已受理,完成質(zhì)量復(fù)核,轉(zhuǎn)CDE。本品為血管緊張素轉(zhuǎn)換酶抑制藥。本身無活性,在體內(nèi)轉(zhuǎn)化成群多普利拉后發(fā)揮作用。其轉(zhuǎn)化率相當(dāng)于依那普利的2.3~10倍。本品作用出現(xiàn)時(shí)間遲而維持時(shí)間長。群多普利拉具有較強(qiáng)的親脂性,組織穿透力大,與血管緊張素轉(zhuǎn)換酶親和力高??诜鹦Э?、作用時(shí)間長、不良反應(yīng)少。臨床上還可以治療充血性心衰和心肌梗死。
安森博有近二十年進(jìn)口藥品注冊經(jīng)驗(yàn),80多個(gè)進(jìn)口藥品成功注冊案例。
業(yè)務(wù)范圍:1、進(jìn)口藥品代理;2、進(jìn)口藥品注冊委托服務(wù);3、尋找進(jìn)口制劑國內(nèi)銷售合作伙伴。
如您對我們的進(jìn)口原料藥感興趣,只需采購即可,我們負(fù)責(zé)進(jìn)口原料藥注冊等。目前我公司已有近30個(gè)進(jìn)口原料藥在CDE排隊(duì)待審,50多個(gè)進(jìn)口原料藥的資料在整理中。已有60多家國內(nèi)制劑廠采購我們的原料藥。
我們代理的進(jìn)口制劑,已經(jīng)在歐美已經(jīng)或即將上市銷售,質(zhì)量可靠,期待與您合作。
We are a trade company. We are very strong in registration and promotion of import drugs in China, with decades of registration experience and over 86 Licenses procured successfully.
We submitted about 10 import drug applications per year since 2011;
Our knowledge, experience and good working relationship with the regulatory department help us to speed up regulatory approvals and to provide sound support for our formulation customers.
We procured 5 new IDLs in 2010, among which one license was obtained within 10 months and another was obtained within 12 months.
We do not manufacture API and formulation, only focus on registration and promotion of import drug in China.