维基百科
蘭伯西實驗室
兰伯西实验室有限公司（Ranbaxy Laboratories Limited）是1961年成立的一家印度制药公司，它在1973年上市，2008年第一三共获得其控股权[2]，2014年被太阳制药收购，后者因此成为印度最大的制药公司。
问题 编辑
自2004年开始，该公司就多次因伪造药物测试报告而被美国食品和药物管理局调查[3][4]。2012年它又多次在荷兰等其他国家召回存在杂质的药物[5][6][7]。
2013年5月，它因制造、销售假药及伪造临床数据而在美国被判有罪[8][9]。同年9月，该公司又被曝存在严重卫生问题，这包括员工厕后不洗手、药物中存在人类毛发等[10][11]。因此FDA决定禁止该公司在达到美国标准前于其莫哈里工厂生产FDA管制药物。[12]
参考文献 编辑
- ^ (PDF). Ranbaxy Laboratories Limited. [2020-10-14]. （原始内容 (PDF)存档于2013-11-05）.
- ^ Matsuyama, Kanoko; Chatterjee, Saikat. Daiichi to Take Control of Ranbaxy for $4.6 Billion (Update3) - Bloomberg. Bloomberg.com. Bloomberg LP. June 11, 2008 [2018-08-11]. （原始内容于2014-12-02）.
- ^ Eban, Katherine. Dirty Medicine. Fortune. 2013-05-15 [2018-02-06]. （原始内容于2021-04-08）. — an in-depth investigation of Ranbaxy Laboratories
- ^ FDA Takes New Regulatory Action Against Ranbaxy's Paonta Sahib Plant in India. Agency halts review of drug applications from plant due to evidence of falsified data; invokes Application Integrity Policy. Press Announcement (Food and Drug Administration). 25 February 2009 [1 June 2013]. （原始内容于2017-01-18）.
The FDA's investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications, and this warrants applying the Application Integrity Policy, said Deborah Autor, director of CDER's Office of Compliance.
- ^ KNMP waarschuwt voor verontreinigde tabletten —. Gezondheidskrant.nl. [2020-10-14]. （原始内容于2016-03-24） （荷兰语）.
- ^ Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin （页面存档备份，存于互联网档案馆）. Forbes.
- ^ Loftus, Peter. Ranbaxy Halts Production of Generic Lipitor. The Wall Street Journal. 29 November 2012 [10 March 2014]. （原始内容于2014-02-26）.
- ^ Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA. The United States Department of Justice (Office of Public Affairs). 13 May 2013 [1 January 2018]. （原始内容于2014-08-12）.
- ^ India drug firm pays record US fine. BBC News. 2013-05-14 [2018-01-03]. （原始内容于2019-12-15） （英国英语）.
- ^ Bureau, Our. FDA finds quality, process lapses at Ranbaxy plant. @businessline. [2020-10-14]. （原始内容于2021-01-18）.
- ^ . [2020-10-14]. （原始内容存档于2013-09-23）.
- ^ FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy's Mohali, India, plant and issues import alert. Press Announcement (Food and Drug Administration). 2013-09-16 [2013-10-08]. （原始内容于2017-01-12）.
The U.S. Food and Drug Administration today issued an import alert under which U.S. officials may detain at the U.S. border drug products manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The firm will remain on the import alert until the company complies with U.S. drug manufacturing requirements, known as current good manufacturing practices (CGMP).