Tsis ntev los no, Fujian Haixi United Pharmaceutical Co., Ltd. (tom ntej no hu ua "Haixi Pharmaceutical"), ib lub tuam txhab ntawm Zhejiang Anglikang Pharmaceutical Co., Ltd.Daim ntawv ceeb toom kev pom zoo rau kev lag luam daim ntawv thov ntawm cov tshuaj active tshuaj muaj tshuajnyob rau hauv kev hwm ntawm Sevoflurane API los ntawm National Medical Products Administration (tom qab no hu ua "NMPA") (Kev Ceeb Toom No.: 2023YS00345). Cov ntaub ntawv cuam tshuam tau tshaj tawm hauv qab no:
1. Cov Lus Qhia Txog Tshuaj
Sau npe No.:Y20210001124
Lub npe ntawm Tshuaj Active Pharmaceutical Ingredient:Sevoflurane
Ntim Cov Lus Qhia: 200kg; 220 kg; 240 kg; 250 kg; 260 kg; 280 kg; 300 kg
Chaw tsim tshuaj paus: Lub npe: Fujian Haixi United Pharmaceutical Co., Ltd. Chaw Nyob: Tsis yog . 15, Zone D, Economic Development Zone, Mingxi County, Fujian Province
Daim Ntawv Pom Zoo Pom Zoo: Raws li qhovPharmaceutical Administration Law of the People's Republic of China, raws li kev tshuaj xyuas, cov khoom no ua raws li cov kev cai cuam tshuam rau kev pom zoo ntawm cov tshuaj generic. Kev tsim cov khoom no tau pom zoo. Cov qauv zoo, cov ntawv ntim khoom thiab cov txheej txheem tsim khoom yuav tsum tau ua raws li cov ntawv txuas.
Lub Sijhawm Siv Tau ntawm Daim Ntawv Ceeb Toom Pom Zoo: Txog Lub Rau Hli 13, 2028
2. Lwm cov ntaub ntawv ntsig txog cov tshuaj
Sevoflurane yog ib qhoinhaled tshuaj loogAmeslikas tshawb fawb thiab tsim los ntawm Maruishi Pharmaceutical Co., Ltd. ntawm Nyiv. Nws cov ntawv sau ua tiav hauv qab yog qhia rau induction thiab kev saib xyuas ntawm kev siv tshuaj loog hauv cov neeg laus thiab menyuam yaus, siv tau rau cov neeg mob hauv tsev thiab cov neeg mob sab nraud.
Haixi Pharmaceutical tau xa daim ntawv thov sau npe tshuaj rau Sevoflurane API thaum Lub Kaum Ob Hlis 2021, uas tau txais.
Tom qab ua tiav cov kev tshuaj xyuas los ntawm Lub Chaw Saib Xyuas Tshuaj Ntsuam Xyuas Tshuaj (CDE) thiab tau txais kev pom zoo los ntawm NMPA, Sevoflurane API tseem raug tshaj tawm rau pej xeem ntawm ib qho"Compliant" resultlos ntawm GMP kev soj ntsuam xyuas los ntawm Fujian Medical Products Administration ua ntej nws tuaj yeem tsim thiab muag hauv Suav teb.
