bi-monthly edition

BULLETIN MNS October 2009

PHARMACEUTICAL STARTING MATERIALS MARKET NEWS SERVICE (MNS) BI-MONTHLY EDITION

1 Market News Service

Pharmaceutical Starting Materials

Market News Service

Pharmaceutical Starting Materials/Essential Drugs

October 2009, Issue 5 The Market News Service (MNS) is made available free of charge to all Trade Support Institutions and enterprises in Sub-Saharan African countries under a joint programme of the International Trade Centre and CBI, the Dutch Centre for the Promotion of Imports from Developing Countries (www.cbi.nl). Should you be interested in becoming an information provider and contributing to MNS' efforts to improve market transparency and facilitate trade, please contact us at [email protected]. This issue continues the series, started at the beginning of the year, focusing on the leading markets in various world regions. This issue covers the trends and recent developments in eastern European pharmaceutical markets. To subscribe to the report or to access MNS reports directly online, please contact [email protected] or visit our website at: http://www.intracen.org/mns.

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Introduction WHAT IS THE MNS FOR PHARMACEUTICAL STARTING MATERIALS/ESSENTIAL DRUGS?

In 1986, the World Health Assembly laid before the Organization the responsibility to provide price information on pharmaceutical starting materials. WHA 39.27 endorsed WHO‟s revised drug strategy, which states “... strengthen market intelligence; support drug procurement by developing countries...” The responsibility was reaffirmed at the 49th WHA in 1996. Resolution WHA 49.14 requests the Director General, under paragraph 2(6) “to strengthen market intelligence, review in collaboration with interested parties‟ information on prices and sources of information on prices of essential drugs and starting material of good quality, which meet requirements of internationally recognized pharmacopoeias or equivalent regulatory standards, and provide this information to member states”. MNS FOR PHARMACEUTICAL STARTING MATERIALS IS AIMED AT YOU:

- If you need to purchase pharmaceutical active ingredients to produce essential drugs at reasonable cost.

- If you wish to stay informed about worldwide prices; - If you need a guide to compare market prices and for your negotiations; - If you seek market information, industry and regulatory news with respect to APIs, generic

drugs; - If you wish to remain informed about overall pharmaceutical industry developments

relevant to developing countries. ASSURING QUALITY

In this publication, quality is expressed in terms of pharmacopoeial standards, when

available1

. When the pharmacopoeial standard is indicated as quality standard, the latest edition of the pharmacopoeia would apply. In accordance with the principles of good manufacturing practices (GMP), it is the dosage form manufacturer who must assume responsibility for the quality of the final pharmaceutical products. The acceptability of each starting material has to be established by developmental (pre-formulation, development of pharmaceutics) studies and confirmed through validation programmes for manufacturing processes. The Information Providers screened by MNS, are those that exhibit their dedication to quality assurance by maintaining up to date ISO 9000 certification, conform to WHO GMP requirements and fulfil minimum batch certification and labelling requirements. MNS collects data from Information Providers on the following: (a) Batch certificate that meets the following minimum requirements including:

Name and batch number of the Pharmaceutical Starting Material Name and address of the manufacturer Manufacture and expiry date/retest date Type of container Net weight of the content per container and the number of the containers Date of latest analysis Quality specifications

(b) Minimum labeling requirements for Pharmaceutical Starting Materials including:

Name of Pharmaceutical Starting Materials Batch number Name and address of manufacturer Specification of active materials Expiry or retest date Storage indication Name of supplier if applicable

1 The list of covered products includes additives and fillers for which no pharmacopoeial standards are available.



The MNS does not guarantee the quality of the substances listed in this report. Licensing authorities in the respective countries of manufacture are expected to be responsible for the review and approval of the detailed composition and formulation when authorizing a pharmaceutical product to be marketed, including the specifications of its ingredients, as submitted by the manufacturer of the dosage form and oversee compliance with GMP requirements as recommended by WHO.



INDEX INTRODUCTION ................................................................................................................... 2

INDUSTRY TRENDS ............................................................................................................ 5 REGIONAL FOCUS .............................................................................................................. 6

North America .................................................................................................................... 6 SELECTED INDUSTRY NEWS ............................................................................................. 9 REGULATORY UPDATES ................................................................................................. 13 PRICE INFORMATION ....................................................................................................... 16 CALENDAR OF EVENTS ................................................................................................... 48 APPENDICES ..................................................................................................................... 50



Industry Trends At the end of the third quarter of 2009, the outlook on future growth for brand drugs has improved compared to what was originally anticipated but will remain low, according to analyses by pharmaceutical consulting firm, IMS Health. Global pharmaceutical sales for 2009 were set to grow by 2.5-3.5% in April. Revised figures place growth rates at 5.5-6.5%.

1 Based on

drug sales information in 220 countries, this trend is attributed to healthy growth in generic drug sales, supported by an upcoming patent expiry, dry drug pipelines and a tough global economic climate. Expansion of pharmaceutical companies into emerging markets, a move already evident at the beginning of the year is confirming itself as pharmaceutical companies, generic and brand alike establish themselves in these markets. The countries concerned, referred to as EM-7 or “pharmerging” markets, include China, India, Russia, Brazil, South Korea, Mexico and Turkey. The strategy adopted by brand pharmaceutical companies is to link up with generic manufacturers who are already quite established in these markets. Earlier in May, Pfizer concluded a deal with Aurobindo aimed at seven emerging markets; a month later, GSK entered into partnership with India‟s Dr. Reddy‟s Laboratories. Companies are also building up local presence through the construction of low-cost manufacturing sites and R&D linkages with local companies and academic institutions. A common strategy

being adopted is to intensify the marketing of drugs which have gone off-patent while expanding into only selected segments of the generic industry.

2

Major pharmaceutical companies are also venturing into the vaccine business, a field which is becoming increasingly attractive in light of recent high demand for vaccines. US-based Abbott Laboratories concluded a USD 6.6 billion deal with Belgian biotechnology company, Solvay, to acquire vaccines. Johnson & Johnson is also set to acquire an 18% stake in Dutch biotechnology firm in order to maximise its vaccine technology. Merck has also entered into partnership with Australia-based CSL for gain marketing rights for its flu vaccine. Favourable developments are boosting the recent growth and developments observed. Vaccines against papilloma virus and pneumococcal disease are being marketed for higher values than was previously the case: around USD 100 rather than a few dollars. The sector is also benefiting from increased investment thus increasing access to the latest technologies. In fact, emerging technologies promise to make biopharmaceutical development quicker and more efficient. While the potential for expansion is there, several possible challenges remain. Namely, the development of such biotechnology products is a long and costly process. Also, because vaccines are manufactured and not reusable, an overproduction of vaccines can often symbolize wastage.



Regional Focus

North America United States of America

General Market Trends The US pharmaceutical market is the largest in the world, ahead of the other major markets: western European countries and Japan. In September 2009, the US pharmaceutical market was valued at USD 229.7 billion, whereas the top 5 European markets valued at USD 105.5 and Japan at USD 77.4 billion. The demand for pharmaceuticals is also high within the US especially where consumption per person is the third largest in the world after France and Spain. The continued research and development of drugs and the ageing population are projected to drive the growth of the local pharmaceutical market. Adults aged 65 and over are major consumers of drugs and are living longer as a result of access to medicines. However, elevated drug prices and consumer cost-consciousness are likely to slow the future growth in demand. Unlike in other developed countries, the government is legally not allowed to negotiate better prices with drug suppliers. Hence, drug prices in the US are 30% above the average of other countries within the OECD. In fact, this has led to greater demand for Canadian drugs which are considerably cheaper. In addition, President Obama is in support of

importing FDA-approved drugs of foreign origin, a measure which would save an estimated USD 50 billion. Another factor which will also slow growth in drug sales is the economic slowdown which has resulted in higher unemployment, stripping many of their employer-provided health insurance. The US pharmaceutical companies are key players on the global pharmaceutical markets as well as domestically. The top four domestic suppliers consist of the following companies—in decreasing order of dominance in the domestic market: Pfizer, Johnson & Johnson, Abbott Laboratories and Merck & Co. These companies are also ranked among the top ten global pharmaceutical companies. Leading pharmaceutical, Pfizer, is benefiting from the success of its cholesterol-lowering drug, Lipitor. This is indicative of the therapeutic areas in which pharmaceutical companies are venturing in, namely chronic illnesses for which medicines are especially profitable. Increasingly, the industry is also shifting towards the R&D of more specialised treatments rather than relying on creating a highly profitable drug for a larger audience.

Generic drugs Generic drugs are occupying an increasingly greater share of the US pharmaceutical market. According to industry research firm, RNCOS, the share of generic prescriptions from the total pharmaceutical prescriptions rose dramatically from 19% in 1984 to 70% in 2008. Growth in sales is set to be boosted by the expiry of patents on highly profitable brand drugs as well as the promotion of generic drug use by the administration as a cost-saving initiative. US president Obama is highly supportive of the legislation to facilitate the development and marketing of biosimilars. Also seen as a healthcare cost-cutting

measure, this will likely boost the demand and sales of biosimilars in the future. As with their brand counterparts, the major generic manufacturers which dominate the US pharmaceutical market are also key global players. These include Mylan, Alpharma and Watson. However, Israel-based Teva Pharmaceuticals remains the top generic manufacturer and a leader in the US pharmaceutical market. Hence, there is intense generic competition which is placing a dent in brand pharmaceutical revenue and likely to be a downward force on prices overall.



Regulation The US pharmaceutical industry is also attempting to rebuild its credibility following a series of events which has decreased consumer confidence. Some antidepressants have been said to increase to incidence of suicide among teenagers. Vioxx, Merck‟s highly profitable pain relief drug was withdrawn from the market in 2004 after allegations that it increased the risk of heart attacks and strokes. In 2008, adverse reactions observed to the anticoagulant, heparin, imported from China raised safety concerns and further damaged the credibility of the industry and the US FDA‟s.

The US FDA has taken measures to tighten regulatory approval and has also established offices in key producing countries, such as India and China. This initiative was taken to further safeguard consumers given the increasingly large share of pharmaceuticals and products imported from foreign sources. Additionally, the government administration has increased the FDA‟s budget for the next fiscal year, a move which should allow the regulatory body to carry out its operations more effectively.

Canada

General Market Trends In 2008, the domestic pharmaceutical market was valued at USD 30.3 billion, based on prescription and OTC drug sales, making Canada the seventh-largest pharmaceutical market in the world. In September 2009, the Canadian pharmaceutical market was valued at USD 15.79 billion, a 6% increase from figures available a year ago. Demand for pharmaceuticals remains high as drug expenditure is the second largest category in total healthcare expenditure. However, in light of the fact that the healthcare system is largely publicly funded, the government bears the majority of the costs, followed by private insurance companies thus dampening the effect of the global economic downturn on drug consumption. Only 15% of the drug expenditure is covered by out-of-pocket payments. Canadian drug exports totalled a value of USD 6.5 billion in 2008 of which about

73% was exported to the United States alone. There is a high demand for cheaper drugs on behalf of US citizens seeking alternatives to relatively highly priced medicines available on the US market. The largest suppliers on the local market are Pfizer, with 13.4% of the market share, followed by AstraZeneca and then Johnson and Johnson. The domestic Canadian pharmaceutical industry is relatively small but Biovail is a major player on the local market. The biotechnology industry, on the other hand, is growing and benefiting from a government push towards a “high technology, innovative, R&D-based industry”. However, the industry is in need of greater investment and funds as many biotech companies are unable to carry out their drug development all the way through clinical trials.

Generic industry Generic drugs constitute a major part of the local pharmaceutical market. One half of the prescriptions are filled by generic drugs. Hence, demand for generics is currently high and showing more growth potential in light of the upcoming patent expiry for several highly profitable drugs.

In 2008, the generic market was valued at USD 4.7 billion, already demonstrating a 20% increase on the previous year. The prices of Canadian generic drugs are beginning to come under attack by government and the Competition Bureau.



Generic drug prices are still relatively high and a reduction in prices estimated to result in major savings. Like the United States, Canada has ventured into biosimilars; it has created legislation to monitor the research, development and marketing of these drugs, seen as a potential cost-saving initiative in the future of the pharmaceutical industry.

Fifteen suppliers constitute the domestic generic drug sector, of which the largest is Apotex. Leading manufacturer, Mylan Pharmaceuticals has also entered the Canadian market through its acquisition of leading domestic manufacturer and Merck KGaA subsidiary, Genpharm.

3 Apotex has

also entered into a partnership with India‟s Biopharmaceuticals Limited to manufacture biosimilars.

Table 1. Total annual pharmaceutical sales (2006-2009)

Country 2006 2007 2008 2009

United States (USD trillion) 320 349 379 351

Canada (USD trillion) 25.3 27.2 30.3 34.1 Source: Economist Intelligence Unit



Selected Industry News

AIDS vaccine: are we there yet?

On September 24th 2009, the Thai Minister

of Health announced positive but preliminary results of an anti-HIV vaccine trial (known as RV 144) carried out in Thailand. The vaccine, he stated, reduced the rate of HIV infection by 31% percent, compared to a placebo. Although offering modest protection, the news was received with much optimism and enthusiasm. The results were obtained from a US Army-sponsored Phase III trial of a large HIV/AIDS vaccine carried out in Thailand by the Ministry of Public Health, with just over 16,000 HIV-negative volunteers. The volunteers came from the general population and not from particularly high-risk populations. The trial began in 2006 with a vaccine and participants received an HIV-test every six months for the next three years. The „prime-boost‟ approach was used in the trial, where two different vaccines (produced by Sanofi-Pasteur and Vaxgen) were combined to form one HIV vaccine. The role of one vaccine was to stimulate (prime) an immune response while the other was to boost the immune response, hence its name. Despite its success, sceptics raised questions about its efficacy on a wider scale, its efficacy in high-risk groups as well as the duration of the protection observed. Some of this scepticism was

founded particularly in light of recent news: additional analyses carried out on RV 144 data and published in the New England Journal of Medicine revealed that the protection observed may not be statistically significant. Hence, the vaccine cannot yet be fully relied upon to curb HIV infection rates. Yet, regardless of the current stumbling blocks, researchers and public health agencies see in RV 144 the confirmation that an effective HIV vaccine could, eventually, become a reality. It opens up a variety of avenues which can be investigated based upon the results of the study, such as different vaccines and different immune responses. In the words of Alan Bernstein, executive director of the Global HIV Vaccine Enterprise, an alliance of governments, AIDS scientists, the World Health Organization and funders such as the Bill and Melinda Gates Foundation: “The bottom line is that those results are real…We for the first time, have evidence of protection, and the nitty gritty (arguments) to me don‟t matter…” He is not alone, many more agree that while we may not have an effective vaccine yet, we have definitely taken a major step towards that goal. Source: Scrip Pharmaceutical News,

Dialog NewsEdge (EIU); 20 October 2009

Ecuador to bypass patents for increased drug access

Ecuador will soon be following in the paths of Thailand and Brazil, two countries who broke patents to either manufacture or import generic versions to address critical local health situations. Back in 2007, Brazil and India broke patents to allow for domestic production of AIDS drugs. Ecuador‟s President, Rafael Correa, recently announced a government decision to permit local drug makers to make generic copies of Western drugs in order to increase the access of local population to much needed drugs. Locally manufactured drugs will have priority but

active ingredients will be imported to support the manufacture of complex drugs. The government issued compulsory licenses for over 2000 patents to local pharmaceutical companies and agreed to pay a foreign multinationals a royalty fee. The decision relies on allowances in the TRIPS agreement, WTO‟s 1995 agreement on intellectual property, which permits governments to break patents to address urgent public health concerns. Figures from the research firm, Intercontinental Marketing Services (IMS), show that the local pharmaceutical market



is dominated by foreign multinational pharmaceutical companies, controlling about 82% of the market. As a result, for the 70% of the local population living in poverty, the prices of the drugs available are unaffordable. The response on behalf of foreign multinationals has been one of understanding. A local industry association, which includes major multinationals such as GlaxoSmithKline and Bayer issued a statement in which they expressed the following: "We accept the democratic decision...to legally implement this extraordinary

measure…No legal right is superior to the requirements of public health, especially in such serious circumstances…” This government measure should bring drug prices down significantly through competition and also strengthen local production capabilities. The challenge ahead now for local drug companies is to meet the now increased demand and maintain a high level of quality for drugs produced. Source: World Markets Research Ltd,

Agence France Presse, Business Monitor International; 27 October 2009

New initiatives boost the fight against fake drugs The European Federation of Pharmaceutical Industries and Associations (EFPIA) is exploring a new scheme to reduce the threat of counterfeit drugs to European patients. The project is a direct response to an EC proposal to create a system to code pharmaceutical products throughout the EU region. The EFPIA pilot will involve 25 retail pharmacies in the Stockholm area and consists of putting a specialized “matrix” on each product to facilitate instant verification. This data matrix is set to provide information such as product code, batch number, expiry data and a unique serial number for each product. If successful, the project could be expanded to the whole Europe region. The industry would welcome such an initiative which would put an end to the loss of revenue brought by fake drugs as well as diminish the risk to patients. The only challenge remains for generic drug makers and small pharmaceutical companies who fear the cost implications for them to implement this initiative. A similar project involving Switzerland‟s Geneva-Lausanne School of Pharmacy and the Fribourg College of Engineering and Architecture is promising for the global

fight against counterfeits, particularly in poorer countries. Counterfeit drugs can have some major health consequences in developing countries, where regulatory, quality and safety enforcement systems are currently weak. In Africa, for example, where about 80% of the drugs are imported, the need for cheap and effective quality control mechanisms is important. WHO estimates that at least 200,000 lives are lost to counterfeit drug use every year. The joint team made up of pharmacists and engineers have constructed a cheap machine which will allow poorer countries to detect fake medicines. The tool will be simple to use and able to stand extreme weather conditions. It rests on the capillary electrophoresis method which separates electrons by size and electric charge. This machine will require only small amounts of organic solvent, used in the process, and also small amounts of water. This should make it easy to operate and, hopefully, materialize into a sustainable option for quality control organisms in developing countries. Source: World Markets Research Ltd,

Economist Intelligence Unit; 15 October 2009

Developing countries step up local generic oseltamivir production Several pharmaceutical companies in developing countries have taken measures to increase the production and availability of generic copies of oseltamivir,

the antiviral drug marketed as Roche‟s Tamiflu against Influenza A H1N1. The imminent threat of the Influenza A H1N1 and the widespread prevalence of flu



outbreaks globally have motivated governments to take preventive measures. Leading the pack, are Indian companies who are taking advantage of a government decree permitting the „restricted‟ sales of generic copies of oseltamivir. Companies are permitted to stock up retail pharmacies that possess a license under “schedule X of the Drugs and Cosmetics Rules for medical prescriptions”. Cipla‟s WHO-approved product, marketed as Antiflu will be available at Rs 475 for 10 capsules. Other Indian companies will also be marketing their products: Natco Pharma‟s product as Natflu, Strides Arcolab‟s product as Starflu and Hetero Drugs‟s product as Fluvir. In light of the rapid spread of the Influenza A H1N1 in Asia, South Korea is pushing ahead with its testing and eventual manufacture of generic oseltamivir. Two

local pharmaceutical companies have received approval from the country‟s drug safety agency to conduct clinical trials to test the bioequivalency of their generic copies to the original Tamiflu. Sales of these copies will only be available for sale in 2016, once Roche‟s patent in the country expires. However, government officials would like to maintain a stock of antivirals in the event of a pandemic or drug shortage. Elsewhere, UAE‟s health ministry has authorized local company, Neopharma, to produce generic copies of oseltamivir. (It is within a joint alliance with Hetero Drugs and a part of the company‟s product portfolio over the next few years.) Source: Scrip Pharmaceutical News,

Economist Intelligence Unit; 2 October 2009

Increased funding for FDA drug centre and office of

generic drugs In the new fiscal year starting October 1

st

2009, the US government has approved legislation which should increase the budget available to the US FDA. This budget increase will be a major boost to the agency and allow it to carry out its operations more effectively. The bill is set to increase direct funding for the FDA by 15%, in addition to its revenue from user fees. This pushes the total agency budget for 2010 fiscal year to USD 3.25 billion.

The drug centre and related field activities will increase by 13%, amounting to USD 880 million, of which the budget for generic drug programme is set to increase by 25%, and set to top USD 51.5 million. The biologics centre and related field activities is also set to benefit, with a 12% budget increase to reach a total of USD 305 million. Source: Scrip Pharmaceutical News; 30

October 2009

Unclear future for Canada’s Access to Medicines Regime Two bills are currently before the Canadian Parliament to revamp Canada‟s Access to Medicines Regime—with the hopes of making it more effective and more usable. The legislation, brought about in 2004, would allow Canadian drug makers to ship cheap generic drugs to needy countries afflicted by the world‟s major killers—HIV, tuberculosis and malaria. However, this legislation has not brought about the expected results due the complexity of the procedures required.

The current procedure requires interested generic companies, for each drug order from a country, to negotiate licenses directly with the patent-holding companies. In addition, these licenses are only for limited time periods and need to be renewed. This difficult process explains to some extent why several companies have not participated to date. Only Canadian generic company, Apotex Inc., has shipped triple-combination AIDS drugs to Rwanda under this scheme. GlaxoSmithKline and Canadian branches



of Shire and Boehringer Ingelheim have granted permission for the manufacture of these AIDS drugs, for which they all have patents. Furthermore, Rwanda is also the only country which has benefited under this scheme, receiving drug shipments over the past year to treat 21,000 HIV-

infected people. However, Apotex Inc. requested a simplification of the current procedure, deemed too costly and complicated, in order to participate again. Source: Dialog NewsEdge, The Toronto

Star; 20 October 2009

Jordan’s Hikma Pharma emerges despite recession While the global economic downturn and the approaching patent cliff is painting a grim picture for major pharmaceutical companies, particularly those based in developed markets, these grim conditions are favoring the growth of companies in other regions. Jordan-based Hikma Pharmacauticals is demonstrating steady growth and is rapidly emerging to become one of the key players in the Middle East. Created in 1978, the company grew to produce patented and off-patented drugs throughout the Middle East two years later. Hikma later expanded into the US market when it bought US generic drug maker, Westward and also started the production of injectable medicines in Portugal. The company also gained greater prominence ever since its listing in the London Stock Exchange in 2005 and has continued to grow ever since. Figures for the first six months of the year reveal that revenue surged by over 7%,

amounting to USD 321.5 million. Its model of operation is the manufacture and sale of patented and off-patent drugs throughout the Middle East and North African region (MENA), while promoting its generic drugs in more developed markets where generics are more in demand in this difficult economic climate. Hikma faced some challenges in trying to crack the highly competitive US, and in response has decided to focus on “high-margin, niche product opportunities” for future growth. However, Hikma remains a dominant pharmaceutical company in the MENA region and is quickly emerging as an attractive partner for major pharmaceutical companies looking to expand into the Middle East region. Source: Economist Intelligence Unit; 12

October 2009

Increased attendance confirm CPhI 2009 a major event Attendance statistics at this year‟s CPhI demonstrate that it remains a major industry event and an invaluable opportunity for business, networking and keeping up with industry developments. Held in Madrid, Spain, CPhI 2009 drew an estimated 25 450 visitors, a 5% increase on last year‟s event. Exhibitor numbers were also on the rise, pooling together about 1808 companies and organizations. This year was also the first year that the Bio-Ph event, exhibition of biotechnology companies, was joined along with CPhI and its parallel exhibitions (ISCE- for contract manufacturing and outsourcing services and P-MEC- for manufacturing equipment).

Emerging markets had a visible presence with sizable pavilions for India and China. Others, such as South Korea, Brazil, Argentina or Iran also had a decent representation. The next CPhI event is set for 5-7 October 2010, in Paris, France. The set up will be different and exhibitors will be arranged according to six main areas: APIs, Custom Manufacturing, Intermediates, Fine Chemicals, Excipients and General. More information available at: http://www.cphi.com

http://www.cphi.com/



Regulatory Updates

Patent Amendments

The following drugs are scheduled to lose market exclusivity and would be available for manufacturing by generic firms.

Table 2. Drug patent expirations through 2009

Drug Name Manufacturer

Acular Allergan

Arimidex AstraZeneca

Avandia GlaxoSmithKline

Avelox Bayer

Cellcept Roche

Cozaar Merck

Flomax (Alna) Boehringer Ingelheim

Glyset Pfizer

Imitrex GlaxoSmithKline

Keppra UCB

Prevacid TAP

Prograf Astellas Pharma US, Inc

Topamax Ortho-McNeil-Janssen Pharmaceuticals, Inc

Valtrex GlaxoSmithKline

Wellbutrin GlaxoSmithKline

Xalatan Pfizer

Xenical Roche Source: GPhA, Drug Topics

Abbreviated New Drug Approvals (ANDA)

The following table lists the generic drugs approved by the US FDA. Generic versions of a brand drug are approved by the ANDA route, which requires generic firms to prove bioequivalence with the originator drug. The original safety and efficacy data submitted by the original drug manufacturer do not need to be resubmitted. The table does not include tentative approvals but may reflect supplemental approvals obtained since the original approval date. The marketing status is assumed to be via “prescription”, unless otherwise indicated.

Table 3. Newly approved generic drugs, September 2009

Drug Name (FDA Application Number)

Active Ingredients Company Approval Date

Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate (ANDA # 078267)

Ethinyl Estradiol; Norethindrone Acetate

Watson Labs 01/09/2009

Risperidone (ANDA # 078452)

Risperidone Aurobindo Pharma 04/09/2009

Temazepam (ANDA # 078581)

Temazepam Mutual Pharm 08/09/2009

Nateglinide (ANDA # 077461)

Nateglinide Dr Reddys Labs Ltd 09/09/2009


Nateglinide Par Pharm 09/09/2009


Nateglinide Teva Pharms 09/09/2009



Drug Name (FDA Application Number)

Active Ingredients Company Approval Date

Granisetron Hydrochloride (ANDA # 079119)

Granisetron Hydrochloride Akorn Inc 10/09/2009

Haloperidol (ANDA # 078347)

Haloperidol Lactate Akorn Strides 14/09/2009

Granisetron Hydrochloride (ANDA # 079078)

Granisetron Hydrochloride Akorn Inc 14/09/2009

Piperacillin And Tazobactam (ANDA # 065386)

Piperacillin Sodium; Tazobactam Sodium

Orchid Hlthcare 15/09/2009

Piperacillin And Tazobactam (ANDA # 065446)

Piperacillin Sodium; Tazobactam Sodium

Orchid Hlthcare 15/09/2009

Galantamine Hydrobromide (ANDA # 077585)

Galantamine Hydrobromide

Actavis Elizabeth 15/09/2009

Deferoxamine Mesylate (ANDA # 078718)

Deferoxamine Mesylate App Pharms 15/09/2009

Irinotecan Hydrochloride (ANDA # 090726)

Irinotecan Hydrochloride Akorn 16/09/2009

Verapamil Hydrochloride (ANDA # 078906)

Verapamil Hydrochloride Glenmark Generics 17/09/2009

Ribavarin (ANDA # 079117)

Ribavirin Aurobindo Pharma 17/09/2009

Zaleplon (ANDA # 090374)

Zaleplon Orchid Hlthcare 17/09/2009

Baclofen (ANDA # 078401)

Baclofen Northstar Hlthcare 18/09/2009

Fluconazole (ANDA # 079150)

Fluconazole Aurobindo Pharm 18/09/2009

Sumatriptan Succinate (ANDA # 079240)

Sumatriptan Succinate App Pharms 18/09/2009

Glimepiride (ANDA # 077911)

Glimepiride Carlsbad 22/09/2009

Ifosfamide (ANDA # 090181)

Ifosfamide App Pharms 22/09/2009

Alendronate Sodium (ANDA # 090258)

Alendronate Sodium Austarpharma Llc 24/09/2009

Ramipril (ANDA # 090697)

Ramipril Zydus Pharms USA Inc 24/09/2009

Atenolol (ANDA # 078254)

Atenolol Northstar Hlthcare 25/09/2009

Cetirizine Hydrochloride (ANDA # 078496)

Cetirizine Hydrochloride Vintage 25/09/2009

Ondansetron Hydrochloride (ANDA # 079224)

Ondansetron Hydrochloride

Gland Pharma Ltd 25/09/2009

Lithium Carbonate (ANDA # 090702)

Lithium Carbonate Hetero Drugs Ltd 25/09/2009

Cilostazol (ANDA # 077708)

Cilostazol Breckenridge Pharm 28/09/2009

Dorzolamide Hydrocloride And Timolol Maleate (ANDA # 078704)

Dorzolamide Hydrochloride; Timolol Maleate

Teva Parntl 28/09/2009

Timolol Maleate (ANDA # 078771)

Timolol Maleate Wockhardt 28/09/2009

Carbidopa And Levodopa (ANDA # 090324)

Carbidopa; Levodopa Mylan 28/09/2009

Oxaliplatin (ANDA # 078815)

Oxaliplatin Hospira Inc 30/09/2009

Caffeine Citrate (ANDA # 090077)

Caffeine Citrate Sun Pharm Inds Ltd 30/09/2009

Caffeine Citrate (ANDA # 090357)

Caffeine Citrate Sun Pharm Inds Ltd 30/09/2009

Metoprolol Tartrate (ANDA # 090386)

Metoprolol Tartrate Luitpold 30/09/2009

Source: Center for Drug Evaluation and Research (FDA)



Table 4. Newly approved generic drugs, October 2009

Drug name (FDA application number)

Active ingredients Company Approval date

Testosterone Enanthate (ANDA # 040647)

Testosterone Enanthate Synerx Pharma 05/10/2009

Cetirizine Hydrochloride (ANDA # 090766)

Cetirizine Hydrochloride Amneal Pharms 07/10/2009

Buprenorphine Hydrochloride (ANDA # 078633)

Buprenorphine Hydrochloride

Roxane 08/10/2009


Risperidone Wockhardt 08/10/2009

Sumatriptan Succinate (ANDA # 077332)

Sumatriptan Succinate Par Pharm 09/10/2009

Topiramate (ANDA # 078418)

Topiramate Mylan 14/10/2009


Topiramate Zydus Pharms USA Inc

14/10/2009


Topiramate Sandoz 14/10/2009

Fentanyl Transdermal System (ANDA # 077775)

Fentanyl Hisamitsu 16/10/2009


Risperidone Sandoz 16/10/2009

Chlorothiazide Sodium (ANDA # 090896)

Chlorothiazide Sodium App Pharms 16/10/2009


Risperidone Synthon Pharms 22/10/2009

Melphalan Hydrochloride (ANDA # 090299)

Melphalan Hydrochloride Generamedix 27/10/2009

Levetiracetam (ANDA # 090992)

Levetiracetam Amneal Pharms 27/10/2009

Source: Center for Drug Evaluation and Research (FDA)



Price information

ACECLOFENAC

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

45/kg 25kg prompt EP5 China IP.13

45/kg 500kg prompt USP27 China IP.09

ACETAZOLAMIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

14.9/kg 500kg prompt BP2008 India IP.13

ACETYLSALICYLIC ACID, 100% granular

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

1.6/kg 1mt prompt BP2008 India IP.13

ACETYLSALICYLIC ACID, crystalline

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

3/kg 500kg prompt BP2008 India IP.13

2.85/kg 1mt prompt BP2008 China IP.01

ACTIVATED CARBON

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

750/mt 10mt prompt BP2008 India IP.13

ACYCLOVIR

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


ALBENDAZOLE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

12.7/kg 100kg prompt USP29 China IP.01

ALLOPURINOL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

18.75/kg 5 mt prompt USP27 China IP.13



ALUMINIUM HYDROXIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

130/mt 10mt prompt USP29 China IP.01

AMIKACIN SULFATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

93/kb 500kb prompt USP27 China IP.01

AMINOPHYLLINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

8.9/kg 500kg 2 weeks USP27 China IP.01

AMODIAQUINE HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

37.5/kg 50kg prompt BP2008 China IP.01

AMOXICILLIN TRIHYDRATE, non-sterile powder, compact

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


AMPICILLIN SODIUM, sterile crystalline

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

61/kg 500kg prompt BP2008 China IP.09


AMPICILLIN TRIHYDRATE, non-sterile powder

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



AMPICILLIN TRIHYDRATE, compact powder

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS





ASCORBIC ACID

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


ATROPINE SULFATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


BENZANTHINE BENZYLPENICILLIN, sterile powder

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

42.7/bou 500bou prompt BP2008 China IP.01

BENZYLPENICILLIN POTASSIUM, sterile powder

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

10/bou 1000bou prompt BP2008 India IP.13


BENZYLPENICILLIN SODIUM, sterile powder

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



BETAMETHASONE SODIUM PHOSPHATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

3.9/g 10kg prompt BP2008 China IP.01

CAFFEINE ANHYDROUS

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CALAMINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CANDESARTAN CILEXETIL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

1550/kg 100kg prompt MS China IP.09



CAPTOPRIL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



CARBAMAZEPINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



CARBOPLATIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

1.9/g 2kg prompt BP2008 China IP.01

CEFRADINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CEFOPERAZONE SODIUM

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

145/kg 100kg prompt USP28 Inida IP.13

CEFOTAXIME SODIUM

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CEFTRIAXONE SODIUM sterile

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CEFUROXIME SODIUM sterile

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CELLULOSE, HYDROXY PROPYL METHYL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

6.15/kg 3mt prompt USP27 India IP.13



CHLORAMPHENICOL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



25/kg 10mt prompt BP2008 India IP.13

CHLORAMPHENICOL PALMITATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


31/kg 1mt prompt BP2008 China IP.01

CHLORHEXIDINE GLUCONATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS





CHLOROQUINE PHOSPHATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CHLOROQUINE SULFATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CHLORPHENIRAMINE HYDROGEN MALEATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CHLORPROMAZINE HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CHLORTERACYCLINE HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS




CHLORTERACYCLINE HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CIMETIDINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CINCHOCAINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CINNARIZINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CIPROFLOXACIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

22.5/kg 300kg prompt USP27 India IP.13


CISPLATIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

21/g 500g prompt USP27 India IP.13

CLARITHROMYCIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

202/kg 25kg prompt USP27 India IP.13

CLINDAMYCIN HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



CLINDAMYCIN PHOSPHATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS




CLINDAMYCIN PHOSPHATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CLOMIFENE CITRATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CLONAZEPAM

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CLOTRIMAZOLE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



CLOXACILLIN SODIUM

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


25/kg 2mt prompt USP29 India IP.13

CLOZAPINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



CODEINE PHOSPHATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



COLCHICINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

10.66/g 1kg prompt USP27 India IP.13



CYANOCOBALAMIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



CYCLOPHOSPHAMIDE, sterile powder

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



CYCLOSPORINE A

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CYPROHEPTADINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


CYTARABINE HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


DAPSONE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


DAUNORUBICIN HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

145/g 10gm prompt USP27 China IP.13

DEXAMETHASONE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS






DEXAMETHASONE ACETATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


DEXAMETHASONE SODIUM PHOSPHATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



DEXTROMETHORPHAN HYDROBROMIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



DEXTROSE ANHYDROUS

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



DIAZEPAM

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


DICLOFENAC POTASIUM

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



DICLOFENAC SODIUM

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS




DIFLOXACIN HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

55/kg 100kg prompt MS India IP.13

79.9/kg 100kg prompt MS China IP.01



DIHYDROARTEMISININ

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

660/kg 5mt prompt MS China IP.13

DIHYDOSTREPTOMYCIN SULFATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

29.35/kb 50kb prompt USP27 India IP.13

48.5/kg 100kb prompt USP29 China IP.01

DL-METHIONINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


DILOXANIDE FUROATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


DIPHENHYDRAMINE HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


DOXAZOSIN MESYLATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


DOXORUBICIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

36/gm 10kg prompt USP28 India IP.13

DOXYCYCLINE HYCLATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



DOXYCYCLINE MONOHYDRATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS




ECONAZOLE NITRATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



EFAVIRENZ

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


EFLORINTHINE HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


ENALAPRIL MALEATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


ENROFLOXACIN HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


EPINEPHRINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


EPIRUBICIN HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

380/gm 5gm prompt USP28 India IP13

ERGOCALCIFEROL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


ERYTHROMYCIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS




ERYTHROMYCIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


ERYTHROMYCIN ESTOLATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


ERYTHROMYCIN ETHYLSUCCINATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


ERYTHROMYCIN STEARATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


ETHAMBUTOL HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


ETHINYLESTRADIOL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

2316/kg 1kg prompt EP5 India IP.13

ETHIONAMIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


ETOPOSIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

3479/kg 5kg prompt USP27 china IP.13


FAMCICLOVIR

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS




FAMOTIDINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



FELODIPINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


FERROUS FUMARATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

2.7/kg 1mt prompt USP29 China IP.01

FERROUS GLUCONATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


FLUCONAZOLE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


FLUOROURACIL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


FLUTAMIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


FOLIC ACID

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

21.6//kg 300kg prompt USP27 India IP.13


FUROSEMIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS




GABAPENTIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


GANCICLOVIR

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


GEMCITABINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

65/gm 1kg prompt USP28 India IP13

GEMFIBROZIL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

32/kg 1mt prompt USP28 China IP.13

GENTAMICIN SULFATE, sterile powder

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

85/kb 200kb prompt USP28 China IP.13

95.55/kb 500kb prompt BP2008 China IP.01

GLIBENCLAMIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


37/kg 500kg prompt BP2008 India IP13

GLICLAZIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



GLIPIZIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS





GLUCOSE ANHYDROUS

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

53.15/mt 10mt prompt USP27 India IP.13

GRISEOFULVIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



HALOPERIDOL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


HEPARIN SODIUM

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

5.8/mega 1000meg prompt BP2008 India IP.13

HYDRALAZINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


HYDROCHLOROTHIAZIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



HYDROCORTISONE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



HYDROCORTISONE ACETATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS





HYDROCORTISONE SODIUM SUCCINATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



HYDROXYCHLOROQUINE SULFATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



HYDROXYPROGESTERONE CAPROATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



IBUPROFEN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS




IFOSFAMIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


INDINAVIR

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


INDOMETHACIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



IPRATROPIUM BROMIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

14/gm 500gm prompt BP2008 India IP.13



ISONIAZID

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS







ISOSORBIDE MONONITRATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

180/kg 100kg 2 weeks BP2008 India IP.13

ITRACONAZOLE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


KETAMINE HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



KETOCONAZOLE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



KETOPROFEN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



LABETALOL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS




LAMIVUDINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


LEVAMISOLE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



LEVOFLOXACIN sterile powder

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


LEVONORGESTREL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


LEVOTHYROXINE SODIUM

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


LIDOCAINE HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


LINCOMYCIN HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


46.2/kg 500bou prompt BP2008 China IP.01

LISINOPRIL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

1000/kg 5kg prompt EP 5 China IP.13

L-METHIONINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS




LORATADINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

348/kg 50kg prompt USP 29 China IP.13

LOVASTATIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



MAGNESIUM TRISILICATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


MAGNESIUM SULFATE DRIED POWDER

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


MANNITOL

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


MEBENDAZOLE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


MEDROXY PROGESTERONE ACETATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


MERCAPTOPURINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


METFORMIN HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS





METFORMIN HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS





METHOTREXATE SODIUM

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



METHYLDOPA

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


METHYL PREDNISOLONE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


METHYL PREDNISOLONE ACETATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


METHYL PREDNISOLONE SODIUM SUCCINATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


METRONIDAZOLE Price / Unit

US$ Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



MICONAZOLE NITRATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS





MORPHINE HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


NAPROXEN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


NAPROXEN SODIUM

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


NATEGLINIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


NELFINAVIR MESYLATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


NEOMYCIN SULPHATE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

31.5/bou 500bou prompt USP28 India IP.13

NEVIRAPINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


NICOTINAMIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS









NITRENDIPINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


NITROFURANTOIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


NORFLOXACIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



NYSTATIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

26.5/bou 500bou prompt BP2008 India IP.13


OFLOXACIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



OMEPRAZOLE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


OXYTETRACYCLINE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



OXYTETRACYCLINE HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS





OXYTOCIN

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS

250/g 300g prompt BP2008 India IP.13

PARACETAMOL, directly compressible granules

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS





3.12/kg 500kg prompt BP 2008 China IP.13


PARACETAMOL, powder

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS



PAROXETINE HYDROCHLORIDE

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


PENCICLOVIR

Price / Unit US$

Minimum Quantity

Delivery Time

Quality standard

Country of origin

IPS


PHENOBARBITAL SODIUM

Price / Unit US$

Minimum Quantity

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PHENOXYMETHYLPENICILLIN K, non-sterile powder

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22.5/kg 100bou prompt BP2008 China IP.01

PHENYTOIN

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PHENYTOIN

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PHTHALYLSULFATHIAZOLE

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PHYTOMENADIONE

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PILOCARPINE

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PIPERAZINE ADIPATE

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PIPERAZINE CITRATE

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PIROXICAM

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POVIDONE

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PRAVASTAIN

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PRAZIQUANTEL

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PREDNISOLONE

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PREDNISOLONE ACETATE

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PROCAINE BENZYLPENICILLIN, sterile powder

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PROCAINE HYDROCHLORIDE

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PROGESTERONE

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PROGESTERONE

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PROMETHAZINE HYDROCHLORIDE

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PROPRANOLOL HYDROCHLORIDE

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PROPYLTHIOURACIL

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PYRANTEL PAMOATE

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PYRAZINAMIDE

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PYRIDOXINE HYDROCHLORIDE, powder

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PYRIMETHAMINE

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QUININE HYDROCHLORIDE

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RAMIPRIL

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RANITIDINE HYDROCHLORIDE

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RETINOL ACETATE

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15.9/kg 3-6mt prompt BP2008 India IP.13


RETINOL PALMITATE

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44.5/kg 3-6mt 2 weeks USP27 India IP.13

RIBOFLAVINE

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RIFAMPICIN

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40.8/kg 500kg prompt BP2008 B.D 0 .5 China IP.13

61.5/kg 1mt prompt BP2008 B.D 0.5 China IP.09

62.5/kg 1mt prompt BP2008 B.D 0.7 China IP.09

ROXITHROMYCIN

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SALBUTAMOL SULFATE

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SIMVASTATIN

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SODIUM CHLORIDE sterile

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SODIUM CROMOGLICATE

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SODIUM LACTATE

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SODIUM NITRITE

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SODIUM THIOSULFATE

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SODIUM THIOPENTAL

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SODIUM VALPROATE

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28/kg 500kg prompte BP2008 India IP.13



SPECTINOMYCIN

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270/bou 100bou prompt USP27 India IP.13

485/bou 100bou prompt USP28 China IP.01

SPIRAMYCIN

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SPIRONOLACTONE

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STREPTOMYCIN SULFATE, sterile powder

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21.2/kb 500kb prompt BP2008 India IP.13

SULFADIAZINE

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SULFADIMIDINE

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SULFADOXINE

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SULFAMETHOXAZOLE

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8.25//kg 500kg prompt USP27 India IP.05






SULFAMETHOXAZOLE

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TAMOXIFEN CITRATE

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TENOXICAM

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TETRACYCLINE HYDROCHLORIDE

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THEOPHYLLINE

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THIAMINE HYDROCHLORIDE

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THIAMPHENICOL BASE

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TIMOLOL MALEATE

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TINIDAZOLE

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TRIMETHOPRIM

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VALACICLOVIR

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VANCOMYCIN HYDROCHLORIDE

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VECURONIUM BROMIDE

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41/g 1kg prompt BP2008 China IP.13

VERAPAMIL

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VINBLASTINE SULFATE

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189/g 1kg prompt USP28 India IP.13

VINCRISTINE SULFATE

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118/g 100g prompt USP27 China IP.13

VINDESINE SULFATE

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682/gm 100gm prompt EP5 India IP.13

VINORELBINE TARTARATE

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250/g 100g prompt USP27 China IP.13



WARFARIN SODIUM

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ZALCITABINE

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ZIDOVUDINE

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ZIPRASIDONE

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Calendar of Events The following list of upcoming conferences and trade fairs are relevant to actors in various aspects of drug research and manufacturing for both brand and generic pharmaceuticals.

World Generic Medicines Congress Americas 2009

Date 17-20 November 2009 Location Washington, DC, USA Website www.terrapinn.com/2009/genericsusa

About the organiser An event organiser, Terrapin has over twenty years of bringing together, among others, leaders in the energy, technology, finance, transport and life science industries. A network of advisors, the Health Network focuses on the life sciences for a varied audience: industry, academia, and regulatory authorities.

Target audience/ Interest areas

Future Generic Growth, Authorised Generics, Regulatory Affairs, Patent Litigation, Outsourcing, Emerging Markets, Pharmacovigilance, Biosimilars, Patents, Hatch- Waxman Settlements, Intellectual Property

12th

APIC European Conference on Active Pharmaceutical Ingredients 2009

Date 18-20 November 2009 Location Venice, Italy Website www.api-conference.org

About the organiser The APIC is a sub-section of the European Chemical Industry Council. In cooperation with major organisations such as the WHO, the EC, US FDA, EMEA and others, its mission is to represent the interests of API and intermediate manufactures as well as chemical companies. It also assists these organisations in accessing relevant regulatory information.


Supply Chain Management, APIs, Pharmaceutical Surveillance, Inspections, Regulatory Affairs, Quality Agreements

International Contract Services Expo (ICSE)/ CPhI/ Pharmaceutical Equipment and Machinery Convention (P-MEC) India 2009

Date 1-3 December 2009

Location Mumbai, India

Website www.cphi-india.com/content/default.aspx

About the organiser United Business Media is a leading organiser of trade shows and professional conferences. UBM organises the CPhI (and concurrent) exhibitions held annually in Europe, China, India, South America and Japan. These are the largest exhibition in the world covering pharmaceutical ingredients and intermediate products


Analytical services, Chemical synthesis/analysis, Clinical research and trials, Consulting services, Contract manufacturing, Contract research, Data management, Data services, Drug discovery, Drug metabolism, E-Business, Formulation development, Logistics and distribution, Marketing services, Packaging, Pharmacodynamics, Pharmacoeconomics, Pharmacokinetics, Pharmacology, Pre clinical, Product characterization, Production equipment, Project management, Quality control, Regulatory affairs, Statistical analysis, Toxicology

http://www.terrapinn.com/2009/genericsusa

http://www.api-conference.org/

http://www.cphi-india.com/content/default.aspx



Generic Pharmaceutical Association (GPhA) Annual Meeting

Date 16-18 February 2010

Location Naples, FL, USA

Website www.gphaonline.org

About the organiser The Generic Pharmaceutical Association (GPhA) represents the manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry.


Generic drugs, Biosimilars, Intellectual Property, Regulatory Affairs

InformEx Pharma


Location San Francisco, CA, USA

Website www.informex.com/home

About the organiser United Business Media is a leading organiser of trade shows and professional conferences. UBM organises the CPhI (and concurrent) exhibitions held annually in Europe, China, India, South America and Japan. These are the largest exhibition in the world covering pharmaceutical ingredients and intermediate products.


Fine chemicals, Brand pharmaceuticals, Generic drugs, Biotechnology, Biopharmaceuticals, Adhesives, Resins

4th

Annual World Generic Medicines Congress Europe 2010


Location London, United Kingdom

Website www.healthnetworkcommunications.com/2010/genericsuk

About the organiser An event organiser, Terrapin has over twenty years of bringing together leaders in the energy, technology, finance, transport and life science industries, among others.


Quality of Medicines, Trends and Future Developments, Emerging Markets, Generic Industry, Hatch-Waxman Reforms, Pharmaceutical Sector Inquiry, Biosimilars, R&D, Drug Distribution, Intellectual Property

DIA’s 22nd Annual EuroMeeting

Date 10-12 March 2010

Location Monaco, Monte Carlo

Website www.diahome.org/DIAHOME/FlagshipMeetings/Home.aspx?meetingid=20292

About the organiser

The DIA is a professional association of approximately 18,000 members worldwide who are involved in the discovery, development, regulation, surveillance or marketing of pharmaceuticals or related products. Its mission is to disseminate information on the development of new medicines or generics and biosimilars, with continuously improved professional practice as the goal.


Clinical Research, Pharmacovigilance, Regulatory, Information Management, Generics



Appendices

Key definitions Brand pharmaceuticals: Medicinal products manufactured from basic chemical compounds,

validated through a series of trials and benefits from market exclusivity for the period under patent. Bioequivalence: Two products are considered bioequivalent if they are absorbed similarly

within the organism when given at the same dosage and under the same conditions. Biopharmaceuticals (or biotechnology drugs): Drugs produced from living organisms or

their derivatives through genetic engineering processes rather than chemical synthesis. Biosimilar: Also referred to as biogenerics or follow-on biologics, these drugs are the generic

versions of biopharmaceuticals. Due to patent restrictions, they are not manufactured using the exact process used to manufacture their brand equivalents. However, they are manufactured using similar methods, hence the name, and still assumed to have the required bioequivalency. Counterfeit drugs (official WHO definition): Counterfeit drugs are “deliberately and

fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging”. Compulsory licenses: A government waiver allowing developing countries with limited

manufacturing abilities, the manufacture, usage or import of generic versions of patented drugs for domestic use. Generic pharmaceuticals: Drugs that are produced and marketed under their chemical/non-

proprietary name after the originator (brand) drug loses its patent. Usually cheaper, generics undergo regulatory approval and must be bioequivalent to the originator drug. Link to WHO essential drugs site:

http://www.who.int/medicines/publications/essentialmedicines/en/ Voluntary licenses: Authorization given to generic manufacturers by brand pharmaceutical

companies to manufacture generic versions of some of its branded products.

Abbreviations API: Active Pharmaceutical Ingredients EC: European Commission EU: European Union EMEA: European Medicines Agency FDA: US Food and Drug Administration GMP: Good Manufacturing Practice GDP: Gross Domestic Product OECD: Organisation for Economic Cooperation and Development OTC: Over-the-counter R&D: Research and Development TB: Tuberculosis USD: United States Dollar WHO: World Health Organisation WTO: World Trade Organisation

Endnotes 1 Scrip Pharmaceutical News (www.scripnews.com/scripnews/home)

2 ICIS Chemical Business (www.icis.com)

3 Canada Newswire (www.newswire.ca/en)

*Industry and regional market analyses obtained from Economist Intelligence Unit

http://www.who.int/medicines/publications/essentialmedicines/en/

http://www.scripnews.com/scripnews/home

http://www.icis.com/

http://www.newswire.ca/en

HANDBOOKVer. 5.3

The International Trade Centre (ITC) is the joint agency of the World Trade Organization and the United Nations.

Street addressInternational Trade Centre54-56 Rue de Montbrillant1202 Geneva, Switzerland

P: +41 22 730 0111F: +41 22 733 4439E: [email protected]

Postal addressInternational Trade CentrePalais des Nations1211 Geneva 10, Switzerland

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