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Ranbaxy Laboratories

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Ranbaxy Laboratories Limited
Company typeSubsidiary
IndustryPharmaceuticals
Founded1961 (1961)
FoundersRanbir Singh
Gurbax Singh
Defunct2014; 10 years ago (2014)
FateAcquired by Sun Pharma
SuccessorSun Pharmaceuticals
Headquarters
Gurgaon, Haryana
,
India
Key people
  • Arun Sawhney (CEO, Ranbaxy Laboratories)
  • Joji Nakayama(CEO, Daiichi Sankyo)
Number of employees
10,983 (2012)[1]
ParentSun Pharmaceuticals

Ranbaxy Laboratories Limited was an Indian multinational pharmaceutical company that was incorporated in India in 1961 and remained an entity until 2014. The company went public in 1973. Ownership of Ranbaxy changed twice over the course of its history.

In 2008, Japanese pharmaceutical company Daiichi Sankyo acquired a controlling share in Ranbaxy[2] and in 2014, Sun Pharma acquired 100% of Ranbaxy in an all-stock deal. The Sun Pharma acquisition brought all new management to Ranbaxy, which had been laden with controversy (see Controversies below). Sun is the world's fifth largest specialty generic pharmaceutical company.[3]

History

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Formation

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Ranbaxy was started by Ranbir Singh and Gurbax Singh in 1937 as a distributor for Japanese company Shionogi. The name Ranbaxy blends the names of its founders: 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., in order to support its entry into the pharmaceutical market in United States.[4]

Trading

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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 had 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-amlodipine besylate, the generic version of Pfizer's Caduet, in the US, starting on 30 November 2011.[citation needed]

On 23 June 2006, the US Food & Drug Administration granted Ranbaxy a 180-day exclusivity period to sell simvastatin (Zocor) in the US as a generic drug at 80 mg strength. Ranbaxy competed 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 and India, whose authorized generic version (licensed by Merck) is exempt from exclusivity.[citation needed]

On 1 December 2011, Ranbaxy got approval from the FDA to launch the generic version of Lipitor in the United States after the drug's patent expired.[6][7]

Acquisition by Daiichi Sankyo

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In June 2008, Daiichi Sankyo acquired a 34.8% stake in Ranbaxy from the family of CEO and Managing Director Malvinder Mohan Singh for ₹ 10,000 crore (US$2.4 billion) at ₹737 per share.[8][9]

In November 2008, Daiichi-Sankyo completed the takeover of the company from the founding Singh family in a deal worth $4.6 billion[dubious – discuss][10] by acquiring a 63.92% stake in Ranbaxy. Ranbaxy's Malvinder Singh remained as CEO after the transaction.[11] The addition of Ranbaxy Laboratories extended Daiichi-Sankyo's operations, with the combined company worth about US$30 billion.[12]

In 2009, it was reported that former Novartis Senior Vice-President Yugal Sikri would lead the Indian operations of Ranbaxy Laboratories.[13][14]

In 2011, Ranbaxy Global Consumer Health Care received the OTC Company of the year award.

In 2012, 2013, and 2014 Brand Trust Reports, Ranbaxy was ranked 161st, 225th, and 184th respectively among India's most trusted brands.[15]

Acquisition by Sun Pharmaceutical

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On 7 April 2014, India-based Sun Pharmaceutical and Japan-based Daiichi Sankyo jointly announced the sale of the entire 63.4% share of Ranbaxy 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]

Controversies

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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.[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 FDA said it had 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 41 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, Ranbaxy pleaded guilty and paid $500 million in fines,[24] for 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 materially false statements to the FDA. Included in the adulterated products were antiretroviral (ARV) drugs destined for treatment of HIV/AIDS in Africa.[17]

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.[27][28] Ranbaxy was prohibited from manufacturing FDA-regulated drugs at the Mohali facility until it complied with United States drug manufacturing requirements.[29]

In 2014, The FDA notified Ranbaxy Laboratories, Ltd., that it was 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 11 January 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.[30][31]

In 2019 author Katherine Eban published Bottle of Lies,[32][33] an in-depth investigation of Ranbaxy. In addition to the incidents described above, Eban describes internal struggles within the FDA as investigators who might have shut down Ranbaxy were overruled due to pressure to increase the supply of cheap generic drugs.

See also

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References

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  1. ^ "Annual Report 2012" (PDF). Ranbaxy Laboratories Limited. Archived from the original (PDF) on 5 November 2013.
  2. ^ Matsuyama, Kanoko; Chatterjee, Saikat (11 June 2008). "Daiichi to Take Control of Ranbaxy for $4.6 Billion (Update3) - Bloomberg". Bloomberg.com. Bloomberg LP. Archived from the original on 2 December 2014. Retrieved 11 August 2018.
  3. ^ a b "Sun Pharma to acquire Ranbaxy for $4 billion in all-share deal". news.biharprabha.com. Indo-Asian News Service. Retrieved 7 April 2014.
  4. ^ "Ranbaxy: Ranbaxy Continues to Add Value and Utility to US Product Portfolio". pharmacytimes.com. Generic Supplement 2013. Pharmacy Times. 23 July 2013. Archived from the original on 6 August 2020. 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
  5. ^ Patent ruling hits Ranbaxy shares. BBC News (19 December 2005).
  6. ^ "Ranbaxys lipitor copy approved by fda threatening pfizer sales". Bloomberg News. Retrieved 5 October 2020.
  7. ^ "Ranbaxy gets approval to launch generic Lipitor in US – The Times of India". The Times of India.
  8. ^ Staff (12 June 2008). "The Ranbaxy-Daiichi Deal: Good Medicine, or a Harbinger of Future Ills? - Knowledge@Wharton". Knowledge@Wharton. Wharton School. Retrieved 11 August 2018.
  9. ^ "Ranbaxy joined "Online Pharma Exhibition"". Archived from the original on 31 January 2013.
  10. ^ TimesOnlineUK – Business – Takeover of Ranbaxy
  11. ^ Matsuyama, Kanoko. (11 June 2008) Daiichi to Take Control of Ranbaxy for $4.6 Billion – 11 June 2008. Bloomberg.
  12. ^ 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.
  13. ^ "Ranbaxy Laboratories Limited > Contact Us > Worldwide Operations > India". Ranbaxy.com. Archived from the original on 4 April 2012.
  14. ^ ET Bureau (11 September 2009). "Yugal Sikri to be New India CEO of Ranbaxy". The Economic Times. Archived from the original on 6 September 2013.
  15. ^ "India's Most Trusted Brands 2014". Trust Research Advisory. Archived from the original on 2 May 2015.
  16. ^ "India's Sun Pharma to Buy Ranbaxy in $4 Billion Deal". Bloomberg News. Retrieved 6 April 2014.
  17. ^ a b Eban, Katherine (15 May 2013). "Dirty Medicine". Fortune. Retrieved 6 February 2018. — an in-depth investigation of Ranbaxy Laboratories
  18. ^ "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.
  19. ^ "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.
  20. ^ "KNMP waarschuwt voor verontreinigde tabletten —" (in Dutch). Gezondheidskrant.nl. 6 March 2016.
  21. ^ Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin. Forbes.
  22. ^ 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)
  23. ^ "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.
  24. ^ Lambert, Jonathan (12 May 2019). "'Bottle Of Lies' Exposes The Dark Side Of The Generic-Drug Boom". NPR.org. Retrieved 17 November 2020.
  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. 14 May 2013. Retrieved 3 January 2018.
  27. ^ "FDA finds quality, process lapses at Ranbaxy plant". @businessline. 18 September 2013.
  28. ^ Ranbaxy import ban: US FDA found suspected hair, oil in tablets Archived 23 September 2013 at the Wayback Machine
  29. ^ "FDA prohibits the 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).
  30. ^ "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.{{cite web}}: CS1 maint: bot: original URL status unknown (link)
  31. ^ "India's Ranbaxy hit by FDA product ban at 4th Indian plant". Reuters. 24 January 2014. Retrieved 3 January 2018.
  32. ^ Eban, Katherine (14 May 2019). Bottle of Lies. HarperCollins. ISBN 9780062338785.
  33. ^ Jonathan Lambert (12 May 2019). "'Bottle of Lies' Exposes The Dark Side of the Generic-Drug Boom". NPR.
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