已受理，完成質(zhì)量復(fù)核，轉(zhuǎn)CDE。本品不通過CYP2D6代謝途徑在其活性狀態(tài)釋放鹽琥珀酸拉法辛主要活性代謝物。此有益于本品可與通過此代謝途徑的其它藥物聯(lián)合用藥。本品是目前zui廣泛處分用藥的抗抑郁藥。由于尚無對嚴(yán)重抑郁患者治療奏效的單一藥物，故琥珀酸去甲*給患者和醫(yī)生提供了治療新藥。
安森博有近二十年進(jìn)口藥品注冊經(jīng)驗，80多個進(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個進(jìn)口原料藥在CDE排隊待審，50多個進(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.
進(jìn)口原料藥代理、注冊，承接進(jìn)口藥品注冊委托服務(wù)
琥珀酸去甲*（Desvenlafaxine succinate） 產(chǎn)品信息
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