Shanghai Pharmaceutical Daim Ntawv Thov Kev Pom Zoo Kev Lag Luam Ntawm Valganciclovir Hydrochloride API Tau Pom Zoo.

Feb 27, 2026

Tso lus

Tsis ntev los no, Shangyao Kangli (Changzhou) Pharmaceutical Co., Ltd. (tom qab no hu ua "Shangyao Kangli"), ib tug nkaus -tus tswv lag luam ntawm Shanghai Pharmaceutical Group Co., Ltd. (tom qab no hu ua "Shanghai Pharmaceutical" lossis "Lub Tuam Txhab Lag Luam"), tau txais daim ntawv thov kev lag luam rau kev siv tshuaj. Cov khoom xyaw (Daim Ntawv Ceeb Toom No.: 2023YS00253) rau Valganciclovir Hydrochloride API (tom qab no hu ua "Product") muab los ntawm National Medical Products Administration (tom qab no hu ua "NMPA"). Cov khoom tau pom zoo rau kev tsim khoom.

1. Cov ntaub ntawv tseem ceeb ntawm cov khoom

Lub npe: Valganciclovir Hydrochloride

Tus Qauv Zauv: YBY63132023

Ntim Cov Lus Qhia: 1KG / nruas, 5KG / nruas, 10KG / nruas, 20KG / nruas, 25KG / nruas

Daim ntawv thov hom: Kev lag luam daim ntawv thov rau domestically manufactured tshuaj active tshuaj cov khoom xyaw

Kev Pom Zoo Cov Lus Nug: Raws li covPharmaceutical Administration Law of the People's Republic of Chinathiab cov kev cai cuam tshuam, thaum tshuaj xyuas, Cov Khoom Muag tau ua raws li cov kev xav tau rau kev sau npe tshuaj, thiab daim ntawv thov rau npe rau cov khoom raug pom zoo.

2. Cov ntaub ntawv ntsig txog ntawm cov khoom

Valganciclovir Hydrochloride feem ntau yog qhia rau kev kho mob ntawm cytomegalovirus (CMV) retinitis nyob rau hauv cov neeg mob uas kis tau tus kab mob immunodeficiency syndrome (AIDS) thiab prophylaxis ntawm CMV kab mob nyob rau hauv cov neeg mob uas muaj kev pheej hmoo siab tom qab hloov khoom nruab nrog cev.Nws yog tsim los ntawm Hoffmann-La Roche Limited ntawm Switzerland.2 nyob rau hauv lub tebchaws United States.

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