亚洲女同精品一区二区99_先鋒資訊_安徽省先鋒制藥有限公司

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2015-03

新版GMP注射劑車(chē)間建設如火如荼

2011年2月12日，《藥品生產(chǎn)質(zhì)量管理規范(2010年修訂)》(簡(jiǎn)稱(chēng)新版GMP)正式發(fā)布實(shí)施，新版GMP要求無(wú)菌制劑生產(chǎn)必須在2013年12月30日前完成改造并通過(guò)認證。為貫徹實(shí)施新版GMP，公司于2012年7月立項上馬“新版GMP注射劑車(chē)間暨注射劑生產(chǎn)車(chē)間技術(shù)改造項目”。該項目位于安徽省先鋒制藥有限公司內預留地塊，新增建筑面積10880平方米，新建普通粉針和凍干粉針生產(chǎn)線(xiàn)各一條，并對動(dòng)力設施、蒸氣熱力管道等公用系統進(jìn)行改造。項目總投資6000萬(wàn)元，預計達產(chǎn)后可實(shí)現年產(chǎn)粉針劑7290萬(wàn)支、凍干粉針劑3240萬(wàn)支，年銷(xiāo)售收入達3億元。該項目已于2012年7月破土動(dòng)工，目前土建工程已基本結束開(kāi)始進(jìn)入緊張的設備安裝調試階段，項目預計將于2013年8月全部完工，2013年9月公司將申報國家食品藥品監督管理局(SFDA)的新版GMP認證。

2015-03-18

2015-03

FDA局長(cháng)與IPEM師生再聚北大

2014年11月17日下午，美國FDA局長(cháng)Margaret Hamburg博士相隔四年后再度與IPEM師生歡聚北大。在題為“全球化與監管科學(xué)”的主題演講中，Hamburg博士為IPEM項目在北大和FDA的共同努力下，發(fā)展成為培養中國制藥業(yè)未來(lái)帶頭人和加速中國制藥業(yè)現代化的世界水平的教育項目深感自豪。她回顧了IPEM的發(fā)展歷程，及其融合監管科學(xué)、制藥科學(xué)、工程科學(xué)及商務(wù)、管理和領(lǐng)導力等國際水準的課程體系。Hamburg博士稱(chēng)贊IPEM取得的長(cháng)足進(jìn)步。Hamburg博士與IPEM師生親切交談，與長(cháng)期支持IPEM的部分國內企業(yè)家交流座談，并在歡快的氣氛中與部分IPEM師生合影留念。

2015-03-18

2015-03

安徽先鋒上海張江藥谷研發(fā)中心正式運行

日前，公司投資建設的安徽先鋒上海張江藥谷研發(fā)中心已正式運行，該中心位于上海張江生物醫藥基地的核心區（張江藥谷），以“上海皓鋒醫藥科技有限公司”的名稱(chēng)進(jìn)行了工商注冊登記。上海張江生物醫藥基地是國內規模最大的生物醫藥高科技產(chǎn)業(yè)集群，為亞洲一流的生物醫藥產(chǎn)業(yè)基地，目前已成為有世界影響的生物醫藥創(chuàng )新平臺。該中心的建設是安徽先鋒在藥品研發(fā)戰略上的又一重大舉措，它的建成運行有利于安徽先鋒匯聚全國乃至全世界的研發(fā)人才和信息優(yōu)勢。

2015-03-18

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