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Firangiz Imamverdiyeva (120564) Topic: Pharmaceutical industry Strategic there: Regulations Company: Part1. This paper will describe my research and analysis about the current situation in terms of regulation and problems in pharmaceutical industry. Specific example, in this case will be Pfizer, currently the world’s top ranked pharmaceutical company, and on 40’s place among the world’s greatest companies announced by Fortune 500. In the first part I present an overview of the pharmaceutical industry as a whole, analyze the current situation, major players and markets, challenges and the prospects of the pharmaceutical industry.

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The pharmaceutical industry is a highly regulated business with many rules dictated by the government to protect the interest of the public. The global pharmaceutical industry is expected to be worth more than $1 trillion in 2014, marking a 5% complex annual growth rate according to research from UrchPublishing. Meanwhile market is a highly competitive and entry is difficult due to a combination of strict regulations and the need for extensive research and development (R&D), involving time-consuming clinical trials.

High R&D and development costs, lengthy clinical trial processes, expiring patents and difficulty in gaining product approval from the appropriate regulatory bodies all mean that companies must produce blockbuster drugs and continue to do so to remain in good standing. Three out of four pharmaceutical companies believe their industry is in the midst of a strategic crisis, new research finds. “The world’s leading pharmaceutical companies face considerable risk to their revenue streams in next three years,” the FactBook concludes.

The global economic crisis that started in late 2007, and pressure from governments and consumers to lower drug prices, isn’t likely to help. Along with the pricing and cost pressures, as was given above regulatory changes and patent expiries are leading to shrinking margins. As the way out in this situation likewise in many other industries is emerging markets with their biggest growth opportunities, albeit with smaller margins. A quality workforce, consumerism and rising costs are some of the issues plaguing the global healthcare industry while pharmaceutical companies strive for transformational strategies to both create and sustain value.

Value chain is another challenge and complex process in developed and emerging countries, where regulatory and pharmaceutical capacity can be stretched. Patient has to get the right medicine at the right time, but ensuring can be weak or broken. Even, if the potential market exists, regulatory barriers a way to discourage manufacturers from marketing their drugs in certain countries or may delay their launch. Obviously, no “one size fits all” approach applies to pharmaceutical policy.

Even two countries with similar objectives may need different sets of policies, depending on their starting position, pre-existing laws and regulations, perceptions among providers and patients, and implementation capacity. Although high-income countries may find industrial policy and innovativeness hard to reconcile with cost containment in the health sector, choices may be even harder for middle-income countries that have to bridge the divide between a demanding urban population and large numbers of poor people in peri-urban and rural areas.

Many low-income countries are struggling to provide basic essential drugs to their populations through still largely state-run delivery systems. At the same time, the growing private markets in these countries may be flooded with drugs of questionable origin and quality. In each case, policy makers and the implementing agencies need to select and combine their policy measures in a way that not only addresses the main problems conceptually but also is practically viable and sustainable.

In the 1970s and 1980s, the average profit margin (as a percentage of revenues) of the Fortune 500 pharmaceutical companies was two times greater than the median for all industries in the Fortune 500. Each drug introduced between 1981 and 1983 ‘made at least $36 million more for its investors, after taxes, than was needed to pay off the costs to develop it . . . Such profitability was two to three percentage points greater than for comparable industries, even after factoring in the risks of new drug development’. Nearly two decades later, in 1999, the industry was still a star.

The pharmaceutical industry ranked at the top in all three of Fortune magazine’s measures of profitability: return on sales, return on assets and return on equity. Over the last several years, Pfizer, GlaxoSmithKline, and Novartis — and most other pharmaceutical giants, which once seemed unassailable, announced huge layoffs. Drug discovery jobs have disappeared by the thousands in the United States and by the hundreds in Europe as the industry has cut costs in order to adjust to what is widely perceived as the end of the blockbuster-drug era. It’s a whole big mess the pharmaceutical industry is in,” says industry journalist Ed Silverman from Pharmalot blog. “It’s an unfortunate set of circumstances… The companies have had fewer new drugs in their product pipelines and … at the same time they’re facing expiring patents on the biggest sellers. ” New drugs have always faced long odds, taken a long time, and cost a lot of money to develop. Of every 10,000 newly synthesized substances, between one and two will be marketed eventually. The process takes an average of 12 or 13 years.

Drug development costs vary, but a reference estimate, from 2005, is $1. 3 billion per drug. Most importantly, the industry is approaching what many people call “the big patent cliff” – the termination of a large number of patents, which will allow generic drug manufacturers to produce cheaper versions of blockbuster drugs. In the United States alone, the patent exclusivity of more than 110 products is set to expire between 2012 and 2014, among them 14 blockbuster drugs. Many leading drugs on the market are to see their patents expire over the next five years.

According to industry reports, the patents for 10 top selling drugs will expire by 2013; namely, they are Lipitor, Plavix, Seroquel, Actos, Enbrel, Singulair and many others. Though patents protect the intellectual property rights of specific drugs, usually for approximately 20 years, pharmaceutical companies face increasing pressure related to generics, which are drugs comprised of the same ingredients as patented drugs but sold under a drug’s chemical name rather than the pharmaceutical brand name.

Medical professionals can prescribe drugs under their chemical name without specifying a brand. Also, expiring patents are opening the way for generic drugs to produce cheaper versions of blockbuster drugs, cutting into pharmaceutical company profits. The US is at the top of the global pharmaceutical market and is expected to hit almost $345 billion in 2014 according to MarketLine. The US is followed by the Japanese market, which is followed by the European market.

However, according to research by the International Federation of Pharmaceutical Wholesalers (IFPW), there are significant disparities between growth rates in developed and emerging markets based on their capacity to bounce back from the economic crisis. The latter includes 17 countries, which pharmaceutical market intelligence firm IMS divides into three segments: * The first includes only China for which analysts predict will become the third-largest pharmaceutical market in the world in 2011-2012, with a forecast $40 billion increase by 2013 to match US market growth.

MatketLine predicts the pharmaceutical market in China will reach almost $49 billion in 2015. Market growth in China is being fuelled by rising cases of chronic diseases, an aging population, and increased healthcare investment and insurance. * The second segment of emerging pharmaceutical markets includes Brazil, India and Russia, which together are predicted to increase between $5 billion and $15 billion by 2013. Additional research from MatketLine shows that Brazil will be growing strong on its own, and is expected to be worth almost $35 billion in 2015. The third segment is comprised of Mexico, Venezuela, Argentina, Turkey, Poland, Thailand, Indonesia, Vietnam, Egypt, South Africa, Pakistan, Ukraine and Romania. All segments combined represent 17 emerging pharmaceutical markets predicted to grow at a rate of around 16% in 2013 to reach between $170 billion-$180 billion largely due to an increase in healthcare spending by government, and private and public bodies, according to IFPW research. Within developed markets, IFPW forecasts around a 6% growth rate, far lower than emerging market growth in 2013.

Even lower growth rates are predicted in Europe, where the top five markets, namely the UK, France, Spain, Italy and Germany, are forecast to grow at around 2%. The key companies are mainly concentrated in US, Japan, Europe, India, Germany and Switzerland. The global drugs market is controlled by corporate behemoths such as Pfizer, Novartis, Sanofi-Aventis, Merck & Co, Roshe, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Abbott Laboratories, Bristol-Myers Squibb, Bayer, Pharmacia, American Home Products and Schering-Plough.

Their market domination enables them to dictate drug prices. In past years, pharmaceutical prices have risen faster than the rate of inflation. The fact that there is very little price elasticity associated with price increases is a major factor contributing to the high profitability of the pharmaceutical industry. A patient will not change the demand for a product with a small change in price when there are no close or available substitutes. Gross Profit margins of some of the leading pharmaceutical companies in different years had been around 50 to 70 percent.

From the other hand the big pharmaceutical companies’ profits can be even higher due to limited competition inside the pharmaceutical industry caused by strict patent laws (when a company owns a patent for a key drug, profits can mount up since the company faces no competition) and high barriers for small firms (new competitors) to enter the industry. In addition, through a recent and ongoing wave of mergers and acquisitions the big companies intensify the process of consolidation (limiting competition in the so-called free market even further).

Also, more frequently strategic alliances (less costly than mergers and acquisitions) are being formed with small biotech companies in order to reap the economic benefits biotechnology offers. The drug giants cannot keep track of all new developments themselves, but want to keep their pipelines full. Other challenges facing the industry include pressure from purchasers, such as hospitals, who negotiate discounts with wholesalers or manufacturers when buying in bulk – thereby increasing pressure on pharmaceutical companies to produce cost-effective drugs to remain competitive and gain approval for new drugs.

According to the Center for Drug Evaluation and Research, on average there have been less than 23 approvals annually over the past decade. Industry observer Pharmalot stated there was a fall in the number of applications for approval received between the period 2009 -2010 by the US Food and Drug Administration from just 40 to 23. The Food and Drug Administration (FDA) continued to bring life-saving drugs to patients in the U. S. quickly and efficiently in fiscal year (FY) 2012 ( October 1, 2011-September 30, 2012).

Matching its performance in FY 2011, FDA approved 35 novel medicines in FY 2012, often more quickly than it was done anywhere else in the world. At the same time, FDA continued to strengthen its ability to rapidly detect and analyze safety problems that emerge after a drug is marketed. FDA also broadened the actions it is taking to support innovation in drug development. Meanwhile, different countries have their own objectives based on varied levels of income. For low-income countries, the most common objective is to secure the population’s access to medicines necessary to achieve major public health goals.

Such goals might be reducing maternal and child mortality or reducing death rates from AIDS, malaria, and tuberculosis. Middle-income countries also must secure access to medicines for basic public health programs for the poor, who represent the majority of the population; however, these countries need to consider the demands of a wealthier urban population as well. The urban middle class in Beijing, Sao Paulo, or Bangalore increasingly enjoys a lifestyle similar to the middle class in high-income countries and expects access to a broader range of drugs.

This demand for innovative and more expensive drugs needs to be balanced against the limited funding available from public budgets or insurance funds, which tends to lag the growth of private incomes. The market for pharmaceutical goods is increasing due to an aging global population, advances in drug-based treatment research, increased investment in healthcare and consumer-driven private health coverage, and rising numbers of patients suffering from cardiovascular disease, cancer and degenerative diseases. Market growth penetration faces the same challenges such as price pressures, strict regulation, lawsuits.

Yet it’s not enough to look externally; internal factors make all the difference. Success is determined in large part by the particular mix of capabilities — the combination of processes, tools, knowledge, skills, human capital, and organizational forms — that companies deploy. To Christian Dokomajilar, manager and senior biotech analyst at Deloitte Recap having digested some of the largest acquisitions in pharma history, gotten costs out and much of the patent cliff behind them, pharma and biotech execs may again be ready to collaborate.

Deals like Pfizer’s ($PFE) $68 billion acquisition of Wyeth Pharmaceuticals in 2009, or Merck ($MRK) paying $41. 1 billion the same year for Schering-Plough. Just a couple of years ago, Sanofi ($SNY) bought Genzyme for $20 billion. “M&A is definitely in a period of consolidation as far as pharma is concerned,” after some of the megamergers of recent years. There are endless ways to slice and dice the major mergers and acquisitions of the year, but the EvaluatePharma filtered out that, 2011 had 70 more deals worth nearly 40% more than in 2012.

And the big year in the last 5 was 2009, when there were not only 25 more deals, 169 vs 146, but the values were much higher. M&A activity in 2009 totaled $142 billion compared to just $57 billion in 2012. “The numbers by themselves are not that important. What is more important is the dollars and structure of the deals,” Dokomajilar says. With the economic turmoil in the last two to three years, he sees deals more focused on things like options to buy after a licensing.

But for now, the top reason for increased consolidation and partnering is that drug companies have a host of blockbusters going off patent at a time when the industry is facing fewer drug approvals. With slowing sales, most drug companies are looking for growth by buying the companies that have solid pipelines that will deliver growth. Opinion shared by a lot of institutional investor’s states, that big pharma companies are also facing with the problems because of their size, they can’t develop drugs and they are too slow. They make decisions for political reasons they have too high barriers.

They have to keep buying small companies just to stay innovative. As the pharmaceutical industry examples shows, regulatory issues can have powerful effects on industry attractiveness and the profitability of the firms that comprise it. Where regulation makes it difficult for competitors to enter and compete. Therefore drugmakers are on the hunt for assets to fill revenue holes left by expired patents. Pfizer’s Lipitor, which drew more than $12 billion in annual revenue at its peak, lost marketing exclusivity in November 2011. Eli Lilly & Co. (LLY) lost patent protection on its top-seller, the antipsychotic Zyprexa, in October 2011.

The drug had drawn more than $5 billion in peak sales. New York-based Bristol-Myers faced generic competition last year to Plavix, its best-seller with more than $7 billion in revenue. It’s obvious that the fast-growing pharmaceutical markets are a logical and clear target for Big Pharma companies. R&D is another ingredient of the industry. Heavy expenditure on R&D were (and still are) required for the arduous processes of drug discovery, development, manufacturing, and approval through the various regulatory bodies, such as the Food and Drug Administration (FDA) in the USA and the Committee on Safety of Medicines (CSM) in the UK.

The process of developing a drug was time-consuming, expensive and precarious. During the 1980s, it took an average of 12 years and $194 million to bring a drug to market, which doesn’t testify that years of investment in R&D for a drug will work. Most major pharma companies have been running at low R&D productivity for a number of years. And the long and tedious process, which includes R&D clinical trials and government approval, as more than 50 per cent of all development dollars were spent on products that never reached the market.

The key challenge, both at present and in near future, is how to speed up R&D while still maintaining the overall operation budget. R&D was not the only exorbitant costs. Sales and marketing costs were also substantial, as pharmaceutical companies spent large sums promoting their drugs to hospitals and doctors. To compete effectively against the industry’s leaders, a new company had to spend millions of dollars annually on large sales forces and other marketing and promotional activities. Substantial as these financial barriers were, they paled in comparison to the protection that governments placed on intellectual property.

Companies generally won patents for their new drugs. These patents were issued on either the drug’s chemical structure or its method of manufacturing or synthesis. This highly favorable competitive environment, in which drug companies obtained patents to protect them from rivals, meant that competitors were effectively blocked from manufacturing and marketing drugs with the same chemical composition for 17 years, which equates to between eight and 12 years once the drug actually gets to market.

Entry barriers are extremely high, resulting in little threat of entry, a very favorable condition for new pharmaceutical start ups that could find a way to enter. New legislation made it easier for generic drug companies to enter the market. In the USA, the 1984 Waxman-Hatch Act, which changed the rules for generic drug manufacturers, reduced the barriers to generic entry. Instead of having to prove the generic drug’s safety and efficacy, the act required companies only to prove their formulas were equivalent to that of the brand name drug.

By 1996, generic drugs accounted for more than 40 per cent of pharmaceutical prescriptions. Aside from the influx of generics, the pharmaceutical companies also saw a wave of biotechnology competitors enter their industry – Genentech, Amgen and many others – suggesting that economies of scale meant less than they used to, and that barriers to entry, while still high in absolute terms, were dropping, thanks in part to the availability of venture capital.

Further, the biotech companies’ new science-focused research model, known as rational drug design, stood the traditional approach to drug discovery on its head. These drug companies worked backwards from known disease biochemistry to identify or design chemical ‘keys’ to fit the biochemical ‘locks’ of that disease. Barriers to entry crept lower, increasing the threat of entry and making the industry somewhat less attractive. The turn of the century, the coming of age of the Internet generated approximately 100,000 health-related websites.

Powered with more information, patients became more knowledgeable and, consequently, more powerful. And, with new legislation that now permitted prescription drug advertising in the USA, patients there began taking a more active and knowledgeable role in their medical decision-making. Buyer power had increased considerably. The result of this increase in buyer power was downward price pressure on prescription drugs. High rivalry among main companies in the industry.

For example the current rivalry in the erectile dysfunction space where Bayer & GlaxoSmithKline claim that Levitra works faster or Eli Lilly & ICOS claim that Cialis works longer than Pfizer’s Viagra. The degree of rivalry among existing firms is a high. The pharmaceutical industry confronted a new business climate and new regulations, born in part from dealing with world market forces and protests by activists in many countries. Animal Rights activism was also a challenge. Animal experiments are widely used to develop new medicines and to test the safety of other products.

Many of these experiments cause pain to the animals involved or reduce their quality of life in other ways. If it is morally wrong to cause animals to suffer then experimenting on animals produces serious moral problems. Animal experimenters are very aware of this ethical problem and acknowledge that experiments should be made as humane as possible. They also agree that it’s wrong to use animals if alternative testing methods would produce equally valid results. In the matter of regulations that apply to animals in laboratories vary across species.

In the U. S. , under the provisions of the Animal Welfare Act (AWA) and the Guide for the Care and Use of Laboratory Animals (the Guide), published by the National Academy of Sciences, any procedure can be performed on an animal if it can be successfully argued that it is scientifically justified. In general, researchers are required to consult with the institution’s veterinarian and its Institutional Animal Care and Use Committee (IACUC), which every research facility is obliged to maintain.

The IACUC must ensure that alternatives, including non-animal alternatives, have been considered, that the experiments are not unnecessarily duplicative, and that pain relief is given unless it would interfere with the study. Larry Carbone, a laboratory animal veterinarian, writes that, in his experience, IACUCs take their work very seriously regardless of the species involved, though the use of non-human primates always rises what he calls a “red flag of special concern”. A study published in Science magazine in July 2001 confirmed the low reliability of IACUC reviews of animal experiments.

Some facts and figures, according to the U. S. Department of Agriculture, in 2006 about 670,000 animals (57%) (Not including rats, mice, birds, or invertebrates) were used in procedures that did not include more than momentary pain or distress. About 420,000 (36%) were used in procedures in which pain or distress was relieved by anaesthesia, while 84,000 (7%) were used in studies that would cause pain or distress that would not be relieved. The investigation, which took three years to complete, compared judgments made by 50 randomly selected animal care and use committees drawn from U. S. colleges and universities.

To assess the consistency of approval decisions, 150 recent research proposals from these institutions were each independently evaluated by two different animal care and use committees. The results showed that approval decisions were statistically unrelated. In most cases, proposals that were disapproved by one committee were approved by the second. Some incidents happen inside the institutions. APHIS has been criticized by its own inspectors and the USDA Inspector General’s office (OIG). Marshall Smith, an APHIS inspector for twelve years, resigned in 1997 recounting a litany of problems at the agency that impeded his duties.

In a prepared statement, Smith made note of a 1992 OIG report citing the agency’s inability to ensure the humane care of animals at dealers. In 2000, Isis Johnson-Brown D. V. M. – another APHIS inspector – quit because of problems she documented at the Oregon National Primate Research Center, in a prepared statement Dr. Johnson said: More than once, I was instructed by a supervisor to make a personal list of violations of the law, cut that list in half, and then cut that list in half again before writing up my inspection reports.

My willingness to uphold the law during my site visits at the Primate Center led to me being ‘retrained’ several times by higher-ups in the USDA. Mainly regulation in many countries dictate that, the experiments must use “the minimum number of animals, involve animals with the lowest degree of neurophysiologique sensitivity, cause the least pain, suffering, distress, or lasting harm, and most likely to produce satisfactory results”.

The German system of AWA is designed to enforce the utilitarian principle that there must be good reason for one to cause an animal harm and identifies that it is the responsibility of human beings to protect the lives and well-being of their fellow creatures. Japanese animal experimentation regulations are considered to be very reasonable worldwide. Incidents, related to the regulation issues in pharmaceutical industry, in terms of animal use is still a reason of debates between animal rights activists, government representatives and different related organizations.

The big pharma companies not once have been mentioned in scandals and incidents regarding animal abuse. Article published by Warren Cooper on December 28, 2012 says: PETA claims that Merck has been “repeatedly cited by the government for failing to adhere to minimal federal regulations governing the treatment of animals in its laboratories,” including caging primates in isolation, for failing to call in a vet for dogs who bled after routine nail trimming or to minister to a dog known to have cysts on its paws, as well as for under-representing the number of animals used in painful experiments.

In addition, PETA’s resolution claims that Merck uses five outside drug testing or development laboratories, including Covance in Princeton, “with numerous violations noted by government inspectors. Merck and Pfizer are among four large U. S. companies whose animal testing policies are under attack by the animal welfare group PETA. In 2011, according to PETA, Merck “held or used in-house,” 12,242 animals, including about 1,700 dogs and 2,100 primates. More than 6,500 of them were used in painful experiments,” the proposed resolution states. Those figures do not include animals used at outside contract laboratories and “vast numbers of mice and rats,” Similarly; PETA wants Pfizer to minimize pain and suffering of experimental animals. The Pfizer resolution asks the board to detail “all measures to reduce the use of animals — especially in painful procedures — and specific plans to promote alternatives to animal use. According to that PETA resolution, “Hundreds of dogs and cats used in painful experiments at Pfizer were not given pain relief, including some who stopped eating and were eventually killed. ” Not once have been mentioned the role of the regulation within the pharma sector. As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, regulatory agencies are being established in various countries across the globe.

Regulatory agencies and organizations play a vital role to meet the requirements of legal procedures related to drug development process in a country, as long as the international regulatory organizations essential in all aspects of pharmaceutical regulations related to drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection. In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug.

Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing and labelling of pharmaceutical products. OTHER ORGANIZATIONS- USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), HEALTH CANADA(CANADA), MCC(South Africa),ANVISA (Brazil) , EMEA (European Union), SFDA (China),NAFDAC(Nigeria), MEDSAFE ( Newzeland ), MHLW(Japan), MCAZ(Zimbabwe), SWISSMEDIC(Switzerland), KFDA(Korea), MoH (Sri Lanka) are the few regulatory  agencies and organizations established in respective countries.

But WHO, Pan American Health Organization (PAHO), World Trade Organization (WTO), International Conference on Harmonization (ICH), World Intellectual Property Organization (WIPO) are some of the international regulatory agencies and organizations which also play essential role in all aspects of pharmaceutical regulations related to drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection.

Member States rely on WHO for expertise and guidance in regulation, safety and quality assurance of medicines through development and promotion of international norms, standards, guidelines and nomenclature. The capacity of national regulatory authorities to interpret and apply WHO norms, standards and guidelines varies from country to country. The development of norms, standards and guidelines to promote quality assurance, medicines regulation and safety of medicines is an integral part of WHO’s Constitution and a unique responsibility.

It has been endorsed and supported through numerous World Health Assembly resolutions, and more recently in those on the Revised Drug Strategy. The increasing globalization of commerce and trade, and the merging of pharmaceutical companies, are internationalizing pharmaceutical production. International pharmaceutical norms and standards are thus more important than ever before since they serve as global tools aiming to ensure safety and quality of medicines. One of WHO’s roles is to continue to develop such international norms and standards, and to help countries implementing them.

Safety and quality of pharmaceuticals are also being promoted through regional and international efforts to harmonize drug regulation, such as those led by, ASEAN (Association of South-East Asian Nations), CAN (Andean Community), CADREAC (The Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries), the European Union, Gulf Cooperation Council (GCC), the International Conference on Harmonisation (ICH), MERCOSUR (Southern Common Market) the Pan American Network on Drug Regulatory Harmonization (PANDRH) and the Southern African Development Community (SADC).

These efforts are to be welcomed since international consensus on quality, safety and efficacy standards can speed up access to medicines. Quality assurance levels differ from country to country; not all countries have the same capacity and resources for implementing agreements on drug regulation harmonization. Drug regulation experts accordingly recommend a step-wise approach for achieving the highest level of medicines safety, regulation and quality assurance in each country. WHO’s role is to identify areas in which further guidance needs to be developed for preliminary and intermediate steps.

Simple screening tests for detecting substandard and counterfeit drugs are just one example. More generally, WHO’s task is to help countries consider the implications of the relevant harmonization agreements. This is particularly true with regard to ICH, which currently does not include representatives from all developing countries. WHO needs to evaluate the impact of ICH guidelines, and advice non-ICH Member States on how to adapt existing guidelines to their own needs and conditions.

At the same time WHO must ensure that its own normative guidelines, such as its guidelines on good manufacturing practice (GMP), are maintained and updated. The GMP guidelines aim to provide globally accepted and applicable standards for ensuring that products are consistently produced and controlled according to quality standards. I could not pass, not saying some words about an influence of lobbying in pharma industry. This is a big business where pharmaceutical companies spend billions to seek the levers to influence on the federal government policy, trying to gain favorable treatment from legislators.

What some may find a bit unnerving is the industry that’s leading the pack in these efforts. the pharmaceutical industry that spends the most each year to influence our lawmakers, forking over a total of $2. 6 billion on lobbying activities from 1998 through 2012, according to OpenSecrets. org. To get some perspective on just how big that number is, consider that oil and gas companies and their trade associations spent $1. 4 billion lobbying Congress over the same time frame while the defence and aerospace industry spent $662 million, a fourth of Big Pharma’s total.

In addition, Big Pharma demonstrates its power, political might and social influence over the nation’s governments and agencies, its health care systems, its doctors and hospitals, as well as the psyche of the American people. Because of the industry’s 1,100-plus paid lobbyists on Capitol Hill, its $188 million annual lobbying budget and the $14 million or so it doles out to political candidates every year, the United States, which makes up 5 percent of the world’s population, accounts for 34 percent of the money spent on prescription drugs.

The American public is not the only sector of society influenced by Big Pharma’s techniques. Doctors, scientists and research organizations, medical journals, teaching hospitals and university medical schools all exhibit disturbing conflicts of interest between their publicly stated missions and their financial and ideological subservience to Big Pharma. Doctors may be persuaded to allow ghost writing, which involves Big Pharma paying physicians to attach their names to positive article about a particular drug with the goal of seeing it published in a reputable medical journal.

In addition, even when a medical reviewer, who is an expert in the field, writes a comprehensive assessment of a new drug for a medical journal, it is common practice for those supposedly unbiased professionals to be on Big Pharma’s payroll. Part 2 The second part focuses on a more detailed analysis of Pfizer business practices, regulations issues, company’s strategy and impact on financial results respectively. Headquartered in New York, Pfizer, operating in more than 150 different countries and employing 110,600 people and is the leading research-based pharmaceutical company worldwide.

Pfizer focuses on research and development activities for the development and commercialization of innovative products candidates in various therapeutic areas. Geographically, the company operates through a wide range of network of subsidiaries and affiliates throughout the US, Europe and the Scandinavian countries, including Australia, Canada, Japan, New Zealand and South Korea, and emerging markets consisting of Asia (excluding Japan and South Korea), Latin America, Middle East, Africa, Central and Eastern Europe, Russia and Turkey.

The key business strategies of the company include the enhanced focus on developing and delivering innovative medicines that help patients throughout the world. A merger agreement between Pfizer and Wyeth  created one of the most “diversified companies in the global health care industry”, with product offerings in growing therapeutic areas, a strong product pipeline, and leading scientific and manufacturing capabilities.

Its key aim is to have the best portfolio of products, pipeline and capabilities in the industry; positioned for sustainable growth; strong revenue diversification from stable, growing areas; leadership positions in key growing therapeutic areas; and focused on delivering patient-centric, innovative therapies. The company mainly aims to achieve flexibility and optimum operational efficiency in its manufacturing and production to cater to diverse needs of its clients in an efficient manner.

It also focuses on emerging markets such as India to fuel its growth prospects in future and which also helps it to tap the massive market potential in the pharmaceutical and healthcare market domain. It also aims to maintain its existing partnerships and to enter new collaborative agreements to fuel its services. Pfizer manufactures products in five areas: Specialty care and oncology, Primary care, Nutrition, Consumer health care. It had been organised into 9 principal operating divisions before: Primary Care, Specialty Care, Oncology, Emerging Markets, Established Products, Consumer Healthcare, Nutrition, Animal Health and Capsugel.

In April 2011 Pfizer agreed to sell its Capsugel unit, the world’s largest maker of hard capsules, for about $2. 38 billion to the private equity firm KKR & Co. Pfizer Animal Health unit had been separated into subsidiary company Zoetis officially in 2012. Pfizer Inc. (NYSE: PFE) on January 29 of 2013 reported financial results for fourth-quarter and full-year 2012. Fourth-quarter 2012 revenues were $15. 1 billion, a decrease of 7% compared with $16. 1 billion in the year-ago quarter, which reflects an operational decline of $802 million, or 5%, and the unfavourable impact of foreign exchange of $271 million, or 2%.

For fourth-quarter 2012, revenues were $5. 8 billion, a decrease of 9% compared with the year-ago quarter. This decrease was primarily the result of the loss of exclusivity of Lipitor in November 2011 and Geodon in March 2012. International revenues were $9. 3 billion, a decrease of 5% compared with the prior-year quarter, mainly due to the losses of exclusivity of Lipitor in developed Europe during second-quarter 2012 and the unfavourable impact of foreign exchange. U. S. evenues represented 38% of total revenues in fourth-quarter 2012 compared with 39% in the year-ago quarter, while international revenues represented 62% of total revenues in fourth-quarter 2012 compared with 61% in the year-ago quarter. Full-year 2012 revenues were $59. 0 billion, a decrease of 10% compared with $65. 3 billion in full-year 2011, which reflects an operational decline of $4. 8 billion, or 8%, and the unfavourable impact of foreign exchange of $1. 5 billion, or 2%. For full-year 2012, U. S. revenues were $23. 1 billion, a decrease of 14% compared with full-year 2011.

This decrease was primarily the result of the aforementioned loss of exclusivity of Lipitor. International revenues were $35. 9 billion, a decrease of 6% compared with the prior year, mainly due to the previously mentioned losses of exclusivity of Lipitor and the unfavourable impact of foreign exchange. U. S. revenues represented 39% of total revenues in full-year 2012 compared with 41% in the previous year, while international revenues represented 61% of total revenues in full-year 2012 compared with 59% in full-year 2011.

In according to the financial data it’s obvious that, company under influence of economic recession in the sector, facing with the competitiveness , expiration patents and getting less benefits from the investments into the R&D. Therefore more and more they are focusing their strategy to develop partnerships with other companies. Company believes in the partnerships and it s a core of their strategy in order to find out innovative solutions, create and deliver qualitative value proposition to their customers. Referring to the information from the official sources ,areas of interest are mainly R&D (Pfizer invests more than $7. billion in research and development 2003), venture Investments, M&A (Warner–Lambert (2000), Pharmacia (2003), and Wyeth (2009). ), since it’s the one of the ways to share the risks, penetrate into the emerging markets, in order to generate additional growth, consumer healthcare, biopharmaceutical , including scientifically collaborations. On January 26, 2009, after more than a year of talks between the two companies, Pfizer agreed to buy pharmaceuticals rival Wyeth for a combined US$68 billion in cash, shares and loans, including some US$22.  billion lent by five major Wall Street banks. The deal cemented Pfizer’s position as the largest pharmaceutical company in the world, with the merged company generating over US$20 billion in cash each year, and was the largest corporate merger since AT&T and BellSouth’s US$70 billion deal in March 2006. On November 30, 2012, Pfizer completed the sale of the Nutrition business to Nestle. Pfizer announced the $12 billion divestiture of its infant nutritional business. There are a number of factors that are going into the continued consolidation of the drug industry.

In part, it was originally fuelled by the consolidating buying groups – the rise of hospital chains, HMO’s, and chain pharmacies – made the selling activity more concentrated. Through the years, as the large drug companies consolidated (Pfizer and Warner Lambert, Merck and Schering-Plough, Astra and Zeneca, Novartis and Alcon, Glaxo and Wellcome, Sanofi and Genzyme), their size alone made maintaining growth rates difficult. Pfizer’s old business model involved either taking experimental treatments from the labs to the market by itself or buying companies that already had promising drug candidates.

Both approaches were expensive — generating fewer successes and alienating investors at a time when some of the company’s best-selling products were losing their patent protection. That meant more competition from lower-cost generics. By the way Pfizer in list of the companies suffering because of the increasing pressure related to generics. . The key drivers for Pfizer’s revenues are twelve drugs that have generated billions of dollars in revenues per year, including Lipitor, Lyrica, Prevnar 13, Enbrel (with Amgen), Celebrex, and Viagra.

Concretely in a recent case Pfizer lost his patent over their bestseller Sildenafil citrate, sold as Viagra, Revatio and under various other trade names. Canada’s Supreme Court struck down the patent on global pharmaceuticals giant Pfizer Inc’s Viagra and opened the door to generic competition. ‘Pfizer expects to face generic competition in Canada shortly. The company … is disappointed with the court’s ruling,” the firm said in a statement e-mailed to Reuters. The incidents occurred, since the Pfizer had been obliged to disclose the components of the patent in order to allow another company to produce Viagra after expiration.

Viagra is Pfizer’s sixth-biggest medicine, with annual sales of about USD 2 billion. Its sales have been crimped by competition from Eli Lilly and Co’s longer-acting Cialis. However, with the patent expiration of Lipitor in November 2011, its best-selling drug with $9. 6B sales, as well as several products that will lose exclusivity within a year, PFE will face a significant decline in sales of existing drugs. These will be partially offset by new products approved of since 2010. In addition Lipitor is PFE’s best-selling drug, and is among the leading drugs in the industry that lower LDL cholesterol. Lipitor alone brought in $9. B or 14% of total revenue for Pfizer in 2011. However, Lipitor’s patent expired in November 2011, which had a significant negative impact on its 2012 sales. Company estimated a slower decline of 20% in the following years, translating to a $0. 14 reduction in earnings per share in 2012 compared to 2011. Effexor, an anti-depression drug that lost exclusivity in mid-2010, has its revenue dropping 60% to $678M in 2011. Xalatan, a drug for glaucoma and ocular hypertension that lost exclusivity in early 2011 experienced a 40% drop in sales to $1. 25B in 2011. Geodon, Detrol, and Revatio, with combined revenues of $2. B in 2011, are expected to lose exclusivity in 2012 and 2013. The patent expiration or lost exclusivity of these drugs (with combined $16. 3B or 24% of total sales) will have a significant negative impact on Pfizer’s revenues going forward. At the moment sales from Pfizer’s new drugs approved since 2010 are expected to partially offset lost revenues from the products with declining sales. These drugs include Prevnar-13, Sutent, Eliquis, Inlyta, and Xalkori. Prevnar 13 is a vaccine for the prevention of pneumococcal diseases, which Pfizer obtained through its acquisition of Wyeth in 2010.

It was approved for infants and children in 2010 and for adults of 50 years of age and older in 2011. In 2010 and 2011, Prevnar 13 had $2. 4B and $3. 6B sales, respectively. As Pfizer expands Prevnar 13 to a broader population worldwide, we estimate that it will have a steady growth rate of 8% between 2012 and 2016. Sutent is a multi-tyrosine kinase inhibitor with $1. 12B sales in 2011. It was first approved in 2006 for the treatment of renal cell carcinoma and gastrointestinal stromal tumours. PFE continues to expand its usage in other cancer types, including pancreatic neuroendocrine cancer.

They estimate that it will have a steady growth of 8% between 2012 and 2016. Finally, Inlyta was approved in early 2012 for patients with advanced renal cell carcinoma (mRCC). While the market size for mRCC is about $2B, there are several other drugs in the market for this indication. Pfizer also tried to expand the uses of Inlyta to treatment naive RCC patients. However, the recent data released suggest that Inlyta did not meet primary endpoint in phase 3 trial in treatment-naive RCC patients. Accordingly, our projected revenues for Inlyta are moderate growth from $300M in 2012 to $700M in 2016.

The combined revenues of these drugs are $5. 4B, which represents 8% of total revenues in 2011. However, compared to the drugs with declining revenues ($16. 3B, 24% of total revenues), sales from these recently approved drugs will be insufficient to offset the lost revenues from Lipitor and other previously mentioned drugs. Their financial projections estimated that PFE will see a significant reduction in revenues in 2012 compared to 2011. The reason its 2012 earnings will not decline as much as the revenues is due to reduced expenses and restructuring cost.

Pfizer has streams of new drugs in its pipeline. In 2011 and 2012 alone, PFE filed several new drug applications (NDA) with the FDA and EMA. However, while these drugs are estimated to contribute $2. 2B to $5. 3B revenues from 2013 to 2016, PFE’s total revenue growth is expected to remain low (at a compound annual growth rate of ~3. 5%) due to declining sales of Lipitor and other drugs that lose marketing exclusivity. Respectively this case will decrease the sales of the drug in region, since people will prefer generic manufactures, where the price plays a major role.

Pfizer Inc. CEO Ian Read said that continuing expirations of drug patents through 2015 will restrain revenue growth, but the world’s largest drug maker is trying to offset that with launches of several medicines and research to create new ones. Company got patent for around 10 new drugs (rheumatoid arthritis pill Xeljanz and five cancer medicine. Also they are targeted to its research on less-common disorders such as sickle cell anemia and cystic fibrosis, and on vaccines against deadly diseases, including an infection often acquired in hospitals, C. difficile.

Other targets include a rare form of dementia and Huntington’s disease, a genetic neurodegenerative disorder that causes cognitive decline, psychiatric problems and decreased muscle coordination. Pfizer’s revenue is suffering from the November 2011 expiration of the patent on cholesterol-lowering drug Lipitor. As was mentioned above, it had reigned as the world’s top-selling drug for nearly a decade and still brought Pfizer more than $10 billion a year when generic competition arrived. That loss is compounded by slowing growth in developed countries.

Read noted that health programs in Europe and the U. S. continue trying to hold down what they pay for medicines. Like other pharmaceutical companies, Pfizer is trying to maintain its bottom line through continued job eliminations and cuts to other expenses. Pfizer reduced expenses by nearly $4 billion in 2012 compared to 2011, according to Read. Pfizer also continues to try to boost sales in emerging markets and saw sales jump about 30 percent last year in China’s enormous market, where Pfizer has launched a joint venture to sell patented drugs both in China and other countries.

Read noted that last year (2011) the company launched a joint venture in China called Hisun-Pfizer Pharmaceuticals to sell off-patent medicines there and in other countries. In November, Pfizer bought NextWave Pharmaceuticals Inc. , which makes the recently approved Quillivant XR, an extended-released liquid medicine for attention deficit disorder. Supply chain of the company’s task as guiding and enabling his organization to implement the well planned, secure and compliant supply and delivery mechanisms enabling to reach patients worldwide.

John Mancuso, Vice President, Global Logistics and Supply, Pfizer Global Supply and his team manage some 30,000 to 35,000 different SKUs provided by a network of over 80 internal manufacturing sites and more than 300 external suppliers. Those products transit over 4,000 international trade lanes to more than 110 markets around the world. Once in a given market, products are then delivered to thousands of customers, including wholesalers, distributors, hospitals, physicians, patients, and veterinarians, retailers, and livestock farmers.

Supply chain is a major enabler of Pfizer’s mission and its commercial, trade and partnership strategies. John and his team are building a delivery chain characterized by holistic management of supply chain processes in a well-planned, high performing, compliant, secure and cost appropriate manner. Pfizer products possess many characteristics requiring specific standards of care, around control preparation, transportation and storage. These include cold chain and controlled substance.

Over the past 18 months, Pfizer has completely re-engineered its complex supply chain introducing a new virtualised layer that delivers common information to all the participants. Instead of operating their own systems and proprietary data, Pfizer and its external providers now use the same platform to manage the supply chain network using performance monitoring, network analysis and other tools. While the network may change over time, the “cloud layer”, which is based on GT Nexus’s cloud supply chain platform, insulates Pfizer from underlying physical changes and allows supply chain network participants to be added or removed rapidly.

Jim Cafone, Pfizer’s vice president of supply network services, says the virtualisation of the supply chain enables Pfizer to respond much faster to unexpected events that might otherwise disrupt its complex supply chain as well as everyday market pressures and provides Pfizer and its partners with “a single version of the truth against which all stakeholders operate”. Pfizer competes in two distinct segments: the “patented” drug market and the “generic” market. The “patented” space requires high supply flexibility and responseveness with a willingness to invest in inventory.

This market segment requires delivery strategies that allow for speed and agility that demand expedited, specialised logistics and higher cost – for example, next-day air delivery. The more commoditised “generic” space requires intensive cost management with a more highly controlled inventory investment and a focus on efficiency, with highly optimised logistics that limit the ability to fund expedited logistics and therefore favour ocean shipping. Unfortunately, markets for individual drugs are not so clearly defined.

For example, Lipitor, a popular cholesterol-lowering drug, is “generic” and therefore price sensitive in many markets but patented in others. In fact, to satisfy the hyper segmented global marketplace with myriad local healthcare regulatory requirements, Pfizer is required to offer Lipitor in more than 600 specific dosage and package combinations. It is the realisation that in order to compete in tomorrow’s healthcare markets Pfizer need a highly flexible and adaptive strategy – one that easily can evaluate and respond to complex.

Pfizer is also now able to prove that in transit its products meet regulators’ requirements, for example for temperature controlled conditions. In little more than 18 months, Pfizer built device independent platform that has already handled more than 40,000 shipments. It is one of the ways of quick value creation. Pointing to the global market shifts underway, John confirms that in terms of pure revenue, the established markets – the US, Europe, Japan, and Australia – remain extremely important for Pfizer.

From the revenue growth perspective, however, Pfizer, like many other companies, is looking toward emerging markets, including the so-called BRIC – Brazil, Russia, India and China markets Of course, each one of those markets calls for a different profile of delivery and support, because regulations and infrastructure are different in each. From an operations perspective, John considers moving data to be equally important as moving product.

As part of its secure and compliant importer effort, Pfizer is promoting legislation in the US recognizing companies with strong compliance profiles and facilitating cross border movement from a customs and regulatory perspective. ‘DHL is a partner with us in supporting this effort,’ adds John. Looking ahead, the supply chain challenges of tomorrow are going to require even more adaptive and innovative approaches to reaching new and existing customer constituencies.

With downward pressure on prices, increased reach and service requirements, patent expirations, and planned launches of new and innovative therapies, some with the potential to be tailored on a patient-specific basis, Pfizer will need a supply chain that is even more predictive, responsive, cost effective, secure and compliant in order to enable rapid border transit, safeguard product quality and availability and reduced working capital investment.

This is why Pfizer is undertaking a number of scenario plans and looking over the horizon to position itself to achieve its goals in concert with the commercial and trade strategies established for its business profile. An analysis of Pfizer’s research capabilities is critical to evaluating its ability to discover and bring new products to market. Pfizer had long been recognized as a research leader in the pharmaceutical space and has continued to traditionally place among the leaders in annual research expenditures with the company spending over $7. 8 billion in fiscal 2012 alone.

Despite allocating over $87. 0 billion to R&D from 2003-2012, the company’s research efforts had largely failed to produce any significant advancements through mid-2011. Through that period several high-profile compounds that had been viewed as potential blockbusters each failed late state testing following the disappointing FDA ruling on Torcetrapib (Atorvastatin) in 2006. Pfizer’s research performance has since become a source of sensitive concern given the lack of new therapies brought to market through either the organic development of in-house compounds or through acquisition.

The end result is that in addition to not developing a continuous revenue source needed to offset revenue lost to patent expirations, these failures activities have further strained company resources given the previously noted level of R&D expenditures coupled with an additional $8. 0 billion in restructuring charges since 2010 alone. Further analysis reveals that Pfizer’s financial commitment to R&D efforts has demonstrated a significant decline in recent years. The company has announced several attempts to narrow its focus areas of research and the overall R&D spend has followed.

Since the recent high in 2007, R&D expenditures expressed as a percentage of revenue, has fallen from 16. 5% to an estimated 11. 8% in 2013. On a total dollar basis the amount that Pfizer dedicated to research has declined by 27. 7% from roughly $9. 4 billion in 2010, a figure partially distorted by the late 2009 Wyeth acquisition, to an estimated $6. 8 billion in 2013. The company’s 2013 guidance came as somewhat of a surprise given that the projected $6. 5 – $7. 0 billion outlay represents a $900 million to $1. 3 billion cut from reported 2012 data and $6. 60 billion range mid-point would represent the lowest total since the pre-Pharmacia acquisition in 2003 $5. 6 billion. Cuts over the period have resulted in the closing or selling off of industry renowned research facilities in Kalamazoo, MI, Sandwich in the UK, and Cork, Ireland as well as Singapore with the company’s primary research facility count falling from 20 to 14. Despite the cuts, Pfizer has been moving to advance its presence in China to gain favour in the expanding market and to initially capitalize on the lower operating costs associated with the country.

In addition to the Shanghai R&D center, where antibiotic research is now headquartered, the company has announced the establishment of a Wuhan Research & Development Center and research partnerships within the. Pfizer further tapped into the developing market early last year with the announced joint venture with its manufacturing partner, Zhejiang Hisun Pharmaceuticals to establish a dedicated research center to develop branded generic drugs for the Chinese market with a $250 million commitment. It appears that the company is beginning to adapt a minimalist approach to research efforts with a heightened focus on development.

We believe that this will allow the company sufficient bandwidth to progress acquired compounds rather than originating the research. We view a continuation of this trend to be the most likely scenario with Pfizer falling to the middle tier of the major pharmaceutical companies in terms of research spend through the end of the decade. Pfizer repeatedly has been involved in loud scandals and incidents associated in the violation of the regulatory issues, same negative reputation due to its corruption activities, and paid millions of penalties. Like: in 2009, Pfizer aced both criminal and civil allegations over illegal marketing of drugs like Bextra, Geodon, Zyvox, Lyrica, Nuerontin, Detrol and Lipitor. Pfizer was accused of telling doctors that certain drugs could be used for unapproved uses, and defrauding the Medicaid program. The case ended with Pfizer agreeing to a $2. 3 billion settlement and a five-year integrity agreement with the Department of Health and Human Services. Additionally, Pfizer were responsible for selling drugs that could have serious side effects. For example, Effexor, the best-selling antidepressant of 2007 that was used by 17. million people that year, and Zoloft, an antidepressant used by 35. 7 million people in 2011, have led to birth defects when taken during pregnancy. As a result, many families have sued the pharmaceutical giant. Pharmaceutical manufacturing giant Pfizer has settled corruption charges levelled against it by the Securities and Exchange Commission (SEC) and the Department of Justice (DOJ), both of which said the company had violated the Foreign Corrupt Practices Act (FCPA) by bribing foreign officials to win business and allow its products to access markets.

SEC said in a statement the company and its agents had bribed officials in Bulgaria, China, Croatia, the Czech Republic, Italy, Kazakhstan, Pakistan, Saudi Arabia, Indonesia, Russia and Serbia, “To obtain regulatory and formulary approvals, sales, and increased prescriptions for the company’s pharmaceutical products. “Regulated activities accounted for a number of the ways Pfizer employees tried to hide the funds used to bribe officials, including clinical trials, advertising, promotional activities, marketing and training.

Pfizer said it would pay more than $60 million to settle the charges, which it noted had been disclosed to SEC and DOJ investigators willingly. Despite Pfizer’s “extraordinary cooperation,” an SEC official said the culture of bribery and corruption was, “So entwined in their sales culture that they offered points and bonus programs to improperly reward foreign officials who proved to be their best customers. “These charges illustrate the pitfalls that exist for companies that fail to appropriately monitor potential risks in their global operations,” wrote Kara Brockmeyer, chief of SEC’s Enforcement Division’s FCPA Unit. I have to mark another big violence is the case with the clinical trial of Trovan in Cano in 1996. as a result of illegal drug Trovan trial in Nigeria (Kano State), 11 children were killed, dozens were disabled. For Pfizer initiated a criminal case, which ended with the settlement agreement.

In the future, companies have filed lawsuits against 546 people. As a result, the experts found guilty of the deaths of four children (their families were paid compensation by $ 175 thousand). Pfizer has agreed to pay about $35 million of a $75 million settlement to the children affected by the trial. Pfizer contends that there was no regulation or law in Nigeria requiring ethical committee approval before conducting a clinical trial or investigative study. Therefore, there was no need to obtain what the law did not require.

The test came to public attention in December 2000, when The Post published the results of a year-long investigation into overseas pharmaceutical testing. The news was met in Nigeria with street demonstrations, lawsuits and demands for reform. Trovan was later banned in the U. S. and Europe. The list of corruption, violation in terms of regulation issues is long … The company currently faces 300 other lawsuits for illegal promotion of this drug. Pfizer has announced it will appeal this judgment. Fact: released report by the Public Citizen’s Health Research Group.

According to this report: “Of the 165 settlements comprising $19. 8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14. 8 billion) have occurred in just the past five years (2006-2010). Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10. 5 billion) of all financial penalties imposed over the past two decades. These leading violators were among the world’s largest pharmaceutical companies. “

Cite this Pharmaceutical Companies

Pharmaceutical Companies. (2016, Oct 02). Retrieved from https://graduateway.com/pharmaceutical-companies-2/

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