Sun pharmaceutical ( international marketing ) term paper
1. Course Code: MKT 625J Course Title: International Marketing
Course Instructor: Mr. MunishSaini
Academic Task Title:Term Paper
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2. SUN PHARMACEUTICAL
Dilip was born in Mumbai. His family later moved to Kolkata. He started off by helping his
father’s wholesale pharma business in Kolkata (then Calcutta). After Graduating from Calcutta
University in the stream of commerce, he started his own business in Kolkata with one
employee, where he marketed and sold psychiatry medicine. He then came to Mumbai, and set
up his first factory in Vapi, Gujarat.
Sun Pharmaceuticals was established by Mr. Dilip Shanghvi in 1983 in Vapi with five products
to treat psychiatry ailments. Cardiology products were introduced in 1987 followed
by gastroenterology products in 1989. Today, it is the largest chronic prescription company in
India and a market leader in psychiatry, neurology, cardiology, orthopedics, ophthalmology,
gastroenterology and nephrology.
The 2014 acquisition of Ranbaxy has made the company the largest pharma company in India,
the largest Indian pharma company in the US, and the 4th largest specialty generic company
globally.
Over 72% of Sun Pharma sales are from markets outside India, primarily in the US. The US is
the single largest market, accounting for about 50% turnover; in all, formulations or finished
dosage forms, account for 93% of the turnover. Manufacturing is across 26 locations, including
plants in the US, Canada, Brazil, Mexico and Israel. In the US, the company markets a large
basket of generics, with a strong pipeline awaiting approval from the U.S. Food and Drug
Administration (FDA).
Sun Pharma was listed on the stock exchange in 1994 in an issue oversubscribed 55 times. The
founding family continues to hold a majority stake in the company. Today Sun Pharma is the
second largest and the most profitable pharmaceutical company in India, as well as the largest
pharmaceutical company by market capitalisation on the Indian exchanges.
The Indian pharmaceutical industry has become the third largest producer in the world in terms
of volumes and is poised to grow into an industry of $20 billion in 2015 from the current
turnover of $12 billion. In terms of value India still stands at number 14 in the world.
In 2009 Sun Pharma's Caraco Pharmaceutical's plant in Detroit was closed due to unsanitary
conditions resulting in the seizure of $20 million of drugs by the FDA for contamination issues.
3. In December 2016 the FDA sent Sun a warning letter about nine violations at its manufacturing
plant in Halol.
Sun Pharma requested the USFDA to withdraw approval for 28 Abbreviated New Drug
Applications (ANDAs) belonging to its wholly owned subsidiary Ranbaxy Laboratories.
4. VISION
Reaching people and touching lives globally as a leading provider of Valued Medicines.
SUNOLOGY of the company
Sunology- it’s a combination of two words, Sun and ideology is at the core of Sun. Humility,
Integrity, Passion, & Innovation together from Sunology. It is a way of life at Sun.
HUMILITY
Under promise and over deliver.
Let your work speak for you.
Always put ‘we’ before me.
Learn from mistakes.
INTEGRITY
Do the right thing with conviction & without fear.
Practice honesty, impartiality & fairness at all time.
Adhere to strong ethical and moral standards.
Courage to call-out what is not right.
PASSION
Infuse energy in everything that you do.
Walk that extra mile.
Inspire others.
Do your best in every situation.
INNOVATION
Strive to implement new ideas and technologies to meet unmet needs.
Encourage others to think out-of-the-box.
Do not limit yourself.
Believe in raising the bar every time.
5. JOURNEY OF SUNPHARMACEUTICAL
Sun Pharmaceutical Industries Ltd. is the fifth largest speciality generic pharmaceutical company
in the world. The company manufactures and markets a large basket of pharmaceutical
formulations covering a broad spectrum of chronic and acute therapies. It includes generics
branded generics complex or difficult to make technology intensive products over-the-counter
(OTC) products anti-retrovirals (ARVs) Active Pharmaceutical Ingredients (APIs) and
intermediates. The product portfolio of over 2000 high quality molecules covers multiple dosage
forms including tablets capsules injectables inhalers ointments creams and liquids.
The products cater to a vast range of therapeutic segments covering psychiatry anti-infectives
neurology cardiology orthopaedic diabetology gastroenterology ophthalmology nephrology
urology dermatology gynaecology respiratory oncology dental and nutritionals. The company
has global presence with 41 manufacturing facilities across the world. India and the US are two
predominant markets accounting for nearly 70% of the company's revenue. The company has a
robust product pipeline and established presence in Europe and high-growth emerging markets
like Russia Romania South Africa Brazil and Mexico. The company has entered into a joint-
venture agreement with MSD (Merck) to develop and bring differentiated branded generics to
emerging markets. Sun Pharmaceutical Industries invests around 7-8% of its global revenue each
year in R&D. The R&D capabilities span the development of differentiated products such as
liposomal products inhalers lyophilized injections and nasal sprays besides controlled release
dosage forms.
Sun Pharmaceutical Industries Ltd was incorporated in the year 1983. The company began
operations in Kolkata with just 5 products to treat psychiatry ailments. They set up a compact
manufacturing facility for tablets/capsules at Vapi. Sales were initially limited to two states in
Eastern India. In the year 1986 the company set up an administrative office in Mumbai. They
extended the customer coverage to select cities in Western India. In the year 1987 they rolled out
their marketing operations nation-wide.In the year 1988 the company launched Monotrate and
Angizem products. In the year 1989 they introduced Products used in gastroenterology. They
moved their corporate office to Baroda. Also they began exporting their products to neighboring
6. countries. In the year 1998 the company established their first research center SPARC and this
created the base for strong product and process development that enabled growth in the
subsequent years. Also they began office in Moscow.
In the year 1994 the company was listed on the main stock exchanges in India. They started
production in a dosage form plant at Silvassa. Also they completed the major expansion at Vapi
plant. In the year 1995 the company's first API plant at Panoli started production. Also a new
division Azura was begun for cardiology products. Inca a new division to market critical care
medication to intensive care units began operations. They strengthened the international
marketing with offices in Ukraine and Belarus. In the year 1996 the company acquired an API
plant at Ahmednagar from the multinational Knoll Pharmaceutical and expanded and
substantially upgraded for regulated markets with capacity addition over the years across
differentiated API lines such as anticancers and peptides. Also the company acquired equity
stake in Gujarat Lyka Organics Ltd. a manufacturer of Cephalexin Active with a USFDA
approval for the intermediate 7ADCA.In the year 1997 the company's headquarters was shifted
to Mumbai India's commercial capital. Also they began the first of their international
acquisitions with an initial $7.5 million investment in Caraco Detroit. Also they took equity stake
in MJ Pharma a manufacturer of several dosage form lines with UK MHRA approval for
Cephalexin capsules.
The company acquired TDPL with an extensive product offering and its portfolio streamlined. In
the year 1998 the company acquired a basket of products including several respiratory/asthma
brands acquired from Natco Pharma. Their new formulation plant at Silvassa commenced
operations. In the year 2001 the company built a new formulation plant in Dadra. Also the
erstwhile TDPL division was renamed Spectra. A new division Arian targeting
cardiologists/physicians and diabetologists was launched. In the year 2004 the company acquired
common stock and options from 2 large shareholders of Caraco increasing stake to over 60%
from 44% at a total outlay of about $42 million. The upgraded and expanded formulation site in
Halol India (the erstwhile MJ Pharma site) received approval from USFDA UK MHRA South
African MCC Brazilian ANVISA and Columbian INVIMA. During the year the company
completed the construction at a formulation manufacturing site at Jammu.
7. They commissioned their first joint venture manufacturing unit in Dhaka Bangladesh. Also two
of their API factories received USFDA approval taking the total number of US FDA approved
sites to three. The company acquired a Cephalosporin Active manufacturer Phlox Pharma with
European approval for cefuroxime axetil amorphous.
In December 2004 a research centre spread over 16 acres was inaugurated by the President of
India with special lab space for drug discovery and innovation. In the year 2005 the company
bought a plant in Bryan Ohio US and the business of ICN Hungary from Valeant Pharma. In
December 2005 they acquired the intellectual property and assets of Able Labs from the US
District Bankruptcy court in New Jersey. In the year 2007 the company de-merged the
innovative research and business into a new company SPARC Ltd. SPARC Ltd was listed on the
stock exchanges in India the first pure research company to be so listed.
In May 2007 the company along with their subsidiaries signed definitive agreements to acquire
Taro Pharmaceutical Industries Ltd. a multinational generic manufacturer with established
subsidiaries manufacturing and products across the US Israel Canada for $454 million.In
November 2008 the company along with their subsidiaries acquired 100% ownership of Chattem
Chemicals Inc. a narcotic raw material importer and manufacturer of controlled substances with
an approved API facility in Tennessee. This offers vertical integration for its controlled
substance dosage form business in the US. In September 2010 the company acquired Taro
Pharmaceuticals. This acquisition doubled the size of their US business and brought them a
range of generics including a strong line of dermatologicals.
In April 2011 MSD in India and Sun Pharmaceutical Industries Ltd announced formation of an
India-specific strategic partnership agreement under which Sun Pharma will have the right to
market promote and distribute MSD's diabetes products sitagliptin and sitagliptin plus metformin
under different brand names in India. In June 14 2011 Caraco Pharmaceutical Laboratories Ltd
(Caroco) merged with a subsidiary of the company. Thus Caraco became a wholly owned
subsidiary of the company.In 2012 Sun Pharma bagged USFDA approval for its AND
Application for generic Zyprexa. The company also acquired URL generic business from Takeda
during the year under review. In 2013 the company announced US FDA approval for generic
8. Cymbalta. The company and Intrexon formed Joint Venture to Develop New Class of
Therapeutics for Ocular Diseases. The Company announces USFDA approval for generic
Prevacid generic DoxilAr and generic DepoAr-Testosterone Injection.
The company also Announces 1:1 Bonus during the year. The company also announces
Tentative USFDA approval for generic Januvia & Glumetza. In 2014 the company announced
US FDA approval for generic Temodar. The company acquires Pharmalucence during the year.
The company and Merck & Co. Inc. enter into Licensing Agreement for Tildrakizumab during
the year under review. The Board of Directors of the Company at its Meeting held on April 06
2014 has approved the scheme of arrangement between Ranbaxy Laboratories Limited and the
Company under the provisions of the sections 391 to 394 and other applicable provisions of the
Companies Act 1956 and corresponding provisions of the Companies Act 2013 subject to receipt
of necessary approvals consents and filings.
In 2015 the company receives US FTC clearance for Ranbaxy acquisition. The company and
AstraZeneca enter into distribution agreement for ticagrelor in India during the year. SPARC
Licenses Xelpros (Latanoprost BAK-free) to Sun Pharma. During the year Hon'ble High Court
of Gujarat at Ahmedabad has approved the Scheme of Amalgamation of Sun Pharma Global Inc.
(SPGI) wholly-owned subsidiary of the Company. The company also announces US FDA
Approval for Ximino TM. The company also announces another successful completion of
Opiates business acquisition in Australia and also acquires InSite Vision Incorporated. The
company announces Absorica patent litigation settlement during the year under review.
On 10 December 2015 Sun Pharmaceutical Industries announced that it has entered into a
tripartite research and option agreement with Israel-based Weizmann Institute of Science and
Spain's Health Research Institute of Santiago de Compostela (IDIS) to develop breakthrough
products for the treatment of neurological diseases like brain stroke as well as glioblastoma a
lethal brain cancer. On 14 December 2015 Sun Pharmaceutical Industries announced that as a
part of its manufacturing consolidation in the US one of its wholly owned subsidiaries has
entered into an agreement with Nostrum Laboratories Inc. (Nostrum) for the divestment of the
9. Bryan (Ohio) unit in the US. As a part of the agreement the Sun Pharma subsidiary has divested
this unit as a going concern along with the employees and related products to Nostrum.
On 19 December 2015 Sun Pharmaceutical Industries announced that it has received a Warning
Letter from the USFDA as a result of the September 2014 inspection for its facility located at
Halol Gujarat in India. Post the September 2014 inspection the US FDA has withheld future
product approvals from the Halol facility. Sun Pharma said that the company expects to request a
re-inspection by USFDA upon completion of its remediation commitments. Sun Pharma also
said at that time that the Halol facility will continue to supply important drug products to meet its
obligations to its customers and the patients who use the drugs in the United States and around
the world.
On 23 March 2016 Sun Pharma and AstraZeneca Pharma India Limited announced a partnership
for the distribution of dapagliflozin an innovative Type 2 diabetes medicine in India.
Dapagliflozin is AstraZeneca India's leading diabetes medicine. Under the agreement Sun
Pharma will promote and distribute dapagliflozin under the brand name Oxra.
AstraZeneca India markets dapagliflozin under the brand name Forxiga and under the terms of
the agreement both companies will promote market and distribute dapagliflozin in India under
different brand names. AstraZeneca will retain the intellectual property rights to dapagliflozin.
Sun Pharma will also gain the rights to promote and distribute the combination of dapagliflozin
with metformin under the brand name Oxramet after requisite regulatory approval.On 29 March
2016 Sun Pharma announced the acquisition of 14 established prescription brands from Novartis
AG and Novartis Pharma AG in Japan. According to the agreements entered into between the
parties a wholly-owned subsidiary of Sun Pharma will acquire the portfolio consisting of 14
established prescription brands from Novartis for a cash consideration of US$ 293 million. These
brands have combined annualized revenues of approximately US$ 160 million and address
medical conditions across several therapeutic areas.
Under the terms of the agreements Novartis will continue to distribute these brands for a certain
period pending transfer of all marketing authorizations to Sun Pharma's subsidiary. The acquired
10. brands will be marketed by a reliable and established local marketing partner under the Sun
Pharma label. The local marketing partner will also be responsible for distribution of the
brands.On 4 May 2016 Sun Pharma and International Centre for Genetic Engineering and
Biotechnology (ICGEB) signed an agreement to develop a novel botanical drug for treatment of
dengue. Through this agreement Sun Pharma will follow up on earlier pre-clinical collaboration
between ICGEB and erstwhile Ranbaxy Laboratories. Sun Pharma will develop Cipa a botanical
drug following a drug registration process similar to a new chemical entity consisting of all
required in-vitro in-vivo pre-clinical and clinical studies meeting all regulatory standards of India
and other regulatory agencies worldwide.
A botanical drug is a plant-derived medicinal product that is intended for use in the diagnosis
cure mitigation treatment or prevention of disease in humans. On 4 June 2016 Sun Pharma
announced that as a part of its manufacturing consolidation in the US one of its wholly owned
subsidiaries has entered into an agreement with Frontida BioPharm Inc. (Frontida) for
divestment of its two oral solid dosage manufacturing facilities located at Philadelphia PA and
Aurora IL both in the US along with 15 related pharmaceutical products. In connection with the
transaction Frontida has agreed to continue manufacturing certain products for Sun Pharma at
these facilities on a contract basis for a predetermined period.
The Board of Directors of Sun Pharma at its meeting held on 23 June 2016 approved buyback of
fully paid up equity shares of the company through the tender offer route at Rs 900 per share.
The purpose of the buyback is to return surplus funds to the equity shareholders and thereby
enhancing the overall returns to shareholders. On 18 July 2016 Sun Pharma and Sun Pharma
Advanced Research Company Ltd. (SPARC) announced a licensing arrangement for SPARC's
ELEPSIA XR (Levetiracetam Extended Release tablets). As per the agreement SPARC will
license ELEPSIA to a wholly-owned subsidiary of Sun Pharma for the US market. SPARC will
receive an up-front payment of US$10 million from Sun Pharma. It is also eligible for certain
additional milestone payments and defined royalties linked to any future sales of ELEPSIA
XR.On 27 July 2016 Sun Pharma and Almirall announced a licensing agreement on the
development and commercialization of tildrakizumab for psoriasis in Europe. Under terms of the
license agreement Almirall will pay Sun Pharma an initial upfront payment of US $50 million.
11. Sun Pharma will be eligible to receive development and regulatory milestone payments and
additionally sales milestone payments and royalties on net sales. Almirall will be able to lead
European studies and participate in larger global clinical studies for psoriasis indication subject
to the terms of the Sun Pharma - Merck agreements as well as certain cost sharing agreements.
Sun Pharma will continue to lead development of tildrakizumab for other indications where
Almirall will have right of first negotiation for certain indications in Europe.On 6 September
2016 Sun Pharma announced that it has signed a strategic distribution alliance with Mitsubishi
Tanabe Pharma Corporation Japan for 14 prescription brands.
Under this alliance Mitsubishi Tanabe Pharma Corporation will market and distribute all the 14
brands as well as provide information on their proper use to healthcare professionals.On 19
October 2016 Sun Pharma and International Centre for Genetic Engineering and Biotechnology
(ICGEB) announced their new collaboration for development of a dengue vaccine targeted
against all the four serotypes of Dengue virus that cause disease in humans. According to the
agreement Sun Pharma will fund and support further development of the vaccine candidate and
existing ICGEB Know-How and Patents. ICGEB will grant Sun Pharma exclusive rights and
licenses for development and commercialization of this vaccine globally. ICGEB will receive
pre-defined royalty and milestone payments.
On 26 October 2016 Sun Pharmaceutical Industries announced the execution of definitive
agreements by its wholly owned subsidiary for the acquisition of 100% of Ocular Technologies
Sarl (OTS) a portfolio company of Auven Therapeutics (Auven) an international private equity
company focused on accelerated development of breakthrough therapeutic drugs.
OTS owns exclusive worldwide rights to Seciera (cyclosporine A 0.09% ophthalmic solution).
Sun Pharma will pay Auven US$ 40 million upfront plus contingent development milestones and
sales milestones as well as tiered royalty on sales of Seciera as consideration for this
acquisition.On 23 November 2016 Sun Pharma announced the execution of definitive
agreements by its wholly owned subsidiary for the acquisition of 85.1% ofJSC Biosintez a
Russian pharmaceutical company engaged in manufacture and marketing of pharmaceutical
products in Russia and CIS region. The equity consideration for the 85.1% stake is US$ 24
12. million. Sun Pharma would also assume a debt of approximately US$ 36 million as part of this
transaction. Biosintez is a Russian pharmaceutical company focusing on the hospital segment
with annual revenues of approximately US$ 52 million for 2015. It has a manufacturing facility
in Penza region with capabilities to manufacture a wide variety of dosage forms including
pharmaceuticals for injections blood substitutes blood preservatives ampoules tablets ointment
creams gels suppositories APIs etc.
On 28 November 2016 Sun Pharma announced the launch of a branded ophthalmic product
BromSite 0.075% in the US market. It was the first branded product launched by the company in
the USA following its focus on Specialty Business. On 12 December 2016 Sun Pharma and
Israel-based Moebius Medical announced that they have entered into an exclusive worldwide
licensing deal to further develop MM-II a novel pharmaceutical candidate for the treatment of
pain in osteoarthritis. According to the agreement Sun Pharma will fund further development of
Moebius Medical's lead product MM-II and undertake its global commercialization. Moebius
Medical will conduct requisite pre-clinical studies and will assume responsibility for product
development and manufacturing through the end of Phase-II studies. Sun Pharma will assume
responsibility for further clinical studies regulatory submissions and product commercialization.
Moebius Medical will receive an upfront payment development-based and sales-based milestone
payments and tiered royalties on sales from Sun Pharma.
On 22 December 2016 Sun Pharma announced its plans to acquire a branded oncology product
Odomzo from Novartis. The agreement was signed for an upfront payment of US$ 175 million
and additional milestone payments. Odomzo (Sonidegib) was approved by the USFDA in July
2015. Odomzo is a hedgehog pathway inhibitor indicated for the treatment of adult patients with
locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation
therapy or those who are not candidates for surgery or radiation therapy.
On 4 January 2017 Sun Pharma announced successful Phase 3 confirmatory clinical trial results
for Seciera for the treatment of dry eye disease. Seciera is being developed by Ocular
Technologies a company acquired by Sun Pharma. Following this acquisition Sun Pharma owns
13. exclusive worldwide rights to Seciera and is developing it to commercialize for global markets
including US Europe and Japan as well as several emerging markets.
On 14 March 2017 Sun Pharmaceutical Industries announced that USFDA will lift the Import
Alert imposed on the company's Mohali Punjab manufacturing facility and remove the facility
from the Official Action Initiated (OAI) status. This proposed action will clear the path for Sun
Pharma to supply approved products from the Mohali facility to the US market subject to normal
USFDA regulatory requirements. The Mohali facility was inherited by Sun Pharma as part of its
acquisition of Ranbaxy Laboratories in 2015. The USFDA had taken action against the Mohali
facility in 2013 when it ordered the facility to be fully subject to Ranbaxy's Consent Decree of
Permanent Injunction. Certain conditions of the consent decree will continue to be applicable to
the Mohali facility.
On 27 June 2017 Sun Pharmaceutical Industries and National Institute of Virology (NIV) Pune
an institution of the Indian Council of Medical Research Department of Health Research
Ministry of Health and Family Welfare New Delhi announced that they have signed an
agreement for testing phytopharmaceutical biologic and chemical entities developed by Sun
Pharma against Zika Chikungunya and Dengue viruses. Sun Pharma will provide drug molecules
to NIV for testing against Zika Chikungunya and Dengue in model systems. Candidate
molecules with encouraging data will then be taken forward for commercial development.
On 4 July 2017 Sun Pharmaceutical Industries and Samsung BioLogics announced a strategic
long-term manufacturing agreement for Tildrakizumab an investigational IL-23p19 inhibitor
being evaluated for the treatment of moderate to severe plaque psoriasis. According to the
agreement Sun Pharma has appointed Samsung BioLogics to manufacture Tildrakizumab. The
approximate value of the contract will be US$ 55.5 million. The regulatory filings associated
with tildrakizumab have been accepted for review by the U.S. Food and Drug Administration
and the European Medicines Agency (EMA).
On 16 January 2018 Sun Pharmaceutical Industries announced that its wholly owned subsidiaries
have reached an agreement with Ironwood Pharmaceuticals Inc. and Allergan plc to resolve the
14. patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a
generic version of Linzess (Linaclotide capsules) in the US. Pursuant to the terms of the
settlement Ironwood Pharmaceuticals and Allergan will grant the wholly owned subsidiaries of
Sun Pharma a license to market a generic version of Linzess in the United States beginning 1
February 2031 (subject to USFDA approval) or earlier under certain circumstances.
15. ACQUISIONS AND JOINT VENTURES
Sun Pharma has complemented growth with select acquisitions over the last two decades. In
1996, Sun purchased a bulk drug manufacturing plant at Ahmednagar from Knoll
Pharmaceuticals and MJ Pharma's dosage plant at Halol that are both U.S. FDA approved today.
In 1997, Sun acquired Tamil Nadu Dadha Pharmaceuticals Limited (TDPL) based in Chennai,
mainly for their extensive gynaecology and oncology brands. Also in 1997, Sun Pharma initiated
their first foray into the lucrative US market with the acquisition of Caraco Pharmaceuticals,
based in Detroit.
In 1998, Sun acquired a number of respiratory brands from Natco Pharma. Other notable
acquisitions include Milmet Labs and Gujarat Lyka Organics (1999), Pradeep Drug Company
(2000), Phlox Pharma (2004), a formulation plant at Bryan, Ohio and ICN, Hungary from
Valeant Pharma and Able Labs (2005), and Chattem Chemicals (2008). In 2010, the company
acquired a large stake in Taro Pharmaceuticals, amongst the largest generic derma companies in
the US, with operations across Canada and Israel. The company currently owns ~ 69% stake in
Taro, for about $260 million.
In 2011, Sun Pharma entered into a joint venture with MSD to bring complex or differentiated
generics to emerging markets (other than India).
In 2012, Sun announced acquisitions of two US companies: DUSA Pharmaceuticals. a
dermatology device company; and generic pharma company URL Pharma. In 2013, the company
announced an R&D joint venture for ophthalmology with the research company, Intrexon.
On 6 April 2014, Sun Pharma announced that it would acquire 100% of Ranbaxy Laboratories
Ltd, in an all-stock transaction, valued at $4 billion. Japan's Daiichi Sankyo held 63.4% stake in
Ranbaxy. After this acquisition, Sun Pharma has become the largest pharmaceutical company in
India, the largest Indian Pharma company in the US, and the 5th largest generic company
worldwide.
In December 2014, the Competition Commission of India approved Sun Pharma's $3.2 billion
bid to buy Ranbaxy Laboratories, but ordered the firms to divest seven products to ensure the
deal doesn't harm competition.
16. In March 2015, Sun Pharma announced it had agreed to buy GlaxoSmithKline's opiates business
in Australia to strengthen its pain management portfolio.