蘭伯西實驗室
| Ranbaxy Laboratories Limited | |
|---|---|
 | |
| 公司結局 | 被太陽製藥收購 |
| 後繼機構 | 太陽製藥 |
| 成立 | 1961年 |
| 創辦人 | Ranbir Singh Gurbax Singh |
| 總部 | 印度古爾岡 |
| 產業 | 製藥 |
| 員工人數 | 10,983 （2012）[1] |
蘭伯西實驗室有限公司（Ranbaxy Laboratories Limited）是1961年成立的一家印度製藥公司，它在1973年上市，2008年第一三共獲得其控股權[2]，2014年被太陽製藥收購，後者因此成為印度最大的製藥公司。
問題
自2004年開始，該公司就多次因偽造藥物測試報告而被美國食品和藥物管理局調查[3][4]。2012年它又多次在荷蘭等其他國家召回存在雜質的藥物[5][6][7]。
2013年5月，它因製造、銷售假藥及偽造臨床數據而在美國被判有罪[8][9]。同年9月，該公司又被曝存在嚴重衛生問題，這包括員工廁後不洗手、藥物中存在人類毛髮等[10][11]。因此FDA決定禁止該公司在達到美國標準前於其莫哈里工廠生產FDA管制藥物。[12]
參考文獻
- ^ Annual Report 2012 (PDF). Ranbaxy Laboratories Limited. [2020-10-14]. （原始內容 (PDF)存檔於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]. （原始內容存檔於2014-12-02）.
- ^ Eban, Katherine. Dirty Medicine. Fortune. 2013-05-15 [2018-02-06]. （原始內容存檔於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]. （原始內容存檔於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]. （原始內容存檔於2016-03-24） （荷蘭語）.
- ^ Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin （頁面存檔備份，存於網際網路檔案館）. Forbes.
- ^ Loftus, Peter. Ranbaxy Halts Production of Generic Lipitor. The Wall Street Journal. 29 November 2012 [10 March 2014]. （原始內容存檔於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]. （原始內容存檔於2014-08-12）.
- ^ India drug firm pays record US fine. BBC News. 2013-05-14 [2018-01-03]. （原始內容存檔於2019-12-15） （英國英語）.
- ^ Bureau, Our. FDA finds quality, process lapses at Ranbaxy plant. @businessline. [2020-10-14]. （原始內容存檔於2021-01-18）.
- ^ Ranbaxy import ban: US FDA found suspected hair, oil in tablets. [2020-10-14]. （原始內容存檔於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]. （原始內容存檔於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).
