Ranbaxy Laboratories

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Ranbaxy Laboratories Limited
Subsidiary
Industry Pharmaceuticals
Fate Acquired by Sun Pharma
Founded 1961 (1961)
Headquarters Gurgaon, Haryana, India
Key people
Arun Sawhney (CEO, Ranbaxy Laboratories)
Joji Nakayama (CEO, Daiichi Sankyo)
Number of employees
10,983 (2012)[1]
Parent Sun Pharmaceuticals
Website www.ranbaxy.com

Ranbaxy Laboratories Limited (BSE500359) 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] In 2014, Sun Pharma acquired the entire 63.4% share of Ranbaxy making the conglomerate the world’s fifth largest specialty generic pharma company.[3]

As of 2013, Ranbaxy was exporting its products to 125 countries with ground operations in 43 and manufacturing facilities in eight countries.[4] In 2011, Ranbaxy Global Consumer Health Care received the OTC Company of the year award. In the 2012, 2013 and 2014 Brand Trust Reports, Ranbaxy was ranked 161st, 225th and 184th respectively among India's most trusted brands.[5]

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 a significant 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 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 US$1,300 million.

Many 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.[citation needed]

In December 2005, Ranbaxy's share price was hit 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.[6] 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.[citation needed]

On 1 December 2011, Ranbaxy got 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.[7][8]

Acquisition by Daiichi-Sankyo

In June 2008, Daiichi-Sankyo acquired a 34.8% stake in Ranbaxy,[9][10] 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[11] by acquiring a 63.92% stake in Ranbaxy. Ranbaxy's Malvinder Singh remained as CEO after the transaction.[12]

The addition of Ranbaxy Laboratories extended Daiichi-Sankyo's operations, with the combined company worth about US$30 billion.[13]

In 2009 it was reported that former Novartis Senior Vice-President Yugal Sikri would lead the India operations of Ranbaxy Laboratories.[14][15]

Acquisition by Sun Pharmaceutical

On 7 April 2014 India based Sun Pharmaceutical and Japan based Daiichi Sankyo jointly announced the sale of the entire 63.4% share from Daiichi Sankyo to Sun Pharmaceutical in a $4 billion all-share deal. Under these agreements, shareholders of Ranbaxy, were to receive a 0.8 share of Sun Pharmaceutical for each share of Ranbaxy.[3] After this acquisition, the partner Daiichi-Sankyo was to hold a stake of 9% in Sun Pharmaceutical.[16] The combination of Sun Pharma and Ranbaxy created the fifth-largest specialty generics company in the world and the largest pharmaceutical company in India.[citation needed]

Controversies

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 pornographic websites using his office computer, forcing him to resign in 2005. Thakur left India for the USA and contacted the Food and Drug Administration which started investigating his claims.[17] 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.[18]

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.[19]

On 8 February 2012, three batches of the proton-pump inhibitor Pantoprazole were recalled in the Netherlands due to the presence of impurities.[20]

On 9 November 2012, Ranbaxy halted production and recalled forty-one lots of atorvastatin due to glass particles being found in some bottles.[21][22] Also in 2012, an apparent dosage mistake was reported in which 20 mg tablets were found in a bottle of atorvastatin labeled as containing 10 mg tablets; this led in 2014 to the voluntary recall in the United States of some 64,000 bottles.[23]

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.[24]

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.[25][26] Ranbaxy is prohibited from manufacturing FDA-regulated drugs at the Mohali facility until the company complies with US drug manufacturing requirements.[27]

Notes

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  2. Matsuyama, Kanoko. (11 June 2008) Daiichi to Take Control of Ranbaxy for $4.6 Billion – 11 June 2008. Bloomberg.
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  6. Patent ruling hits Ranbaxy shares – 19 December 2005. BBC News (19 December 2005).
  7. http://www.businessweek.com/news/2011-11-30/ranbaxy-s-lipitor-copy-approved-by-fda-threatening-pfizer-sales.html
  8. Lua error in package.lua at line 80: module 'strict' not found.
  9. India Knowledge@Wharton – The Ranbaxy-Daiichi Deal: Good Medicine, or a Harbinger of Future Ills? – 12 June 2008. Knowledge.wharton.upenn.edu.
  10. Ranbaxy joined "Online Pharma Exhibition"
  11. TimesOnlineUK – Business – Takeover of Ranbaxy
  12. Matsuyama, Kanoko. (11 June 2008) Daiichi to Take Control of Ranbaxy for $4.6 Billion – 11 June 2008. Bloomberg.
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  17. Lua error in package.lua at line 80: module 'strict' not found. -- In-depth investigation of Ranbaxy Laboratories – Fortune Magazine, CNN.
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  21. Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin. Forbes.
  22. Lua error in package.lua at line 80: module 'strict' not found.(subscription required)
  23. Lua error in package.lua at line 80: module 'strict' not found.
  24. Lua error in package.lua at line 80: module 'strict' not found.
  25. FDA finds quality, process lapses at Ranbaxy plant
  26. Ranbaxy import ban: US FDA found suspected hair, oil in tablets
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External links