Beruflich Dokumente
Kultur Dokumente
March 2015
Table of contents:
1. Introduction
(i)History
(ii)Chronological events
2. IPR Regime of Indian Pharmaceutical industry
6
3. Environmental Analysis
(i) PESTEL Analysis
4. Industry analysis:
(i)Porters Five Forces
(ii)Competitive Landscape
(a)Major Competitors
(b)Competition vs Coopetition
5.
6.
7.
8.
3
3
4
10
10
14
14
15
16
18
Segmentation, Targeting & Positioning
19
Company analysis
20
(i)SWOT analysis
20
(ii)VRIN analysis
20
Daaichi Sankhyo-Ranbaxy merger
26
(i)Strategic Rationale
26
(ii) Value chain efficiency for boosting innovative pharma
26
(iii)Ranbaxy: Debt free and a stronger balance sheet
26
(iv) Daaichi sankhyo: Emerging Markets are future growth
engines
27
(v)Competitive strengths and pain points
27
(vi)Daaichi Sankhyo
28
(vii) R&D Focus Alignment with Business Growth
28
(viii)Conclusion
28
Sun Pharma- Ranbaxy merger
29
(i)Chronology of the deal
31
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33
34
35
1.Introduction
The Pharmaceutical industry in India is the worlds third-largest in terms of
volume and 10th largest in value terms. India is now among the top five
pharmaceutical emerging markets of the world. Indian Pharmaceutical
industry is highly fragmented. Indias drugs and pharmaceuticals industry is
expected to grow at a compound annual growth rate (CAGR) of 14% to reach
a turnover of Rs 2.91 trillion ($ 47.06 billion) by 2018 as per the Indian Brand
Equity Foundation. However, the domestic market is worth $25.87bn.
Ranbaxy Laboratories Limited is the largest Indian multinational
pharmaceutical firm exported 125 countries, ground operated in 43 and
having manufacturing plant in 8 countries. Ranbaxy was founded in 1961;
head office at Gurgaon, BSE listed public company and employees 15,300
over 50 nationalities. Total global consolidated sale during Jan 2013 to March
2014 is Rs. 130.4 billion. Ranbaxy major sale comes from us Rs. 68 billion
and from developed country Rs. 54 billion. North America has significant
growth in sale Rs.42 billion.
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.
Ranbaxy joined Daiichi Sankyo Group in 2008. Daiichi Sankyo is a leading
global pharma innovator, headquartered in Tokyo, Japan. The company use
hybrid business model to achieved sustainable growth and accelerate
innovation drug creation. They are a vertically integrated company that
develops, manufactures and markets Generic, Branded Generic, Value-added
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(ARVs),
Active
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1988: The Company got Food and Drug Administrative approval from US to
enter in the US market.
1990: Ranbaxy is granted US patent for Doxycyline .
1992: The Company made joint venture with Eli Lilly, which was largest drug
marketer in the world and formed Eli Lilly Ranbaxy Ltd (ERL). ERL marketed
its branded drugs both in India, US, Europe etc.
1993: the company made another millstone. The company enters into the
Chinese
market
with
Joint
venture
with
Guangzhou
Qiaoguang
Pharmaceutical Co. Ltd and forms Ranbaxy Guangzhou China Ltd (RGCL). It is
first JV between two countries.
1995: Ranbaxy acquired of Ohm Laboratories, a manufacturing facility in the
US and build state-of-the-art new manufacturing wing, at Ranbaxys US
subsidiary Ohm Laboratories Inc.
1998: Ranbaxy enters USA, worlds largest pharmaceutical market, with
products under its own name. Ranbaxy filed its first Investigational New Drug
(IND) application with the Drugs Controller General of India (DCGI) for
approval to conduct Phase I clinical trials.
1999: Bayer AG, Germany and Ranbaxy sign an agreement where Bayer
obtains exclusive development and worldwide marketing rights to an oral
once daily formulation of Ciprofloxacin, originally developed by Ranbaxy.
2000: Ranbaxy acquires Bayers Generics business (trading under the name
of Basics) in Germany.
Ranbaxy enter into Brazil, the largest pharmaceutical market in South
America and achieves global sales of US $ 2.5 million in this market.
2001: Ranbaxy took a significant step forward in Vietnam by initiating the
setting up of a new manufacturing facility with an investment of US $ 10
million. Ranbaxy USA crosses sales of US $ 100 million, fastest growing
company in the US.
2002: It acquires Aventis in Franc.
2003: The Company enters into a crucial alliance with Glaxo Smith Kline
(GSK) for drug discovery and development.
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2005: The Company enters into JV with Nippon Chemiphar in Japan. The
company successfully ventured into foreign market including Canada Spain,
Germany, Romania.
2006: Acquires leading Romanian pharma company Terapia and Be-Tabs
pharmaceuticals, 5th largest generics company in South Africa.
2007: Ranbaxys Drug Discovery Team achieves significant milestone in GSK
research collaboration with the candidate selection of compound for
Respiratory Inflammation. Business World ranks Ranbaxy as the Most
Respected Company in the pharmaceutical industry.
2008: Ranbaxy partners with Daiichi Sankyo (DS) (34.4% share) establishing
a unique and powerful Hybrid Business Model; DS becomes a majority
partner.
2009: Ranbaxy partners with Daiichi Sankyo (DS) establishing a unique and
powerful Hybrid Business Model; DS becomes a majority partner. Ranbaxy
commences Phase-III studies on its anti-malaria combination new drug,
Arterolane Maleate + Piperaquine Phosphate.
2010: Project Viraat launched in India a key initiative to strengthen
companys leadership position in India. Ranbaxy delivers Quarterly Sales of
over US $ 500 Million for the first time.
2011: The Golden Jubilee Year 50 Years of an inspiring, pioneering and
historic journey.
2013: The top 10 drug manufacturers (by market value) account for 80 per
cent of the industrys market capitalization, much higher than their revenue
share of 58 per cent.
2014: Sun Pharmaceutical acquired the entire 63.4% share of Ranbaxy
making
the
conglomerate
worlds
fifth
largest
specialty
generic
pharmaceutical company
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The
existing
frame
work
of
intellectual
property
laws
recognized
India has amended this Patent Act, 1970 several times, but final amendment
came in March 2005 with
retrospective effect from Jan, 1, 2005 (due to TRIPS obligations) that made
Product patent law of the land and with that came an effective legal backing
to the original inventors/innovators. This amendment made it difficult for
Indian pharmaceutical firms to market the illegally reproduced products
extremely difficult. In the international market, they were already facing
considerable number of legal suits from the multinationals for exporting the
illegally replicated products
India for instance did not provide product patents for pharmaceutical drugs.
It only provided for process patents. The laws in India gave rise to a thriving
generic drug industry wherein practically every foreign drug was reverse
engineered without fear of any sanction. The pharmaceutical industry was
greatly affected by this practice and reversing this trend among developing
countries was top priority for the US as TRIPS negotiations were being
conducted.
Exempted from paying for licenses and royalties, Indian companies could
now access the newest molecules from across the globe and reformulate
them for sale in the domestic and foreign (wherever accessible) markets at a
fraction of the price charged by the inventing multinational firms.
Indian Pharmaceutical IndustryThe Cabinet Secretariat notified creation of a new Department, namely the
Department of Pharmaceuticals, under the Ministry of Chemicals & Fertilizers
which came into being w.e.f. 1st July 2008 with the objective to give greater
focus and thrust on the development of pharmaceutical sector in the country
and to regulate various complex issues related to pricing and availability of
medicines at affordable prices, research & development, protection of
intellectual property rights and international commitments related to
pharmaceutical sector which required integration of work with other
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Development
of
infrastructure,
manpower
and
skills
for
the
of
Industry
has
shown
tremendous
progress
in
terms
of
time
for
drug
intermediates
and
bulk
activities
without
2010-11
2011-12
2012-13
(Source CMIE Industry Outlook)
Import
of
Medicines
&
Pharmaceuticals
Products (Rupees in Crore)
11113.86
14287.66
16965.09
Exports of medicinal and pharmaceuticals products for the last three years
were as follows:
Year
2010-11
2011-12
2012-13
(Source CMIE Industry Outlook)
Exports
of
Medicines
&
Pharmaceuticals
Products (Rupees in Crore)
42353.28
51393.29
55692.53
these takeovers could affect the domestic Pharma Industry especially the
Generic Medicines. At present FDI in pharmaceutical sector is 100% through
automatic route for greenfield investment and through Government approval
route for brownfield investment. Further in brownfield investment noncompete clause is not allowed except in special circumstances with the
approval of the Foreign Investment Promotion Board (FIPB).
Regulatory Bodies of Indian Pharmaceutical industry
Drugs Controller General of India (DCGI) and Indian Council for Medical
Research (ICMR)
Ministry of Commerce
3. Environmental Analysis
PESTEL
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Patent Act, comes under IPR (Intellectual Property Rights) regime. This
Act impacts the Pharmaceutical Industry the most. Earlier the patents
were provided on the process rather than on product. So Indian
company took the advantage and started using a different chemical
route. They used the reverse-engineering route to invent alternate
manufacturing methods. A lot of money was saved this way. This also
encouraged competing company to market their versions of the same
drug. But in 2005 the government started providing patents on the
product.
Also some of the life saving drugs are very costly and unaffordable for
the poor, as the government started charging the excise duty on the
MRP.
Economic factors
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Product life cycle has shortened and R&D costs, in-licensing and
marketing costs have risen
Social factors
Technological Factors
Technological advancements will create new business prospects both in
terms of new therapy systems and service provisions.
The online opportunities will see the growth in new info and
communications technologies, social media for healthcare,
customized treatments, direct to patient advertising and direct to
patient communications.
Due to advancement in the technology the companies use
automatic machines which have increased the efficiency and
output.
But the high technology solutions are quiet expensive.
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Environmental Factors
Legal Factors
The pharmaceutical industry is now a highly regulated and compliance
enforcing industry. There is also a growing culture of litigation in many
countries. The evolution of the internet is also stretching the legislative
boundaries with patients demanding more rights in their healthcare
programs. As a result of which there are immense legal, regulatory and
compliance overheads for the industry to absorb. This tends to restrict its
dynamism but in recent years, government has begun to request industry
proposals on regulatory overheads to encourage innovation in the face of
mounting global challenges from external markets.
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4. Industry Analysis
Porters five forces model
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Barriers to
entry
LOW
Bargaining
power
of
power of
suppliers
suppliers
LOW
LOW
Industry
competiti
on
HIGH
Bargaining
Bargaining
power of
buyers
LOW
Threat
of
Threat of
substitutes
LOW
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Market Share
27%
Domestic
Multi-national
73%
India currently represents just U.S. $6 billion of the $550 billion global
pharmaceutical industry but its share is increasing at 10 percent a year,
compared to 7 percent annual growth for the world market overall. Also,
while the Indian sector represents just 8 percent of the global industry total
by volume, putting it in fourth place worldwide, it accounts for 13 percent by
value,2 and its drug exports have been growing 30 percent annually.
The organized sector of India's pharmaceutical industry consists of 250 to
300 companies, which account for 70 percent of products on the market,
with the top 10 firms representing 30 percent. However, the total sector is
estimated at nearly 20,000 businesses, some of which are extremely small.
Approximately 75 percent of India's demand for medicines is met by local
manufacturing.
According to the German Chemicals Association, India's top 10
pharmaceutical companies are Ranbaxy which now has been acquired by
SunPharma, Cipla, Dr. Reddy's Laboratories, Lupin, Nicolas Piramal,
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Lupin
It is one of the world's largest manufacturers of APIs and finished
formulations for TB, bacterial infections and cardiovascular disease
Its products are sold in more than 50 countries which represents its
strong global presence.
With its US launches its exports has increased to 56% of its production.
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It
manufactures
generics
and
APIs
in
the
antibiotic,
antiretroviral,cardiovascular,
central
nervous
system,
gastroenterological and anti-allergy fields and markets them in over
100 countries.
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Of its major selling products its sales were led by 83 percent annual
growth for the diabetes treatment Lantus (insulin glargine), followed by
the rabies vaccine Rabipur (+22 percent),the diabetes drug Amaryl
(glimepiride) and epilepsy treatment Frisium (clobazam), both up 18
percent, the angiotensin-coverting enzyme inhibitor Cardace (ramipril
+15 percent),Clexane (enoxaparin), an anticoagulant, growing 14
percent and Targocid (teicoplanin), an antibiotic, whose sales advanced
8 percent.
Competition vs Coopetition
Though they compete
Pharma, Zydus Cadila,
Ranbaxy Laboratories nearly $8 billion among
their best practices, in
rising operating costs.
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6. Company Analysis
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SWOT
1. Top 10 Global Generic Company
with a spread over 125 countries
2. Low cost products
3. Large skilled marketing force.
4. Market leader products like
Revital.
5. Developed Industry with Strong
Manufacturing Base
6. Well Established R&D
infrastructure
SWO
T
Strength
Opportunity
Weakness
Threat
VRIN analysis:
Focusing on production of generic drugs by Ranbaxy played an important
role in their global expansion. When a drug is marketed by pharmaceutical
company, it is usually under a patent which allows only that particular
company to sell it. So usually, it will be sold at a price premium. So generic
drug manufacturers will start producing and marketing these drugs at a very
low price, once the patent is expired if any. These drugs will be sold at price
which is affordable for the consumers especially in developing countries.
Ranbaxys strategy was to wait for the drugs patent to expire and then flood
the world market with its generic drugs. Ranbaxys major strength is its
advancement in technology; they started their research program in 1970s.
They leveraged on this strength to form strategic alliance with various
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industry leaders through which they were able to manufacture generic drugs
at low cost in India and sell these drugs to other countries through these
alliances. Indias low cost of production and innovation allowed it to sell at
competitive price across various countries. Ranbaxy exploited various
government policies which promoted the introduction of generic drugs to
reduce overall healthcare cost and make it affordable to everyone. Ranbaxy
entered foreign markets through the production of generic drugs through
strategic alliances. Through this strategy Ranbaxy ventured into new
markets becoming the tenth largest firm in the world in producing generic
drugs. This could be adopted by other companies as well, but in case of
Ranbaxy the skilled labor which Ranbaxy enjoys along with the base in R&D
is a rare resource for Ranbaxy. Though even this can be imitated by
competitors, Ranbaxy will benefit from the first mover advantage in generic
drug across the world. Focusing on R&D from initial stages of its growth
period had given clear cut advantage to the company and added value to the
firm. By 1994 Ranbaxy had a fully operational research centre at Gurgaon.
The unique historic conditions made the expertise in R&D a rare asset for
Ranbaxy compared to its competitors which is difficult to imitate
Ranbaxy views its R&D capabilities as a vital component of its business
strategy that will provide the company with a sustainable, long-term
competitive advantage. The Company today has a pool of over 1,200
scientists engaged in path-breaking research. The Companys multidisciplinary R&D centre at Gurgaon, in India, houses dedicated facilities for
generics research and innovative research. The companys robust R&D
environment for both drug discovery & development reflects the Companys
commitment to be a leader in the generics space and offer value added
formulations based on its Novel Drug Delivery System (NDDS) and New
Chemical Entity (NCE) research outcomes. Ranbaxy has enhanced its focus
on NCE research with the proposed De-merger of its New Drug Discovery
Research (NDDR) unit into a separate entity, Ranbaxy Life Science Research
Ltd, subject to requisite approvals. This significant step will open up new
growth opportunities and provides a platform for increased collaboration. The
new drug research areas at Ranbaxy include anti-infectives, inflammatory /
respiratory, metabolic diseases, oncology, urology and anti-malaria.
Presently, the Company has 8-10 programs comprising one anti-malaria
molecule in Phase-II clinical trials. The Company has two programs in Phase I
and the remaining in the pre-clinical stage. This includes a collaborative
research program with GSK. The company's NDDS focus is mainly on the
development of NDA/ANDAs of oral controlled- release products for the
regulated markets. The Companys first significant international success
using the NDDS technology platform came in September 1999, when
Ranbaxy out-licensed its first once-a-day formulation to a multinational
company.
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R & D EXPENSES
35.01
45.79
45.64
192.17
276.13
483.82
471.38
The company steadily increased its R&D expenditure from Rs.35 crores in
1995 to Rs. 45.64 in 2000, which is a percentage increase of over 30% within
a period of five years. During the next seven years, the R&D expenditure
increased from Rs.55.39 crores in 2001 to a whopping Rs.639.33 crores,
again a percentage increase of 1054 % between 2001 and 2007. However
the R&D expenditure dropped to Rs.483.82 crores in the year 2008, with a
further decline in 2009 (Rs.460.51) and 2010 (Rs.471.38).(Source: CMIE,
Prowess Database ). The reason behind this drop is that after the first
successful NDDS product ciprofloxacin, there were hardly any other returns
from the huge R&D investments Ranbaxy was making. Ranbaxy is seen
adopting a combination of Competitive & Collaborative strategies.
Ranbaxys Competitive Strategies:
1) NDDS : - The R&D focus is to modify existing drugs so as to develop new
formulations, that can be patented and sold at a higher price. The new
formulations include Novel Drug Delivery System (NDDS) such as, developing
a controlled or extended release formulation of existing oral therapies to
reduce side effects or increase patient compliance; developing alternative
delivery routes, including oral as opposed to injectibles, to increase patient
convenience and compliance; and enhancing purification of product to
reduce dosing and side effects. Ranbaxy developed NDDS for ciprofloxacin. It
is also actively involved in developing NDDS in several other therapeutic
areas such as gastric retention. In the area of NDDS, Ranbaxy recorded the
most noteworthy success. The firm was able to develop an improved version
of one the new generation antibiotics, viz. ciprofloxacin, which was
developed by Bayer AG and was under patent protection until 2003. Ranbaxy
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enough new drugs for the domestic market and they can no longer take
drugs from MNCs, they are looking for in-licensing arrangements with MNCs
to lauch their products in India. The arrangements are either pure marketing
relationships or local production and sharing profit margins with the MNC.
This strategy helps Indian companies to bring novel medications to the
country at reasonable prices and also makes regulatory procedure easier and
faster. Agreement between Ranbaxy and K. S. Biomedix Ltd accords Ranbaxy
exclusive marketing rights for TransMID, a biopharmaceutical product used in
the treatment of brain cancer in India with an option to expand this to China
and other South East Asian countries (IBEF and Ernst and Young, 2004b, p.
26). Co-marketing alliances are taking place not only among Indian and
foreign producers, but also among Indian producers. Recently, Jupiter
Bioscience entered into a 10-year co-marketing agreement with Ranbaxy,
under which the company would license out to Ranbaxy five generic peptide
drugs worth US$ 3 billion at innovators price. It is believed that this tie-up
helps Jupiter Biosciences to bring its products to international market rapidly,
as Ranbaxy already has strong presence in the global market. Ranbaxy and
Cipla, have entered into a strategic partnership to jointly market a select
basket of drugs. The alliance will bring forth their strengths in the strongly
emerging cardiovascular and perennial anti-infectives market.
2) Collabarative R&D :- Glaxo SmithKline and Ranbaxy have a collaborative
R&D arrangement for the development of new drugs in the areas of infective
diseases and diabetes. Ranbaxy and Avestagen Laboratories have
collaboration for the production of NCEs using biotechnological techniques.
Ranbaxy has entered into a collaborative programme with MMN, Geneva for
an anti-malarial molecule, Rbx 11160; and also with Vectura, a drug delivery
company for development of platform technologies in the areas of oral
controlled release system.
3) CRAMS : ONE of the most important collaborative strategy that has
emerged recently is CRAMS. In 2005, CRAMS market in India was valued at
USD532.10 million, of which contract manufacturing accounted for 84% of
the total market, while the remaining 16% was accounted by contract
research (excluding clinical trials). Both the segments of CRAMS have
registered a robust growth rate of over 40% in 2005 over the previous year
(Cygnus Research). GlaxoSmithKline has tied with Ranbaxy to work on lead
compounds until second round of clinical trial are completed
Another valuable strategy by Ranbaxy is the acquisitions made by the
pharmaceutical giant over the years. In order to expand its global footprint
and diversify its product portfolio, Ranbaxy also acquired a number of foreign
generic drug manufacturing companies.
Acquisition History of Ranbaxy
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The above analysis indicates that Ranbaxy adopted a High-Risk-HighReturns strategy, both in R&D as well as in its attempt to become a global
company. Eventually, the increasing expenditure on risky R&D, patent
challenges with inadequate returns, high entry costs in foreign markets,
numerous acquisitions by the company to increase its geographical presence
took its toll on the financial health of the company. Consequently, in 2008,
Ranbaxy redefined its business model. The company brought in Daiichi
Sankyo Company limited as a majority to create a strategic combination of
an innovator and generic powerhouse. The inability to cope up with these
financial troubles is believed to be an important factor behind the decision of
the Indian promoters of Ranbaxy, the Singh family, to relinquish their control
to Daiichi Sankyo. According to the Report of Ministry of Commerce &
Industry, 2008, pp. 42-43, this may have been good for Ranbaxy which
needed an influx of funds but whether this has a positive impact from the
point of view of access to medicines is questionable. Ranbaxys activities
may be re-oriented to suit the interests of the MNC that acquired it rather
than the generic requirements of developing countries. Thus in June 2008,
Ranbaxy entered into an alliance with one of the largest Japanese innovator
companies, Daiichi Sankyo Company Ltd., to create an innovator and generic
pharmaceutical powerhouse. The combined entity now ranks among the top
20 pharmaceutical companies, globally. The transformational deal will place
Ranbaxy in a higher growth trajectory and it will emerge stronger in terms of
its global reach and in its capabilities in drug development and
manufacturing.
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First to file status for 18 drugs with annual sales potential of $27 billion
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certain other companies in India have caused the multi-billion dollar Indian
generic pharmaceutical industry severe loss in international markets.
Strategic rationale: The acquisition by Sun Pharma may result in a
turnaround for the beleaguered Ranbaxy. Several reasons may be attributed
to such M&A activity by pharma companies, some of them being:
i.
ii.
This deal involves 3 parties: Sun Pharma, Ranbaxy and Daiichi. In connection
with the transaction, Daiichi Sankyo has agreed to indemnify Sun Pharma
and Ranbaxy for, among other things, certain costs and expenses that may
arise from the recent subpoena which Ranbaxy has received from the United
States Attorney for the Toansa facility.
Merging Company
Ranbaxy
Surviving Company
Sun Pharma
Total
equity
Transaction
value
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of
Date
April 6, 2014
Event
Resolutions
regarding
the
amalgamation agreement and other
matters passed at the Board of
Directors meetings of Sun Pharma
and Ranbaxy
Court-convened
extraordinary
general meeting of shareholders of
Sun Pharma conducted pursuant to
an order dated August 5, 2014 of
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of
Punjab
and
September 4, 2014
Court-convened
extraordinary
general meetings of shareholders
Ranbaxy to be conducted pursuant
to an order dated August 5, 2014 of
the High Court of Punjab and
Haryana 35
December 5, 2014
January 2015
Merger/amalgamation
completed
with approval from high courts in
India,
the
Indian
central
government and relevant state
governments, stock exchanges and
approval under the Hart-ScottRodino Act in the US
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9. Future Strategies
Mission: Enriching
pharmaceuticals
lives
globally,
with
quality
and
affordable
Strategies:
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EXHIBITS
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