Guobang Pharmaceutical Group Co., Ltd. (tom qab no hu ua "Lub Tuam Txhab") tshaj tawm tias nws tag nrho -tus tswv lag luam, Zhejiang Guobang Pharmaceutical Co., Ltd. (tom qab no hu ua "Zhejiang Guobang"), tau txais lubDaim Ntawv Pom Zoo Pom Zoo rau Kev Lag Luam Daim Ntawv Thov ntawm BlonanserinActive Pharmaceutical Ingredients (API)tso tawm raws li kev pom zoo los ntawm lubNational Medical Products Administration (NMPA)nyob rau lub Peb Hlis 22, 2024.
Cov ntsiab lus tseem ceeb tau tshaj tawm hauv qab no:
I. Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Daim ntawv ceeb toom: 2024YS00232
Txais No.: CYHS2260366
Lub npe ntawm cov tshuaj nquag siv tshuaj (API): Blonanserin
Kev Sau Npe Tus Qauv No. ntawm API: YBY62762024
Lub Sijhawm Siv Tau: 18 lub hlis
Ntim Cov Lus Qhia: 1 kg / nruas, 5 kg / nruas, 10 kg / nruas
Daim ntawv thov khoom: Daim ntawv thov kev lag luam rau hauv teb chaws - tsim cov tshuaj API
Kev Pom Zoo Cov Lus Nug: Raws li covTxoj Cai Tswj Tshuaj Txhaum Cai ntawm Cov Neeg Sawv Cev ntawm Tuam Tshoj, raws li kev tshuaj xyuas, cov khoom no ua raws li cov kev cai tswjfwm kev pom zoo ntawm cov tshuaj siv tshuaj, thiab kev tsim cov khoom no tau pom zoo los ntawm no. Cov txheej txheem zoo, cov ntawv ntim khoom thiab cov txheej txheem tsim khoom yuav tsum tau ua raws li cov ntaub ntawv txuas nrog.
Chaw tsim tshuaj paus: Zhejiang Guobang Pharmaceutical Co., Ltd.
Chaw Nyob Chaw Tsim Khoom: Tsis yog . 6 Weiwu Road, Shangyu Economic & Technological Development Zone, Hangzhou Bay, Zhejiang Province
Lub Sijhawm Muaj Peev Xwm ntawm Daim Ntawv Pom Zoo Pom Zoo: Tag Nrho Lub Peb Hlis 21, 2029
II. Lwm Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Blonanserin yog ib qho tshiab atypical antipsychotic tshuaj, exerting antagonistic los ntawm ob qho tib si dopamine receptors thiab 5-hydroxytryptamine (5-HT) receptors. Nws yog qhia rau kev kho mob schizophrenia. Raws li kev nug, cov tuam txhab loj hauv tsev ntawm Blonanserin API tam sim no suav nrog Zhuhai Free Trade Zone Livzon Synthetic Pharmaceutical Co., Ltd. thiab Hebei Guolong Pharmaceutical Co., Ltd., thiab lwm yam. Cov ntaub ntawv los ntawm PharmaCloud qhia tias lub ntiaj teb noj ntim ntawm Blonanserin API tau nce 26.68% hauv 2021 thiab 17.23% hauv 2022.
