Ranbaxy Laboratories: Difference between revisions
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In September 2013, further problems were reported, including apparent human hair in a tablet, oil spots on other tablets, toilet facilities without running water, and a failure to instruct employees to wash their hands after using the toilet.<ref>[http://www.thehindubusinessline.com/companies/fda-finds-quality-process-lapses-at-ranbaxy-plant/article5142039.ece FDA finds quality, process lapses at Ranbaxy plant]</ref><ref>[http://www.niticentral.com/2013/09/18/ranbaxy-import-ban-usfda-found-suspected-hair-oil-in-tablets-134445.html Ranbaxy import ban: US FDA found suspected hair, oil in tablets]</ref> Ranbaxy is prohibited from manufacturing FDA-regulated drugs at the Mohali facility until the company complies with U.S. drug manufacturing requirements.<ref>{{cite news | title = FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert | date = 2013-09-16 | publisher = [[Food and Drug Administration]] | url = http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm368445.htm | work = Press Announcement | accessdate = 2013-10-08 | quote = 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).}}</ref> |
In September 2013, further problems were reported, including apparent human hair in a tablet, oil spots on other tablets, toilet facilities without running water, and a failure to instruct employees to wash their hands after using the toilet.<ref>[http://www.thehindubusinessline.com/companies/fda-finds-quality-process-lapses-at-ranbaxy-plant/article5142039.ece FDA finds quality, process lapses at Ranbaxy plant]</ref><ref>[http://www.niticentral.com/2013/09/18/ranbaxy-import-ban-usfda-found-suspected-hair-oil-in-tablets-134445.html Ranbaxy import ban: US FDA found suspected hair, oil in tablets]</ref> Ranbaxy is prohibited from manufacturing FDA-regulated drugs at the Mohali facility until the company complies with U.S. drug manufacturing requirements.<ref>{{cite news | title = FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert | date = 2013-09-16 | publisher = [[Food and Drug Administration]] | url = http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm368445.htm | work = Press Announcement | accessdate = 2013-10-08 | quote = 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).}}</ref> |
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In 2013, Ranbaxy USA Inc., a North American subsidiary agreed to pay a total of $500 million USD to settle various criminal and civil allegations filed. Concerning the criminal allegations, Ranbaxy pleaded guilty and agreed to pay a fine of $150 million. The civil settlement, which resolves False Claims Act violations, was for $350 million. The allegations included poor oversight and inadequate testing and maintenance of drugs manufactured at its facilities in Paonta Sahib and Dewas, India. These allegations lead to false claims being submitted to various U.S. government agencies. <ref>{{cite news|last=Tycko|first=Jonathan|title=Top Whistleblower Settlements of 2013 – To Date|url=http://www.natlawreview.com/article/top-whistleblower-settlements-2013-to-date-0|accessdate=6 November 2013|newspaper=The National Law Review|date=October 21, 2013|author2=Tycko & Zavareei LLP}}</ref> |
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===Acquisition=== |
===Acquisition=== |
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Revision as of 04:39, 6 November 2013
 | |
| Company type | Public company |
|---|---|
| BSE: 500359 NSE: RANBAXY | |
| Industry | Pharmaceuticals |
| Founded | 1961 |
| Fate | Takeover by Daiichi Sankyo |
| Headquarters | Gurgaon, Haryana , |
| Revenue | ₹99,769 million (US$1.2 billion)(2011)[1] |
| EBITDA ₹18,299 million (US$220 million)(2011) | |
Number of employees | 10,435[1] |
| Parent | Daiichi Sankyo |
| Website | www |
Ranbaxy Laboratories Limited (BSE: 500359) is an Indian multinational pharmaceutical company that was incorporated in India in 1961. The company went public in 1973 and Japanese pharmaceutical company Daiichi Sankyo acquired a controlling share in 2008.[2] Ranbaxy exports its products to 125 countries with ground operations in 43 and manufacturing facilities in eight countries.[3] In 2011, Ranbaxy Global Consumer Health Care received the OTC Company of the year award.
History
Formation
Ranbaxy was started by Ranbir Singh and Gurbax Singh in 1937 as a distributor for a Japanese company Shionogi. The name Ranbaxy is a portmanteau of the names of its first owners Ranbir and Gurbax. Bhai Mohan Singh bought the company in 1952 from his cousins Ranbir and Gurbax. After Bhai Mohan Singh's son Parvinder Singh joined the company in 1967, the company saw an increase in scale.
Trading
In 1998, Ranbaxy entered the United States, the world's largest pharmaceuticals market and now the biggest market for Ranbaxy, accounting for 28% of Ranbaxy's sales in 2005.[citation needed]
For the twelve months ending on 31 December 2005, the company's global sales were at US$1,178 million with overseas markets accounting for 75% of global sales (USA: 28%, Europe: 17%, Brazil, Russia, and China: 29%). For the twelve months ending on 31 December 2006, the company's global sales were at US$1,300 million.
Most of Ranbaxy's products are manufactured under licence from foreign pharmaceutical developers, though a significant percentage of their products are off-patent drugs that are manufactured and distributed without licensing from the original manufacturer because the patents on such drugs have expired.
In December 2005, Ranbaxy's shares were hit hard by a patent ruling disallowing production of its own version of Pfizer's cholesterol-cutting drug Lipitor, which has annual sales of more than $10 billion.[4] In June 2008, Ranbaxy settled the patent dispute with Pfizer allowing them to sell Atorvastatin Calcium, the generic version of Lipitor and Atorvastatin Calcium-Amylodipine Besylate, the generic version of Pfizer's Caduet in the US starting on 30 November 2011. The settlement also resolved several other disputes in other countries.[citation needed]
On 23 June 2006, Ranbaxy received from the United States Food & Drug Administration a 180-day exclusivity period to sell simvastatin (Zocor) in the US as a generic drug at 80 mg strength. Ranbaxy competes with the maker of brand-name Zocor, Merck & Co.; IVAX Corporation (which was acquired by and merged into Teva Pharmaceutical Industries Ltd.), which has 180-day exclusivity at strengths other than 80 mg; and Dr. Reddy's Laboratories, also from India, whose authorised generic version (licensed by Merck) is exempt from exclusivity.
In June 2008, Japan's Daiichi Sankyo Company took a majority (50.1%) stake in Ranbaxy, with a deal valued at about US$4.6 billion. Ranbaxy's Malvinder Singh remained as CEO after the transaction.[5]
On 1 December 2011, Ranbaxy got the much-awaited approval from the US Food and Drug Administration to launch the generic version of drug lipitor in the United States of America after its patent expired.[6][7]
Issues
During 2004–2005, Dinesh Thakur and Rajinder Kumar, two Indian employees of Ranbaxy, blew the whistle on Ranbaxy's fabrication of drug test reports. Thakur's office computer was soon found tampered with. Ranbaxy then accused Thakur of visiting graphic websites using his office computer, forcing him to resign in 2005. Thakur escaped from India to the USA and contacted the Food and Drug Administration which started investigating his claims.[8]
As a result, on 16 September 2008, the Food and Drug Administration issued two warning letters to Ranbaxy Laboratories Ltd. and an Import Alert for generic drugs produced by two manufacturing plants in India.[9] By 25 February 2009 the US Food and Drug Administration said it halted reviews of all drug applications including data developed at Ranbaxy's Paonta Sahib plant in India because of a practice of falsified data and test results in approved and pending drug applications.[10]
On 8 February 2012, three batches of the proton-pump inhibitor Pantoprazole were recalled in the Netherlands due to the presence of impurities.[11]
On 9 November 2012, Ranbaxy halted production and recalled forty-one lots of atorvastatin due to glass particles being found in some bottles.[12][13]
In May 2013 the US fined the company US$500 million after it was found guilty of misrepresenting clinical generic drug data and selling adulterated drugs to the United States.[14]
In September 2013, further problems were reported, including apparent human hair in a tablet, oil spots on other tablets, toilet facilities without running water, and a failure to instruct employees to wash their hands after using the toilet.[15][16] Ranbaxy is prohibited from manufacturing FDA-regulated drugs at the Mohali facility until the company complies with U.S. drug manufacturing requirements.[17]
In 2013, Ranbaxy USA Inc., a North American subsidiary agreed to pay a total of $500 million USD to settle various criminal and civil allegations filed. Concerning the criminal allegations, Ranbaxy pleaded guilty and agreed to pay a fine of $150 million. The civil settlement, which resolves False Claims Act violations, was for $350 million. The allegations included poor oversight and inadequate testing and maintenance of drugs manufactured at its facilities in Paonta Sahib and Dewas, India. These allegations lead to false claims being submitted to various U.S. government agencies. [18]
Acquisition
In June 2008, Daiichi-Sankyo acquired a 34.8% stake in Ranbaxy,[19][20] for a value $2.4 billion. In November 2008, Daiichi-Sankyo completed the takeover of the company from the founding Singh family in a deal worth $4.6 billion[21] by acquiring a 63.92% stake in Ranbaxy.
The addition of Ranbaxy Laboratories extends Daiichi-Sankyo's operations – already comprising businesses in 22 countries.[citation needed] The combined company is worth about US$30 billion.[22]
In 2009 it was reported that former Novartis Senior Vice-President Yugal Sikri would lead the India operations of Ranbaxy Laboratories.[23][24]
See also
Notes
- ^ a b "Annual Report 2011". Ranbaxy Laboratories Limited.
- ^ Matsuyama, Kanoko. (11 June 2008) Daiichi to Take Control of Ranbaxy for $4.6 Billion – 11 June 2008. Bloomberg.
- ^ "Ranbaxy Laboratories Limited, India : Pharmaceuticals Business, pharmaceutical company india, pharma outsourcing india, pharmaceuticals brand, pharmaceuticals intellectual property". Ranbaxy.com. Retrieved 3 September 2013.
- ^ Patent ruling hits Ranbaxy shares – 19 December 2005. BBC News (19 December 2005).
- ^ Matsuyama, Kanoko. (11 June 2008) Daiichi to Take Control of Ranbaxy for $4.6 Billion – 11 June 2008. Bloomberg.
- ^ http://www.businessweek.com/news/2011-11-30/ranbaxy-s-lipitor-copy-approved-by-fda-threatening-pfizer-sales.html
- ^ "Ranbaxy gets approval to launch generic Lipitor in US – The Times of India". The Times of India.
- ^ In-depth investigation of Ranbaxy Laboratories – Fortune Magazine, CNN. Features.blogs.fortune.cnn.com.
- ^ "FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India. Actions affect over 30 different generic drugs; cites serious manufacturing deficiencies". Press Announcement. Food and Drug Administration. 16 September 2008. Retrieved 1 June 2013.
- ^ "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. Retrieved 1 June 2013.
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 —" (in Template:Nl icon). Knmp.nl.
{{cite web}}: CS1 maint: unrecognized language (link) - ^ Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin. Forbes.
- ^ Loftus, Peter. (29 November 2012) Ranbaxy Halts Production of Generic Lipitor – WSJ. The Wall Street Journal.
- ^ "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. Retrieved 1 June 2013.
- ^ FDA finds quality, process lapses at Ranbaxy plant
- ^ Ranbaxy import ban: US FDA found suspected hair, oil in tablets
- ^ "FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy's Mohali, India, plant and issues import alert". Press Announcement. Food and Drug Administration. 16 September 2013. Retrieved 8 October 2013.
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).
- ^ Tycko, Jonathan; Tycko & Zavareei LLP (21 October 2013). "Top Whistleblower Settlements of 2013 – To Date". The National Law Review. Retrieved 6 November 2013.
- ^ India Knowledge@Wharton – The Ranbaxy-Daiichi Deal: Good Medicine, or a Harbinger of Future Ills? – 12 June 2008. Knowledge.wharton.upenn.edu.
- ^ Ranbaxy joined "Online Pharma Exhibition"
- ^ TimesOnlineUK – Business – Takeover of Ranbaxy
- ^ Daiichi Sankyo gobbles Ranbaxy Laboratories for $4.6 billion[dead link]
- ^ "Ranbaxy Laboratories Limited > Contact Us > Worldwide Operations > India". Ranbaxy.com.
- ^ ET Bureau 1url=http://articles.economictimes.indiatimes.com/2009-09-11/news/27658542_1_japanese-company-daiichi-sankyo-ranbaxy-laboratories-yugal-sikri (11 September 2009). "Yugal Sikri to be New India CEO of Ranbaxy – Economic Times". The Economic Times.
{{cite web}}: Missing or empty|url=(help)CS1 maint: numeric names: authors list (link)
