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) was an Indian 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 100% of Ranbaxy in an all-stock deal, 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]

History[edit]

Formation[edit]

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.

In the late 1990s, Ranbaxy formed a US company, Ranbaxy Pharmaceuticals Inc., and to support its entry into the pharmaceutical market in the United States.[5]

Trading[edit]

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%).[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.[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[edit]

In June 2008, Daiichi-Sankyo acquired a 34.8% stake in Ranbaxy from the family of CEO and Managing Director Malvinder Mohan Singh for Rs. 10,000 crore (USD 2.4 billion) at Rs. 737 per share.[9][10]

In November 2008, Daiichi-Sankyo completed the takeover of the company from the founding Singh family in a deal worth $4.6 billion[dubious ][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]

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.[16]

Acquisition by Sun Pharmaceutical[edit]

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.[17]

Controversies[edit]

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 to have been compromised. Ranbaxy then accused Thakur of visiting pornographic sites using his office computer, forcing him to resign in 2005. Thakur left India for the United States and contacted the Food and Drug Administration (FDA), which started investigating his claims.[18] 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.[19]

By 25 February 2009 the FDA 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.[20]

On 8 February 2012, three batches of the proton-pump inhibitor Pantoprazole were recalled in the Netherlands due to the presence of impurities.[21]

On 9 November 2012, Ranbaxy halted production and recalled 41 lots of atorvastatin due to glass particles being found in some bottles.[22][23] 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.[24]

In May 2013 Ranbaxy pleaded guilty to felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy’s manufacturing facilities in India, and misrepresenting clinical generic drug data.[25][26] Ranbaxy pleaded guilty to three felony FDCA counts, and four felony counts of knowingly making material false statements to the FDA. Included in the adulterated products were antiretroviral (ARV) drugs destined for treatment of HIV/AIDS in Africa.[27]

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.[28][29] Ranbaxy is prohibited from manufacturing FDA-regulated drugs at the Mohali facility until the company complies with United States drug manufacturing requirements.[30]

In 2014, The FDA notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The FDA's inspection of the Toansa facility, which concluded on January 11, 2014, identified significant CGMP violations. These included Toansa staff retesting raw materials, intermediate drug products, and finished API after those items failed analytical testing and specifications, in order to produce acceptable findings, and subsequently not reporting or investigating these failures.[31][32]

References[edit]

  1. ^ "Annual Report 2012" (PDF). Ranbaxy Laboratories Limited. Archived from the original (PDF) on 5 November 2013. 
  2. ^ Matsuyama, Kanoko; Chatterjee, Saikat (June 11, 2008). "Daiichi to Take Control of Ranbaxy for $4.6 Billion (Update3) - Bloomberg". Bloomberg.com. Bloomberg LP. Archived from the original on 2014-12-02. Retrieved 2018-08-11. 
  3. ^ a b "Sun Pharma to acquire Ranbaxy for $4 billion in all-share deal". IANS. news.biharprabha.com. Retrieved 7 April 2014. 
  4. ^ "Ranbaxy Laboratories Limited, India : Pharmaceuticals Business, pharmaceutical company india, pharma outsourcing india, pharmaceuticals brand, pharmaceuticals intellectual property". Ranbaxy.com. Archived from the original on 26 February 2013. Retrieved 3 September 2013. 
  5. ^ "Ranbaxy: Ranbaxy Continues to Add Value and Utility to US Product Portfolio". pharmacytimes.com. Pharmacy Times. Retrieved 11 August 2018. Ranbaxy [..] entered the U.S. generic pharmaceutical market in 1995 introducing its first product under the Ranbaxy Pharmaceuticals Inc. label in January 1998 
  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. ^ "Ranbaxy gets approval to launch generic Lipitor in US – The Times of India". The Times of India. 
  9. ^ Staff (June 12, 2008). "The Ranbaxy-Daiichi Deal: Good Medicine, or a Harbinger of Future Ills? - Knowledge@Wharton". Knowledge@Wharton. Wharton School of Business. Retrieved 2018-08-11. 
  10. ^ Ranbaxy joined "Online Pharma Exhibition" Archived 31 January 2013 at Archive.is
  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.
  13. ^ Chatterjee, Surojit (12 June 2008). "Japanese drugmaker Daiichi Sankyo gobbles Ranbaxy Laboratories for $4.6 billion". International Business Times. New York. Archived from the original on 16 November 2009. 
  14. ^ "Ranbaxy Laboratories Limited > Contact Us > Worldwide Operations > India". Ranbaxy.com. Archived from the original on 4 April 2012. 
  15. ^ ET Bureau (11 September 2009). "Yugal Sikri to be New India CEO of Ranbaxy – Economic Times". The Economic Times. 
  16. ^ "India's Most Trusted Brands 2014". Trust Research Advisory. Archived from the original on 2 May 2015. 
  17. ^ "India's Sun Pharma to Buy Ranbaxy in $4 Billion Deal". Retrieved 2014-04-06. 
  18. ^ Eban, Katherine (2013-05-15). "Dirty Medicine". Fortune. Retrieved 2018-02-06.  — an in-depth investigation of Ranbaxy Laboratories
  19. ^ "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. 
  20. ^ "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. 
  21. ^ "KNMP waarschuwt voor verontreinigde tabletten —" (in Dutch). Gezondheidskrant.nl. 
  22. ^ Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin. Forbes.
  23. ^ Loftus, Peter (29 November 2012). "Ranbaxy Halts Production of Generic Lipitor". The Wall Street Journal. Archived from the original on 26 February 2014. Retrieved 10 March 2014. (subscription required)
  24. ^ "Ranbaxy recalls over 64,000 bottles of generic Lipitor in US". Business Standard. India. Press Trust of India. 8 March 2014. Archived from the original on 10 March 2014. Retrieved 10 March 2014. 
  25. ^ "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 January 2018. 
  26. ^ "India drug firm pays record US fine". BBC News. 2013-05-14. Retrieved 2018-01-03. 
  27. ^ Eban, Katherine (2013-05-15). "Dirty Medicine". Fortune. Retrieved 2018-02-06. Who cares? It's just blacks dying. 
  28. ^ FDA finds quality, process lapses at Ranbaxy plant
  29. ^ Ranbaxy import ban: US FDA found suspected hair, oil in tablets Archived 23 September 2013 at the Wayback Machine.
  30. ^ "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. Retrieved 2013-10-08. 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). 
  31. ^ "FDA prohibits Ranbaxy's Toansa, India facility from producing and distributing drugs for the U.S. market". Food and Drug Administration. Archived from the original on 12 January 2017. Retrieved 1 January 2018. 
  32. ^ "India's Ranbaxy hit by FDA product ban at 4th Indian plant". Reuters. 2014-01-24. Retrieved 2018-01-03. 

External links[edit]