1. Ọganihu ọrụ kachasị ọhụrụ:
Nkwupụta nchịkwa nke paclitaxel eke:
● China CDE:
Na Disemba 13, 2021, emechaala ngwa mgbakwunye CDE (ọkwa CDE kacha ọhụrụ ka egosiri na foto a).na Hande nabatara nyocha nnabata GMP na saịtị nke Yunnan Provincial Food and Drug Administration na Jenụwarị 18-20, 2022. Ebe ọ bụ na CDE agaghịzi enye akwụkwọ nkwado ọ bụla maka ndebanye aha API na ngbanwe nyocha, ọ gaghị enye akwụkwọ nkwado ọ bụla maka nke ahụ. oge, mana enwere ike ịkọwa ya site na nkwadebe na ngwaọrụ.Dị ka nkwenye CDE si dị, biko rụtụ aka na email ngosi mgbanwe maka usoro emetụtara yana mgbanwe ọkọlọtọ..
Mgbe nyocha nke saịtị ahụ gasịrị, Yunnan Hande ga-amaliteghachi azụmaahịa azụmaahịa n'ahịa China.Ụlọ ọrụ gị nwere ike iji ngwaahịa Hande maka nyocha na mmepe, obere ule, ule pilot na iji ụlọ ọgwụ dịka mkpa gị siri dị.Ngwa ngwa nwere ike ikwu ihe Hande CDE ozugbo.
● EU EDQM:
Hande enwetala asambodo CEP na “Akwụkwọ Asambodo maka mbupụ API na EU” (“WC”), ahịa EU amaliteghachila ahịa azụmaahịa gọọmentị.Ọ bụrụ na ụlọ ọrụ gị chọrọ akwụkwọ CEP na akwụkwọ ikike ma ọ bụ ngwaahịa, biko kpọtụrụ anyị n'oge.
● US FDA:
E nyefeela ozi mgbanwe DMF.
● Obodo ma ọ bụ mpaghara ndị ọzọ:
Russia: Ndị ahịa dị ugbu a amalitela ime ka ndebanye aha rụọ ọrụ;
India: Enyere data DMF;
Brazil: DMF data nkwadebe;
Japan: E nyefeela akwụkwọ ndebanye aha;
Australian TGA: Na nkwadebe;
EU GMP: na nkwadebe;
Mba ndị ọzọ ga-etinye akwụkwọ n'otu oge.N'ọdịnihu, Hande ga-enyere ụlọ ọrụ gị aka ịgbasa ahịa atụmatụ mba ụwa.
2. 10-DAB semi-synthetic paclitaxel mmepụta akara:
Mmepụta pilot agwụla ma emechaa nnwale.Ugbu a mee nyocha nyocha na nkwụsi ike dị mma.Atụmatụ mmepụta batch nke 3 ga-amalite na Jenụwarị 2022 ka emechara nrụnye na ntinye nke akụrụngwa.
Atụmatụ ndebanye aha paclitaxel ọkara synthetic 10-DAB:
● China CDE: Akwụkwọ Mba: Y20210000685, a na-eme atụmatụ ịmalite ngwa ahụ na nkeji nke abụọ nke 2022;
● EDQM na FDA: Mee atụmatụ itinye akwụkwọ na nkeji nke anọ nke 2022.
3. Ahịrị nhazi nke izizi:
Site na ọnụ ọgụgụ na-ahụ anya na nlele nlele nke ọtụtụ ntọala ihe ọkụkụ yew, a na-emejuputa atụmatụ ịzụ ahịa kwa afọ site na nnukwu ntọala ihe ọkụkụ 3 iji hụ na ihe akụrụngwa zuru oke nke paclitaxel dị irè.Ihe mmepụta kwa afọ nke 10-DAB bụ 2000kg / afọ, nwere àgwà kwụsiri ike na ogologo oge.
● Ntinye akwụkwọ nchịkwa 10-DAB III:
DMF: Enwetala nọmba DMF.
2. Ozi ndị ọzọ
1. N'ihi ọrịa na-efe efe metụtara, Hande agaghịzi esonye na ngosi CPHI.Iji na-ejere ụlọ ọrụ gị ozi nke ọma, anyị ga-aga n'ihu na-eme nleta ndị ahịa ma na-akwado ọrụ mmepe ahịa nke ụlọ ọrụ gị na ọrụ ka mma.
Oge nzipu: Feb-18-2022