BULLETIN MNS October 2009

PHARMACEUTICAL STARTING

MATERIALS

MARKET NEWS SERVICE (MNS) BI -MONTHLY EDITION

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.

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1 Market News Service Pharmaceutical Starting Materials 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 1 available . 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. 2 Market News Service Pharmaceutical Starting Materials

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.

3 Market News Service Pharmaceutical Starting Materials

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

4 Market News Service Pharmaceutical Starting Materials Industry Trends

At the end of the third quarter of 2009, the being adopted is to intensify the marketing outlook on future growth for brand drugs of drugs which have gone off-patent while has improved compared to what was expanding into only selected segments of originally anticipated but will remain low, the generic industry.2 according to analyses by pharmaceutical consulting firm, IMS Health. Global Major pharmaceutical companies are also pharmaceutical sales for 2009 were set to venturing into the vaccine business, a field grow by 2.5-3.5% in April. Revised figures which is becoming increasingly attractive place growth rates at 5.5-6.5%.1 Based on in light of recent high demand for drug sales information in 220 countries, vaccines. US-based Abbott Laboratories this trend is attributed to healthy growth in concluded a USD 6.6 billion deal with generic drug sales, supported by an Belgian biotechnology company, Solvay, upcoming patent expiry, dry drug pipelines to acquire vaccines. Johnson & Johnson is and a tough global economic climate. also set to acquire an 18% stake in Dutch biotechnology firm in order to maximise its vaccine technology. Merck has also Expansion of pharmaceutical companies entered into partnership with Australia- into emerging markets, a move already based CSL for gain marketing rights for its evident at the beginning of the year is flu vaccine. confirming itself as pharmaceutical companies, generic and brand alike Favourable developments are boosting the establish themselves in these markets. recent growth and developments The countries concerned, referred to as observed. Vaccines against papilloma EM-7 or “pharmerging” markets, include virus and pneumococcal disease are being China, India, Russia, Brazil, South Korea, marketed for higher values than was Mexico and Turkey. The strategy adopted previously the case: around USD 100 by brand pharmaceutical companies is to rather than a few dollars. The sector is link up with generic manufacturers who also benefiting from increased investment are already quite established in these thus increasing access to the latest markets. technologies. In fact, emerging technologies promise to make Earlier in May, Pfizer concluded a deal biopharmaceutical development quicker with Aurobindo aimed at seven emerging and more efficient. While the potential for markets; a month later, GSK entered into expansion is there, several possible partnership with India‟s Dr. Reddy‟s challenges remain. Namely, the Laboratories. Companies are also building development of such biotechnology up local presence through the construction products is a long and costly process. of low-cost manufacturing sites and R&D Also, because vaccines are manufactured linkages with local companies and and not reusable, an overproduction of academic institutions. A common strategy vaccines can often symbolize wastage.

5 Market News Service Pharmaceutical Starting Materials Regional Focus North America United States of America

General Market Trends

The US pharmaceutical market is the importing FDA-approved drugs of foreign largest in the world, ahead of the other origin, a measure which would save an major markets: western European estimated USD 50 billion. Another factor countries and Japan. In September 2009, which will also slow growth in drug sales is the US pharmaceutical market was valued the economic slowdown which has at USD 229.7 billion, whereas the top 5 resulted in higher unemployment, stripping European markets valued at USD 105.5 many of their employer-provided health and Japan at USD 77.4 billion. The insurance. demand for pharmaceuticals is also high within the US especially where The US pharmaceutical companies are consumption per person is the third largest key players on the global pharmaceutical in the world after France and Spain. markets as well as domestically. The top four domestic suppliers consist of the The continued research and development following companies—in decreasing order of drugs and the ageing population are of dominance in the domestic market: projected to drive the growth of the local Pfizer, Johnson & Johnson, Abbott pharmaceutical market. Adults aged 65 Laboratories and Merck & Co. These and over are major consumers of drugs companies are also ranked among the top and are living longer as a result of access ten global pharmaceutical companies. to medicines. However, elevated drug Leading pharmaceutical, Pfizer, is prices and consumer cost-consciousness benefiting from the success of its are likely to slow the future growth in cholesterol-lowering drug, Lipitor. This is demand. Unlike in other developed indicative of the therapeutic areas in which countries, the government is legally not pharmaceutical companies are venturing allowed to negotiate better prices with in, namely chronic illnesses for which drug suppliers. Hence, drug prices in the medicines are especially profitable. US are 30% above the average of other Increasingly, the industry is also shifting countries within the OECD. In fact, this towards the R&D of more specialised has led to greater demand for Canadian treatments rather than relying on creating drugs which are considerably cheaper. In a highly profitable drug for a larger addition, President Obama is in support of audience.

Generic drugs

Generic drugs are occupying an measure, this will likely boost the demand increasingly greater share of the US and sales of biosimilars in the future. pharmaceutical market. According to industry research firm, RNCOS, the share As with their brand counterparts, the major of generic prescriptions from the total generic manufacturers which dominate the pharmaceutical prescriptions rose US pharmaceutical market are also key dramatically from 19% in 1984 to 70% in global players. These include Mylan, 2008. Growth in sales is set to be boosted Alpharma and Watson. However, Israel- by the expiry of patents on highly based Teva Pharmaceuticals remains the profitable brand drugs as well as the top generic manufacturer and a leader in promotion of generic drug use by the the US pharmaceutical market. Hence, administration as a cost-saving initiative. there is intense generic competition which US president Obama is highly supportive is placing a dent in brand pharmaceutical of the legislation to facilitate the revenue and likely to be a downward force development and marketing of biosimilars. on prices overall. Also seen as a healthcare cost-cutting

6 Market News Service Pharmaceutical Starting Materials Regulation

The US pharmaceutical industry is also The US FDA has taken measures to attempting to rebuild its credibility following tighten regulatory approval and has also a series of events which has decreased established offices in key producing consumer confidence. Some countries, such as India and China. This antidepressants have been said to initiative was taken to further safeguard increase to incidence of suicide among consumers given the increasingly large teenagers. Vioxx, Merck‟s highly profitable share of pharmaceuticals and products pain relief drug was withdrawn from the imported from foreign sources. market in 2004 after allegations that it Additionally, the government increased the risk of heart attacks and administration has increased the FDA‟s strokes. In 2008, adverse reactions budget for the next fiscal year, a move observed to the anticoagulant, heparin, which should allow the regulatory body to imported from China raised safety carry out its operations more effectively. concerns and further damaged the credibility of the industry and the US FDA‟s.

Canada

General Market Trends

In 2008, the domestic pharmaceutical 73% was exported to the United States market was valued at USD 30.3 billion, alone. There is a high demand for cheaper based on prescription and OTC drug drugs on behalf of US citizens seeking sales, making Canada the seventh-largest alternatives to relatively highly priced pharmaceutical market in the world. In medicines available on the US market. September 2009, the Canadian The largest suppliers on the local market pharmaceutical market was valued at USD are Pfizer, with 13.4% of the market share, 15.79 billion, a 6% increase from figures followed by AstraZeneca and then available a year ago. Demand for Johnson and Johnson. The domestic pharmaceuticals remains high as drug Canadian pharmaceutical industry is expenditure is the second largest category relatively small but Biovail is a major in total healthcare expenditure. However, player on the local market. The in light of the fact that the healthcare biotechnology industry, on the other hand, system is largely publicly funded, the is growing and benefiting from a government bears the majority of the government push towards a “high costs, followed by private insurance technology, innovative, R&D-based companies thus dampening the effect of industry”. However, the industry is in need the global economic downturn on drug of greater investment and funds as many consumption. Only 15% of the drug biotech companies are unable to carry out expenditure is covered by out-of-pocket their drug development all the way through payments. clinical trials.

Canadian drug exports totalled a value of USD 6.5 billion in 2008 of which about

Generic industry

Generic drugs constitute a major part of In 2008, the generic market was valued at the local pharmaceutical market. One half USD 4.7 billion, already demonstrating a of the prescriptions are filled by generic 20% increase on the previous year. drugs. Hence, demand for generics is currently high and showing more growth The prices of Canadian generic drugs are potential in light of the upcoming patent beginning to come under attack by expiry for several highly profitable drugs. government and the Competition Bureau.

7 Market News Service Pharmaceutical Starting Materials Generic drug prices are still relatively high and a reduction in prices estimated to Fifteen suppliers constitute the domestic result in major savings. generic drug sector, of which the largest is Apotex. Leading manufacturer, Mylan Like the United States, Canada has Pharmaceuticals has also entered the ventured into biosimilars; it has created Canadian market through its acquisition of legislation to monitor the research, leading domestic manufacturer and Merck development and marketing of these KGaA subsidiary, Genpharm.3 Apotex has drugs, seen as a potential cost-saving also entered into a partnership with India‟s initiative in the future of the Biopharmaceuticals Limited to pharmaceutical industry. 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

8 Market News Service Pharmaceutical Starting Materials Selected Industry News

AIDS vaccine: are we there yet?

On September 24th 2009, the Thai Minister founded particularly in light of recent news: of Health announced positive but additional analyses carried out on RV 144 preliminary results of an anti-HIV vaccine data and published in the New England trial (known as RV 144) carried out in Journal of Medicine revealed that the Thailand. The vaccine, he stated, reduced protection observed may not be the rate of HIV infection by 31% percent, statistically significant. Hence, the vaccine compared to a placebo. Although offering cannot yet be fully relied upon to curb HIV modest protection, the news was received infection rates. with much optimism and enthusiasm. Yet, regardless of the current stumbling The results were obtained from a US blocks, researchers and public health Army-sponsored Phase III trial of a large agencies see in RV 144 the confirmation HIV/AIDS vaccine carried out in Thailand that an effective HIV vaccine could, by the Ministry of Public Health, with just eventually, become a reality. It opens up a over 16,000 HIV-negative volunteers. The variety of avenues which can be volunteers came from the general investigated based upon the results of the population and not from particularly high- study, such as different vaccines and risk populations. The trial began in 2006 different immune responses. In the words with a vaccine and participants received of Alan Bernstein, executive director of the an HIV-test every six months for the next Global HIV Vaccine Enterprise, an alliance three years. The „prime-boost‟ approach of governments, AIDS scientists, the was used in the trial, where two different World Health Organization and funders vaccines (produced by Sanofi-Pasteur and such as the Bill and Melinda Gates Vaxgen) were combined to form one HIV Foundation: “The bottom line is that those vaccine. The role of one vaccine was to results are real…We for the first time, stimulate (prime) an immune response have evidence of protection, and the nitty while the other was to boost the immune gritty (arguments) to me don‟t matter…” response, hence its name. He is not alone, many more agree that while we may not have an effective Despite its success, sceptics raised vaccine yet, we have definitely taken a questions about its efficacy on a wider major step towards that goal. scale, its efficacy in high-risk groups as well as the duration of the protection Source: Scrip Pharmaceutical News, observed. Some of this scepticism was Dialog NewsEdge (EIU); 20 October 2009

Ecuador to bypass patents for increased drug access

Ecuador will soon be following in the paths active ingredients will be imported to of Thailand and Brazil, two countries who support the manufacture of complex broke patents to either manufacture or drugs. The government issued compulsory import generic versions to address critical licenses for over 2000 patents to local local health situations. Back in 2007, Brazil pharmaceutical companies and agreed to and India broke patents to allow for pay a foreign multinationals a royalty fee. domestic production of AIDS drugs. The decision relies on allowances in the TRIPS agreement, WTO‟s 1995 Ecuador‟s President, Rafael Correa, agreement on intellectual property, which recently announced a government permits governments to break patents to decision to permit local drug makers to address urgent public health concerns. make generic copies of Western drugs in order to increase the access of local Figures from the research firm, population to much needed drugs. Locally Intercontinental Marketing Services (IMS), manufactured drugs will have priority but show that the local pharmaceutical market

9 Market News Service Pharmaceutical Starting Materials is dominated by foreign multinational measure…No legal right is superior to the pharmaceutical companies, controlling requirements of public health, especially in about 82% of the market. As a result, for such serious circumstances…” the 70% of the local population living in poverty, the prices of the drugs available This government measure should bring are unaffordable. drug prices down significantly through competition and also strengthen local The response on behalf of foreign production capabilities. The challenge multinationals has been one of ahead now for local drug companies is to understanding. A local industry meet the now increased demand and association, which includes major maintain a high level of quality for drugs multinationals such as GlaxoSmithKline produced. and Bayer issued a statement in which they expressed the following: "We accept Source: World Markets Research Ltd, the democratic decision...to legally Agence France Presse, Business Monitor implement this extraordinary International; 27 October 2009

New initiatives boost the fight against fake drugs

The European Federation of fight against counterfeits, particularly in Pharmaceutical Industries and poorer countries. Counterfeit drugs can Associations (EFPIA) is exploring a new have some major health consequences in scheme to reduce the threat of counterfeit developing countries, where regulatory, drugs to European patients. The project is quality and safety enforcement systems a direct response to an EC proposal to are currently weak. In Africa, for example, create a system to code pharmaceutical where about 80% of the drugs are products throughout the EU region. The imported, the need for cheap and effective EFPIA pilot will involve 25 retail quality control mechanisms is important. pharmacies in the Stockholm area and WHO estimates that at least 200,000 lives consists of putting a specialized “matrix” are lost to counterfeit drug use every year. on each product to facilitate instant verification. This data matrix is set to The joint team made up of pharmacists provide information such as product code, and engineers have constructed a cheap batch number, expiry data and a unique machine which will allow poorer countries serial number for each product. If to detect fake medicines. The tool will be successful, the project could be expanded simple to use and able to stand extreme to the whole Europe region. The industry weather conditions. It rests on the capillary would welcome such an initiative which electrophoresis method which separates would put an end to the loss of revenue electrons by size and electric charge. This brought by fake drugs as well as diminish machine will require only small amounts of the risk to patients. The only challenge organic solvent, used in the process, and remains for generic drug makers and small also small amounts of water. This should pharmaceutical companies who fear the make it easy to operate and, hopefully, cost implications for them to implement materialize into a sustainable option for this initiative. quality control organisms in developing countries. A similar project involving Switzerland‟s Geneva-Lausanne School of Pharmacy Source: World Markets Research Ltd, and the Fribourg College of Engineering Economist Intelligence Unit; 15 October and Architecture is promising for the global 2009

Developing countries step up local generic oseltamivir production

Several pharmaceutical companies in the antiviral drug marketed as Roche‟s developing countries have taken Tamiflu against Influenza A H1N1. The measures to increase the production and imminent threat of the Influenza A H1N1 availability of generic copies of oseltamivir, and the widespread prevalence of flu

10 Market News Service Pharmaceutical Starting Materials outbreaks globally have motivated local pharmaceutical companies have governments to take preventive measures. received approval from the country‟s drug Leading the pack, are Indian companies safety agency to conduct clinical trials to who are taking advantage of a government test the bioequivalency of their generic decree permitting the „restricted‟ sales of copies to the original Tamiflu. Sales of generic copies of oseltamivir. Companies these copies will only be available for sale are permitted to stock up retail pharmacies in 2016, once Roche‟s patent in the that possess a license under “schedule X country expires. However, government of the Drugs and Cosmetics Rules for officials would like to maintain a stock of medical prescriptions”. antivirals in the event of a pandemic or drug shortage. Cipla‟s WHO-approved product, marketed as Antiflu will be available at Rs 475 for 10 Elsewhere, UAE‟s health ministry has capsules. Other Indian companies will also authorized local company, Neopharma, to be marketing their products: Natco produce generic copies of oseltamivir. (It is Pharma‟s product as Natflu, Strides within a joint alliance with Hetero Drugs Arcolab‟s product as Starflu and Hetero and a part of the company‟s product Drugs‟s product as Fluvir. portfolio over the next few years.)

In light of the rapid spread of the Influenza Source: Scrip Pharmaceutical News, A H1N1 in Asia, South Korea is pushing Economist Intelligence Unit; 2 October ahead with its testing and eventual 2009 manufacture of generic oseltamivir. Two

Increased funding for FDA drug centre and office of generic drugs

In the new fiscal year starting October 1st The drug centre and related field activities 2009, the US government has approved will increase by 13%, amounting to USD legislation which should increase the 880 million, of which the budget for budget available to the US FDA. This generic drug programme is set to increase budget increase will be a major boost to by 25%, and set to top USD 51.5 million. the agency and allow it to carry out its The biologics centre and related field operations more effectively. The bill is set activities is also set to benefit, with a 12% to increase direct funding for the FDA by budget increase to reach a total of USD 15%, in addition to its revenue from user 305 million. fees. This pushes the total agency budget for 2010 fiscal year to USD 3.25 billion. Source: Scrip Pharmaceutical News; 30 October 2009

Unclear future for Canada’s Access to Medicines Regime

Two bills are currently before the The current procedure requires interested Canadian Parliament to revamp Canada‟s generic companies, for each drug order Access to Medicines Regime—with the from a country, to negotiate licenses hopes of making it more effective and directly with the patent-holding companies. more usable. The legislation, brought In addition, these licenses are only for about in 2004, would allow Canadian drug limited time periods and need to be makers to ship cheap generic drugs to renewed. This difficult process explains to needy countries afflicted by the world‟s some extent why several companies have major killers—HIV, tuberculosis and not participated to date. malaria. Only Canadian generic company, Apotex However, this legislation has not brought Inc., has shipped triple-combination AIDS about the expected results due the drugs to Rwanda under this scheme. complexity of the procedures required. GlaxoSmithKline and Canadian branches

11 Market News Service Pharmaceutical Starting Materials of Shire and Boehringer Ingelheim have infected people. However, Apotex Inc. granted permission for the manufacture of requested a simplification of the current these AIDS drugs, for which they all have procedure, deemed too costly and patents. Furthermore, Rwanda is also the complicated, in order to participate again. only country which has benefited under this scheme, receiving drug shipments Source: Dialog NewsEdge, The Toronto over the past year to treat 21,000 HIV- Star; 20 October 2009

Jordan’s Hikma Pharma emerges despite recession

While the global economic downturn and amounting to USD 321.5 million. Its model the approaching patent cliff is painting a of operation is the manufacture and sale of grim picture for major pharmaceutical patented and off-patent drugs throughout companies, particularly those based in the Middle East and North African region developed markets, these grim conditions (MENA), while promoting its generic drugs are favoring the growth of companies in in more developed markets where other regions. Jordan-based Hikma generics are more in demand in this Pharmacauticals is demonstrating steady difficult economic climate. growth and is rapidly emerging to become one of the key players in the Middle East. Hikma faced some challenges in trying to crack the highly competitive US, and in Created in 1978, the company grew to response has decided to focus on “high- produce patented and off-patented drugs margin, niche product opportunities” for throughout the Middle East two years future growth. However, Hikma remains a later. Hikma later expanded into the US dominant pharmaceutical company in the market when it bought US generic drug MENA region and is quickly emerging as maker, Westward and also started the an attractive partner for major production of injectable medicines in pharmaceutical companies looking to Portugal. The company also gained expand into the Middle East region. greater prominence ever since its listing in the London Stock Exchange in 2005 and Source: Economist Intelligence Unit; 12 has continued to grow ever since. October 2009

Figures for the first six months of the year reveal that revenue surged by over 7%,

Increased attendance confirm CPhI 2009 a major event

Attendance statistics at this year‟s CPhI Emerging markets had a visible presence demonstrate that it remains a major with sizable pavilions for India and China. industry event and an invaluable Others, such as South Korea, Brazil, opportunity for business, networking and Argentina or Iran also had a decent keeping up with industry developments. representation. Held in Madrid, Spain, CPhI 2009 drew an estimated 25 450 visitors, a 5% increase The next CPhI event is set for 5-7 October on last year‟s event. Exhibitor numbers 2010, in Paris, France. The set up will be were also on the rise, pooling together different and exhibitors will be arranged about 1808 companies and organizations. according to six main areas: APIs, This year was also the first year that the Custom Manufacturing, Intermediates, Bio-Ph event, exhibition of biotechnology Fine Chemicals, Excipients and General. companies, was joined along with CPhI and its parallel exhibitions (ISCE- for More information available at: contract manufacturing and outsourcing http://www.cphi.com services and P-MEC- for manufacturing equipment).

12 Market News Service Pharmaceutical Starting Materials 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 Active Ingredients Company Approval Date Number) Norethindrone Acetate And Ethinyl Ethinyl Estradiol; Watson Labs 01/09/2009 Estradiol And Ferrous Fumarate Norethindrone Acetate (ANDA # 078267) Risperidone Risperidone Aurobindo Pharma 04/09/2009 (ANDA # 078452) Temazepam Temazepam Mutual Pharm 08/09/2009 (ANDA # 078581) Nateglinide Nateglinide Dr Reddys Labs Ltd 09/09/2009 (ANDA # 077461) Nateglinide Nateglinide Par Pharm 09/09/2009 (ANDA # 077463) Nateglinide Nateglinide Teva Pharms 09/09/2009 (ANDA # 077467)

13 Market News Service Pharmaceutical Starting Materials Drug Name (FDA Application Active Ingredients Company Approval Date Number) Granisetron Hydrochloride Granisetron Hydrochloride Akorn Inc 10/09/2009 (ANDA # 079119) Haloperidol Haloperidol Lactate Akorn Strides 14/09/2009 (ANDA # 078347) Granisetron Hydrochloride Granisetron Hydrochloride Akorn Inc 14/09/2009 (ANDA # 079078) Piperacillin And Tazobactam Piperacillin Sodium; Orchid Hlthcare 15/09/2009 (ANDA # 065386) Tazobactam Sodium Piperacillin And Tazobactam Piperacillin Sodium; Orchid Hlthcare 15/09/2009 (ANDA # 065446) Tazobactam Sodium Galantamine Hydrobromide Galantamine Actavis Elizabeth 15/09/2009 (ANDA # 077585) Hydrobromide Deferoxamine Mesylate Deferoxamine Mesylate App Pharms 15/09/2009 (ANDA # 078718) Irinotecan Hydrochloride Irinotecan Hydrochloride Akorn 16/09/2009 (ANDA # 090726) Verapamil Hydrochloride Verapamil Hydrochloride Glenmark Generics 17/09/2009 (ANDA # 078906) Ribavarin Ribavirin Aurobindo Pharma 17/09/2009 (ANDA # 079117) Zaleplon Zaleplon Orchid Hlthcare 17/09/2009 (ANDA # 090374) Baclofen Baclofen Northstar Hlthcare 18/09/2009 (ANDA # 078401) Fluconazole Fluconazole Aurobindo Pharm 18/09/2009 (ANDA # 079150) Sumatriptan Succinate Sumatriptan Succinate App Pharms 18/09/2009 (ANDA # 079240) Glimepiride Glimepiride Carlsbad 22/09/2009 (ANDA # 077911) Ifosfamide Ifosfamide App Pharms 22/09/2009 (ANDA # 090181) Alendronate Sodium Alendronate Sodium Austarpharma Llc 24/09/2009 (ANDA # 090258) Ramipril Ramipril Zydus Pharms USA Inc 24/09/2009 (ANDA # 090697) Atenolol Atenolol Northstar Hlthcare 25/09/2009 (ANDA # 078254) Cetirizine Hydrochloride Cetirizine Hydrochloride Vintage 25/09/2009 (ANDA # 078496) Ondansetron Hydrochloride Ondansetron Gland Pharma Ltd 25/09/2009 (ANDA # 079224) Hydrochloride Lithium Carbonate Lithium Carbonate Hetero Drugs Ltd 25/09/2009 (ANDA # 090702) Cilostazol Cilostazol Breckenridge Pharm 28/09/2009 (ANDA # 077708) Dorzolamide Hydrocloride And Dorzolamide Teva Parntl 28/09/2009 Timolol Maleate Hydrochloride; Timolol (ANDA # 078704) Maleate Timolol Maleate Timolol Maleate Wockhardt 28/09/2009 (ANDA # 078771) Carbidopa And Levodopa Carbidopa; Levodopa Mylan 28/09/2009 (ANDA # 090324) Oxaliplatin Oxaliplatin Hospira Inc 30/09/2009 (ANDA # 078815) Caffeine Citrate Caffeine Citrate Sun Pharm Inds Ltd 30/09/2009 (ANDA # 090077) Caffeine Citrate Caffeine Citrate Sun Pharm Inds Ltd 30/09/2009 (ANDA # 090357) Metoprolol Tartrate Metoprolol Tartrate Luitpold 30/09/2009 (ANDA # 090386) Source: Center for Drug Evaluation and Research (FDA)

14 Market News Service Pharmaceutical Starting Materials

Table 4. Newly approved generic drugs, October 2009 Drug name Active ingredients Company Approval date (FDA application number) Testosterone Enanthate Testosterone Enanthate Synerx Pharma 05/10/2009 (ANDA # 040647) Cetirizine Hydrochloride Cetirizine Hydrochloride Amneal Pharms 07/10/2009 (ANDA # 090766) Buprenorphine Hydrochloride Buprenorphine Roxane 08/10/2009 (ANDA # 078633) Hydrochloride Risperidone Risperidone Wockhardt 08/10/2009 (ANDA # 078744) Sumatriptan Succinate Sumatriptan Succinate Par Pharm 09/10/2009 (ANDA # 077332) Topiramate Topiramate Mylan 14/10/2009 (ANDA # 078418) Topiramate Topiramate Zydus Pharms USA 14/10/2009 (ANDA # 078877) Inc Topiramate Topiramate Sandoz 14/10/2009 (ANDA # 079206) Fentanyl Transdermal System Fentanyl Hisamitsu 16/10/2009 (ANDA # 077775) Risperidone Risperidone Sandoz 16/10/2009 (ANDA # 078528) Chlorothiazide Sodium Chlorothiazide Sodium App Pharms 16/10/2009 (ANDA # 090896) Risperidone Risperidone Synthon Pharms 22/10/2009 (ANDA # 078187) Melphalan Hydrochloride Melphalan Hydrochloride Generamedix 27/10/2009 (ANDA # 090299) Levetiracetam Levetiracetam Amneal Pharms 27/10/2009 (ANDA # 090992) Source: Center for Drug Evaluation and Research (FDA)

15 Market News Service Pharmaceutical Starting Materials Price information

ACECLOFENAC Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

45/kg 25kg prompt EP5 China IP.13 45/kg 500kg prompt USP27 China IP.09

ACETAZOLAMIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

14.9/kg 500kg prompt BP2008 India IP.13

ACETYLSALICYLIC ACID, 100% granular Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1.6/kg 1mt prompt BP2008 India IP.13

ACETYLSALICYLIC ACID, crystalline Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

3/kg 500kg prompt BP2008 India IP.13 2.85/kg 1mt prompt BP2008 China IP.01

ACTIVATED CARBON Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

750/mt 10mt prompt BP2008 India IP.13

ACYCLOVIR Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

48/kg 100kg prompt USP29 China IP.01

ALBENDAZOLE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

12.7/kg 100kg prompt USP29 China IP.01

ALLOPURINOL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

18.75/kg 5 mt prompt USP27 China IP.13

16 Market News Service Pharmaceutical Starting Materials ALUMINIUM HYDROXIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

130/mt 10mt prompt USP29 China IP.01

AMIKACIN SULFATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

93/kb 500kb prompt USP27 China IP.01

AMINOPHYLLINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

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

AMODIAQUINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin 37.5/kg 50kg prompt BP2008 China IP.01

AMOXICILLIN TRIHYDRATE, non-sterile powder, compact Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

38.5/kg 100kg prompt BP2008 China IP.01

AMPICILLIN SODIUM, sterile crystalline Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

61/kg 500kg prompt BP2008 China IP.09 46.65/kg 100kg prompt BP2008 China IP.01

AMPICILLIN TRIHYDRATE, non-sterile powder Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

30.5/kg 1mt prompt BP2008 China IP.09 37.50/kg 500kg prompt BP2008 China IP.01

AMPICILLIN TRIHYDRATE, compact powder Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

30.5/kg 1mt prompt BP2008 China IP.09 37.7/kg 1mt prompt BP2008 China IP.01

17 Market News Service Pharmaceutical Starting Materials

ASCORBIC ACID Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

9.5/kg 100kg prompt BP2008 China IP.01

ATROPINE SULFATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

150/kg 100kg prompt BP2008 China IP.01

BENZANTHINE BENZYLPENICILLIN, sterile powder Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

42.7/bou 500bou prompt BP2008 China IP.01

BENZYLPENICILLIN POTASSIUM, sterile powder Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

10/bou 1000bou prompt BP2008 India IP.13 14.90/bou 500bou prompt BP2008 China IP.01

BENZYLPENICILLIN SODIUM, sterile powder Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

11/bou 1000bou prompt BP2008 India IP.13 14.75/bou 500bou prompt BP2008 China IP.01

BETAMETHASONE SODIUM PHOSPHATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

3.9/g 10kg prompt BP2008 China IP.01

CAFFEINE ANHYDROUS Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

5.05/kg 1mt prompt BP2008 India IP.13

CALAMINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin 2.4/kg 500kg prompt BP2008 India IP.13

CANDESARTAN CILEXETIL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin 1550/kg 100kg prompt MS China IP.09

18 Market News Service Pharmaceutical Starting Materials CAPTOPRIL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

68.8/kg 100kg prompt BP2008 China IP.13 71.25/kg 1mt prompt BP2008 China IP.01

CARBAMAZEPINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

25/kg 500kg prompt BP2008 China IP.13 22.8/kg 1mt prompt BP2008 China IP.01

CARBOPLATIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1.9/g 2kg prompt BP2008 China IP.01

CEFRADINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

120/kg 50kg prompt BP2008 China IP.01

CEFOPERAZONE SODIUM Price / Unit Minimum Delivery Quality Coun try of IPS US$ Quantity Time standard origin

145/kg 100kg prompt USP28 Inida IP.13

CEFOTAXIME SODIUM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

130.8/kg 100kg prompt BP2008 India IP.13

CEFTRIAXONE SODIUM sterile Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

134.5/kg 500kg prompt BP2008 India IP.13

CEFUROXIME SODIUM sterile Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

132/kg 50kg prompt BP2008 China IP.13

CELLULOSE, HYDROXY PROPYL METHYL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

6.15/kg 3mt prompt USP27 India IP.13

19 Market News Service Pharmaceutical Starting Materials

CHLORAMPHENICOL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

31.5/kg 2mt prompt BP2008 China IP.09 22.55/kg 1mt prompt BP2008 China IP.01 25/kg 10mt prompt BP2008 India IP.13

CHLORAMPHENICOL PALMITATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

34.5/kg 2mt prompt BP2008 India IP.13 31/kg 1mt prompt BP2008 China IP.01

CHLORHEXIDINE GLUCONATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

3.85/kg 1mt prompt BP2008 India IP.05 4/kg 500kg prompt BP2008 India IP.05 4.5/kg 250kg prompt BP2008 India IP.05 7/kg 100kg prompt BP2008 India IP.05

CHLOROQUINE PHOSPHATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

22.8/kg 1mt prompt BP2008 China IP.01

CHLOROQUINE SULFATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

51/kg 1mt prompt BP2008 China IP.01

CHLORPHENIRAMINE HYDROGEN MALEATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

14.75/kg 1mt prompt BP2008 China IP.01

CHLORPROMAZINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

31.5/kg 100kg prompt BP2008 China IP.01

CHLORTERACYCLINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

17.5/kg 12mt prompt BP2008 India IP.13

20 Market News Service Pharmaceutical Starting Materials CHLORTERACYCLINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

27.55/kg 1mt prompt BP2008 China IP.01

CIMETIDINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

8.6/kg 1mt prompt USP27 India IP.13

CINCHOCAINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

281.6/kg 50kg prompt USP27 China IP.13

CINNARIZINE Price / Unit M inimum Delivery Quality Country of IPS US$ Quantity Time standard origin

55.5/kg 500kg prompt BP2008 China IP.01

CIPROFLOXACIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

22.5/kg 300kg prompt USP27 India IP.13 25.85/kg 100kg prompt USP29 China IP.01

CISPLATIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

21/g 500g prompt USP27 India IP.13

CLARITHROMYCIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

202/kg 25kg prompt USP27 India IP.13

CLINDAMYCIN HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

71.6/kg 500kg prompt USP27 India IP.13 86.6/kg 500kg prompt USP27 China IP.01

CLINDAMYCIN PHOSPHATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

132/kg 100kg prompt USP27 China IP.13

21 Market News Service Pharmaceutical Starting Materials CLINDAMYCIN PHOSPHATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

192.3/kg 100kg prompt USP29 China IP.01

CLOMIFENE CITRATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1687/kg 1kg prompt BP2008 India IP.13

CLONAZEPAM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1800/kg 1kg prompt USP28 China IP.13

CLOTRIMAZOLE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

12.5/kg 25kg prompt USP27 India IP.13 9.6/kg 100kg prompt USP29 China IP.01

CLOXACILLIN SODIUM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

95.3/kg 100kg prompt USP29 China IP.01 25/kg 2mt prompt USP29 India IP.13

CLOZAPINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin 45/kg 100kg prompt BP2008 India IP.13 62.7/kg 100kg prompt BP2008 China IP.01

CODEINE PHOSPHATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1000/kg 50kg prompt BP2008 India IP.13 1098/kg 100kg prompt BP2008 China IP.01

COLCHICINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

10.66/g 1kg prompt USP27 India IP.13

22 Market News Service Pharmaceutical Starting Materials

CYANOCOBALAMIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

3660/kg 10kg prompt USP27 India IP.13 2250/kg 10kg prompt USP27 China IP.09

CYCLOPHOSPHAMIDE, sterile powder Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

120/kg 25kg prompt USP27 India IP.13 108/kg 5kg prompt USP29 China IP.01

CYCLOSPORINE A Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

2800/kg 100kg prompt USP27 India IP.13

CYPROHEPTADINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

145/kg 30kg prompt BP2008 India IP.13

CYTARABINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

962/kg 50kg prompt BP2008 India IP.13

DAPSONE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

11/kg 50kg prompt BP2008 China IP.13

DAUNORUBICIN HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

145/g 10gm prompt USP27 China IP.13

DEXAMETHASONE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1530/kg 50kg prompt BP2008 India IP.13 1050/kg 20kg prompt BP2008 China IP.09 1880/kg 10kg prompt BP2008 China IP.01

23 Market News Service Pharmaceutical Starting Materials DEXAMETHASONE ACETATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1050/kg 20kg prompt BP2008 China IP.09

DEXAMETHASONE SODIUM PHOSPHATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1080/kg 8kg prompt USP27 India IP.13 1050/kg 20kg prompt BP2008 China IP.09

DEXTROMETHORPHAN HYDROBROMIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

125/kg 300kg prompt BP2008 China IP.13 270/kg 100kg prompt BP2008 China IP.01

DEXTROSE ANHYDROUS Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

0.44/kg 15mt prompt USP27 India IP.13 0.80/kg 500kg prompt BP2008 China IP.01

DIAZEPAM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

35/kg 100kg prompt BP2008 China IP.13

DICLOFENAC POTASIUM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin 7.85/kg 1mt prompt BP2008 China IP.13 12.8/kg 50kg prompt BP2009 China IP.01

DICLOFENAC SODIUM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

6.15/kg 500kg prompt BP2008 India IP.13 6/kg 10mt prompt BP2008 China IP.09 7.9/kg 1mt prompt BP2008 China IP.01

DIFLOXACIN HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

55/kg 100kg prompt MS India IP.13 79.9/kg 100kg prompt MS China IP.01

24 Market News Service Pharmaceutical Starting Materials

DIHYDROARTEMISININ Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

660/kg 5mt prompt MS China IP.13

DIHYDOSTREPTOMYCIN SULFATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

29.35/kb 50kb prompt USP27 India IP.13 48.5/kg 100kb prompt USP29 China IP.01

DL -METHIONINE Price / Unit Min imum Delivery Quality Country of IPS US$ Quantity Time standard origin

4.5/kg 500kg prompt BP2005 India IP.13

DILOXANIDE FUROATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

12.65/kg 2mt prompt BP2008 India IP.13

DIPHENHYDRAMINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

8.5/kg 5mt prompt BP2008 India IP.13

DOXAZOSIN MESYLATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

430/kg 100kg prompt USP28 India IP.13

DOXORUBICIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

36/gm 10kg prompt USP28 India IP.13

DOXYCYCLINE HYCLATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

46.5/kg 100kg prompt BP2008 India IP.13 47/kg 100kg prompt BP2008 China IP.01

DOXYCYCLINE MONOHYDRATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

50.9/kg 100kg prompt USP28 China IP.01

25 Market News Service Pharmaceutical Starting Materials

ECONAZOLE NITRATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

28/kg 50kg prompt USP27 China IP.13 48.8/kg 500kg prompt USP27 China IP.01

EFAVIRENZ Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1190/kg 25kg prompt MS China IP.13

EFLORINTHINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

2300/kg 1kg prompt MS China IP.13

ENALAPRIL MALEATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

72.9/kg 25kg prompt USP28 India IP.13

ENROFLOXACIN HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

28/kg 500kg prompt MS India IP.13

EPINEPHRINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

2421/kg 1kg prompt BP2008 India IP.13

EPIRUBICIN HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

380/gm 5gm prompt USP28 India IP13

ERGOCALCIFEROL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1960/kg 1kg prompt USP27 India IP.13

ERYTHROMYCIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

50/kg 500kg prompt BP2008 India IP.13

26 Market News Service Pharmaceutical Starting Materials ERYTHROMYCIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

65.3/kg 100kg prompt BP2008 China IP.01

ERYTHROMYCIN ESTOLATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

34.25/kg 500kg prompt BP2008 India IP.13

ERYTHROMYCIN ETHYLSUCCINATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

65.6/kg 500kg prompt BP2008 India IP.13

ERYTHROMYCIN STEARATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

30/kg 500kg prompt BP2008 India IP.13

ETHAMBUTOL HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

38/kg 5mt prompt USP27 India IP.13

ETHINYLESTRADIOL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

2316/kg 1kg prompt EP5 India IP.13

ETHIONAMIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

111/kg 25kg prompt BP20008 India IP.13

ETOPOSIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

3479/kg 5kg prompt USP27 china IP.13 5176/kg 1kg prompt USP2008 china IP.01

FAMCICLOVIR Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

710/kg 50kg prompt MS India IP.13

27 Market News Service Pharmaceutical Starting Materials FAMOTIDINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

47/kg 2mt prompt USP27 India IP.13 75.5/kg 500kg prompt USP27 China IP.01

FELODIPINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

4900/kg 10kg prompt USP28 China IP.13

FERROUS FUMARATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

2.7/kg 1mt prompt USP29 China IP.01

FERROUS GLUCONATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

2.3/kg 1mt prompt BP2008 India IP.13

FLUCONAZOLE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

85/kg 500kg prompt BP2008 India IP.13

FLUOROURACIL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

72/kg 50kg prompt USP27 India IP.13

FLUTAMIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

65/kg 50kg prompt USP27 India IP.13

FOLIC ACID Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

21.6//kg 300kg prompt USP27 India IP.13 35.45/kg 1mt prompt BP2008 China IP.01

FUROSEMIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

24/kg 1mt prompt BP2008 India IP.13

28 Market News Service Pharmaceutical Starting Materials

GABAPENTIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

120/kg 500kg prompt USP29 China IP.09

GANCICLOVIR Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin 445.87/kg 10kg prompt USP28 China IP.13

GEMCITABINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

65/gm 1kg prompt USP28 India IP13

GEMFIBROZIL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

32/kg 1mt prompt USP28 China IP.13

GENTAMICIN SULFATE, sterile powder Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

85/kb 200kb prompt USP28 China IP.13 95.55/kb 500kb prompt BP2008 China IP.01

GLIBENCLAMIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

165.5/kg 1mt prompt BP2008 China IP.01 37/kg 500kg prompt BP2008 India IP13

GLICLAZIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

72.5/kg 350kg prompt BP2008 India IP.13 75/kg 500kg prompt BP2008 China IP.01

GLIPIZIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

700/kg 100kg prompt BP2008 India IP.13 825/kg 100kg prompt BP2008 China IP.01

29 Market News Service Pharmaceutical Starting Materials GLUCOSE ANHYDROUS Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

53.15/mt 10mt prompt USP27 India IP.13

GRISEOFULVIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

46/kg 1mt prompt BP2008 China IP.13 44.7/kg 100kg prompt BP2008 China IP.01

HALOPERIDOL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

420/kg 1kg prompt BP2008 India IP.13

HEPARIN SODIUM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

5.8/mega 1000meg prompt BP2008 India IP.13

HYDRALAZINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

680/kg 10kg prompt BP2008 India IP.13

HYDROCHLOROTHIAZIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

15.5/kg 200kg prompt BP2008 India IP.13 8.75/kg 100kg prompt BP2008 China IP.01

HYDROCORTISONE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

498/kg 12kg prompt USP27 China IP.13 550.5/kg 100kg prompt BP2008 China IP.01

HYDROCORTISONE ACETATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

400/kg 50kg prompt USP27 India IP.13 551/kg 100kg prompt BP2008 China IP.01

30 Market News Service Pharmaceutical Starting Materials HYDROCORTISONE SODIUM SUCCINATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

719/kg 100kg prompt BP2008 India IP.13 698/kg 100kg prompt BP2008 China IP.01

HYDROXYCHLOROQUINE SULFATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

178.2/kg 100kg prompt USP27 India IP.13 265/kg 100kg prompt USP29 China IP.01

HYDROXYPROGESTERONE CAPROATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

157/kg 100kg prompt BP2008 India IP.13 250/kg 50kg prompt BP2008 China IP.01

IBUPROFEN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

7.9/kg 1mt prompt BP2008 India IP.13 8.15/kg 10mt prompt BP2008 China IP.09 9.95/kg 1mt prompt BP2008 China IP.01

IFOSFAMIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1400/kg 1kg prompt USP27 India IP.13

INDINAVIR Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

330/kg 100kg prompt USP29 India IP.13

INDOMETHACIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

13/kg 100kg prompt BP2008 India IP.13 12.8/kg 1mt prompt BP2008 China IP.01

IPRATROPIUM BROMIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

14/gm 500gm prompt BP2008 India IP.13

31 Market News Service Pharmaceutical Starting Materials ISONIAZID Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

7/kg 1mt prompt BP2008 India IP.05 9.65/kg 1mt prompt BP2008 China IP.01 18/kg 100kg prompt BP2008 India IP.05 16/kg 250kg prompt BP2008 India IP.05 14.5/kg 500kg prompt BP2008 India IP.05 14/kg 1mt prompt BP2008 India IP.05

ISOSORBIDE MONONITRATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

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

ITRACONAZOLE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

685/kg 50kg prompt BP2008 China IP.13

KETAMINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

161/kg 50kg prompt BP2008 India IP.13 243.6/kg 100kg prompt BP2008 China IP.01

KETOCONAZOLE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

57.65/kg 500kg prompt BP2008 India IP.13 125/kg 100kg prompt BP2008 China IP.01

KETOPROFEN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

110/kg 240kg prompt BP2008 India IP.13 72.2/kg 100kg prompt BP2008 China IP.01

LABETALOL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

380/kg 1kg prompt BP2008 India IP.13

32 Market News Service Pharmaceutical Starting Materials LAMIVUDINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

315/kg 5kg prompt USP28 India IP.13

LEVAMISOLE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

16/kg 500kg prompt EP5 India IP.13 24.6/kg 500kg prompt BP2008 China IP.01

LEVOFLOXACIN sterile powder Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

66/kg 10kg prompt USP27 India IP.13

LEVONORGESTREL Price / Unit Minimum Del ivery Quality Country of IPS US$ Quantity Time standard origin

2100/kg 25kg prompt USP28 India IP.13

LEVOTHYROXINE SODIUM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

4000/kg 25kg prompt BP2008 China IP.13

LIDOCAINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

13.85/kg 1mt prompt BP2008 China IP.13

LINCOMYCIN HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

37/bou 200bou prompt BP2008 India IP.13 46.2/kg 500bou prompt BP2008 China IP.01

LISINOPRIL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

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

L-METHIONINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

24/kg 150kg prompt USP27 India IP.13

33 Market News Service Pharmaceutical Starting Materials

LORATADINE Price / Unit Minimum Delivery Quali ty Country of IPS US$ Quantity Time standard origin 348/kg 50kg prompt USP 29 China IP.13

LOVASTATIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

605/kg 10kg prompt USP27 India IP.13 855/kg 50kg prompt USP29 China IP.01

MAGNESIUM TRISILICATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1.35/kg 1mt prompt USP28 China IP.01

MAGNESIUM SULFATE DRIED POWDER Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

2.35/kg 1mt prompt USP27 India IP.13

MANNITOL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

2.3/kg 2500kg prompt BP2008 India IP.13

MEBENDAZOLE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

14.25/kg 2mt prompt BP2008 India IP.13

MEDROXY PROGESTERONE ACETATE Price / Unit Minimum Delivery Quality C ountry of IPS US$ Quantity Time standard origin

305/kg 1kg prompt BP2008 India IP.13

MERCAPTOPURINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

75/kg 10kg prompt USP27 china IP.13

METFORMIN HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

3.35/kg 1mt prompt BP2008 India IP.05 5/kg 100kg prompt BP2008 India IP.05

34 Market News Service Pharmaceutical Starting Materials METFORMIN HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

4/kg 250kg prompt BP2008 India IP.05 3.5/kg 500kg prompt BP2008 India IP.05 2.65/kg 10mt prompt BP2008 India IP.13 5.85/kg 1mt prompt BP2008 China IP.01

METHOTREXATE SODIUM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

0.998/kg 1kg prompt USP27 India IP.13 1.95/kg 10kg prompt USP29 China IP.01

METHYLDOPA Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

39.7/kg 500kg prompt USP28 India IP.13

METHYL PREDNISOLONE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

2450/kg 10kg prompt USP27 China IP.13

METHYL PREDNISOLONE ACETATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

2350/kg 1kg prompt BP2008 China IP.13

METHYL PREDNISOLONE SODIUM SUCCINATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin 4080/kg 10kg prompt BP2008 China IP.13

METRONIDAZOLE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

7.10/kg 1mt prompt BP2008 China IP.13 5.75/kg 1mt prompt BP2008 China IP.01

MICONAZOLE NITRATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

41.25/kg 500kg prompt BP2008 India IP.13 47.5/kg 100kg prompt BP2008 China IP.01

35 Market News Service Pharmaceutical Starting Materials MORPHINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

870/kg 10kg prompt BP2008 China IP.13

NAPROXEN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

35.50/kg 320kg prompt BP2008 India IP.13

NAPROXEN SODIUM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

29/kg 500kg prompt USP27 India IP.13

NATEGLINIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

368/kg 50kg prompt USP28 India IP.13

NELFINAVIR MESYLATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

860/kg 500kg prompt MS India IP.13

NEOMYCIN SULPHATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

31.5/bou 500bou prompt USP28 India IP.13

NEVIRAPINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin 318/kg 50kg prompt EP5 China IP.13

NICOTINAMIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

9.5/kg 100kg prompt BP2008 India IP.05 7.75/kg 250kg prompt BP2008 India IP.05 7.15/kg 500kg prompt BP2008 India IP.05 6.9/kg 1mt prompt BP2008 India IP.05 10.10/kg 2mt prompt BP2008 India IP.13 8.8/kg 1mt prompt BP2008 China IP.01

36 Market News Service Pharmaceutical Starting Materials NITRENDIPINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

200/kg 10kg prompt BP2008 India IP.13

NITROFURANTOIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

18.5/kg 100kg prompt BP2008 China IP.13

NORFLOXACIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

17.8/kg 500kg prompt USP27 India IP.13 23.7/kg 500kg prompt BP2008 China IP.01

NYSTATIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

26.5/bou 500bou prompt BP2008 India IP.13 29.6/bou 100bou prompt BP2008 China IP.01

OFLOXACIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

42.5/kg 420kg prompt USP27 India IP.13 47.5/kg 100kg prompt USP29 China IP.01

OMEPRAZOLE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

32.5/kg 2200kg prompt BP2008 China IP.13

OXYTETRACYCLINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

6.6/kg 1mt prompt USP27 India IP.13 7.65/kg 1mt prompt USP29 China IP.01

OXYTETRACYCLINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

15.5/kg 500kg prompt BP2008 India IP.13 6.95/kg 1mt prompt BP2008 China IP.01

37 Market News Service Pharmaceutical Starting Materials OXYTOCIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

250/g 300g prompt BP2008 India IP.13

PARACETAMOL, directly compressible granules Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

7/kg 100kg prompt BP2008 India IP.05 5.25/kg 250kg prompt BP2008 India IP.05 4.5/kg 500kg prompt BP2008 India IP.05 4/kg 1mt prompt BP2008 India IP.05 3.12/kg 500kg prompt BP 2008 China IP.13 4.25/kg 100kg prompt USP29 China IP.01

PARACETAMOL, powder Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

2.9/kg 5mt prompt USP27 India IP.13 2.9/kg 1mt prompt BP2008 China IP.01

PAROXETINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

980/kg 50kg prompt EP5 India IP.13

PENCICLOVIR Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

800/kg 50kg prompt MS India IP.13

PHENOBARBITAL SODIUM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

25/kg 50kg prompt USP27 China IP.13

PHENOXYMETHYLPENICILLIN K, non-sterile powder Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

12.8/bou 500bou prompt BP2008 India IP.13 22.5/kg 100bou prompt BP2008 China IP.01

PHENYTOIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin 15.7/kg 50kg prompt USP27 India IP.13

38 Market News Service Pharmaceutical Starting Materials PHENYTOIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin 11.85/kg 100kg prompt BP2008 China IP.01

PHTHALYLSULFATHIAZOLE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

9/kg 1mt prompt BP2008 India IP.05 11/kg 100kg prompt BP2008 India IP.05 10.5/kg 250kg prompt BP2008 India IP.05 10/kg 500kg prompt BP2008 India IP.05 7.65/kg 500kg prompt BP2008 India IP.13

PHYTOMENADIONE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

339/kg 5kg prompt BP2008 India IP.13

PILOCARPINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

2226/kg 5kg prompt BP2008 India IP.13

PIPERAZINE ADIPATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

9/kg 100kg prompt BP2008 India IP.05 6/kg 250kg prompt BP2008 India IP.05 5.25/kg 500kg prompt BP2008 India IP.05 5/kg 1mt prompt BP2008 India IP.05

PIPERAZINE CITRATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

4/kg 1mt prompt USP27 India IP.05 4/kg 500kg prompt USP27 India IP.05 6/kg 250kg prompt USP27 India IP.05 8/kg 100kg prompt USP27 India IP.05

PIROXICAM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

33.4/kg 100kg prompt BP2008 China IP.13

39 Market News Service Pharmaceutical Starting Materials POVIDONE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

9.25/kg 500kg prompt USP27 India IP.13 9.50/kg 10mt prompt USP27 China IP.09

PRAVASTAIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

2100/kg 1kg prompt EP5 India IP.13 1980/kg 10kg prompt EP5 China IP.01

PRAZIQUANTEL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

106/kg 25kg prompt USP28 India IP.13 145/kg 100kg prompt USP29 China IP.01

PREDNISOLONE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

542/kg 80kg prompt BP2008 China IP.13 580/kg 50kg prompt BP2008 China IP.09 625/kg 100kg prompt BP2008 China IP.01

PREDNISOLONE ACETATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

590/kg 80kg prompt BP2008 China IP.13 570/kg 100kg prompt BP2008 China IP.01

PROCAINE BENZYLPENICILLIN, sterile powder Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

17.1/bou 500bou prompt BP2008 India IP.13 19.20/bou 500bou prompt BP2008 China IP.01

PROCAINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

6.3/kg 100kg prompt BP2008 China IP.01

PROGESTERONE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

170/kg 5kg prompt USP27 India IP.13

40 Market News Service Pharmaceutical Starting Materials PROGESTERONE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

203/kg 100kg prompt USP29 China IP.01

PROMETHAZINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

21/kg 500kg prompt BP2008 India IP.13 19.85/kg 1mt prompt BP2008 China IP.01

PROPRANOLOL HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

11.25/kg 500kg prompt BP2008 China IP.01

PROPYLTHIOURACIL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

48/kg 50kg prompt USP28 China IP.13

PYRANTEL PAMOATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

17.5/kg 100kg prompt BP2008 China IP.01

PYRAZINAMIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

15/kg 1mt prompt BP2008 India IP.05 17/kg 250kg prompt BP2008 India IP.05 16/kg 500kg prompt BP2008 India IP.05 19/kg 100kg prompt BP2008 India IP.05 22/kg 100kg prompt BP2008 India IP.13

PYRIDOXINE HYDROCHLORIDE, powder Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

14.86/kg 500kg prompt USP27 India IP.13 19.8/kg 100kg prompt BP2008 China IP.01

PYRIMETHAMINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

21.5/kg 500kg prompt BP2008 India IP.13 36.8/kg 100kg prompt BP2008 China IP.01

41 Market News Service Pharmaceutical Starting Materials

QUININE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Count ry of IPS US$ Quantity Time standard origin 55/kg 250kg prompt BP2008 India IP.13

RAMIPRIL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1560/kg 1kg prompt EP5 India IP.13

RANITIDINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

14.5/kg 2mt prompt USP27 India IP.13 26.35/kg 100kg prompt BP2008 China IP.01

RETINOL ACETATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

15.9/kg 3-6mt prompt BP2008 India IP.13 24.65/kg 5mt prompt BP2008 China IP.01

RETINOL PALMITATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

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

RIBOFLAVINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

17.9/kg 500kg prompt USP27 India IP.13 29.3/kg 1mt prompt BP2008 China IP.01

RIFAMPICIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin BP2008 B.D 0 40.8/kg 500kg prompt .5 China IP.13 BP2008 B.D 61.5/kg 1mt prompt 0.5 China IP.09 BP2008 B.D 62.5/kg 1mt prompt 0.7 China IP.09

ROXITHROMYCIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

119/kg 500kg prompt USP28 India IP.13

42 Market News Service Pharmaceutical Starting Materials

SALBUTAMOL SULFATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

59/kg 500kg prompt BP2008 China IP.13

SIMVASTATIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

500/kg 3kg prompt USP28 India IP.13

SODIUM CHLORIDE sterile Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

0.36/kg 1mt prompt USP27 India IP.13 0.65/kg 1mt prompt USP27 China IP.01

SODIUM CROMOGLICATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

330/kg 12kg prompt BP2008 China IP.13

SODIUM LACTATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

807/mt 10mt prompt BP2008 India IP.13

SODIUM NITRITE Price / Unit Minimum Deliv ery Quality Country of IPS US$ Quantity Time standard origin

230/mt 10mt prompt BP2008 India IP.13

SODIUM THIOSULFATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

135/mt 10mt prompt BP2005 India IP.13

SODIUM THIOPENTAL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

915/kg 50kg prompt BP2008 India IP.13

SODIUM VALPROATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

28/kg 500kg prompte BP2008 India IP.13

43 Market News Service Pharmaceutical Starting Materials SPECTINOMYCIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

270/bou 100bou prompt USP27 India IP.13 485/bou 100bou prompt USP28 China IP.01

SPIRAMYCIN Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

110/kg 500kg prompt EP5 India IP.13

SPIRONOLACTONE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

287/kg 500kg prompt USP27 India IP.13 250/kg 100kg prompt USP27 China IP.09

STREPTOMYCIN SULFATE, sterile powder Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

21.2/kb 500kb prompt BP2008 India IP.13

SULFADIAZINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

6.9/kg 1mt prompt BP2008 China IP.13 8.95/kg 1mt prompt BP2008 China IP.01

SULFADIMIDINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

8.8/kg 2mt prompt BP2008 India IP.13 5.85/kg 100kg prompt BP2008 China IP.01

SULFADOXINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

33.7/kg 100kg prompt BP2008 China IP.01

SULFAMETHOXAZOLE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

8.25//kg 500kg prompt USP27 India IP.05 8.75/kg 250kg prompt USP27 India IP.05 10/kg 100kg prompt USP27 India IP.05 8/kg 1mt prompt USP27 India IP.05

44 Market News Service Pharmaceutical Starting Materials SULFAMETHOXAZOLE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

8.7/kg 1mt prompt BP2008 India IP.13 11.55/kg 100kg prompt BP2008 China IP.01

TAMOXIFEN CITRATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

380/kg 100kg prompt BP2008 China IP.13

TENOXICAM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

642/kg 15kg prompt BP2008 China IP.13

TETRACYCLINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

13.2/kg 500kg prompt BP2008 China IP.01

THEOPHYLLINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

6/kg 500kg prompt USP27 India IP.13

THIAMINE HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

18/kg 6mt prompt USP27 India IP.13 19.6/kg 100kg prompt BP2008 China IP.01

THIAMPHENICOL BASE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

44/kg 2mt prompt BP2008 China IP.09

TIMOLOL MALEATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1060/kg 20kg prompt BP2008 India IP.13

TINIDAZOLE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

9.8/kg 500kg prompt BP2008 India IP.13

45 Market News Service Pharmaceutical Starting Materials

TRIMETHOPRIM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

9.7/kg 200kg prompt BP2008 India IP.13 12.3/kg 1mt prompt BP2008 China IP.01

VALACICLOVIR Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

608/kg 1kg prompt MS India IP.13

VANCOMYCIN HYDROCHLORIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

1930/kg 1kg prompt USP27 India IP.13

VECURONIUM BROMIDE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

41/g 1kg prompt BP2008 China IP.13

VERAPAMIL Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

150/kg 500kg prompt BP2008 India IP.13

VINBLASTINE SULFATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

189/g 1kg prompt USP28 India IP.13

VINCRISTINE SULFATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

118/g 100g prompt USP27 China IP.13

VINDESINE SULFATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

682/gm 100gm prompt EP5 India IP.13

VINORELBINE TARTARATE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

250/g 100g prompt USP27 China IP.13

46 Market News Service Pharmaceutical Starting Materials

WARFARIN SODIUM Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

400/kg 30kg prompt USP28 China IP.13

ZALCITABINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin

6900/kg 1kg prompt MS China IP.13

ZIDOVUDINE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin 665/kg 50kg prompt USP28 India IP.13

ZIPRASIDONE Price / Unit Minimum Delivery Quality Country of IPS US$ Quantity Time standard origin 1350/kg 5kg prompt MS China IP.13

47 Market News Service Pharmaceutical Starting Materials 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/ Future Generic Growth, Authorised Generics, Regulatory Affairs, Patent Interest areas 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.

Target audience/ Supply Chain Management, APIs, Pharmaceutical Surveillance, Inspections, Interest areas 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

Target audience/ Analytical services, Chemical synthesis/analysis, Clinical research and trials, Interest areas 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

48 Market News Service Pharmaceutical Starting Materials 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.

Target audience/ Generic drugs, Biosimilars, Intellectual Property, Regulatory Affairs Interest areas

InformEx Pharma

Date 16-19 February 2010 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. Target audience/ Fine chemicals, Brand pharmaceuticals, Generic drugs, Biotechnology, Interest areas Biopharmaceuticals, Adhesives, Resins

4th Annual World Generic Medicines Congress Europe 2010

Date 23-26 February 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. Target audience/ Quality of Medicines, Trends and Future Developments, Emerging Markets, Interest areas 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 The DIA is a professional association of approximately 18,000 members organiser 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. Target audience/ Clinical Research, Pharmacovigilance, Regulatory, Information Management, Interest areas Generics

49 Market News Service Pharmaceutical Starting Materials 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

50 Market News Service Pharmaceutical Starting Materials HANDBOOK Ver. 5.3

SHAPE THE FUTUR OF YOUR SECTOR’S SUCCESS

HOW TO DEVELOP A SECTOR STRATEGY

Street address P: +41 22 730 0111 Postal address International Trade Centre F: +41 22 733 4439 International Trade Centre 54-56 Rue de Montbrillant E: [email protected] Palais des Nations 1202 Geneva, Switzerland www.intracen.org 1211 Geneva 10, Switzerland

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