Ranbaxy Laboratories

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Ranbaxy Laboratories Limited
Type Public company
Traded as BSE500359
NSERANBAXY
Industry Pharmaceuticals
Fate Takeover by Sun Pharma
Founded 1961 (1961)
Headquarters Gurgaon, Haryana, India
Key people Arun Sawhney (CEO, Ranbaxy Laboratories)
Joji Nakayama (CEO, Daiichi Sankyo)
Revenue Increase INR122529 million (US$2.0 billion) (2012)[1]
Net income Decrease EBITDA INR18227 million (US$300 million) (2012)[1]
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 world’s fifth largest specialty generic pharma company.[3] Ranbaxy exports 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.

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.

Trading[edit]

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.[5] 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.

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]

On 27 June 2014 Ranbaxy has got approval from the US FDA to make a generic version of Novartis blood pressure drug Diovan. This approval comes almost two years after the 3.5 billion dollar drug lost patent protection.[8]

Issues[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 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.[9]

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.[10] 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.[11]

On 8 February 2012, three batches of the proton-pump inhibitor Pantoprazole were recalled in the Netherlands due to the presence of impurities.[12]

On 9 November 2012, Ranbaxy halted production and recalled forty-one lots of atorvastatin due to glass particles being found in some bottles.[13][14] 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.[15]

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.[16]

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.[17][18] Ranbaxy is prohibited from manufacturing FDA-regulated drugs at the Mohali facility until the company complies with U.S. drug manufacturing requirements.[19]

There is some sigh of relief for Ranbaxy. As its Gurgaon based plant & Romania R&D centres are got FDA approval. Also in March, Ranbaxy's Paonta Sahib plant in Himachal Pradesh, which has faced a US regulatory ban since 2008, was also cleared in a joint inspection by five global drug regulatory agencies of the UK, Canada, the WHO and Singapore.[20]

Acquisition[edit]

In June 2008, Daiichi-Sankyo acquired a 34.8% stake in Ranbaxy,[21][22] 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[23] by acquiring a 63.92% stake in Ranbaxy. Ranbaxy's Malvinder Singh remained as CEO after the transaction.[24]

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.[25]

In 2009 it was reported that former Novartis Senior Vice-President Yugal Sikri would lead the India operations of Ranbaxy Laboratories.[26][27]

On 7 April 2014 India based Sun Pharmaceutical and Japan based Daiichi Sankyo jointly announced the sale of entire 63.4% share from Daiichi Sankyo to Sun Pharma in a $4 billion all share deal. Under these agreements, shareholders of Ranbaxy, will receive 0.8 share of Sun Pharmaceutical for each share of Ranbaxy.[3] After this acquisition, the partner Daiichi-Sankyo will hold a stake of 9% in Sun Pharmaceutical.[28] The combination of Sun Pharma and Ranbaxy creates the fifth-largest specialty generics company in the world and the largest pharmaceutical company in India.[29]

See also[edit]

Notes[edit]

  1. ^ a b c "Annual Report 2012". Ranbaxy Laboratories Limited. 
  2. ^ Matsuyama, Kanoko. (11 June 2008) Daiichi to Take Control of Ranbaxy for $4.6 Billion – 11 June 2008. Bloomberg.
  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. Retrieved 3 September 2013. 
  5. ^ Patent ruling hits Ranbaxy shares – 19 December 2005. BBC News (19 December 2005).
  6. ^ http://www.businessweek.com/news/2011-11-30/ranbaxy-s-lipitor-copy-approved-by-fda-threatening-pfizer-sales.html
  7. ^ "Ranbaxy gets approval to launch generic Lipitor in US – The Times of India". The Times of India. 
  8. ^ "Ranbaxy Gets USFDA Nod For Diovan – Bloomberg TV India". Bloomberg TV India. 
  9. ^ In-depth investigation of Ranbaxy Laboratories – Fortune Magazine, CNN. Features.blogs.fortune.cnn.com.
  10. ^ "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. 
  11. ^ "FDA Takes New Regulatory Action Against Ranbax 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." 
  12. ^ "KNMP waarschuwt voor verontreinigde tabletten —" (in Dutch). Gezondheidskrant.nl. 
  13. ^ Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin. Forbes.
  14. ^ 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)
  15. ^ "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. 
  16. ^ "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. 
  17. ^ FDA finds quality, process lapses at Ranbaxy plant
  18. ^ Ranbaxy import ban: US FDA found suspected hair, oil in tablets
  19. ^ "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)." 
  20. ^ "Good News for Ranbaxy - Plants of Gurgaon and Romania gets FDA nod". PharmaTutor. Retrieved 16 April 2014. 
  21. ^ India Knowledge@Wharton – The Ranbaxy-Daiichi Deal: Good Medicine, or a Harbinger of Future Ills? – 12 June 2008. Knowledge.wharton.upenn.edu.
  22. ^ Ranbaxy joined "Online Pharma Exhibition"
  23. ^ TimesOnlineUK – Business – Takeover of Ranbaxy
  24. ^ Matsuyama, Kanoko. (11 June 2008) Daiichi to Take Control of Ranbaxy for $4.6 Billion – 11 June 2008. Bloomberg.
  25. ^ 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. 
  26. ^ "Ranbaxy Laboratories Limited > Contact Us > Worldwide Operations > India". Ranbaxy.com. 
  27. ^ ET Bureau (11 September 2009). "Yugal Sikri to be New India CEO of Ranbaxy – Economic Times". The Economic Times. 
  28. ^ "India's Sun Pharma to Buy Ranbaxy in $4 Billion Deal". Retrieved 2014-04-06. 
  29. ^ "Sun Pharma to buy Ranbaxy in 4 billion USD". Retrieved 2014-04-07. 

External links[edit]