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Sun Pharma Analysis
Sun Pharma Analysis
Sun Pharma, established in 1983, makes specialty pharmaceuticals and APIs for use in Chronic therapy areas such as cardiology, psychiatry, neurology, gastroenterology, diabetes and respiratory conditions, sold in 26 markets worldwide. Sun Pharma enjoys a good market share in pharmaceutical industry. Sun Pharma is build of four different companies that are Caraco Pharmaceutical Laboratories, Sun Pharmaceutical Industries Inc. (SPI), Sun Pharmaceutical (Bangladesh) and Alkaloida Chemical Company Exclusive Group Ltd. In first section of my report I had given brief information about pharmaceutical industry and in second section I had given brief information of Sun Pharmaceutical Industries.
Company Ranbaxy Labs Dr Reddys Labs Cipla Nicholas Piramal Sun Pharma Lupin Cadila Healthcare Torrent Pharma Glenmark Biocon
Profit( per cent) 167.2 65.8 5.2 473.9 35.8 26.8 66.4 313.7 74.5 26.1
Opportunities
The main opportunities for the Indian pharmaceutical industry are in the areas of: Generics (including biotechnology generics) Biotechnology Outsourcing (including contract manufacturing, information technology (IT) and R&D outsourcing).
1) Generics
Prescription drugs worth $40 billion in the U.S. and $25 billion in Europe are due to lose patent protection by 2007-08. Indian firms will likely take around 30 percent of the increasing global generics market, the Associated Chambers of Commerce and Industry of India (Assocham) forecast. Currently, the Indian industry is estimated to account for 22 percent of the generics world market. Low production costs give India an edge over other generics-producing nations, especially China and Israel. It will be easier for Indian firms to win larger generics market shares overseas than at home, particularly in the U.S. and Europe. Indian drug manufacturers currently export their products to more than 65 countries worldwide.14 Their largest customer is the U.S., the world's biggest pharmaceutical market. The use of generic drugs is growing quickly in the U.S. due to cost pressure by payers and the introduction on January 1 this year of the Medicare Part D prescription benefit, giving seniors and people with disabilities prescription drug coverage for the first time. With 74 facilities, India has the largest number of U.S. Food and Drug Administration (FDA)- approved drug manufacturing facilities outside the U.S. Indian firms now account for 35 percent of Drug Master File applications and one in four of all U.S. Abbreviated New Drug Application (ANDA) filings submitted to the FDA. Analysts at Credit Lyonnais Securities Asia say they expect the number of generic drug launches by Indian companies in the U.S. to increase from 93 in 2003 to over 250 by 2008.
2) Biotechnology
In 2003-04, biopharmaceuticals accounted for 60 percent of India's total biotechnology market, which was worth an estimated $709 million-up 39 percent over the previous period. Investment in the sector was up 26 percent to $137 million-and exports accounted for 56 percent of industry revenues. The domestic biopharmaceuticals sector grew 38.5 percent and had the largest local market share, at 76 percent, followed by bioagriculture at 8.4 percent, bioservices at 7.7 percent, and industrial products at 5.5 percent and bio-informatics at 2.5 percent. With 200 biotech companies and total revenues of $500 million annually, India's Biotechnology sector is still in the relatively early stages of development. However, it is growing fast, with an initial emphasis on vaccines and bioservices. The industry is situated mainly in Karnataka, although there are operations in Andra Pradesh, Hyderabad, Kerala, Maharashtra and West Bengal. The top 10 players in terms of
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revenues in 2004 were Biocon, Serum Institute of India, Panacea Biotec, Nicholas Piramal, Novo Nordisk, Venkateshwara Hatcheries, Wockhardt, GSK, Bharat Serums & Vaccines, and Eli Lilly & Co, reports Burrill & Co, the U.S.-based life sciences merchant bank. As is generally the case worldwide, most biotech companies in India have developed along the contract or collaborative research models.
3) Outsourcing
I. IT Outsourcing
India's status as an information technology superpower, with access to specialist skills and 24/7 work hours, is a huge advantage as it strengthens its position as the destination of choice for contract research, including drug discovery. Eighty-two percent of U.S. companies overall rank India as their first-choice IT outsourcing destination, says leading international clinical research organization Chiltern International, adding that IT and IT enabled services (ITES) companies have been expanding their activities in India to new business segments such as bioinformatics and life sciences; those doing so or planning to include Accenture, Intel, Satyam, Cognizant, IBM, Oracle and TCS. Wipro Spectramind, India's largest third-party offshore business process outsourcing provider, is conducting bioinformatics work for global pharmaceutical companies.
II. Contract Manufacturing
The global pharmaceutical market is estimated to represent a $48 billion opportunity for India by 2007, in terms of: manufacturing outsourcing-supply of active pharmaceutical ingredients (APIs) and Intermediates Development outsourcing-conducting preclinical and clinical trials customized chemistry services-contract research services for compounds pre-launch. Worldwide revenues for pharmaceutical industry contract manufacturing and research services (CRAMS) totalled $100 billion in 2004 and will grow at an average annual rate of 10.8 percent to reach $168 billion by 2009, say analysts at Frost & Sullivan. Within this total, the global market for contract manufacturing of prescription drugs is estimated to increase from a value of $26.2 billion to $43.9 billion, although the over-the-counter medicines and nutritional products sector will show the fastest growth.
Challenges
The three strategic drivers for accelerating growth of the pharmaceutical industry in India are intellectual property rights-its implementation in letter and spirit; liberal drug pricing policies; and regulatory (as well as labor) law reforms,
2) Pricing Issues
The prices of 74 bulk drugs and their formulations, which account for around 40 percent of the retail pharmaceutical market, are controlled by the Drug Price Control Order (DPCO) of 1995. The government's 2002 Pharmaceutical Policy would have reduced the numbers of price-controlled drugs still further, but this proposal is currently under judicial review in the Supreme Court. If it is approved, the number of price-controlled drugs is expected to drop to 25.
3) Regulatory Reforms
The government is now starting to develop an infrastructure for clinical trials in India, with amendments made recently to Schedule Y of the Drugs and Cosmetics Rules of 1945 to allow for multicenter concurrent clinical trials in India and address the protection of trial participants, and the integration and quality of data. Among other developments, Good Clinical Practice guidelines have been published and made mandatory. The government is now starting to develop an infrastructure for clinical trials in India, with amendments made recently to Schedule Y of the Drugs and Cosmetics Rules of 1945 to allow for multicenter concurrent clinical trials in India and address the protection of trial participants, and the integration and quality of data. Among other developments, Good Clinical Practice guidelines have been published and made mandatory.
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Financial Strength:
Indian market has full financial strength not only that but finance is also available at low rate of interest and credibility is also high.
Human Capital:
India has a pool of personnel with high managerial and technical competence as also skilled workforce. It has an educated work force and English is commonly used. Professional services are easily available.
Globalization:
After 1994 Government has adopted new policy of globalization in which country is committed to a free market economy and above all, it has a 70 million middle class market, which is continuously growing and expanding.
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Consolidation:
For the first time in many years, the international Pharmaceutical industry is finding great opportunities in India. The process of consolidation, which has become a generalized phenomenon in the world Pharmaceutical industry, has started taking place in India.
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Strengths:
1. Indian with a population of over a billion is a largely untapped market. In fact the penetration of modern medicine is less than 30% in India. To put things in perspective, per capita expenditure on health care in India is US$ 93 while the same for countries like Brazil is US$ 453 and Malaysia US$189. 2. The growth of middle class in the country has resulted in fast changing lifestyles in urban and to some extent rural centers. This opens a huge market for lifestyle drugs, which has a very low contribution in the Indian markets. 3. Indian manufacturers are one of the lowest cost producers of drugs in the world. With a scalable labor force, Indian manufactures can produce drugs at 40% to 50% of the cost to the rest of the world. In some cases, this cost is as low as 90%. 4. Indian pharmaceutical industry posses excellent chemistry and process reengineering skills. This adds to the competitive advantage of the Indian companies. The strength in chemistry skill helps Indian companies to develop processes, which are cost effective.
Weakness:
1. The Indian pharma companies are marred by the price regulation. The companies, which are lowest cost producers, are at advantage while those who cannot produce have either to stop production or bear losses. 2. Indian pharma sector has been marred by lack of product patent, which prevents global pharma companies to introduce new drugs in the country and
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discourages innovation and drug discovery. But this has provided an upper hand to the Indian pharma companies. 3. Indian pharma market is one of the least penetrated in the world. However, growth has been slow to come by. As a result, Indian majors are relying on exports for growth. To put things in to perspective, India accounts for almost 16% of the world population while the total size of industry is just 1% of the global pharma industry. 4. Due to very low barriers to entry, Indian pharma industry is highly fragmented with about 300 large manufacturing units and about 18,000 small units spread across the country. This makes Indian pharma market increasingly competitive. The industry witnesses price competition, which reduces the growth of the industry in value term.
Opportunities
1. The migration into a product patent based regime is likely to transform industry fortunes in the long term. The new patent product regime will bring with it new innovative drugs. This will increase the profitability of MNC pharma companies and will force domestic pharma companies to focus more on R&D. 2. Large number of drugs going off-patent in Europe and in the US between 2005 to 2009 offers a big opportunity for the Indian companies to capture this market. Since generic drugs are commodities by nature, Indian producers have the competitive advantage, as they are the lowest cost producers of drugs in the world. 3. Opening up of health insurance sector and the expected growth in per capita income are key growth drivers from a long-term perspective. This leads to the expansion of healthcare industry of which pharma industry is an integral part. 4. Being the lowest cost producer combined with FDA approved plants, Indian companies can become a global outsourcing hub for pharmaceutical products.
Threats:
1. There are certain concerns over the patent regime regarding its current structure. It might be possible that the new government may change certain provisions of the patent act formulated by the preceding government.
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2. Threats from other low cost countries like China and Israel exist. However, on the quality front, India is better placed relative to China. So, differentiation in the contract manufacturing side may wane. 3. The short-term threat for the pharma industry is the uncertainty regarding the implementation of VAT. Though this is likely to have a negative impact in the short-term, the implications over the long-term are positive for the industry. 4. Increase in over the counter medicines also create problem for medicines because people will buy it directly from market.
Political Factors:
1. The Minister in charge of the industry has been threatening to impose even more stringent Price Control on the industry than before. This is throwing many an investment plan into the doldrums. 2. DPCO which is the bible for the industry has in effect worked contrary to the stated objectives. DPCO nullifies the market forces from encouraging competitive pricing of goods dictated by the market. Now the pricing is determined by the Government based on the approved costs irrespective of the real costs. 3. Effective January, 2005 the country goes in for the IPR (Intellectual Property Rights) regime, popularly known as the Patent Act. This Act will impact the Pharmaceutical Industry the most. Thus far an Indian company could escape paying a patent fee to the inventor of a drug by manufacturing it using a different chemical route. Indian companies exploited this law and used the reverse-engineering route to invent a lot of alternate manufacturing methods. A lot of money was saved this way. This also encouraged competing company to market their versions of the same drug.
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4. In Pharma industry there is a huge PSU segment which is chronically sick and highly inefficient. The Government puts the surpluses generated by efficient units into the price equalization account of inefficient units thereby unduly subsidizing them. On a long term basis this has made practically everybody inefficient. 5. Effective the January, 2005 the Government has shifted from charging the Excise Duty on the cost of manufacturing to the MRP thereby making the finished products more costly. Just for a few extra bucks the current government has made many a life saving drugs unaffordable to the poor. 6. The Government provides extra drawbacks to some units located in specified area, providing them with subsidies that are unfair to the rest of the industry, bringing in a skewed development of the industry. As a results Pharma units have come up at place unsuitable for a best cost manufacturing activity.
Economic Factors:
1. India spends a very small proportion of its GDP on healthcare ( A mere 1% ). This has stunted the demand and therefore the growth of the industry. 2. Per capita income of an average Indian is low ( Rs. 12,890 ), therefore, spending on the healthcare takes a low priority. An Indian would visit a doctor only when there is an emergency. This has led to a mushrooming of unqualified doctors and spread of non-standardized medication. 3. The incidence of Taxes are very high. There is Excise Duty ( State & Central), Custom Duty, Service Tax, Profession Tax, License Fees, Royalty, Pollution Clearance Tax, Hazardous substance (Storage & Handling) license, income tax, Stamp Duty and a host of other levies and charges to be paid. On an average it amounts to no less than 4045% of the costs. 4. The number of Registered Medical practitioners is low. As a result the reach of Pharmaceuticals is affected adversely. 5. There are only 50,00,000 Medical shops. Again this affects adversely the distribution of medicines and also adds to the distribution costs. 6. India is a high interest rate regime. Therefore the cost of funds is double that in America. This adds to the cost of goods.
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7. India has poor roads and rail network. Therefore, the transportation time is higher. This calls for higher inventory carrying costs and longer delivery time. All this adds to the invisible costs. Its only during the last couple of years that good quality highways have been constructed.
Socio-cultural Factors:
1. Poverty and associated malnutrition dramatically exacerbate the incidence of Malaria and TB, preventable diseases that continue to play havoc in India decades after they were eradicated in other countries. 2. Poor Sanitation and polluted water sources prematurely end the life of about 1 million children under the age of five every year. 3. In India people prefer using household treatments handed down for generations for common ailments. 4. The use of magic/tantrics/ozhas/hakims is prevalent in India. 5. Increasing pollution is adding to the healthcare problem. 6. Smoking, gutka, drinking and poor oral hygiene is adding to the healthcare problem. 7. Large joint families transmit communicable diseases amongst the members. 8. Cattle-rearing encourage diseases communicated by animals. 9. Early child bearing affects the health standards of women and children. 10. Ignorance of inoculation and vaccination has prevented the eradication of diseases like polio, chicken-pox, small-pox, mumps and measles. 11. People dont go in for vaccination due superstitious beliefs and any sort of ailment is considered as a curse from God for sins committed.
Technological Factors:
1. Advanced automated machines have increased the output and reduced the cost. 2. Computerization has increased the efficiency of the Pharma Industry.
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3. Newer medication, molecules and active ingredients are being discovered. As of January 2005, the Government of India has more than 10,000 substances for patenting. 4. Ayurveda is a well recognized science and it is providing the industry with a cutting edge. 5. Advances in Bio-technology, Stem-cell research have given India a step forward. 6. Humano-Insulin, Hepatitis B vaccines, AIDS drugs and many such molecules have given the industry a pioneering status. 7. Newer drug delivery systems are the innovations of the day. 8. The huge unemployment in India prevents industries from going fully automatic as the Government as well as the Labor Unions voice complains against such establishments.
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PROFILE
Sun Pharma makes specialty pharmaceuticals and active pharmaceutical ingredients. The brands are prescribed in chronic therapy areas like cardiology, psychiatry, neurology, gastroenterology, diabetology and respiratory. Sun Pharma has the same drive for growth that marked our early days. Sun Pharma came into existence as a startup with just 5 products in 1983. In the time since, Sun Pharma have crossed several milestones to emerge as a leading pharma company in India, a rank that we have now been at for more than 5 years. (IMS-ORG Retail Store Audit, March 2006) Sun Pharma has reached leadership in each of the therapy areas that we operate in, and are rated among the leading companies by key customers. Strengthening market share and keeping this customer focus remains a high priority area for the company. In the post 1996 years, Sun Pharma used a combination of internal growth and acquisitions to drive growth; important mergers were those of the US, Detroit based Caraco Pharm Labs and that of the plant at Halol which is now UKMHRA and USFDA approved. Under a recent corporate development, the areas related to new molecular entities and drug delivery systems are proposed to be demerged into a separate company.
HISTORY
Sun Pharma began in 1983 with just 5 products to treat psychiatry ailments. Sales were initially limited to 2 states - West Bengal and Bihar. Sales were rolled out nationally in 1985. Products that are used in cardiology were introduced in 1987, and Monotrate, one of the first products launched at that time has since become one of our largest selling products. Important products in Cardiology were then added; several of these were introduced for the first time in India. Realizing the fact that research is a critical growth driver, it established its research center SPARC in 1993 and this created a base of strong product and process development skills. Sun Pharma was listed on the main stock exchanges in India in 1994; and the Rs. 55 crore issue of a Rs. 10 face value equity share at a premium of Rs. 140/- was oversubscribed 55 times. The minimum 25% that was required under the regulations then for listing was offered to the public, the owner family continues to hold a majority stake in Sun Pharma. It used this money to build a greenfield site for API manufacture, as well as for acquisitions. For the acquisitions, typically companies or assets that could be turned around and brought on track were identified. Its first API manufacturing plant was built in Panoli in 1995, for access to high quality
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actives ahead of competition, and to tap the vast international opportunity for speciality APIs. Another API plant, its Ahmednagar plant, was acquired from the multinational Knoll Pharmaceuticals in 1996, and upgraded for approvals from regulated markets, with substantial capacity addition over the years. This was the first of several sensibly priced acquisitions, each of which would bring important parts to the long-term strategy. By 1997, its headquarters were shifted to Mumbai, the commercial capital of the country. Sun Pharma began on the first of its international acquisitions with an initial $7.5 million investment in Caraco Pharm Labs, Detroit. By 2000, it had completed 8 acquisitions, each such move adding new therapy areas or offering an entry to important international markets. A new research center was set up in Mumbai for generic product development for the US market. In India, as new therapy areas were entered into post acquisition; customer attention, product selection and focused marketing helped us gain a foothold in areas like orthopedics, gynecology, oncology, etc. From a ranking at 38th in 1994, by 2000 it was ranked 5th with a leadership in 8 of the 11 therapy areas that it is present in. The year 2000 was the year of turnaround at the US subsidiary, Caraco, as it began to receive approvals after successful inspection by the USFDA. In December 2004, a research center spread over 16 acres was inaugurated by the President of India, with special lab space for drug discovery and innovation. The post 2005 years have witnessed important acquisitions to strengthen our US business- the purchase of manufacturing assets for controlled substances in Cranbury,NJ; that of a site to make creams and lotions in Bryan, that of Alkaloida, a Hungary based API and dosage form manufacturer , and recently, Chattem Ltd., a Tennessee-based controlled substance API manufacturer. The tally at the end of 2008:
1) 17 manufacturing plants in 3 continents
2) 3) 4) 5) 6) 7)
8000 employees 2 World class research centers Brand selling in markets worldwide A growing presence in the US generic market Increasing research investments 60% of sales from international markets
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SHAREHOLDING PATTERN
The company has share capital base of Rs.15.4 crore. The number of total outstanding shares is 1.54 crore. The face value per share is Rs. 10. The share is currently trading at Rs. 625, as on 16th May, 2001. The market capitalization of the company is Rs. 962.5 crore. The free float available is 11% and the promoters hold 73% stake in the company.Shareholding
BOARD OF DIRECTORS
Dilip S. Shanghvi, Chairman and Managing Director. Mr. Shanghvi founded the company in 1982. Sudhir V. Valia Executive Director Sailesh T. Desai Executive Director Hasmukh S. Shah Non-Executive Independent Director Keki M. Mistry Non-Executive Independent Director Ashwin Dani Non-Executive Independent Director Arvind Joshi President
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GROUP COMPANIES
Caraco Pharmaceutical Laboratories: Based in Detroit, Michigan, Caraco develops, manufactures, market and distributes generic and private label pharmaceuticals* and markets them throughout the United States. The corporation's present portfolio consists of a number of products in various strengths and package sizes, across a variety of therapeutic segments, including epilepsy and hypertension. For the most recent year ending March 2008, Caraco had sales of over $350 mill. Caraco's manufacturing facility and executive offices were constructed in 1991, after a $9.1 million loan from the Economic Development Corporation of the city of Detroit. Since August 1997, capital infusions and loans have primarily come from Sun Pharma. Sun Pharma's investment in and support of Caraco has resulted in, since the second quarter of 2002, Caraco achieving the sales to support its operations. As on March 2008, Sun Pharma owns approx 76% on a diluted basis of the outstanding common shares of Caraco. Sun Pharma has two R&D centers in Baroda and Mumbai, where development work for generics is done.
Sun Pharmaceutical Industries Inc. (SPI): Sun Pharmaceutical Industries Inc is a Michigan Corporation and a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd, India. In the second half of 2004, Sun Pharma acquired the trademarks, manufacturing know-how and other intellectual property of certain pharmaceutical products from Women's First Healthcare, Inc, which was under bankruptcy proceedings. On completion of the acquisition in December 2004, these products were assigned to Sun
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Pharma Inc. In December 2005, Sun Pharma Inc completed the purchase of dosage form manufacturing operations of Able Labs in the US for USD 23.15 million from the US Bankruptcy Court of the District of New Jersey, Trenton. A plant spread over 35,000 sq ft, in Bryan, Ohio, manufactures liquids, creams, and ointments. This plant was purchased from Valeant Pharma. The Ohio plant is now approved by the USFDA and the Cranbury plant expects to receive approval shortly. In January 2005, the company entered into a distribution and sale agreement with Caraco. Under the agreement, Caraco distributes and sells SPIs products using its business organization, management personnel, and distribution set up. Sun Pharmaceutical (Bangladesh) : Sun Pharmaceutical (Bangladesh) is a private limited company incorporated in March 2001 under the Companies Act 1994. This company was formed jointly with Sun Pharma, City Overseas Ltd, a company incorporated in Bangladesh and Sun Pharma Global Inc, a company incorporated under the laws of the British Virgin Islands. The company began commercial operations in October 2004. The company owns and operates a pharmaceutical factory and makes pharmaceutical products that are sold in the local market. It currently markets 58 products and had reported a turnover of 105 mill Rs with a profit of Rs.22 mill Rs for the year ending March 08 . Alkaloida Chemical Company Exclusive Group Ltd. ICN Hungary, purchased from Valeant Pharmaceuticals in 2005, is one of the few units worldwide, authorized to make controlled substances. ICN Hungary has now been renamed Alkaloida Chemical Company. This 170 acre site has facilities spread over 1,75,000 sq ft for the manufacture of bulk actives, with 500 KL capacity and designated areas to make controlled substances. It has a 150,000 sq ft facility for different dosage forms such as film coated and effervescent tablets, capsules, etc. A large 65,000 sq ft research center has labs across synthetic chemistry, instrumentation analytical and structural elucidation. The site is operational with 450 people and additional recruitments are planned over time.
MANUFACTURING
With worldclass technology and a team of strong professionals, we have built sites and systems that meet the most stringent international manufacturing standards. Expert quality teams ensure that systems and processes remain in compliance with the
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latest standards. A number of our plants hold approvals from the USFDA and the UK MHRA. APIs and Dosage forms are made in 19 sites across India, US, Hungary and Bangladesh.
Formulation Sun Pharma makes speciality formulations across a range of dosage forms- oral, injectable and delivery system based. API( Active Pharmaceutical Ingredients) Sun Pharma makes specialty APIs including peptides, steroids, hormones and anticancers at internationally approved worldclass sites. Quality Policy Regularly updated system, procedures and an expert team support a stringent quality policy. Environmental Policy At Sun pharma, a concern for safety and the environment is part of our plan.
LOOKING AHEAD
Over the last few years, we have been moving towards a profile that is much more international and formulation-driven. The Sun Pharma of tomorrow will have brands registered in major markets of the world, and in most markets, promoted by a high quality field force. In India, we expect to retain our position of market leadership in our key therapy areas, and reach leadership in newer therapy areas that we entered after 1997. In key international
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markets across Asia, South East Asia, Russia, China, the Middle East, Latam and Africa we would be a strong speciality company with prescription driven sales. With a strong network and established company equity, we would be an excellent partner for a company seeking to license out products across markets. In the high value generic markets of the US we expect to become a respected generic company, with a portfolio comprising both of complex and simple-to-file generics, building an edge with technology and the cost advantage of vertical integration. While we have recently completed our fourth acquisition in the US, we believe there are excellent opportunities in the US generic space, where we can affect a turnaround and add value to a business. We have about $400 million earmarked for acquisitions in the US generic/drug discovery space. Its innovation-based R&D programs were recently demerged into a separate company. The new R&D company will have projects covering new molecule and novel drug delivery in late phase human trials over the next few years, which it may seek to license out.
BUSINESS DEVELOPMENT
Sun Pharma is an international speciality pharma company. We have a significant presence in the US through our subsidiary Caraco. In the rest of world markets, we have a strong ground network of 400 committed field force in 30 countries, with a pipeline of over 2600 products of which 1600 are registered and marketed. We have 2500-person strong sales team in India distributing through 2000 stockists, We are now at a stage of rapid growth across geographies spanning Russia and CIS countries, China and South east Asia, Africa and Latin America, where we are rapidly emerging as a branded generic company of choice. In India, we are among the largest pharmaceutical companies and command a 3.6% market share (ORG IMS Stockist Audit, Aug 2009). In India, we market over 500 products through 18 speciality marketing divisions that are built around chronic therapy areas. Typically, every year we introduce 25-30 new products. All of these are developed in-house supported by strong bulk synthesis, formulation development, bioequivalence and regulatory teams. CMARC (A prescription audit agency) has ranked us as No.1 in key chronic therapy areas of Neuropsychiatry, Cardiology, Orthopedics and Ophthalmology. We rank among the top 5 companies for Diabetology, Respiratory, Pain, Cancer and Gynecology.
In-Licensing
We look at partnering and collaborating as an important strategic approach that will complement our growth in India and international markets. Our constant need is to add to our speciality product portfolio for prescription leadership in India. We also seek to strengthen our presence, with a complete basket of specialty products, in Russia and CIS countries,
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China and South East Asia, Africa, Brazil and Mexico. We are currently interested in in-licensing products that are already marketed or are in late stage clinical development in our key therapy areas. We seek products that leverage our core strengths and complement our existing product portfolio in the following therapy areas:
CNS disorders Cardiology Diabetes and Metabolic disorders Gastroenterology Ophthalmology Oncology Pain Allergy, Asthma and Inflammation Gynecologicals
We also have strategic interest in licensing biosimilar products and new products based on recombinant/humanized monoclonal antibody technology that find use in these therapy areas We seek to establish a long term, mutually rewarding relationship based on exclusive marketing rights business model for the above listed geographies, as well as co-marketing or strategic alliances for co-development including clinical trials of products for necessary regulatory approvals. Out-licensing Its formulation development expertise enables us to develop complex generic products which are bioequivalent, sustained release oral dosage forms and long acting injectable depot formulations. We offer a range of dosage forms for oral, injectable, topical and transdermal routes developed through non-infringing routes and/or patented routes. Our Organic synthesis team develops highly complex bulk actives like Peptides, Hormones, Steroids, Anticancer drugs and Cephalosporins through non-infringing routes and/or patented routes. We offer over 150 bulk actives manufactured at USFDA/UK MHRA approved sites. We seek out-licensing opportunities for our speciality generics, super generics, and bulk drugs for global markets. C V S
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CNS Pain Cancer Gynecologicals Allergy, Asthma other respiratory diseases Our Organic synthesis team develops highly complex bulk actives like Peptides, Hormones, Steroids, Anticancer drugs and Cephalosporins through non-infringing routes and/or patented routes. We offer over 150 bulk actives manufactured at USFDA/UK MHRA approved sites. We seek out-licensing opportunities for our speciality generics, super generics, and bulk drugs for global markets.
API
Our API (Active Pharmaceutical Ingredients) program began in 1995 with a simple objective - facilitating the manufacture of complex formulations, for which, sourcing the API would restrict entry. Over time, we have been able to take the benefits of vertical integration to international markets and our US generic subsidiary, Caraco, has been able to source the active of several key products to its advantage. Starting with 2 actives in 1995, our API list has since expanded to over 150, and this includes a number of APIs with regulated market approvals such as US and European drug master files (DMFs), filed out of Indian plants that hold international regulatory approval and one plant in Hungary. At our 8 world-class locations, all of which are ISO 14001 and ISO 9002 approved, besides being approved by the respective foreign regulatory authorities, every year we scale up about 30 APIs, and make a large number of filings, the technology for all of which is developed at our research centre. Currently this list addresses customers-both innovator companies and generic companies, in markets across Europe , Latam and the US .
A range of APIs including complex actives like anticancer, steroids, peptides and hormones are manufactured in dedicated areas that follow international norms for systems and processes. Our buyout, in 2005, of ICN Hungary (Alkaloida) has enabled us to enter the controlled substance API manufacturing space, one of the few sites in the world to hold these approvals. In November 2008, we acquired Chattem Chemicals, Inc., it is licensed by the DEA to manufacture Schedule 1 to 5 controlled substances. It has a facility spread over 6.5
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acres in Chattanooga, Tennessee, where it manufactures a variety of APIs with a focus on controlled substances. Complex APIs, controlled substances, APIs for the regulated markets - all of these are expected to power our API strategy going ahead.
complex. We began with simpler dosage forms, then moved on to novel drug delivery systems and complex API. Across areas, 76 patents have been received of 233 patents filed. Every year, we typically bring about 40 new products to the Indian market, scale up 25 API, develop and file for 30 plus ANDAs for the US and 8-10 DMFs for US / Europe .
Solid oral dosage form labs Semisolid lab Nanotechnology/liposome lab Sterile lab for parenterals Aerosol area Packaging development lab Stability testing labs
SWOT ANALYSIS
Strengths: Sun Pharma is highly regarded for its ability to launch new products with a great amount of speed and consistency. The company has only 20% exposure to the DPCO. he past growth rate of the company has always been double that of the industry as a whole. Weaknesses: Continuous losses of Caraco Pharma is a major concern for Sun Pharma.
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The profit margins are declining for the company. Opportunities: The relaxation of DPCO will be a big boost for the company and this might marginally improve the profit margin. The company has already made ANDAs (Abbreviated new drug application) in USA and it provides a great opportunity for growth for the company. The company has entered the US market through its subsidiary Caraco Pharma. This provides a great opportunity for the company to make the most out of the expiring patents in USA. Threats: The entry of foreign players will pose a major threat to the company. The company is more into acquisition based growth and this might lead to a stage of financial crunch as it has already happened in the case of Caraco pharma. Sun pharma provided debt to Caraco and is facing problems due to the continuous losses made by the latter.
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Product Acamprosate Calcium Alendronate Sodium [#] Amitriptyline [$] Anastrozole Atomoxetine Hcl Balsalazide Bicalutamide Budesonide Bupropion Hcl Calcitonin Capecitabine Carbamazepine Carboplatin [$,*] Carisoprodol [$] Carvedilol [$,*] Cefuroxime Axetil [*] Cisplatin [*] Citalopram Hbr. [$] Clomipramine Hcl [*] Clonazepam [$] Clopidogrel Bisulfate Danazol Desloratadine [$] Desmopressin Monoacetate Divalproex Sodium Dobutamine Hcl Donepezil [$] Dothiepin Hcl [*] Entacapone Eptifibatide Drug Escitalopram Oxalate Eszopiclone Finasteride Flurbiprofen [*] Flurbiprofen R(-) Flurbiprofen S(-) Fluticasone Propionate
Therapeutic Category Alcoholism Treatment Antiosteoporosis Antidepressant Antineoplastic Antidepressant Antiinflammatory NSAID Antiinflammatory Steroid Antidepressant Antiosteoporosis Antineoplastic Antiepileptic Anticancer Muscle Relaxant Antihypertensive 3rd Generation Cephalosporin Anticancer Antidepressant Antidepressant Antiepileptic Antithrombotic Androgen Derivative Antihistaminic Vasopressin Analogue Antiepileptic Cardiovascular Antialzheimer Antidepressant Antiparkinsons Antithrombotic Antidepressant Hypnotic Antialopecia Agent NSAID NSAID NSAID Antiallergic 34
Specifications BP / EP EP USP PN PN PN USP BP / EP BP / EP / USP BP PN BP BP / EP / USP USP BP / EP EP EP / USP USP BP / EP EP / USP USP USP PN EP PN EP / USP PN BP / EP PN PN PN PN PN BP / EP / JP PN PN BP / EP
CAS No. [77337-73-6] [121268-17-5] [50-48-6] [120511-73-1] [82248-59-7] [82101-18-6] [90357-06-5] [51333-22-3] [31677-93-7] [47931-85-1] [154361-50-9] [298-46-4] [41575-94-4] [78-44-4] [72956-09-3] [64544-07-6] [15663-27-1] [59729-32-7] [17321-77-6] [1622-61-3] [135046-48-9] [17230-88-5] [100643-71-8] [62288-83-9] [76584-70-8] [49745-95-1] [120014-06-4] [897-15-4] [130929-57-6] [188627-80-7] [59729-33-8] [138729-47-2] [98319-26-7] [5104-49-4] [51543-40-9] [51543-39-6] [80474-14-2]
[$,*] Fluvoxamine Maleate [$] Fosphenytoin Sodium [$] Gabapentin [$, #] Gemcitabine Hcl [$,#] Glimepiride [$] Granisetron Hcl [$] Ibandronate Sodium Imatinib Mesylate [$] Irbesartan Irinotecan Hcl Isradipine [$] Lamotrigine [$] Lercanidipine Hcl Letrozole Losartan Potassium [#] Loteprednol Etabonate Magnesium Valproate Meloxicam [#] Memantine Hcl Mesalazine [$,*] Metamizol Magnesium Metaxalone Metformin Hcl [$,*] Methylphenidate Hcl Metoprolol Succinate [*] Metoprolol Tartrate [$,*] Mifepristone Mirtazapine [$] Modafinil [$] Mometasone Furoate Naltrexone Hcl Netaglinide Octreotide Acetate [$,#] Olanzapine Ondansetron Base [$] Ondansetron Hcl [$,*] Oxaliplatin [$] Oxcarbazepine [$]
Antidepressant Antiepileptic Antiepileptic Anticancer Antidiabetic Antiemetic Bone Resorption Inhibitor Anticancer Antihypertensive Anticancer Antihypertensive Antiepileptic Antihypertensive Anticancer Antihypertensive Antiinflammatory Antiepileptic Antiinflammatory Antiparkinsons Antiinflammatory Antispasmodic Muscle Relaxant Antidiabetic CNS Stimulant Antihypertensive/Antianginal Cardiovascular Abortifacient Antidepressant CNS Stimulant Antiinflammatory Steroid Narcotic Antagonist Antidiabetic Somatostatin Analologue Antipsychotic Antiemetic Antiemetic Anticancer Antiepileptic 35
BP / EP USP USP EP / USP EP / USP EP PN PN PN PN USP PN PN EP USP PN PN BP / EP PN EP / USP PN PN BP / EP / USP USP BP / EP / USP BP / EP / USP PN USP USP USP USP PN PN PN EP / USP EP / USP EP PN
[61718-82-9] [92134-98-0] [60142-96-3] [122111-03-9] [93479-97-1] [107007-99-8] [138926-19-9] [220127-57-1] [138402-11-6] [100286-90-6] [75695-93-1] [84057-84-1] [132866-11-6] [112809-51-5] [124750-99-8] [82034-46-6] [62959-43-7] [71125-38-7] [41100-52-1] [89-57-6] [6150-97-6] [1665-48-1] [1115-70-4] [298-59-9] [98418-47-4] [56392-17-7] [84371-65-3] [61337-67-5] [68693-11-8] [83919-23-7] [16676-29-2] [105816-04-4] [79517-01-4] [132539-06-1] [116002-70-1] [103639-04-9] [61825-94-3] [28721-07-5]
Oxethazaine Pamidronate Disodium [$,#] Pentoxifylline [$,*] Perindopril Pioglitazone Piroxicam Betacyclodextrine Raloxifene Hcl Repaglinide [$] Rivastigmine Tartrate [$] Ropinirole Sertraline Hcl [$] Sodium Valproate [$,*] Sumatriptan Succinate [$] Temozolomide Terlipressin Testosterone Tiagabine Hcl [$] Tizanidine Hcl [$] Topiramate [$,#] Tramadol Hcl [$,*] Valproic Acid Venlafaxine Hcl Ziprasidone Hcl Zoledronic Acid Zolpidem Tartrate [$,*] Zonisamide [$] PN** Producer's Norms
Local Anaesthetic Antiosteoporosis Peripheral Vasodialotor Calcium Channel Blocker Antidiabetic Antiinflammatory Antiosteoporosis Antidiabetic Acetylcholinesterase inhibitors, Cognition-enhancing drugs Antiparkinsons Antidepressant Antiepileptic Antimigraine Anticancer Vasopressor Analogue Androgen Derivative Antiepileptic Muscle Relaxant Antiepileptic Analgesic Antiepileptic Antidepressant Antipsychotic Bone Resorption Inhibitor Hypnotic Antiepileptic $ USDMF, # EDMF, * COS
[126-27-2] [109552-15-0] [6493-05-6] [107133-36-8] [105355-27-9] [96684-40-1] [82640-04-8] [135062-02-1] [129101-54-8] [91374-21-9] [79559-97-0] [1069-66-5] [103628-48-4] [85622-93-1] [14636-12-5] [58-22-0] [145821-59-6] [64461-82-1] [97240-79-4] [36282-47-0] [99-66-1] [99300-78-4] [138982-67-9] [165800-06-6] [99294-93-6] [68291-97-4]
Intermediates available on request for above Active Pharmaceutical Ingredients. All transactions are carried out in conformity with patent laws applicable in the user country. Responsibility with respect to third partys patent rights in a specific country lies exclusively with the buyer.
Specifications Ph.Hg. PN
Analgesic 36
EP
[53152-21-9]
Buspirone base [$, #] Buspirone HCl [$, #] Codeine base Codeine HCl Codeine phosphate hemihydrate [*] Concentrate of poppy straw (CPS) Dihydrocodeine hydrogentartrate Ethylmorphine HCl Glibornuride [#] Hydroxychloroquine sulphate [$] Morphine HCl Morphine sulphate Noroxymorphone Noscapine base Noscapine HCl Oxycodone Oxymorphone Phenobarbital acid [$, #] Phenobarbital sodium Pholcodine Sennoside A+B Thebaine Topiramate [$] PN** Producer's Norms
Anxiolytics Anxiolytics Analgesic,Antitussive Analgesic,Antitussive Analgesic,Antitussive Intermediate Analgesic,Antitussive Analgesic,Antitussive Antidiabetic Antimalarias,Antirheumatic Analgesic Narcotic analgesic Intermediate Antitussive Antitussive Intermediate Intermediate Antiepileptic Antiepileptic Antitussive Laxative Intermediate Anticonvulsants
[36505-84-7] [33386-08-2] [76-57-3] [1422-07-7] [41444-62-6] [57-27-2] [5965-13-9] [125-30-4] [26944-48-9] [747-36-4] [52-26-6] [64-31-3] [33522-95-1] [128-62-1] [912-60-7] [76-42-6] [76-41-5] [50-06-6] [57-30-7] [509-67-1] [128-57-4] & [517-43-1] [115-37-7] [97240-79-4]
Intermediates available on request for above Active Pharmaceutical Ingredients. All transactions are carried out in conformity with patent laws applicable in the user country. Responsibility with respect to third partys patent rights in a specific country lies exclusively with the buyer.
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BIBLIOGRAPHY
1) http://www.sunpharma.com/index.php 2) en.wikipedia.org/wiki/Sun_Pharmaceutical 3) connect.in.com/sun-pharma/profile-311528.html 4) portfolio.rediff.com/quotes/sun+pharmaceutical+industries+ltd 5) www.business-standard.com/stockpage/stock_details.php?bs. 6) www.pharmaceutical-drug-manufacturers.com/pharmaceutical-industry/ 7) www.in.kpmg.com/pdf/Indian%20pharma%20outlook.pdf 8) en.wikipedia.org/wiki/Pharmaceuticals_in_India 9) www.espicom.com/prodcat.nsf/Product_ID.../00001851?...
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