira:
Kugadzirwa kwePilot kwapera uye kuyedzwa kwapera.Iye zvino ita tsvagiridzo yemhando yepamusoro uye kuongorora kugadzikana.Iyo 3 batch yekuongorora batch yekugadzira chirongwa ichatanga muna Ndira 2022 mushure mekugadzwa uye kutumirwa kwemidziyo kwapera.
10-DAB semi-synthetic paclitaxel regulatory kunyoresa chirongwa:
● China CDE: Gwaro Nhamba: Y20210000685, inorongwa kutanga kushandiswa muchikamu chechipiri che2022;
● EDQM neFDA: Ronga kufaira muchikamu chechina cha2022.
3. Mutsara wekutanga wekugadzirisa:
Kuburikidza nen-on-the-spot statistics uye sampling kuyedzwa kwemabhesi akawanda ekudyara yew, chirongwa chegore negore chekutenga chakaitwa nemabhesi matatu makuru ekudyara kuitira kuti ive nechokwadi chekuwaniswa kwezvinhu zvakaringana zvehuwandu hunoshanda hwepaclitaxel.Kubuda kwegore negore kwe10-DAB ndeye 2000kg / gore, nemhando yakagadzikana uye kwenguva refu.
● 10-DAB III faira remutemo:
DMF: Nhamba yeDMF yawanikwa.
2. Mamwe mashoko
1. Yabatwa nedenda, Hande haichapindi mushoo yeCPHI.Kuti ushandire kambani yako zvirinani, isu ticharamba tichishanya nevatengi uye tichishandira pamwe nebasa rekambani yako rekusimudzira musika nemasevhisi ari nani.
Nguva yekutumira: Feb-18-2022