Ranbaxy

Topmost Pharmaceutical company in India 2012

Ms. Vandana Dubey Ms. Priti Tawde Mr. Narendra Daundkar

Introduction
Largest pharmaceutical company
Turnover of Rs 4,198.96 crore (Rs 41.989 billion) Major strengths are

-Global business strategy -Collaborative research -Dynamic market network

History
1937 The company started as a distributor for Japanese vitamins and antituberculosis drugs. 1951 alliance with the Italian company Lapetit under which Ranbaxy distributed Lapetits products in India.
1966 The association with Lapetit ended due to Ranbaxys determination to formulate more products locally.

The name Ranbaxy is a combination of the names of its first owners Ranbir and Gurbax.

1961 Lapetit assisted Ranbaxy to set up some limited local manufacture. This was the first example of Ranbaxys use of alliances to gain technical expertise.

1969 Faced with an ensuing product shortage, Ranbaxy reverseengineered Lapetits products

History.
1970 Indian government introduced patent legislation ,however, this only protected processes. 1975 exporting either generic products, which were out of patent, or copies of patented drugs
.

1992 joint venture with Eli Lilly

1971 Ranbaxy, which established its bulk drugs facility at Mohali, Punjab and went public in

1980 The company transformed from a local to an international company

1993 Ranbaxy restructured into four regions India and Middle East; Europe CIS and Africa; Asia Pacific; and North and South America

History.
1994 Lilly also contracted Ranbaxy to make generics for it 1998 Ranbaxy entered the United State

1997 Ranbaxy engaged in a spate of alliances and acquisitions to gain scale domestically.

BOARD OF DIRECTORS
Dr. Tsutomu Une Chairman Non Executive & Non Independent Director
Mr. Arun Sawhney CEO & Managing Director Mr. Takashi Shoda Non Executive & Non Independent Director

Dr. Kazunori Hirokawa

Non Executive & Non Independent Director

Dr. Anthony H. Wild Independent Director

Mr. Rajesh V. Shah

Independent Director

Mr. Akihiro Watanabe Independent Director Mr. Percy K. Shroff Independent Director

TOP 10 MOLECULES

Valacyclovir Simvastatin Donepezil Atorvastatin & Combinations Co-amoxyclav & Combinations Ciprofloxacin & Combinations Ketorolac Tromethamine Imipenem+Cilastatin Ginseng+Vitamins Loratadine & Combinations

FORMULATIONS
One of the largest distribution networks that comprises 2500+ skilled field force. Dedicated task forces for specialised & chronic therapies
A strong player in the NDDS segment. Key brands include Cifran OD (Ciprofloxacin), Zanocin OD (Ofloxacin) & Sporidex AF (Cephalexin) Strong brand building capabilities, reflected in the fact that around 20 brands feature in the Top-300 brands of the Industry list. Leading brands are Sporidex (Cephalexin), Cifran (Ciprofloxacin), Mox (Amoxycillin), Zanocin (Ofloxacin) & Volini (Diclofenac)

 With a futuristic approach, the India operations attempt to capitalize on

the fast- emerging, high-growth segments with innovative products and services:

Biological formulations such as Verorab (Rabies Vaccine) and Vaxigrip (Flu Vaccine), which require competencies to propagate the newer concepts in the market place. These products are being in-licensed or taken on Co-

promotion from Sanofi Pastuer.

High end anti-infectives such as Cilanem (Imipenem+Cilastatin) & Faronem (Faropenem) have been launched for the first time in India. Ranbaxy is championing the concept of Penems/ Carbapenmens , locally Dry Power & Metered Dose Inhalers have been launched in the Respiratory

segment. All Metered Dose Inhalers are HFA based formulations, environment friendly inhalers. It is for the first time in India, that a company has launched its entire HFA propellant based MDI range. The worlds first novel product, Osovair (Formoterol + Ciclesonide) inhalation capsules has been introduced in the Indian market. Anti-diabetic franchise has been further consolidated with launch of Insucare (Insulin) with an innovative delivery mechanism - Controlled Insulin Logistics This ensures that the cold chain, vital for product efficacy, is maintained. A slew of products have been launched in the Dermatology segment: Suncross (Sunscreen lotion), Sotret (Isotretnoin), Eflora (Eflornithine)

MANUFACTURING
An organisations' capabilities and intent are strongly reflected in the product it manufactures.

In other words, the manufacturing competencies and facilities echo truly, the R&D extent and the ability to implement it for the best of the market it targets.

API

Contd..
Ranbaxy has world-class manufacturing facilities in 8

countries namely Ireland, India, Malaysia, Morocco, Nigeria, Romania, South Africa, and USA. Its overseas facilities are designed to cater to the requirements of the local regulatory bodies of that country while the Indian facilities meet the requirements of all International Regulatory Agencies. Some of the agencies such as MCAUK, MCC-South Africa, FDA-USA and TGA-Australia, have audited Ranbaxys manufacturing facilities for the compliance with international Good Manufacturing Practices and have registered its products for safety, quality and efficacy.

COMPETITORS
Sun Pharmaceuticals
Dr Reddys Laboratories Lupin pharmaceuticals

Glaxosmithkline ( GSK)

COMPETITORS.

th 19

JANUARY 2010

Ranbaxy Laboratories said it will acquire Bangalore-

based Biovel Lifesciences for an undisclosed amount. "The proposed transaction will give Ranbaxy access to all of Biovels products, pipeline, intellectual property know-how and manufacturing facility. The products that are part of the transaction are Typhoid VI antigen and Hib conjugate vaccines for which Ranbaxy also has the regulatory approvals in India. It would also give Ranbaxy an access to Biovels future product pipeline comprising a range of vaccines,bio therapeutics and other products. "This transaction provides an entry platform to manufacture vaccines as well as biotherapeutics."

Contd
The vaccine and biotherapeutics business will be an important part

of growth strategy. "Ranbaxy, with its global market reach, quality and manufacturing expertise, will be able to leverage this to its full potential, and create a business of scale," . According to the industry experts, the proposed acquisition would give a strong product pipeline to Ranbaxy in the Rs 3,600 crore (Rs 36 billion) domestic vaccine market, which is growing at the rate of 10 percent. The global market for vaccines in around $21 billion and estimated to grow at a rate of 9 per cent per annum to reach $34 billion by 2014. Bangalore-based Biovel, which started operations in 2007, is a biotechnology firm focused on research, manufacturing and marketing of biogenerics, bio-superiors and bio-pharmaceuticals. Gurgaon-based Ranbaxy Laboratories is India's largest pharmaceutical company in which Japanese drug maker Daiichi Sankyo has over 63 per cent stake.

Bulk Drug Pilot Plant Ranbaxy Laboratories, Ponta Sahib

This facility is only a part of a large industrial complex for production bulk drugs. It is relatively small in size but plays a very vital role for the overall development. As the first building in the vast open site, it was to establish an architectural style to be followed in future development to bring in an overall identifiable unifying character. Tilted square column Colonnades, recessed Bulk Drug Pilot of blue color, are windows and selected usePlant Ranbaxy Laboratories, Ponta Sahib the important elements of this vocabulary. The plant has three distinct blocks housing its three different functions. The first accommodates the administration, canteen and guest rooms, the second the production areas and the third the services. The second and third has simple rectangular forms to suite their function, where as the front block has been given an interesting semi circular form as it also houses the informal activities.

R&D
Ranbaxy views its R&D capabilities as a vital component of its

business strategy that will provide a sustainable, long-term competitive advantage. The company has a pool of over 1,200 R&D personnel engaged in path-breaking research. Ranbaxy is among the few Indian pharmaceutical companies in India to have started its research program in the late 70's, in support of its global ambitions. A first-of-its-kind world class R&D centre was commissioned in 1994. Today, the company has multi-disciplinary R&D centers at Gurgaon, in India, with dedicated facilities for generics research and innovative research. The R&D environment reflects its commitment to be a leader in the generics space offering value added formulations and development of NDA/ANDAs, based on its Novel Drug Delivery System (NDDS) research capability. The NDDS research at Ranbaxy focuses on maximizing the overall therapeutic and commercial value of commonly prescribed pharmaceutical formulations by enhancing their performance and reducing their adverse event profile. Such innovation also helps to improve the overall patient convenience and compliance.

The company's NDDS focus is mainly on the development of New Drug Applications (NDA) / Abbreviated New Drug Applications (ANDAs) of oral controlled- release products for the regulated markets. The Company's first significant international success using the NDDS technology platform came in September 1999, when Ranbaxy licensed its once-aday Ciprofloxacin formulation on a worldwide basis to a multinational Company. Ranbaxy's in-house NDDS programs are primarily focused on the oral segment. Inhalation (patented devices) and trans-dermal (patented adhesive polymers) programs are also being pursued through collaborations. In the oral NDDS space, Ranbaxy has already developed four platform technologies namely Gastro Retentive, Modified Matrix, Multiparticulate and AeroGel. Several products leveraging these technologies have been successfully developed.

New R&D facility for Drug Discovery research (DDR)

R&D III

R&D I

R&D II

R&D IV

In July 2010, Ranbaxys New Drug Discovery Research (NDDR) was transferred to Daiichi Sankyo India Pharma Private Limited as part of the strategy to strengthen the global Research and Development structure of the Daiichi Sankyo Group. While NDDR has become an integral part of Daiichi Sankyo Life Science Research Center in India, based in Gurgaon, Ranbaxy continued to independently develop the anti-malarial new drug, Arterolanemaleate + Piperaquine phosphate. In 2011, Ranbaxy received permission from the Indian Drug Regulator, Drug Controller General of India (DCGI), to manufacture and market this drug in India. The company has now launched Indias first new drug, SynriamTM, for the treatment of uncomplicated Plasmodium falciparum malaria, in adults. Ranbaxy will also explore the further development of late stage programs developed by NDDR in the last few years, including the development programs in the GSK collaboration. Within Ranbaxy, R&D of Generics will now get a sharper focus, as the company is increasingly working on more complex and specialist areas.

SYNRIAM
Ranbaxy Laboratories Limited (Ranbaxy) launched Indias

first new drug, Synriam, for the treatment of uncomplicated plasmodium falciparum malaria, in adults, opening a new chapter in the history of Research & Development in India. At a function held in New Delhi, Ghulam Nabi Azad, Minister of Health and Family Welfare, Government of India and Vilasrao Deshmukh, Minister of Science & Technology and Earth Sciences, Government of India, unveiled Indias first new drug Synriam with Ranbaxy dedicating the new age cure for malaria to the nation, on World Malaria Day.

The new drug, has been approved by the Drug Controller General of India (DCGI) for marketing in India and conforms to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria. Synriam provides quick relief from most malaria-related symptoms, including fever, and has a high cure rate of over 95 per cent. Phase III clinical trials for the drug conducted in India, Bangladesh and Thailand successfully demonstrated the efficacy and tolerability of Synriam as comparable to the combination of artemether and lumefantrine. The dosage regimen is simple as the patient is required to take just one tablet per day, for three days, compared to other medicines where two to four tablets are required to be taken, twice daily, for three or more days making Synriam a convenient option, leading to better compliance.

The drug is also independent of dietary restrictions for fatty foods or milk, as is the case with older anti-malarial therapies. Since Synriam has a synthetic source, unlike artemisinin-based drugs, production can be scaled up whenever required and a consistent supply can be maintained at a low cost.

Felicitating the scientific team from Ranbaxy, Dr Tsutomu Une, chairman, Ranbaxy, said, I applaud all our scientists who have worked incessantly over eight years and with great diligence to successfully develop a new drug. This is a tribute to the indomitable spirit of the Indian scientific community. The drug fills a vital therapy gap not only in India but also worldwide. We will make all possible efforts to make Synriam accessible to the world.

The drug is also independent of dietary restrictions for fatty foods or milk, as is the case with older anti-malarial therapies. Since Synriam has a synthetic source, unlike artemisinin-based drugs, production can be scaled up whenever required and a consistent supply can be maintained at a low cost.

Felicitating the scientific team from Ranbaxy, Dr Tsutomu Une, chairman, Ranbaxy, said, I applaud all our scientists who have worked incessantly over eight years and with great diligence to successfully develop a new drug. This is a tribute to the indomitable spirit of the Indian scientific community. The drug fills a vital therapy gap not only in India but also worldwide. We will make all possible efforts to make Synriam accessible to the world.

Arun Sawhney, CEO and managing director, Ranbaxy said, It is indeed gratifying to see that Ranbaxys scientists have been able to gift our great nation its first new drug, to treat malaria, a disease endemic to our part of the world. Synriam will certainly become the preferred option in the hands of doctors to fight malaria, which every year claims more than half a million lives globally. He further added that this is a historic day for science and technology in India as well as for the pharmaceutical industry in the country, as India today joins the elite and exclusive club of nations of the world that have demonstrated the capability of developing a new drug. Heralding the arrival of the new drug, Dr Sudershan Arora, presidentR&D, Ranbaxy, said, "The new drug, which will be marketed first in India, is developed as a fixed dose combination consisting of arterolane maleate 150 mg and piperaquine phosphate 750 mg drug, in line with WHO recommendations. It is among the best options available today. I applaud the success of R&D at Ranbaxy in the creation of this new age cure for malaria and am sure that innovative drug products will continue to be developed at Ranbaxy-R&D labs, even in the future."

Ranbaxy is also working to make this new treatment available in African, Asian and South American markets where Malaria is rampant. Synriam trials are ongoing for plasmodium vivax malaria and a paediatric formulation. Traditional drugs are proving ineffective against the deadly malarial parasite because it has progressively acquired marked resistance to available drugs. Availability of plant based artemesinin, a primary ingredient in established anti-malarial therapies is finite and unreliable. This leads to price fluctuations and supply constraints. Most of the existing therapies have a high pill burden that increases the possibility of missing a dose. There was a critical need for a new anti-malaria drug that would address these challenges. Ranbaxy embarked upon this development project with the aim of coming up with a new anti-malarial drug that would be highly effective as well as address the issues associated with the most commonly used therapies.

Global sales trend

Past performances of pharma company

Ranbaxy latest drug market share

FINANCIAL SALES

SUPPLY CHAIN SOLUTIONS

Situation anaalysis Ranbaxy is one of the leading multinational companies in India in the area of pharmaceuticals. It deals with large quantities of exports and imports of pharma products, and hence, required extensive warehousing facilities. It had to store its consignments and transport them by air, ocean or combination of both, ie. multi-modal transportation. Key challenges Ranbaxy had to face many challenges during the execution of its project. The main challenges faced by the company werecontinuously maintaining critical temperature during storage and transportation of pharma products, maintaining the delivery schedules and meeting the deadlines. Besides this, other challenges were setting up of warehouses at important locations and distribution centres at various overseas and domestic locations by properly identifying them, ensuring compliance of norms set up by Food and Drug Administration (FDA), complying with all regulatory requirements such as documentation required for export and import and keeping track of the current position of the shipment dispatched by it.

SOLUTION To deal with these problems, Ranbaxy decided to make use of services provided by Aqua Logistics. Aqua was assigned the task of tracking and tracing the shipments. To accomplish this, it set up a warehouse located at a central location, which was at optimum distance from the ports. It also set up effective tie ups with air carriers to maintain cold chains and to improve transit times. To transport generic products under optimum temperature conditions, Aqua provided cost-effective consol solution for LCL sea shipments. Further, Aqua provided consultancy on EXIM, which assisted in getting various licenses from DGFT and their various finalisations and closures as well as related customs formalities. It also provided locational implants for better co-ordination and to carry out mundane documentation procedures including overseas invoicing as well as EXIM documentation. With the help of services offered by Aqua, considerable improvement was achieved in the planning process and on-time delivery of goods. The company could accurately track and trace it so that it could plan for its future strategies. Due to tieups with air carriers, cold storage chains were maintained properly and it also reduced the transit time taken by cargo from origin point to the final destination. The company could anticipate the number of days for which remaining inventory will last. Hence, it did not have to keep excessive stock of materials, which reduced the inventory carrying cost and also reduced the loss of goods lying unattended at warehouses for several days. It also controlled the transportation and administration cost. Besides this, it also led to reduction in costs associated with holding fixed assets for their warehousing and management. Ranbaxy was able to comply with the regulatory requirements as per norms set up by FDA. This resulted in easier flow and exchange of information between Ranbaxy and its trading partners.

International Regulatory filings and approvals Dosage forms

Approvals USA 4 Filings 9#

EUROPE
-National -MRP -DCP Other Key Markets Australia/N.Zealand Brazil Canada China

21
9 3 9 12 4 2 -

15
4 4 7 7 4 11 9

Russia/CIS
S.Africa Other markets Total

20
2 86 151

7
6~ 162 230

#including 1 PEPFAR filing ~ including 5 Out-sourced products

PLANTS APPROVAL
Plants Aprroval

Ohm laboratories (USA)

Mohali (Punjab)

USFDA EU
USFDA,WHO Geneva, ANVISA Brazil, TGA Australia

Paonta Sahib Goa South Africa

Goa

GCC, Ukraine MOH,ANVISA Brazil, WHO Geneva, MoH Uganda, MoH Malawi MCC
GCC, MoH Ukraine ,NDA Uganda, Germany,PPB Kenya ANVISA Brazil

Batamandi

 During the year, the team filed 27 patents in India,

including 8 patents in Novel Drug Delivery System and 4 in Packaging.

API APPROVALS
SITE
Toansa, Punjab Approvals USFDA, EDQM, EUGMP, PMDA, TGA, MCC

Dewas, Madhya Pradesh

EDQM, EUGMP,PMDA, TGA, MCC

Paonta Sahib, Himanchal Pradesh

EDQM, EUGMP,PMDA, TGA, MCC

EHS (Environment, Health & Safety Certifications)

Certification
ISO 14001:2004

Certified sites
Dewas, Toansa & Mohali

OHSAS 18001:2007

Dewas & Toansa

STRATEGIES
RANBAXY Innovation Licensing IP to global firms Clinical trials in other markets Creating new intellectual property Alliances Drug discovery Alliances Globalisation Marketing the Ups Globalization entracing global reputation Contract manufacturing for global firms

Research

STRATEGIES.
Key - Generation of intellectual Property
3 steps a) creating intellectual property

b) expanding the markets c) complementing competencies through alliances.

STRATEGIES
Brief overview Sourcing intermediates (alliance with Vorin) Bulk drug manufacturing (alliance with Dr Reddys Laboratories) Marketing (Hoechst Marion ,Eli lilly) Diversification (alliances with Dade, Terumo, Speciality labs) Drug discovery (alliance with University Department of Chemical Technology, Mumbai and Indian Institute of Chemical Technology ,Hyderabad) Clinical trials (alliance with Merck)

STRATEGIES..
Main Enablers Scanning the industry senario and developing a directional focus. Getting the commitment from people at various levels to innovateand to reduce the cycle time . Identifying the opportunities that allow the firm to move ahead compared to its competitors. Working with partners in cohesive team to achieve a short product development cycle time.

KEY PERFORMANCE HIGHLIGHTS

47%

EMERGING MARKETS contribution to global sales

151 ABBREVIATED NEW DRUG APPLICATIONS (ANDAs) approved across different global markets.

$2 Bn SALES turnover achieved. First pharmaceutical company of Indian origin to cross this landmark

42 INSPECTIONS across 18 manufacturing facilities by International Regulatory Agencies.

KEY PERFORMANCE HIGHLIGHTS

Research SYNRIAMTM , a breakthrough
molecule developed by Ranbaxy to treat Malaria. Ranbaxy is

Regulatory
REGULATORY issues resolved in the US opening up several growth possibilities for the company in the region.

the first pharmaceutical company from India to successfully develop a New Drug.

Launch
ATORVASTATIN, a generic version of the worlds largest drug, launched by Ranbaxy in the US, helping millions of Americans manage healthy cholesterol levels.

Hybrid Business Model

SYNERGIES forged in more than 15 geographies so far across the pharmaceutical value chain.

Intellectual Property Rights

50 IP professionals
Due Diligence Patent portfolio management

Identifying opportunities proactively

Long patent litigation experience Efficient Product and process clearance

FOCUS AREAS
Biotech and Vaccines ,the lead vehicle for

these will be Zenotech (Biotech) and Ranbaxy Biologics (Vaccines) . Cost management Investing in a greenfield facility in Nigeria & Malaysia project complete by 2012 -2014 resp.

CSR
Health For All & Health education - main

objective Ranbaxy Rural Development Trust Ranbaxy Community Healthcare Society Partnerships with Government, Medical Colleges, NGOs, Educational Institutions making Ranbaxy ARVs available in their respective treatment programs AIDS awareness and counselling Environment, Health and Safety

OVERVIEW
A vertically integrated global pharmaceutical

Company Presence across all key developed & emerging markets Strong distribution network & brand building capabilities Cost efficient India based Research & Development and Manufacturing Robust generic product flow New high growth specialty segments

REFERENCES
www.ranbaxy.com
The TMTC Journal of Management - Medicines

without frontiers by Nrupesh Mastakar www.googleimages.com www.rediff.com www.ugarch.com/ranbaxy Pharmabiz.com/articles details.aspx www.mbaskool.com/brandguide/pharmaceuticals and healthcare/8596-ranbaxy.html

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