Tsis ntev los no, Beijing Fuyuan Pharmaceutical Co., Ltd. (tom qab no hu ua "Lub Tuam Txhab") tau txais "Daim Ntawv Pom Zoo rau Kev Tso Cai Ua Lag Luam Daim Ntawv Thov Kev Siv Tshuaj Siv Tshuaj (API)" rau Meglumine API, raug pom zoo thiab muab los ntawm National Medical Products Administration (NMPA) ntawm Cov Neeg Sawv Cev ntawm Tuam Tshoj.
I. Lwm cov ntaub ntawv ntsig txog API
Thaum Lub Xya Hli 2023, daim ntawv thov kev tshuaj xyuas txog Meglumine API xa los ntawm Lub Tuam Txhab rau NMPA tau txais. Tsis ntev los no, Lub Tuam Txhab tau txais "Daim Ntawv Ceeb Toom Pom Zoo rau Kev Tso Cai Ua Lag Luam Daim Ntawv Thov Kev Siv Tshuaj API" los ntawm NMPA. Cov xwm txheej sau npe ntawm API no ntawm Lub Chaw Rau Kev Ntsuas Tshuaj (CDE) Cov Khoom Siv, APIs thiab Cov Ntaub Ntawv Ntim Cov Ntaub Ntawv Sau Npe Platform tau teev tseg raws li "A".
Meglumine yog qhia rau cov hlab ntsha thiab retrograde urography; angiography ntawm cerebral, thoracic, plab, thiab sab kawg ntawm cov hlab ntsha; venography; thiab suav tomography (CT) imaging.
