Jiuzhoutong Pharmaceutical Group Co., Ltd. (tom qab no hu ua "Company" lossis "Jiuzhoutong")
Nws tuav cov chaw muag khoom, Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd., tau txais "Kev Pom Zoo Kev Lag Luam Daim Ntawv Ceeb Toom rau Cov Khoom Siv Tshuaj Siv Tshuaj (API)" pom zoo thiab muab los ntawm National Medical Products Administration (NMPA) thaum Lub Kaum Ob Hlis 20, 2024, rau daim ntawv thov kev lag luam ntawm L-Malic Acid. Cov ntaub ntawv cuam tshuam tau tshaj tawm raws li hauv qab no:
I. Cov ntaub ntawv tseem ceeb ntawm Daim Ntawv Pom Zoo Kev Lag Luam Kev Lag Luam
Chemical API Name: L-Malic Acid (Generic Name); L-Malic Acid (Lub Npe Lus Askiv / Latin Lub Npe)
Tus lej sau npe: Y20210000645
Chemical API Registration Standard NumberPIB: YBY76452024
Ntim SpecificationNtim: 10kg / nruas
Cov khoom siv: Daim ntawv thov kev lag luam rau domestically tsim tshuaj API
Chaw tsim tshuaj paus: Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd.
Lub Sijhawm siv tau ntawm Daim Ntawv Ceeb Toom: Txog rau lub Kaum Ob Hlis 19, 2029
Kev pom zoo xaus: Raws li "Drug Administration Law of the People's Republic of China" thiab cov kev cai cuam tshuam, tom qab kev tshuaj xyuas, cov khoom no ua tau raws li cov kev cai tsim nyog rau kev sau npe tshuaj thiab raug pom zoo rau kev sau npe.
II. Lwm cov ntaub ntawv ntsig txog cov khoom
L-Malic Acid yog dav siv nyob rau hauv cov tshuaj rau daim siab dysfunction, uremia, kub siab, mob cancer, kab mob plawv, thiab lwm yam mob. Ntxiv L-Malic Acid rau cov tshuaj tuaj yeem txhim kho lawv txoj kev ruaj ntseg, txhawb kev nqus thiab nthuav tawm ntawm cov tshuaj hauv tib neeg lub cev, thiab tib lub sijhawm txo cov tshuaj lom ntawm cov tshuaj tiv thaiv kab mob hauv lub cev.
L-Malic Acid yog API rau Compound Electrolyte Txhaj Tshuaj (II), uas yog siv los kho cov kua qaub kom lub cev qhuav dej thiab ntxiv cov kua dej ntxiv. Tam sim no, nws tau pom zoo los ntawm ntau yam kev cai lij choj hauv tebchaws thiab thoob ntiaj teb thiab muaj kev siv tshuaj kho mob dav dav. Raws li Yaozhi Cov Ntaub Ntawv, lub tsev kho mob muag ntawm Compound Electrolyte Txhaj Tshuaj (II) tau tshaj RMB 150 lab nyob rau hauv ob qho tib si 2022 thiab 2023. Cov chaw tsim khoom tseem ceeb yog B. Braun (Lub Tebchaws Yelemees), thiab muaj qee tus neeg tsim khoom hauv tsev tam sim no, qhia txog kev cia siab rau kev loj hlob.
