RanbaxyTopmost

Pharmaceutical company in India 2012

Ms. Vandana DubeyMs. Priti TawdeMr. Narendra Daundkar

IntroductionLargest pharmaceutical companyTurnover 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 anti-tuberculosis

drugs.

1951 alliance with the Italian company Lapetit under which Ranbaxy distributed Lapetit’s products in India.

1966 The association with

Lapetit ended due to Ranbaxy’s

determination to formulate more

products locally.

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

.

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

1992 joint

venture with Eli

Lilly

History….

1994 Lilly also contracted Ranbaxy to make

generics for it1998 Ranbaxy entered

the United State

BOARD OF DIRECTORS

Mr.

Arun SawhneyCEO & 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

PRODUCTS

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 world’s 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 MCA-UK, MCC-South Africa, FDA-USA and TGA-Australia, have audited Ranbaxy’s 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 LaboratoriesLupin pharmaceuticalsGlaxosmithkline ( GSK)

COMPETITORS….

19th 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

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 windows and selected use of blue color, are the important elements of this vocabulary.The plant has three distinct blocks housing it’s 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&DRanbaxy 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-a-day 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, Ranbaxy’s 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 India’s 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.

SYNRIAMRanbaxy Laboratories Limited (Ranbaxy) launched

India’s 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 India’s 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 Ranbaxy’s 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, president-R&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 anaalysisRanbaxy 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 challengesRanbaxy had to face many challenges during the execution of its project. The main challenges faced by the company were—continuously 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.

SOLUTIONTo 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 tie-ups with air carriers, cold storage chains were maintained properly and it also reduced thetransit 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 formsApprovals Filings

USA 4 9#

EUROPE 21 15

-National 9 4

-MRP 3 4

-DCP 9 7

Other Key Markets

Australia/N.Zealand 12 7

Brazil 4 4

Canada 2 11

China - 9

Russia/CIS 20 7

S.Africa 2 6~

Other markets 86 162

Total 151 230

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

PLANTS APPROVALPlants Aprroval

Ohm laboratories (USA) USFDAEU

Mohali (Punjab) USFDA,WHO Geneva, ANVISA Brazil, TGA Australia

Paonta SahibGoa

GCC, Ukraine MOH,ANVISA Brazil, WHO Geneva, MoH Uganda, MoH Malawi

South Africa MCC

Goa GCC, MoH Ukraine ,NDA Uganda, Germany,PPB Kenya

Batamandi ANVISA Brazil

During the year, the team filed 27 patents in India, including 8 patents in Novel Drug Delivery System and 4 in Packaging.

API APPROVALSSITE Approvals

Toansa, Punjab

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 Certified sites

ISO 14001:2004 Dewas, Toansa & Mohali

OHSAS 18001:2007 Dewas & Toansa

STRATEGIESRANBAXY

Innovation Alliances Globalisation

•Licensing IP to global firms

•Drug discovery

•Marketing the Ups

•Clinical trials in other markets

•Alliances •Globalization entracing global reputation

•Creating new intellectual property

•Research •Contract manufacturing for global firms

STRATEGIES….Key - Generation of intellectual Property3 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 Reddy’s

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 EnablersScanning 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.

47%EMERGING MARKETS

contributionto global sales

151ABBREVIATED

NEW DRUG APPLICATIONS

(ANDAs) approved across different global

markets.

$2 BnSALES turnover

achieved.First

pharmaceutical company of Indian origin to cross this

landmark

42INSPECTIONS

across 18 manufacturing

facilitiesby International

Regulatory Agencies.

KEY PERFORMANCE HIGHLIGHTS

KEY PERFORMANCE HIGHLIGHTSResearch

SYNRIAMTM , a breakthrough

molecule developed by

Ranbaxy to treat Malaria.

Ranbaxy isthe first

pharmaceutical company from

India to successfully

develop a New Drug.

RegulatoryREGULATORY issues resolved

in the US opening up

several growth possibilities for

thecompany in the

region.

LaunchATORVASTATIN, a generic version of

theworld’s largest

drug, launched by Ranbaxy in the US, helping millions of Americans manage healthy cholesterol

levels.

Hybrid Business

ModelSYNERGIES

forged in more than 15

geographies so far across the

pharmaceutical value chain.

Intellectual Property Rights

50 IP professionalsDue Diligence Patent portfolio management Identifying opportunities proactively Long patent litigation experience Efficient Product and process clearance

FOCUS AREASBiotech and Vaccines ,the lead vehicle forthese will be Zenotech (Biotech) andRanbaxy 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 TrustRanbaxy Community Healthcare SocietyPartnerships with Government, Medical

Colleges, NGO’s, Educational Institutions making Ranbaxy ARVs available in their respective treatment programs

AIDS awareness and counsellingEnvironment, 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.comThe TMTC Journal of Management -

Medicines without frontiers by Nrupesh Mastakar

www.googleimages.comwww.rediff.comwww.ugarch.com/ranbaxyPharmabiz.com/articles details.aspxwww.mbaskool.com/brandguide/pharmaceuti

cals and healthcare/8596-ranbaxy.html

THANK YOU