Ranbaxy Laboratories

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Template:Short description Template:Use Indian English Template:Use dmy dates {{#invoke:Infobox|infobox}}Template:Template otherTemplate:Main other{{#invoke:Check for clobbered parameters|check|nested=1|template=Infobox company|cat=Template:Main other|name; company_name|logo; company_logo|logo_alt; alt|trade_name; trading_name|former_names; former_name|type; company_type|predecessors; predecessor|successors; successor|foundation; founded|founders; founder|defunct; dissolved|hq_location; location|hq_location_city; location_city|hq_location_country; location_country|num_locations; locations|areas_served; area_served|net_income; profit|net_income_year; profit_year|owners; owner |homepage; website }}{{#invoke:Check for unknown parameters|check|unknown=Template:Main other|preview=Page using Template:Infobox company with unknown parameter "_VALUE_" | ignoreblank=y | alt | area_served | areas_served | assets | assets_year | aum | brands | company_logo | company_name | company_type | defunct | dissolved | divisions | embed | equity | equity_year | fate | footnotes | former_name | former_names | foundation | founded | founder | founders | genre | homepage | hq_location | hq_location_city | hq_location_country | incorporated | image | image_alt | image_caption | image_size | image_upright | income_year | industry | ISIN | key_people | location | location_city | location_country | locations | logo | logo_alt | logo_caption | logo_class | logo_size | logo_upright | members | members_year | module | name | native_name | native_name_lang | net_income | net_income_year | num_employees | num_employees_year | num_locations | num_locations_year | operating_income | owner | owners | parent | predecessor | predecessors | production | production_year | products | profit | profit_year | rating | ratio | revenue | revenue_year | romanized_name | services | subsid | successor | successors | traded_as | trade_name | trading_name | type | website| qid | fetchwikidata | suppressfields | noicon | nocat | demo | categories }} 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<ref name="BB20180611merger">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> 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 Template:Xref. Sun is the world's fifth largest specialty generic pharmaceutical company.<ref name="bp" />

HistoryEdit

FormationEdit

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.<ref>Template:Cite journal</ref>

TradingEdit

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%).Template: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.<ref>Patent ruling hits Ranbaxy shares. BBC News (19 December 2005).</ref>

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.Template: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.Template: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.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref>Template:Cite news</ref>

Acquisition by Daiichi SankyoEdit

In June 2008, Daiichi Sankyo acquired a 34.8% stake in Ranbaxy from the family of CEO and Managing Director Malvinder Mohan Singh for [[Indian Rupee|Template:INR]] 10,000 crore (US$2.4 billion) at Template:INR737 per share.<ref name="Wharton20080612">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

In November 2008, Daiichi-Sankyo completed the takeover of the company from the founding Singh family in a deal worth $4.6 billion{{ safesubst:#invoke:Unsubst||date=__DATE__ |$B= Template:Fix }}<ref>TimesOnlineUK – Business – Takeover of Ranbaxy</ref> by acquiring a 63.92% stake in Ranbaxy. Ranbaxy's Malvinder Singh remained as CEO after the transaction.<ref>Matsuyama, Kanoko. (11 June 2008) Daiichi to Take Control of Ranbaxy for $4.6 Billion – 11 June 2008. Bloomberg.</ref> The addition of Ranbaxy Laboratories extended Daiichi-Sankyo's operations, with the combined company worth about US$30 billion.<ref>Template:Cite news</ref>

In 2009, it was reported that former Novartis Senior Vice-President Yugal Sikri would lead the Indian operations of Ranbaxy Laboratories.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

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.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

Acquisition by Sun PharmaceuticalEdit

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.<ref name="bp">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> After this acquisition, the partner Daiichi-Sankyo was to hold a stake of 9% in Sun Pharmaceutical.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

ControversiesEdit

During 2004–2005, Dinesh Thakur and Rajinder Kumar, two Indian employees at 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.<ref name=eban2013>Template:Cite news — an in-depth investigation of Ranbaxy Laboratories</ref> 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.<ref>Template:Cite news</ref>

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.<ref>Template:Cite news</ref>

On 8 February 2012, three batches of the proton-pump inhibitor pantoprazole were recalled in the Netherlands due to the presence of impurities.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

On 9 November 2012, Ranbaxy halted production and recalled 41 lots of atorvastatin due to glass particles being found in some bottles.<ref>Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin. Forbes.</ref><ref>Template:Cite newsTemplate:Subscription required</ref> 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.<ref>Template:Cite news</ref>

In May 2013, Ranbaxy pleaded guilty and paid $500 million in fines,<ref>Template:Cite news</ref> 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.<ref name='13-542'>Template:Cite news</ref><ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> 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.<ref name=eban2013 />

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>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref>Ranbaxy import ban: US FDA found suspected hair, oil in tablets Template:Webarchive</ref> Ranbaxy was prohibited from manufacturing FDA-regulated drugs at the Mohali facility until it complied with United States drug manufacturing requirements.<ref>Template:Cite news</ref>

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.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

In 2019 author Katherine Eban published Bottle of Lies,<ref name=eban2019>Template:Cite book</ref><ref name=npr>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> 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 alsoEdit

ReferencesEdit

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External linksEdit

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