已受理，完成質(zhì)量復(fù)核，轉(zhuǎn)CDE。采用我們?cè)系闹苿┮言跉W美國(guó)家上市銷售。本品為標(biāo)準(zhǔn)藥物左旋多巴/芐絲肼或左旋多巴/卡比多巴的輔助用藥，用于以上藥物不能控制的帕金森病及劑末現(xiàn)象（癥狀波動(dòng)）。我們的原料，實(shí)測(cè)總雜質(zhì)小于0.05%。
安森博有近二十年進(jìn)口藥品注冊(cè)經(jīng)驗(yàn)，80多個(gè)進(jìn)口藥品成功注冊(cè)案例。
業(yè)務(wù)范圍：1、進(jìn)口藥品代理；2、進(jìn)口藥品注冊(cè)委托服務(wù)；3、尋找進(jìn)口制劑國(guó)內(nèi)銷售合作伙伴。
如您對(duì)我們的進(jìn)口原料藥感興趣，只需采購(gòu)即可，我們負(fù)責(zé)進(jìn)口原料藥注冊(cè)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(guó)內(nèi)制劑廠采購(gòu)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.
進(jìn)口原料藥代理、注冊(cè)，承接進(jìn)口藥品注冊(cè)委托服務(wù)
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