Kusintha kwa malo atsopano a Hande

1. Ntchito yaposachedwa:
Kulengeza kwachilengedwe kwa paclitaxel:
● China CDE:
Pa Disembala 13, 2021, ntchito yowonjezera ya CDE yamalizidwa (ma CDE aposachedwa akuwonetsedwa pachithunzichi).ndipo Hande adavomera kuyang'anira kutsata kwa GMP pamalo a Yunnan Provincial Food and Drug Administration pa Januware 18-20, 2022. nthawi ikukhalapo, koma imatha kutchulidwa kale ndi kukonzekera ndi zida.Malinga ndi chivomerezo cha CDE, chonde tumizani ku imelo yodziwitsa zosintha kuti mumve zofananira ndikusintha kokhazikika..
Pambuyo poyang'ana pamalopo, Yunnan Hande ayambiranso kugulitsa malonda pamsika waku China.Kampani yanu ikhoza kugwiritsa ntchito zinthu za Hande pofufuza ndi chitukuko, kuyesa kochepa, kuyesa woyendetsa ndege ndi kugwiritsa ntchito kuchipatala malinga ndi zosowa zanu.Zida zogwiritsira ntchito zitha kutchula mwachindunji zida za Hande CDE.

● EU EDQM:
Hande wapeza chiphaso cha CEP ndi “Chikalata Chopereka Chikalata Chotumiza Ma API ku EU” (“WC”), ndipo msika wa EU wayambiranso kugulitsa zamalonda.Ngati kampani yanu ikufuna satifiketi ya CEP ndi kalata yololeza kapena zinthu, chonde titumizireni munthawi yake.

● US FDA:
Zosintha za DMF zatumizidwa.

● Mayiko kapena zigawo zina:
Russia: Makasitomala omwe alipo ayamba kuyambitsa kulembetsa;
India: Deta ya DMF yatumizidwa;
Brazil: Kukonzekera kwa deta ya DMF;
Japan: Zida zolembetsera zatumizidwa;
TGA ya ku Australia: Pokonzekera;
EU GMP: pokonzekera;
Mayiko ena onse adzagwiritsa ntchito nthawi imodzi.M'tsogolomu, Hande ithandiza kampani yanu kukulitsa msika wapadziko lonse lapansi.

2. 10-DAB semi-synthetic paclitaxel mzere wopanga:
Kupanga oyendetsa ndege kwatha ndipo kuyesa kwatha.Tsopano chitani kafukufuku wabwino ndikuwunika kukhazikika.Dongosolo lopanga batch 3 lotsimikizira batch liyamba mu Januware 2022 kukhazikitsa ndi kutumiza zida kumalizidwa.
10-DAB semi-synthetic paclitaxel regulatory regulatory plan:
● China CDE: Document No.: Y20210000685, ikukonzekera kuyambitsa ntchito mu gawo lachiwiri la 2022;
● EDQM ndi FDA: Konzekerani kuti mupereke fayilo mu kotala yachinayi ya 2022.

3. Pulayimale processing mzere:
Kupyolera mu ziwerengero zapo-pomwepo komanso kuyesa kwachitsanzo kwa madera angapo obzala yew, ndondomeko yogulira zinthu zapachaka yakhazikitsidwa ndi madera atatu odzala mbewu zazikulu kuti awonetsetse kuti paclitaxel pali zopangira zokwanira.Kutulutsa kwapachaka kwa 10-DAB ndi 2000kg / chaka, ndi khalidwe lokhazikika komanso nthawi yayitali.
● 10-DAB III kusungitsa malamulo:
DMF: Nambala ya DMF yapezeka.
2. Zambiri
1. Atakhudzidwa ndi mliriwu, Hande satenga nawo gawo pachiwonetsero cha CPHI.Kuti mutumikire bwino kampani yanu, tipitilizabe kuyendera makasitomala ndikugwirizana ndi ntchito yotukula msika ya kampani yanu ndi ntchito zabwinoko.