Best Pharma Companies in India by Nadimidoddi Prasad

A Space Marketing Feature FRIDAY I DECEMBER 17 I 2010

Best Pharma

companies in India

THE INDIAN EXPRESS: AHMEDABAD I CHANDIGARH I DELHI I JAMMU I KOLKATA I LUCKNOW I MUMBAI I NAGPUR I PUNE I VADODARA

THE FINANCIAL EXPRESS: AHMEDABAD I BANGALORE I CHANDIGARH I CHENNAI I HYDERABAD I KOCHI I KOLKATA I LUCKNOW I MUMBAI I DELHI I PUNE

Indian Pharma on the Rise The rise of Indian Pharma industry has been phenomenal since 2004, the domestic market has been growing at 8.9 % per annum. It is expected that India’s total Pharma market (domestic & export) would grow from US$ 7.5 billion to US$ 15 billion plus US$ 5 billion of chemical services by the end of 2010. Domestic markets and export markets are expected to rise to US$ 9 billion and US$ 12 billion respectively by the same period.

ad there not been any Pharma companies in the world today, probably we wouldn’t have born to see this world at least in the healthiest condition. Thanks to the world of pharma and biotechnology and to those who initiated early research and development for the mass production of vital drugs to eliminate wide spread and contagious deadly life threatening diseases troubling millions of people across the world. Today, Pharma Industry in India is one among the fastest growing sectors of the Indian economy and has made rapid strides over the years. From being an import dependent industry in the 1950s the industry has achieved self sufficiency and gained global recognition as a producer of low cost high quality bulk drugs and formulations. In the last few years several pharmaceutical companies have demonstrated that they possess the ability to engage in commercially viable research and development activities and become significant players in the world. Healthy growth of Pharma industry was visible in 2004 in the wake of higher exports, increased focus on acquisitions, and exploration of new markets. Indeed, this industry has geared itself well to seize the opportunities in the challenging international environment post 2005. India is one of the top 5 manufacturers of bulk drugs in the world and is among the top 20 pharmaceutical exporters in the world. The industry manufactures almost the entire range of therapeutic products and is capable of producing raw materials for manufacturing a wide range of bulk drugs from the basic stage. In the recently conducted study of ASSOCHAM it has been found that the current world market is US$521 billion with Indian market accounting for US$7.5 billion (inclusive exports). India accounts for 8 percent of world’s production by volume and 1.5 % by value. India’s exports have been growing at a CAGR of 22.9 % and reached US$ 3 billion in FY 2004. The domestic market has been growing at 8.9 % per annum. It is expected that India’s total Pharma market (domestic & export) would grow from US$ 7.5 billion to US$ 15 billion plus US$ 5 billion of 5 billion of chemical services by 2010.

Domestic markets may reach a size of US$ 9 billion by 2010 and exports US$ 12 billion. (inclusive of US$ 4 billion services) The Indian Government has taken measures to

give impetus to domestic production of drugs and formulations, creating an environment conducive for channeling new investment into the pharmaceutical sector. However the industry is of the opinion that new policy initiatives should be announced particularly relating to some research and development (R&D) and pricing regime in order to propel the industry into a high growth track as well as to face the challenges of a WTO led trading system. Some important areas which need immediate attention include, implementation of the recommendations of the Expert committees Report on a comprehensive Examination of Drug regulatory issues including the problems of spurious Drugs. These recommendations are intended to help prepare the Health Ministry to strengthen regulation in this vital industry. Secondly, expeditious strengthening of the physical software and human infrastructure in the patent offices is the need of the hour. Assessing the issue relating to data exclusivity needs to be examined and the role of SSIs in the sector needs clarity and if any steps are required they should be documented and presented to the planning commission. Other important area that needs attention pertains to the issues relating to human capital including setting up of new institutions investment in pharmaceutical R &D has been rising steadily, as the industry has come to realize the importance of R&D and as its gamuts is now spreading across various areas such as, new chemical entities (NCE’s) novel drugs delivery systems (NDDS), Process development activities and Clinical research trials. The R&D investments are projected to rise from Rs 320 crore in 199-2000 to Rs 1500 crore by 2005. At present, R&D spends account for 5 per cent of the pharmaceutical turnover. Research and Development cost in India are much less than those i n

the developed world and it is possible to conduct both New Drug Discovery Research center and novel drug delivery system programmes at competitive rates. Apart from comparative cost advantages Indian R&D efforts are also added by the presence of a well established network of research laboratories and skilled pool of scientific personnel. Right now the Pharmaceutical industry is going through a transition phase. On 1st January 2005, the product patent regime came into force. Drugs patented after January, 1995 will no longer be allowed to be reverse engineered and copied. This means that Indian companies, scientists and researchers have to align themselves to a new environment R&D in the Indian Pharmaceutical industry is gaining momentum, as more and more innovator companies in regulated markets are keen to tap Indian intellectual inputs in this respect, apart from availing of our low cost production capabilities. The next decade will see more global partnership and made in India drugs making their debut on world state. There are immense opportunities in pre-clinical outsourcing and clinical test outsourcing too. Most Indian companies realize that it will be difficult for them to commercialize their discoveries on an international basis on their own. Therefore they are entering licensing deals and strategic alliances with international companies. This way their development costs will get shared and returns will accrue faster in terms of Drug Master File (M/DMF) submission during 1998-2003. India is a clear leader in comparison to china, Italy, Spain and Israel. Further with India garnering highest approval from USFDA for plants outside US it is likely that USFDA would be setting up a permanent office in India. A critical challenge to the Pharma industry is the reduction of the cos t and time frame from discovery to marketing a drug. The increasing cost of drug discovery can be attributed largely to the declining R&D productivity(high attrition rates and cost of failures) and increasing regulatory demands at the USFDA in terms of highest

nu mber of patients in clinical trials) for drug approval. The ap-

plication of new age technology like high throughput screening genomics combinational chemistry and bioinformatics are capable of significantly bringing down the attrition rates and addressing the productivity problems. However competitive advantage would go to firms that best control clinical trials which alone account for a third of the total cost of drug development and almost half the time taken. Many Pharma majors are meeting this challenge by conducting clinical trials for their drugs in developing countries like India, where cost

are one-seventh of that in the EU & USA. The need to reduce the time and cost also explains the increasing trends towards outsourcing research to Contract research organization and partnering and alliances between pharma-pharma and pharmabiotech for joint research and development. Global competitiveness will be the key to growth and survival under the new IPR regime. The greater incentive for original drug discovery will create opportunities for Indian companies to develop new competen-

cies through collaborative research global alliances and will at the same time make India a more attractive destination for global Pharma majors for establishing their R&D bases. The new product processes are getting unbundled as contract research contract manufacturing and clinical trails are expected to create new opportunities for focused service providers. The Indian Pharma Industry is expected to witness a lot of consolidation through M&A activities for promoting economics of size and scale.

FRIDAY I DECEMBER 17 I 2010

Best Pharma Companies in India

Ranbaxy Gurgaon

ay back in 1961, when Ranbaxy Laboratories Limited (Ranbaxy) was set out on its way, little did anyone could have realized the impact it would make on the Indian and global pharmaceutical industry. Since its inception to till date, Ranbaxy is constantly delivering value to its stakeholders and inspiring its people to innovate, achieve excellence and set new global benchmarks. Today, the Pharma giant has grown into India’s largest pharmaceutical company and is tasting the fruits of its hard work gone in during the past 4 decades. Producing a wide range of quality, affordable generic medicines trusted by healthcare professionals and patients across geographies, the company has earned a brand name of its own and is renowned internationally as an integrated, research based, pharmaceutical company. Ranbaxy possesses the manufacturing strengths that have established it as a producer of world-class generics, branded generics and a major supplier of its range of Active Pharmaceutical Ingredients for pharmaceutical products across the globe. The company has made a mark in 23 of the top 25 pharmaceutical markets of the world. The Company has a global footprint in 46 countries, world-class manufacturing facilities in 7 countries and serves customers in over 125 countries.

Journey Incorporated in the year 1961, Ranbaxy has build a unique brand of its own kind over the past 4 decades. In the year 1973 Ranbaxy had gone for initial public offering (IPO) and attained Public Limited company status in 1794. In the same year a multipurpose chemical plant was set up for manufacturing APIs at Mohali (punjab). In the year 1978 the company formed its first joint venture in Nigeria. A modern pharmaceutical plant at Dewas goes on stream in Madhya Pradesh in 1983. four years after in 1987 the company started production at the modern API plant at Toansa in Punjab. With this event Ranbaxy became India’s largest manufacturer of antibiotics/ anti-bacterials. The Tansa plant got

Trusted Global Brand Driven by the passion of it’s around 14,000 strong multicultural workforce comprising of over 50 nationalities, Ranbaxy continues to aggressively pursue its mission to become a Research-based International Pharmaceutical Company. USFDA approval in the year 1988 which gave a great boost to its international drug trading. By the year 1993, Ranbaxy enunciated a corporate mission“To become a Research based International Pharmaceutical Company” and initiated regional restructuring of international operations. By the end of 1994 the company developed state-of-the-art New Research Center at Gurgaon (near Delhi), which became fully operational. Another major milestone was achieved when Ranbaxy acquired Ohm Laboratories Inc., a manufacturing facility in USA in the year 1995. In the year 1997, Ranbaxy achieved record sales turnover of Rs 1000 crores with exports over Rs 500 crores. The company launched its first product in 1998 under Ranbaxy label introduced in the US market, the world’s largest pharmaceutical market. Ranbaxy out licensed Ciprofloxacin OD, it’s original NDDS research product to Bayer AG Germany during the year 1999. In 2000 Ranbaxy entered Brazil, the largest pharmaceutical market in South America and acquired Bayer’s Generic business, Basics, in Germany. After 3 years Ranbaxy & GSK enter into a global alliance for drug discovery & development and it also entered into collaborative research with ‘Medicines for Malaria Venture’ (MMV), Geneva, for development of Anti-Malaria Drug and Joined hands with Clinton Foundation on drugs for HIV/AIDS. In 2004 Ranbaxy’s global sales crossed $1 billion and joined the

elite club of billion dollar companies in the world. It commissioned its new state of the art manufacturing facility in Malaysia sdn Bhd (RMSB) in the year 2005. In the same year, World Health Organization, Geneva, included Ranbaxy’s seven ARVs in its pre-qualification list. With the establishement of its wholly owned subsidiary, Ranbaxy entered the Canadian Healthcare system. In 2006 Ranbaxy acquired

– with the candidate selection of a compound for Respiratory inflammation. The company acquired 13 brands from Bristol Myers Squibb to expand its presence in the US Dermatology Market during the same year. In June 2008, Ranbaxy entered into an alliance with one of the largest Japanese innovator companies, Daiichi Sankyo Company Ltd., to create an innovator and generic pharma-

drug, Arterolane Maleate + Piperaquine Phosphate in India and South East Asia and launched DS product Evista in Romania and also sets up a new division in Mexico to specifically market DS products. Recently in 2010, Ranbaxy launched its project VirAAT in India. The company is aiming for the No. 1 position in the Indian Pharmaceutical market by 2012. For the first time in the history, Ranbaxy delivered quarterly sales of over $ 500 million. It has also entered in to its Golden Jubilee Year on 16th June 2010, 50 years of an inspiring, pioneering and historic journey.

Financials

Ranbaxy Global Corporate Headquarters, Gurgaon, India

leading Romanian Pharma company, Terapia and 5th largest South African generics company called Be-Tabs pharmaceuticals. It also entered into an agreement with community Investment Holdings (CIH), South Africa, to form JV christened “Sonke Pharmaceuticals (Pty) Ltd” to market ARV medicines. In the year 2007, Ranbaxy’s Drug Discovery Team achieves significant milestone in GSK research collaboration

ceutical powerhouse. The combined entity now ranks among the top 20 pharmaceutical companies, globally. The transformational deal will place Ranbaxy in a higher growth trajectory and it will emerge stronger in terms of its global reach and in its capabilities in drug development and manufacturing. In the year 2009 Ranbaxy launched DS innovative hypertensive, Olvance (Olmesartan) in India. It also commenced Phase III studies on its novel anti-malaria

For the year 2009, the Company recorded Global Sales of US $ 1519 Mn. The Company has a balanced mix of revenues from emerging and developed markets that contribute 54% and 39% respectively. In 2009, North America, the Company’s largest market contributed sales of US $ 397 Mn, followed by Europe garnering US $ 269 Mn and Asia clocking sales of around US $ 441 Mn.

Strategy Ranbaxy is focused on increasing the momentum in the generics business in its key markets through organic and inorganic growth routes. Growth is well spread across geographies with focus on developed and emerging markets. It is the Company’s constant endeavour to provide a wide basket of generic and innovator products, leveraging the unique Hybrid Business Model with Daiichi

A Space Marketing Feature Sankyo. The Company will also increasingly focus in high growth potential segments like Vaccines and Biogenerics. These new areas will add significant depth to the existing product pipeline.

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 center 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. Ranbaxy’s first significant international success using the NDDS technology platform came in September 1999, when the Company out-licensed its first oncea-day formulation to a multinational company. 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 will now become an integral part of Daiichi Sankyo Life Science Research Center in India, based in Gurgaon, Ranbaxy will continue to independently develop and later commercialise the anti-malarial new drug, Arterolane + PQP, which is currently in Phase III trials. 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 get a sharper focus, as the Company is increasingly working on more complex and specialist areas.

Quality Complier An untapped niche and a global opportunity, faith in the concept and confidence in the team are the drivers for Caliber Technologies. Leveraging with cutting edge technology caliber has become a one-stop-shop for quality complying products for pharma and biotech industry.

ince its inception in the year 2001, Caliber Technologies has focused to deliver specialized solutions for the Pharma and Biotech sector across the globe. With a vision to excel in LIMS domain, Caliber designed its products to meet the regulatory expectations by leveraging with cutting edge technology. In the Biotech, pharmaceutical and petro-chemical industries, increasing demands on production coupled with stringent quality requirements mandated the necessity for integration between quality systems and enterprise resource. It is no longer acceptable to maintain islands of information in areas that impact heavily on each other. Keeping this in view, Caliber Technologies Limited has visualized the need for a comprehensive Laboratory software like LIMS a decade ago, that would seamlessly integrate with other enterprise applications to have uninterrupted information flow. Today Caliber’s Flagship product CaliberLIMS has become central and crucial for an exclusive and secure laboratory data management in the Pharma and Biotechnology industry. Entering into its 10th year in 2011, Caliber Technologies has proved its calibre by emerging as a clear market leader in India and a recognized global player in its own right, with offices in India and USA. Founded by vastly experienced and dynamic professionals, Caliber is a ‘one-stop shop’ for complete automation of key quality management processes and managing effective regulatory compliance in analytical laboratories, especially in pharma-

Sathya Sekhar Surabhi MD, Caliber Technologies

ceutical companies. Caliber Product Suite is a family of feature rich, cost effective laboratory information management system software designed to meet regulatory compliance, effectively, convincingly and demonstrably. Quality has been given top priority for Caliberians. Solutions designed for Pharma are of a different breed, where software code is just one piece of the puzzle where other pieces like implementation, validation, validation state management, training etc. are some of the other key components of the solution. Software products from Caliber are mostly categorized as Critical Applications in Pharma industry. Mr. Sathya Sekhar Surabhi, CEO of Caliber says, “We have been chosen as quality partners by many leading pharmaceutical companies because of the immense value our products and services add to their processes. Very frequently our products help our customers to sail through the stringent regulatory audits with ease. We are delighted to have our CaliberLIMS as the back

bone of Bharat Petroleum Corporation Ltd. (BPCL’s) Quality initiative programme “Pure for sure’, which monitors quality of petroleum products.” With its products being used both in the domestic and international markets, Caliber has become a leader in providing Laboratory information management systems with more than 3500 satisfied hands-on users and many multi site installations across the world. The company enjoys more than 85 percent market share in India, with a considerable presence in other world markets. “Being vendors to the pharma companies has its own share of challenges. Stringent adherence to the quality systems in our day to day process is a minimum requirement. Change management, documentation, personnel training become an important part of our operations. These practices have helped us in successfully clearing vendor audits by large MNCs and other certifications” Says Bhaskar Phanikar who heads Quality Management and Validation practices. Caliber is in the process of building a center of excellence for Lab informatics. “We are developing a Center of Excellence for Lab informatics which will be the first of its kind in the country. This center will have a state of the art training center to provide training to the industry in lab informatics and regulatory standards in managing software applications in critical operations. As a part of corporate social responsibility, Caliber believes in giving back to the community and create the desired eco system for the industry to flourish.” added Mr. Sekhar.

Best Pharma Companies in India

FRIDAY I DECEMBER 17 I 2010

A Space Marketing Feature

AP’s Generic Outlook Indian Global Player Amguth Raju Correspondent-Hyderabad

he pharmaceutical industry in Andhra Pradesh is one of the success stories of India ensuring that good quality essential drugs are made available at affordable prices to the vast population of the country as well as competing with some of the best names in the global markets. The industry is an intellectual industry and is in the front rank of India’s sciencebased industries with investment in research and development and wide ranging capabilities in the complex field of drug manufacture and technology. India’s pharmaceutical industry is now the third largest in the world in terms of volume and 14th in terms of value. One reason for lower value share is the lower cost of drugs in India ranging from 5% to 50% less as compared to developed countries. According to data published by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, total turnover of India’s pharmaceuticals industry between September 2008 and September 2009 was $ 21.04 billion. Of this, the domestic market was worth $ 12.3 billion. According to an Ernst & Young and an industry body study released in September 2009, the increasing population of the higher income group in the country will by 2015 open a potential $ 8 billion market. Besides, the report said the domestic pharma market is likely to touch $ 20 billion by 2015, making India a lucrative destination for clinical trials for global giants. The accelerated growth over the years has been fueled by exports to more than 200 countries with a sizeable share in the advanced regulated markets of US and Western Europe. 40% of the world’s active ingredient requirement is met by India. Pharmaceutical industry in India ranks very high in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisticated antibiot-

ics and complex cardiac compounds, almost every type of medicine is now made indigenously. The industry has made significant progress in creation of required infrastructure, meeting global needs f o r supply of qua li t y medic i n e s and active pharmaceutical ingredients (APIs), as also entering into the highly opportune area of contract research and manufacturing (CRAM) and clinical trials. Export of pharmaceutical products from India showed a combined annual growth rate (CAGR) of 21.25% during three consecutive years ending 2008-09 but grew only by 13% in 2009-10. India tops the world in exporting generic medicines worth of $ 11 billion. According to a report published by PricewaterhouseCoopers (PwC) in April 2010, India will join the league of top 10 global pharmaceuticals markets in terms of sales by 2020 with the total value reaching $ 50 billion. The sector is estimated to have so far created 4.2 million employment opportunities with more than 20,000 registered units. Despite the fragmentation and price competition, the leading 250 pharmaceutical companies control 70% of the market with the leader holding nearly 7% of the market share. While pharmaceutical products are exported primarily to USA, Germany, Russia, UK and Brazil amongst a large basket of countries, India’s imports emanate mainly from China, Switzerland, USA and Italy. India currently exports drug intermediates, APIs, Finished Dosage Formulations (FDFs), biopharmaceuticals, clinical services to various parts of the world. The global market for contract manufacturing of prescription drugs

is estimated to increase from a value of $ 26.2 billion to $43.9 billion. India could potentially capture 20% to 40% of the outsourced market share for active pharmaceutical ingredients, finished dosage for mulations and intermediates. Frost and Sullivan estimates outsourced contract research in India to reach $ 2 billion by 2012. India is significantly ahead in chemistry services such as analog preparation, analytical chemistry, combinatorial chemistry, structural chemistry, structural drug design, computer aided drug design, high throughput screening and assay development. There are opportunities such as licensing deals with MNCs for New Chemical Entities and New Drug Delivery Systems, marketing alliances for MNC products in domestic and international markets and contract manufacturing arrangements with MNCs.

Challenges Price sensitivities get tested in a crowded market where price tends to sag while volume business gets done. Competing pharmaceutical companies have several similar bio-equivalent products in the same market manufactured at facilities that have been approved by the highest regulatory authorities. All of them stay focused on the same markets with the result price elasticity is tested and margins get eroded. The challenges are greater from Indian manufacturers who have similar production facilities. It is also common to find managers with similar talents and experiences in the industry. Indian manufacturers have made an impact on the global stage and have worked hard to get shelf space.

Wellness on the rise Targeting a revenue turnover of more than $ 2 billion by the year 2014, Aurobindo Pharma Limited (APL) has become one of Asia’s Biggest Pharma companies from India.

wenty years ago, APL started operations with a single unit in Pondicherry, manufacturing Semi-Synthetic Penicillin (SSPs). Today the company has vertically integrated its operations to offer a diverse portfolio of more than 300 products in key therapeutics: cardiovascular, neurological, gastroenterological, anti-diabetics, anti-retrovirals, antibiotics and antiallergics. These products are manufactured in one of its 15 state-of-the-art manufacturing plants across the world, which are approved by USFDA, UKMHRA, WHO, MCC-South Africa, ANVISA-Brazil, TGA- Australia, for both APIs and Formulations. But driving APL’s meteoric rise is its strong pipeline of ANDAs (Abbreviated New drug Applications), DMFs (Drug Master Files) for APIs and dossiers for generic formulations; filed in US, Europe and the Rest of the world. This forms the basis of APL’s unique business model. It takes advantage of the expanding market potential of branded generics as many patents expire this year. Mr. K. Nithyananda Reddy, Managing Director, APL explains, “we have filed a large number of filings around the world and converted them into ‘marketable products’ to create multiple streams of business. This model has helped us enter into partnerships with some of the biggest multinational companies of the world, allowing us to market these products in over 100 countries ourselves”. With the expiry of patent protection and the chances of new molecules hitting the market bleak, APL was quick to seize the opportunities offered by generics. Leveraging on its vast experience in IPR (intellectual property rights), manufacturing capabilities, customized R&D services, total Quality management and a supply line that cuts both time

K. Nithyananda Reddy MD, Aurobindo Pharma Limited

and costs; APL is successfully entering into strategic partnerships with Global Pharma Giants for licensing and long term supply of products to both generics and branded markets in US, Europe, Australia, New Zealand and Canada. However, the company already has a formidable global market presence in over 120 countries. With 8000 employees, over 700 scientists, operations in 34 countries and manufacturing facilities across 4 continents, it is small wonder that APL is among the top five Indian pharmaceutical companies, in terms of exports and revenue. The company exports to over 125 countries and generates more than 70 percent of its revenues from international operations. Excellent performance in formulation exports won APL the “Outstanding Export Performance Award” in 2009 from Pharmaceuticals Export Promotion Council of India (Pharmexil) set up by Ministry of Commerce and Industry. Though a new entrant, APL gained a critical mass in the US market with the commercialization of its new products and the growing market share of its launched products. It has successfully established a strong network of distribution channels through strategic selection of whole-

salers, warehouse chains, retailers and mail orders. In US it has developed and filed more than 185 ANDAs, out of which 126 products have been approved by the USFDA as on 30th September 2010, making it one of the fastest growing Pharmaceutical companies in the world’s largest Pharmaceutical market. The company has begun operations at its manufacturing facility in New Jersey. The plant along with catering to local markets through institutional sales and will also manufacture controlled substance products. The company is boosting its formulations distributions pan Europe, through Malta in dossier licensing operations, Quality Control/ Quality Assurance, Packaging and centralized warehousing. Along with expanding its global footprint, APL continues to capture a large portfolio of product approvals with focused R&D efforts to develop intellectual properties in resolving complex chemistry challenges, improving process efficiencies and developing bio-equivalents. The company’s technological expertise in complex chemistry, product development and bio-studies gives it an edge in developing formulations for sustained release, fixed dose combination products, pediatrics and sterile injectables. The company’s R&D assets have ensured it repeatedly emerged as a major player in regulated markets for lifestyle disease drugs and sterile and non-sterile cephalosporins. APL has till date filed over 185 ANDAs, 151 DMFs and 450 patents. ”These filings were in turn a result of our huge investments on R&D, manufacturing, IPR and Regulatory affairs”, agrees Mr. K. Nithyananda Reddy. It’s a small wonder then that APL’s formulations business grew to $500 million in seven years.

Realizing R&D as core strength, NATCO has ventured into drug discovery & proved successful in discovering 3 important oncology molecules.

yderabad Based NATCO Pharma Limited is one of the fastest growing integrated pharmaceutical companies in India and is characterized by its pre-eminence in Research. Guided by its vision to provide affordable medicare to humanity, NATCO, started about 26 years back as a simple formulations unit, with an investment of about Rs. 12 lakhs - is now a conglomerate of six manufacturing units (two of them having several international accreditions including that of US FDA) and employs more than 2000 personnel. Credited with the introduction of sustained / delayed – release technology to India during the late 1980s, NATCO has entered into the niche oncology area during 2003 and has ever since, consistently recorded a growth rate of over 25 per cent every year and is now ranked number one company in terms of revenues, among all the domestic pharmaceutical companies in the oncology space. In India, NATCO has taken up the responsibility of providing third generation oncology drugs to the suffering millions. Known for its aggressive pricing policies, oriented towards the patients, NATCO has been making available lifesaving drugs at a fraction of the price charged by the innovator multi-national companies and in fact, has launched generic versions of certain products for the first time in the World. The R & D skills of the company and its pricing policies have earned the company several awards, including one for best R & D efforts by the Government of India. Taking its core strengths of R & D a step further, NATCO has ventured into drug discovery and is currently working on three oncology molecules which are very promising. One of the

P. Bhaskara Narayana Director & CFO, NATCO Pharma Limited

molecules has already undergone the Phase I clinical trials and is ready for Phase II clinical trials. These molecules, when developed, would prove to be a boon for millions of patients suffering from different types of cancers. The R & D teams have been responsible for developing drugs based on novel technologies such as – nanotechnology platform, (such as albumin bound paclitaxel) and cracking most complex technologies such as those involved in Capoxane (Glatiramer Acetate). As a result, NATCO has been able to develop generic versions of important molecules such as Revlimid (Lenalidomide), Pravacid (Lansaprazole) etc. NATCO’s technical abilities have attracted several multi-nationals such as Mylan Inc., Actavis, Watson Pharmaceuticals, Lupin Limited, Dr. Reddy’s Laboratories Limited etc.to it for tie-ups. NATCO has been successfully able to negotiate valuable arrangements with these companies which facilitate marketing of NATCO’s products all over the world. In respect of Lenalidomide – which has a global market of over US $ 2 Billion, and growing at over 40% every year – NATCO is likely to get 180 days exclusivity in

four different strengths. This would straight away catapult NATCO in to big league. NATCO has been able to achieve efficiencies of scale and cost effectiveness owing to its vertical integration. For most of its premier oncology products, the raw material is made by NATCO itself, giving it an enviable and un-matched price advantage. Thanks to the vision of the promoters’, NATCO has always been in the forefront of technology and strategic planning. NATCO has always been and continues to believe in quality and this has enabled the Company to undertake contract manufacturing for several well-known pharmaceutical companies such as Ranbaxy Laboratories Limited, Dr. Reddy’s Laboratories Limited, Wyeth Limited, gsk Pharmaceuticals etc. These companies get their products meant for exports manufactured at NATCO’s state of the art, world class facilities. NATCO’s manufacturing facilities are constantly upgraded to comply with international standards. NATCO’s manufacturing facility for active pharmaceutical ingredients is a zero discharge facility with ISO:14001 certification for its environmental management systems. Giving more insights about NATCO’s export earnings, Mr. P. Bhaskara Narayana, Director & CFO, NATCO, says “More than 25% of revenue comes from exports, which accounts to $ 125 Million per annum.” NATCO’s contribution towards the state exchequer in terms of taxes is also quite significant. NATCO values its human resources as its biggest asset and attempts to provide equal opportunities for growth for all its employees. Freedom to operate within one’s own sphere of responsibility results in excellent output and brings out the best in the human resources.

FRIDAY I DECEMBER 17 I 2010

Best Pharma Companies in India

A Space Marketing Feature

Top pharma giants in India A roll call of the top pharma companies of India Ranbaxy

Dr. Reddy’s Laboratories

Cipla

Cadila Healthcare

Sun Pharma Industries

he company established in 1984, Dr. Reddy’s Laboratories (DRL) it is an emerging global pharmaceutical company. As a fully integrated pharmaceutical company, it is to provide affordable and innovative medicines through three core businesses. Pharmaceutical Services and Active Ingredients, comprising its active pharma and custom pharma businesses. The Hyderabad-based DRL has 16 world-class manufacturing facilities of which nine have a long history of regular US FDA inspections. With an annual capacity of nine billion tablets/ capsules a year, dedicated to servicing the more regulated markets, one of DRL’s finished dosages facilities is among the largest in Asia.

nitially based in Vadodara, Sun Pharma came into existence as a start-up with just five products in 1983. Now based in Mumbai, the company has crossed several milestones to emerge as one of the leading pharma companies in India. Post 1996, the company used a combination of internal growth and acquisitions to drive growth; important mergers were those of the US, Detroit based Caraco Pharma Labs and more recenlty the Israeli Taro Pharma. Realizing the fact that research is a critical growth driver, Sun Pharma established a separate research center SPARC in 1993 and this created a base of strong product and process development skills. With world-class technology and a team of strong professionals, the company has built sites and systems that meet the most stringent international manufacturing standards.

anbaxy Laboratories Ltd (Ranbaxy), is a member of the Daiichi Sankyo Group, a leading global pharma innovator, headquartered in Tokyo, Japan. The combined entity now ranks among the top 20 pharmaceutical companies, globally. The transformational deal has placed Ranbaxy in a higher growth trajectory and it will emerge stronger in terms of its global reach and in its capabilities in drug development and manufacturing. The Gurgaon-based Ranbaxy is an integrated, research based, international pharma company, producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy today has a presence in 23 of the top 25 pharmaceutical markets of the world. The Company has a global footprint in 46 countries, world-class manufacturing facilities in 7 countries and serves customers in over 125 countries. It has focused on increasing the momentum in the generics business in its key markets through organic and inorganic growth routes. Growth is well spread across geographies with focus on developed and emerging markets.

Ipca Laboratories

pca is a fully integrated, rapidly growing Indian pharmaceutical company with a strong thrust on exports. Ipca’s APIs and Formulations produced at worldclass manufacturing facilities are approved by leading drug regulatory authorities including the US-Food and Drug Administration (FDA), UK-Medicines and Healthcare products Regulatory Agency (MHRA), South Africa-Medicines Control Council (MCC), Brazil-Brazilian National Health Vigilance Agency (ANVISA) and AustraliaTherapeutic Goods Administration (TGA). With operations in over 100 countries, exports account for over 52 percent of the company’s income. Ipca is one of the biggest manufacturers in the world of APIs Atenolol (Antihypertensive), Chloroquine Phosphate (Antimalarial), Furosemide (Diuretic) and Pyrantel Salts (Anthelmintic) right from the basic stage. Ipca is also one of the largest suppliers of these APIs and their intermediates world over. Ipca is a globally acknowledged Anti Malarial company and has forged strong links with WHO, UNICEF, Global Fund, Clinton Foundation, MOH in Africa and other major stakeholders. Ipca has a Special Task force formed (around 20 committed Team members) to understand the issues and challenges of Malaria diseases.

Lupin

upin Ltd is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world. The company’s vision is achieving the distinction of becoming one of the fastest growing generic players globally. The Mumbai-based Lupin first gained recognition when it became one of the world’s largest manufacturers of tuberculosis drugs. Over the years, the company has moved up the value chain and has not only mastered the business of intermediates and APIs, but has also leveraged its strengths to build a formidable formulations business globally. The year 2008-09 was yet another year with impressive growth of 32 percent in revenue and 50 percent (excluding IP income) in profits.

ipla laid foundations for the Indian pharmaceutical industry back in 1935 with the vision to make India self-reliant and self-sufficient in healthcare. Over the years Cipla has emerged as one of the most respected pharma names not just in India but worldwide. Its R&D centre has given the country and the world many firsts. This includes the revolutionary HIV/AIDS cocktail for less than a dollar a day. With over 40 state of the art manufacturing units across the country, the Mumbai-based Cipla manufactures over 1200 products in 80 therapeutic areas. With a turnover of over US $ 1.2 billion, Cipla serves doctors and patients in over 180 countries. It has earned a name for maintaining one global standard across all its products and services.

Aventis Pharma

ventis Pharma Ltd was incorporated in May 1956 under the name Hoechst Fedco Pharma Pvte Ltd. Over the years, its name was changed to Hoechst Pharmaceuticals Pvt Ltd, Hoechst India Ltd and Hoechst Marion Roussel Ltd. Sanofiaventis, one of the world’s leading pharmaceutical companies, and its 100 percent subsidiary, Hoechst GmbH, are the major shareholders of Aventis Pharma Ltd and together hold 60.4 percent of its paid-up share capital. The Mumbai-based Aventis Pharma Limited in India provides medicines for the treatment of patients in several therapeutic areas: cardiology, thrombosis, oncology, diabetes, central nervous system and internal medicine. Throughout 2010, the Company’s plan was to incur planned expenditure in two critical projects-slated to be growth drivers : “Prayas” and entering the Over-The-Counter (OTC) market.

Aurobindo Pharma

ounded in 1986 by P.V Ramaprasad Reddy, K Nityananda Reddy and a small, highly committed group of professionals, Aurobindo Pharma became a public venture in 1992. It commenced operations in 1988-89 with a single unit manufacturing semi synthetic penicillins (SSPs) at Pondicherry. It had gone public in 1995 by listing its shares in various stock exchanges in the country. The company is the market leader in semi-synthetic penicillin drugs. It has a presence in key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardio-vascular, gastroenterology, etc. Over the years, the Hyderabad-based Aurobindo Pharma has evolved into a knowledge driven company. It is R&D focused, has a multi-product portfolio with multicountry manufacturing facilities, and is becoming a marketing conglomerate across the world.

ydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. The group’s operations range from API to formulations, animal health products and cosmeceuticals. Head quartered in Ahmedabad, the group has global operations in four continents spread across USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets.

GlaxoSmithKline Pharma

laxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company globally and one of the first to start operations in India. The GSK India product portfolio includes prescription medicines and vaccines. The company’s prescription medicines range across therapeutic areas such as antiinfectives, dermatology, gynaecology, diabetes, oncology, cardiovascular disease and respiratory diseases. The Mumbai-based GSK India is the market leader in most of the therapeutic categories in which it operates. GSK also offers a range of vaccines, for the prevention of hepatitis A, hepatitis B, invasive disease caused by H, influenzae, chickenpox, diphtheria, pertussis, tetanus, rotavirus, cervical cancer and others.GSK is committed to developing new and effective healthcare solutions. The values on which the group was founded have always inspired growth and will continue to do so in times to come.

Natco Pharma Limited

atco Pharma Limited is a pharmaceutical company based in Hyderabad. It has four manufacturing facilities & employs 1,500 people. The company makes branded & generic dosage forms, bulk actives & intermediates. It is also involved in contract research & manufacturing. NATCO Pharma Limited manufactures a range of branded and generic dosage forms, bulk actives and intermediates for both Indian, as well as international markets. The products manufactured by the Company include Diltiazem, Omeprazole , Lansoprazole, Isosorbides, Sumatriptan succinate, Ondansetron, Sertraline, Granisetron and Paroxetine.