Sources and prices of selected medicines and diagnostics ... · tarian aid organization that provides emergency medi-cal assistance to populations in danger in more than 80 countries,

Sources and pricesof selected medicines and

diagnostics forpeople living with

HIV/AIDS

A JOINT UNICEF – UNAIDS – WHO – MSF PROJECT

JUNE 2004

WHO/EDM/PAR/2004.4

WHO

Inside cover

Sources and pricesof selected medicines and

diagnostics forpeople living with

HIV/AIDS

JUNE 2004

A joint UNICEF – UNAIDS Secretariat – WHO – MSF Project

WHO/EDM/PAR/2004.4

WHO

This report is also available

On the following web pages:

UNICEF: www.unicef.org/supply

UNAIDS: www.unaids.org

WHO/ Department of Essential Drugsand Medicines Policy: www.who.int/medicines

WHO/ Department of HIV/AIDS:www.who.int/HIV_AIDS

Médecins Sans Frontières (MSF):www.accessmed-msf.org

© World Health Organization, United Nations Children’s Fund, Joint United Nations Programme on HIV/AIDS (UNAIDS),Médecins Sans Frontières, 2004. All rights reserved.

Published by WHO, also on behalf of UNICEF, the UNAIDS Secretariat, and Médecins Sans Frontières.

WHO, UNICEF, the UNAIDS Secretariat, and Médecins Sans Frontières have made every effort to ensure the accuracy of price, supplier,and other information presented in this report. Reader’s attention is drawn to the introduction, which describes the specific sourcesand limitations of information provided in this report.

Reader’s attention is also drawn to the importance of quality assurance for pharmaceutical products. Licensing authorities in therespective countries of manufacture are expected to be responsible for the review and approval of the detailed composition andformulation when authorizing a pharmaceutical product to be marketed, including the specifications of its ingredients, as submitted bythe manufacturer of the dosage form, and to oversee compliance with Good Manufacturing Practice requirements as recommended byWHO.

The data and information contained herein are being provided as is and WHO, UNICEF, the UNAIDS Secretariat, and Médecins SansFrontières make no representations or warranties, either expressed or implied, as to their accuracy, completeness or fitness for aparticular purpose. Neither WHO, UNICEF, the UNAIDS Secretariat, nor Médecins Sans Frontières accepts any responsibility or liabilitywith regard to the reliance on, or use of, such data and information.

The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended byWHO, UNICEF, the UNAIDS Secretariat or Médecins Sans Frontières in preference to others of a similar nature that are not mentioned.Errors or omissions excepted, the names of proprietary products are distinguished by initial capital letters.

The designations employed and the presentation of the material in this report, including tables and maps, do not imply the expressionof any opinion whatsoever on the part of WHO, UNICEF, the UNAIDS Secretariat and Médecins Sans Frontières concerning the legalstatus of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dottedlines on maps represent approximate border lines for which there may not yet be full agreement.

Design and layout by minimum graphicslayout/production Janet PetitpierrePrinted in France

Or by contacting:

Pharmaceuticals and Micronutrients Team,UNICEF Supply DivisionFax: +45 35 269421

Department of Social Mobilization and Information,UNAIDSFax: +41 22 7914741

Essential Drugs and Medicines Policy (EDM),World Health OrganizationFax: +41 22 7914167

Campaign for Access to Essential Medicines,Médecins Sans FrontièresFax: +41 22 8498404

Information on HIV/AIDS diagnostic support, HIV test kit evaluations and bulk procurement are available on the WHO/Department of Essential Health and Technologies website: www.who.int/eht

Information on HIV/AIDS and substance abuse dependence is available from www.who.int/substance_abuse

WHO Library Cataloguing-in-Publication Data

Sources and prices of selected medicines and diagnostics for people living withHIV/AIDS / a joint UNICEF, UNAIDS Secretariat, WHO, MSF project.1. Pharmaceutical preparations - supply and distribution2. Reagent kits, Diagnostic - supply and distribution3. HIV infections - diagnosis4. HIV infections - drug therapy5. Price lists6. Catalogs, Drug I.UNICEF

ISBN 92 4 159179 X (LC/NLM classification: QV 772)

Contents

ANNEX 4.FURTHER READING, REFERENCES, AND CONTACTS

iii

Glossary v

1. Introduction 1

2. Diagnostics 9

3. Access to quality HIV/AIDS medicines 10

4. Prices of medicines and diagnostics 11

5. List of manufacturers - medicines and diagnostics 26

Annex 1 A. CD4+ T- cell enumeration technologies 37

B. Summary of main characteristics of Viral Load Technologies 39

Annex 2 A. Registration status of products included in the sources and prices survey 41

B. Sources of medicines 106

Annex 3 Further reading, references and contacts 117

Annex 4 Untangling the web of price reductions: a pricing guide for the purchase of ARVsfor developing countries 121

Feedback and enquiry form

Tables

Table 1. Anti-infective medicines 11

Anthelminthics 11

Antibacterials, beta lactam medicines 11

Other antibacterials 12

Antifilarials 14

Antifungal medicines 15

Aniprotozoal medicines 15

Antiviral medicines 15

Antiviral medicines - Antiretrovirals 16

Table 2. Antineoplastic medicines 18

Cytotoxic medicines 18

iv

Table 3. Medicines used for the treatment of mental and substance use disorders 19

Medicines used in depressive disorders 19

Medicines used in generalized anxiety and sleep disorders 19

Medicines used in the treatment of opioid dependence 19

Table 4. Analgesics 20

Opioid analgesics 20

Table 5. Gastrointestinal medicines 20

Antacids and other antiulcer medicines 20

Antiemetic medicines 21

Laxatives 21

SOURCES AND PRICES OF SELECTED DRUGS AND DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS

GlossaryAIDS1 Acquired Immune Deficiency Syndrome – the late

stage of HIV disease. AIDS involves the loss of functionof the immune system as CD4 cells are infected anddestroyed, al lowing the body to succumb toopportunistic infections (e.g., Pneumocystis cariniipneumonia, toxoplasmosis) that are generally notpathogenic in people with intact immune systems.

CIF2 Cost Insurance and Freight – (…named port ofdestination) the seller delivers when the goods passthe ship’s rail in the port of shipment. The seller mustpay the cost of freight if necessary to bring the goodsto the named port of destination but the risk of loss ordamage to the goods, as well as any additional costsdue to events occurring after the time of delivery, aretransferred from the seller to the buyer. This term canbe used only for sea or inland waterway transport.

COF Consejo General de Colegios Oficiales deFarmacéuticos (General Spanish Council of Pharma-cists and Pharmaceutical Associations) – Spanish or-ganization of Pharmaceutical Colleges, whichrepresents all colleges in the national and internationalforum, develops norms, rules, and professional policy,and acts as the interlocutor with Spanish Ministries.

Diagnostics Laboratory tests used in the diagnosis ofinfection.

ELISA Enzyme-linked immunosorbent assay – first HIVantibody test which requires a machine to measurecolor change in test wells.

Endemic1 The continuous presence of a disease in ageographic location, community or population.

Epidemic1 An outbreak of a disease within a population.See also pandemic.

EXW2 Ex-works – (... named place) the seller’s onlyresponsibility is to make the goods available at theseller’s premises, i.e., the works or factory. The selleris not responsible for loading the goods on the vehicleprovided by the buyer unless otherwise agreed. Thebuyer bears the full costs and risk involved in bringingthe goods from there to the desired destination. Exworks represents the minimum obligation of the seller.

FCA (nearest port)2 Free Carrier – (... named place) Thisterm has been designed to meet the requirements ofmultimodal transport, such as container or roll-on, roll-off traffic by trailers and ferries. It is based on thesame name principle as F.O.B. (free on board), exceptthe seller fulfils its obligations when the goods aredelivered to the custody of the carrier at the namedplace. If no precise place can be named at the time ofthe contract of sale, the parties should refer to theplace where the carrier should take the goods into itscharge. The risk of loss or damage to the goods istransferred from seller.

FOB2 Free-on-board – (... named port of shipment) Under“F.O.B” the goods are placed on board the ship by theseller at a port of shipment named in the salesagreement. The risk of loss of or damage to the goodsis transferred to the buyer when the goods pass theship’s rail (i.e., off the dock and placed on the ship).The seller pays the cost of loading the goods.

Generic medicine3 The term “generic product” hassomewhat different meaning in different jurisdictions.In many technical documents, use of this term isavoided, and the term ‘multisource pharmaceuticalproduct’ is used instead. In this document, where theterm generic medicine is used, it means apharmaceutical product usually intended to beinterchangeable with the innovator product, which isusually manufactured without a license from theinnovator company and marketed after expiry of patentor other exclusivity rights where these have previouslyexisted. Generic products may be marketed eitherunder the non-proprietary approved name or under anew brand (proprietary) name. They may sometimesbe marketed in dosage forms and/or strengths differentfrom those of the innovator products.

GMP Good Manufacturing Practice

HAART Highly Active Antiretroviral Therapy

HDI Human Development Index

HIV Human Immunodeficiency Virus – a slow-actingretrovirus of the lentivirus family, believed to be thesole or primary cause of AIDS. HIV is transmittedsexually, through blood or vertically (from mother tochild). There are 2 known types: HIV-1 and HIV-2.

HIV Test kit There are 3 main types of test for detectingthe presence of HIV antibodies: simple/rapid tests,ELISA tests, and confirmatory tests.

International Drug Price Indicator Guide 2003 A jointpublication by the World Health Organization and Man-agement Sciences for Health (MSH). Provides a spec-trum of prices from non-profit drug suppliers,procurement agencies, and ministries of health, basedon their current catalogs or price lists.

ITC International Trade Centre – technical cooperationagency of the United Nations Conference on Trade andDevelopment (UNCTAD) and the World Trade Organiza-tion (WTO) for operational, enterprise-oriented aspectsof trade development.

GLOSSARY

v

1 AIDS Education Global Information System

2 International Chamber of Commerce

3 World Health Organization. Quality Assurance of Pharmaceu-ticals. A compendium of guidelines and related materials. Vol1, 1997

vi

Manufacturing license Granted by national licensingauthorities and gives authorization to manufacture aspecific product in a specified manufacturing plant.

MSF Médecins Sans Frontières is an international humani-tarian aid organization that provides emergency medi-cal assistance to populations in danger in more than80 countries, since 1971.

MSH Management Sciences for Health is a private, non-profit educational and scientific organization. Since1971, MSH has worked with its worldwide partners toimprove the management of, and access to, publichealth services.

MTCT Mother-to-child transmission (of HIV)

Opportunistic infection1 (OI) An illness caused by amicro-organism that usually does not cause disease inpersons with healthy immune systems, but which maycause serious illness when the immune system issuppressed. Common OIs in HIV positive people includePneumocystis carinii pneumonia (PCP), Mycobacteriumavium complex (MAC) and cytomegalovirus (CMV)infection.

Originator [pharmaceutical manufacturers]Manufacturers that produce mainly innovativemedicines

Palliative care4 Pain and symptom management, andpsycho-social support for persons living with a terminalillness, as well as for their families and caregivers.

Pandemic1 A widespread disease outbreak affecting thepopulation of an extensive area of the world. See alsoepidemic.

Patents5 A title granted by the public authoritiesconferring a temporary monopoly for the exploitationof an invention upon the person who reveals it, furnishesa sufficiently clear and full description of it, and claimsthis monopoly.

PLWA People Living With HIV/AIDS

Protease inhibitor (PI) Type of antiretroviral medicine

Proprietary medicines Medicines that are under patentrestrictions belonging to a company, institution, or gov-ernment.

Reverse transcriptase inhibitor Type of ARV medicine.Can be divided into two classes: Nucleoside ReverseTranscriptase Inhibitor (NRTI) and Non NucleosideReverse Transcriptase Inhibitor (NNRTI)

Simple/rapid test Can generally be carried out in 15minutes and results are read with the naked eye. Theyare easy to use and require limited training and little orno equipment, making them particularly suitable foruse in Voluntary Counselling and Testing (VCT) centres.

The World Bank Group Established in 1944 it is one ofthe world’s largest sources of development assistance.

In Fiscal Year 2003, the institution provided more thanUS$18.5 billion in loans to its client countries.

TRIPS6 Agreement on Trade Related Aspects of Intellec-tual Property Rights

UNAIDS The Joint United Nations Programme on HIV/AIDS (UNAIDS) – by the mid-1990s, it became clearthat the epidemic’s devastating impact on all aspectsof human development, were creating an emergencythat would require a greatly expanded United Nationseffort. UNAIDS created in 1995 was tasked tocoordinate this effort.

UNCTAD United Nations Conference on Trade andDevelopment, established in 1964, aims at thedevelopment-friendly integration of developingcountries into the world economy. It is the focal pointwithin the United Nations for the integrated treatmentof trade and development and the interrelated issuesin the areas of finance, technology, investment andsustainable development.

UNFPA United Nations Population Fund – began opera-tions in 1969. It is the largest international source ofpopulation assistance. About a quarter of all populationassistance from donor nations to developing countriesis channelled through UNFPA.

UNICEF United Nations Children’s Fund – Created bythe United Nations General Assembly in 1946 to helpchildren after World War II in Europe. Headquartered inNew York, UNICEF carries out its work through eightregional offices and 126 country offices covering morethan 160 countries, territories and areas.

WHO World Health Organization – Founded in 1948, theWorld Health Organization leads the world alliance forHealth for All. WHO promotes technical cooperationfor health among nations, carries out programmes tocontrol and eradicate disease and strives to improvethe quality of human life.

WIPO World Intellectual Property Organization – Foundedin 1970, WIPO administers 23 international treatiesdealing with different aspects of intellectual propertyprotection.

WTO World Trade Organization – succeeded the GeneralAgreement on Tariffs and Trade (GATT), first signed in1947 by 23 countries and aimed at protecting andregulating international trade. WTO now has 147members, three quarters of which are developing orleast developed countries.

4 Council on palliative care, Canada

5 Globalization and access to drugs—perspectives on the WTOTRIPS Agreement. Health Economics and Drugs EDM Series7. WHO, Geneva, 1999

6 http:// www.wto.org


1

1. Introduction

framework. WHO’s 3 by 5 team assembled and refinedthe framework in intensive consultation with partners. Thisconsultation will continue, and the framework itself willcontinue to evolve.

WHO’s strategic framework for emergency scaling up ofantiretroviral therapy contains 14 key strategic elements.These elements fall into five categories – the pillars ofthe 3 by 5 campaign:

1. Global leadership, strong partnership and advocacy

2. Urgent, sustained country support

3. Simplified, standardized tools for deliveringantiretroviral therapy

4. Effective, reliable supply of medicines and diag-nostics

5. Rapidly identifying and reapplying new knowledgeand successes

The full text of the WHO strategic framework can be foundat : http://webitpreview.who.int/entity/3by5/publications/documents/en/3by5StrategyMakingItHappen.pdf

In addition, drug users, PLWA and their advocates fromaround the world have urged WHO to ensure the inclusionof injecting drug users in the scale-up of ARV therapy inits 3 by 5 initiative (Media Alert dated 19 February 2004).

The new simplified ARV therapy guidelines mentioned inthe 3rd pillar also allow for cost savings and real scaling-up activities through the potential use of cheaper fixed-dose combinations (FDCs), where countries are favorableto import generics or where local production facilitiesexist8 .

1.1 Background

Antiretroviral therapy, prevention and treatment of oppor-tunistic infections and cancers, as well as palliative careare important elements of HIV/AIDS care and support.HIV/AIDS care hence requires a wide range of essentialmedicines. If available, these effective and often relativelyinexpensive medicines can prevent, treat, or help manageHIV/AIDS and most of the common HIV-related diseases.

Less than 8% of people who require antiretroviral (ARV)treatment can access these medicines in developingcountries (see Figure 1).

The high price of many of the HIV-related medicines anddiagnostics offered by common suppliers – especiallyantiretroviral and anti-cancer medicines – is one of themain barriers to their availability in developing countries.

There are several other important barriers, including alack of the basic components required for care, treatment,and support of people living with HIV/AIDS (PLWA) suchas: trained staff in health facilities, constant availability oflaboratory equipment and supplies, sufficient funding,efficient pharmaceutical services, strong political will andgovernment commitment. Wider availability of informationon prices and reliable sources of medicines can help thoseresponsible for procurement make better decisions.

Since 2000, prices of important first-line ARVs have fallenconsiderably. This trend is attributable to a cumulation offactors including advocacy, corporate responsiveness,competition from generic manufacturers, sustained pub-lic pressure, and the growing political attention paid tothe AIDS epidemic. In addition, originator companies be-gan announcing discount offers for the benefit of the poor-est countries or those where HIV/AIDS prevalence ishighest7 .

Furthermore, the announcement of WHO’s “3 by 5” initia-tive of providing ARV treatment to 3 million PLWA in devel-oping countries by the end of 2005 has lead to anticipationthat increased volumes of medicine will be purchased.This may further reduce the prices of certain medicines.

Treating 3 million people by the end of 2005 will requireconcerted, sustained action by many partners. To chartthe direction and to show what WHO itself will be doing toaccelerate action, WHO has developed an initial strategic


7 HIV prevalence status of countries see www.who.int/emc-hiv/fact_sheets/All_countries.html

8 More information on fixed dose combinations can be obtainedfrom the MSF briefing note: Two pills a day saving lives: Fixed-dose combinations (FDCs) of antiretroviral drugs, MSF, Feb2004 (see http://www.accessmed-msf.org/documents/factsheetfdc.pdf)


2

1.2 Aim

This report sets out to provide market information thatcan be used to help procurement agencies make informeddecisions on the sources of medicines and diagnostics,and serve as the basis for negotiating affordable prices.The aim is to help increase access to treatment for PLWAin developing countries.

The data provided by the manufacturers serve to drawattention to the multiplicity of suppliers and the variationin price of some essential HIV/AIDS-related medicines onthe international market. Without this information, thereis a risk that low-income countries may be paying morethan needed to obtain HIV/AIDS-related medicines. Pricevariations are highlighted through the tables and graphsincluded.

However, provision of price information addresses onlyone barrier to access to medicines in countries with lim-ited resources. It should be noted that many other fac-tors will affect the availability of medicines. Some of theother issues that must be considered are health infrastruc-ture, human resources, funding and supply and distribu-tion systems9 .

1.3 Target audience

This report is intended for use primarily by national pro-curement agencies in resource-limited countries that lackeasily accessible information on reliable sources andprices of medicines and diagnostics.

It may also be useful to others involved in the procure-ment of medicines and diagnostics, such as not-for-profitorganizations, distributors, importers and wholesalers orpublic health professionals interested in current price lev-els of medicines and diagnostics for PLWA.

Those who will become involved in planning and imple-menting HIV/AIDS care and treatment interventions willfind important regulatory information in this document.

Source: WHO/UNAIDS. Treating 3 million by 2005 – Making it happen. Geneva, WHO, 2003.

Figure 1. Estimated percentage of people covered among those in need of antiretroviral treatment,situation as of November 2003

9 Management Sciences for Health and the World HealthOrganization second edition of Managing Drug Supply providesa complete overview as well as step-by-step approaches onhow to manage pharmaceutical systems effectively.

3

1.4 Generating the report

This is the fifth in a series of annual reports commencedin 1999, investigating sources and prices of medicinesand diagnostics commonly required by PLWA, but diffi-cult to obtain locally due to a small number of producers,the lack of distribution channels, or high prices. Thesesurveys will be continued and the report will be regularlyupdated and made available when appropriate.

A survey was carried out from December 2003 throughto January 2004. The responses of 84 manufacturers in29 different countries as well as those participating in theWHO bulk procurement scheme (see Chapter 2) formedthe basis of this report. The number of manufacturersreached has greatly increased since the first survey in1999 as more resources are made available via industrywebsites and cooperation with other international organi-zations. Manufacturers that participated in previous sur-veys, those held in various databases, and those belongingto National Pharmaceutical Associations were contactedfor voluntary participation and for completion of a ques-tionnaire.

The UNAIDS Secretariat, UNICEF, MSF, and WHO haveworked jointly to conduct a price survey and put togetherthe results into a comprehensive publication, whilst re-specting the manufacturers’ requests for confidentialitywith respect to their individual pricing information.

It must be pointed out that the companies included in thisreport have been screened only through the complete-ness of the requested documents they have provided,such as the questionnaire, a National GMP certificate, andassociated documents relating to the company and theirproducts. Inclusion in this report does not necessarily con-stitute prequalification or approval of any sort by UNICEF,WHO, UNAIDS or MSF. Only those products identified inAnnex 2B in bold and with an asterisk (*) have (at the timeof publication of this document) been approved throughthe ongoing Pre-qualification Project (see Chapter 3).

Additional companies are sought for future updates ofthis publication.

1.5 Theme of the report: Diagnostics

Increased access to ARV medicines has also highlightedthe need for appropriate and cost-effective HIV/AIDSdiagnostic support. Diagnostic technologies are impor-tant to monitor the progression of the safety and efficacyof treatment, and the development of resistance.

The existing systems for assessment and procurementof HIV test kits is being expanded to include technologiesused to monitor ARV therapy (CD4+ counts and viral load)and drug resistance. An overview of types of CD4+ T-cell

enumeration technologies available are given in Annex 1Awhilst information on HIV viral load technologies is givenin Annex 1B.

1.6 How to use this report:

1.6.1 Information on prices

Detailed price information is provided in Chapter 4 and inthe MSF document included in Annex 5.

Chapter 4 provides prices of medicines and diagnostictests based on data obtained from the survey. Official UNexchange rates for the month of February 2004 were usedto convert local currencies into US dollars. The pricesyou will find listed in section 4.1 are provided as statisti-cal ranges explained below.

Price ranges and how these prices are distributed indi-cate what a purchaser should expect to pay when plan-ning procurement. Section 4.2 provides negotiated pricesof essential HIV test kits of the UN bulk procurementscheme 2004.

Annex 5 is a contribution from MSF and is the latest ver-sion of their bi-annual publication Untangling the Web ofPrice Reductions: a pricing guide for the purchase of ARVsfor developing countries.

Most of the prices in this report are ex-works (EXW) orFree Carrier (FCA). They do not include added costs suchas freight, insurance, import duties or taxes. For this rea-son the prices in this report cannot be compared withconsumer prices. Many countries continue to imposeconsiderable import duties, tariffs and taxes on the priceof essential medicines10 . In addition, wholesale and retailmark-ups vary from one country to another. As a result,the EXW price is often less than half end-price to the con-sumer.

10 See Policy and programming options for reducing the pro-curement costs of essential medicines in developing coun-tries, Levinson, L, Boston University School of Public Health,2003

INTRODUCTION


4

(a) Therapeutic category (according to the WHO ModelList of Essential Medicines)

(b) The number of manufacturers that provided an in-dicative price and the number of countries they rep-resent

(c) The indicative price

unitThe price quoted relates to the unit described. For exam-ple, if the unit is “tablet” the price quoted is for one singletablet.

maxThe maximum price listed represents the highest priceamong products in this category, with no differentiationbetween originator or generic products.

minThe minimum price listed represents the lowest priceamong products in this category, with no differentiationbetween originator or generic products.

medianThe median price is the middle price, or where there is aneven number of prices listed, it is the mean of the twomiddle numbers. This means that half the prices quotedare above this median price, and the other half arebelow it.

25th percThe 25th percentile is the value point representing the firstquartile of quoted prices in ascending order. It is used togive some indication of the dispersion of prices for a givenproduct.

For example, if 4 suppliers were identified as manufactur-ing cefixime paediatric oral suspension, 100 mg/5 ml,and the 25th percentile is US$ 0.023 per ml of suspen-sion: 1 out of the 4 (a quarter) manufacturers surveyedoffer a price equal to or less than US$ 0.023.

(d) The List prices are used to indicate the differencein price, if any, between a developing and a devel-oped country. Brazilian prices are selected as Bra-zil is a developing country with considerablemanufacturing capacity; and Spanish prices becausethese are generally considered the lowest in Europe.

Brazilian list priceThe Brazilian list price included in this report representsthe minimum price payable by Brazilian health institutions,between 01/01/2003 and 01/01/2004, for the productand is taken from the Brazilian databank of healthpurchases (refer to http://bpreco.saude.gov.br/pls/BPREFD/consulta.inicio). Where the entry reads “none”,this indicates no purchase has been made for that prod-uct, therefore no minimum price payable is available.

Spanish list priceThis EXW price has been calculated by applying the newmargins (as stated in the Royal Decree 286/2001) to theconsumer price as published by The General SpanishCouncil of Pharmacists and Pharmaceutical Associations.(www.portalfarma.com). It should be noted that Spanishlist prices are generally considered the lowest in Europe.In most cases, the indicative prices listed in the reportare a fraction of the comparative prices in the Spanishlist.

1.6.2 Information on sources

Complete lists of manufacturers, their contact informa-tion, and the HIV/AIDS-related medicines and diagnosticsthey manufacture are given in Chapter 5. Annexes 2Aand 2B provide a country by country list of the registra-tion status and sources for each of these medicines.

The following structure is used for reporting the price information:

(a) (b) (c) (d)

Therapeutic category Manufacturer Indicative prices, US$ List prices, US$

No No

of ofmanuf countries unit max min median 25th perc Brazil Spain

5

1.6.3 Selection of medicines and diagnostics

This report includes antiretroviral medicines, medicinesused to treat a range of opportunistic infections, medi-cines for use in palliative care, medicines for the treat-ment of HIV/AIDS-related cancers and medicines for themanagement of opioid dependence. It also provides in-formation on a range of test kits available for diagnosisof HIV/AIDS.

The medicines included in the report were selected basedon recommendations from available WHO treatment guide-lines. The list is not intended to be exhaustive but tobroadly cover the most commonly used medicines ormedicine categories, in order to ensure that combinedwith their own resources, purchasing agencies can haveat their disposal all medicines and diagnostics requiredfor the comprehensive treatment of HIV/AIDS.

Additional medicines are often provided as they may behelpful due to:

— Greater cost offset by greater safety, e.g.fluconazole instead of ketoconazole;

— Fewer unwanted adverse effects, e.g. alternativesto amitriptyline.

Paediatric formulations have been included whereverpossible.

Antiretroviral therapySince October 2000, this report has included informationon the availability and price range of antiretroviralmedicines for use in Highly Active Antiretroviral Therapy.In resource - poor settings, it is critical that these medi-cines are used in conjunction with WHO treatment guide-lines which are intended to support and facilitate the propermanagement and scale-up of ART in the years to come,by proposing a public health approach to achieve thesegoals.

The topics addressed in the treatment guidelines includewhen to start ART, which antiretroviral regimens to start,reasons for changing ART, and what regimens to continueif treatment needs to be changed. They also address howtreatment should be monitored, with specific referenceto the side effects of ART, and make specif icrecommendations for certain patient subgroups.

The newly recommended first - line ARV regimens in adultsand adolescents consist of a thymidine analog nucleosidereverse transcriptase inhibitor (NRTI) [stavudine (d4T) orzidovudine (ZDV)], a thiacytidine NRTI [lamivudine (3TC)]and a non-nucleoside reverse transcriptase inhibitor(NNRTI) [nevirapine (NVP) or efavirenz (EFV)].

The full text of the treatment guidelines can be found at:http://www.who.int/3by5/publications/documents/arv_guidelines/en/

Antituberculosis medicinesThis report does not include data on sources and pricesof medicines for first line treatment of tuberculosis (TB)as this information is available on the website of the Inter-national Price Indicator Guide 200311 or of the GlobalDrug Facility at http://www.stoptb.org/GDF/drugsupply/drugs.available.html.

Further resources for information on TB can be found inAnnex 3, including links to the DOTS-plus for multidrugresistant TB website and the prequalification of TBmedicines.

1.7 Offers of medicine donationsand price reductions

Public pressure, advocacy, competition from genericmanufacturers and initiatives from pharmaceuticalcompanies have led to reduced prices of some medicinesfor developing countries. There is no systematic approachto this equitable pricing. Each company determines itsown eligibility criteria for countries, sectors and institu-tions that may benefit from its reduced price. Some com-panies offer donations of medicines for specific indicationssuch as to prevent mother-to-child transmission of HIV, orto treat certain opportunistic infections affecting PLWAs.

The prices that are quoted in Chapter 4 of this report donot necessarily reflect all agreements that may have beennegotiated with individual countries. Information on priceoffers for ARVs publicly announced by pharmaceuticalmanufacturers, including information on countries eligi-ble for the offers and other conditions, can be found inthe MSF report Untangling the web of price reductions: apricing guide for the purchase of ARVs for developingcountries (see Annex 4). Apart from providing prices ofARVs as offered by originator companies and selectedgeneric companies, it highlights the lack of standardiza-tion among different companies on eligibility and termsand conditions of price offers. For example, some com-panies use UNCTAD classification (Least Developed Coun-tries), or the World Bank classification (Low Income/ MiddleIncome Countries) or a combination of UNDP classifica-tion (Human Development Index) and UNAIDS prevalencedata.

11 The International Price Indicator Guide 2003 is a jointpublication of MSH and WHO. For more information refer toAnnex 4, Websites: Drug Prices.

INTRODUCTION


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1.8 Additional Methods of Costreduction

In addition to generic competition and advocacy for thereduced pricing in line with the purchasing power of coun-tries, important parallel avenues to be pursued by gov-ernments include the active use of compulsory licensing,government use of patents, and parallel importation12.

As agreed by the Member States of the WTO in 2001,Least developed countries (LDCs) are not obliged toenforce pharmaceutical patents until at least 201613. LDCsshould make use or avail themselves of this provision topurchase lowest cost medicines on the world market. Forvaluable and concise information on this subject, pleasesee the MSF report Drug patents under the spotlight: Shar-ing practical knowledge about pharmaceutical patents andHIV/AIDS medicines and related supplies: Contemporarycontext and procurement.12 Alternatively, to obtain fur-ther guidance from the appropriate organisation, pleasefill in the feedback form in Annex 5.

The Global Fund to Fight AIDS, Malaria and Tuberculosis“encourages recipients to comply with national laws andapplicable international obligations in the field of intellec-tual property including the flexibilities provided in the TRIPS

agreement and referred to in the Doha Declaration in amanner that achieves the lowest possible price for prod-ucts of assured quality.”14

Other measures may include reducing or eliminating im-port duties and taxes. As data clearly demonstrate, thesefactors can severely distort the prices patients will payfor medicines compared with the price at which they weresold (see Figure 2). Increasing demand through pooledprocurement may also be an option for purchasers to ex-plore.

Figure 2. Some examples of taxes and mark-ups as a percentage of the import price.

12 For further details, refer to the practical guide “HIV/AIDS Medi-cines and related supplies: Contemporary context andprocurement” Chapter 2: Intellectual Property Rights: a Con-cise Guide. The World Bank, Washington, February 2004.

13 Doha Declaration on the TRIPS agreement and Public Health,paragraphs 6 & 7

14 The Global Fund to Fight AIDS, Tuberculosis and Malaria, Reportof the Third Board Meeting, GF/B4/2, page 25, para 10 (a).

Source: http://www.haiweb.org/medicineprices

7

1.9 Other price information projects

1.9.1 Medicine Prices: a newapproach to measurement

Initiated at the WHO–NGO Round Table in 2000, this projecthas developed technical guidance for a standard approachto the measurement of the prices people pay for key medi-cines. Availability and retail prices are recorded for a corelist of 30 widely used medicines in their originator brand,most-sold and lowest-priced generic versions. Supplemen-tary lists with different medicines can be tailored to meetlocal needs using the same method.

Price information is collected at a sample set of pharma-cies in public, private and one other sector which can bedefined to fit local conditions (eg. NGO agencies, religiousmissions or other charity services, or other types of not-for profit service providers). The method uses median pricesprovided by Management Sciences for Health (MSH) forthe core medicines as a benchmark and the spreadsheet(CD-ROM included) calculates price ratios for each medi-cine to the MSH “reference” price.

The principal add-ons or “price components” between themanufacturer sales price and retail price are estimated forselected medicines, and treatment affordability is calcu-lated for ten common conditions, relative to the daily wageof the lowest paid government worker. The concept ofaffordability is especially important, because it allows toevaluate “access” by referring to the actual income of theindividual, according to a patient-focused approach.

A manual and accompanying spreadsheet on CD-ROM arefreely available in English, French and Spanish on the websites of both WHO: http://www.who.int/medicines/library/prices.shtml and Health Action International: http://www.haiweb.org/medicineprices/

Arabic and Russian versions will be produced in the courseof 2004.

The HAI website also contains an open-access repositoryof data from studies undertaken so far, and a synthesis ofresults from the nine pilot studies.

1.9.2 Price monitoring of pharma-ceutical starting materials

With today’s immense flow of information, finding the rightsource for unbiased, accurate and timely marketintelligence can be difficult, costly and time-consuming.Identifying the right source of information is the first steptoward maximizing international business opportunities.The Market News Service (MNS) of the UNCTAD/Interna-tional Trade Centre (ITC) strives to fill this need by provid-ing detailed price and market information on selectedprimary and semi-processed products of particular inter-est to developing countries and economies in transition,including a monthly report on Pharmaceutical StartingMaterials of Essential Drugs.

The Market News Service (MNS) for Pharmaceutical Start-ing Materials was established in 1992 in collaborationwith the Essential Drugs and Medicine Policy (EDM) of theWorld Health Organization (WHO) to issue a monthly re-port providing up-to-date prices and supporting commer-cial data on pharmaceutical starting materials used in theproduction of essential medicines. The report of Decem-ber 2003 listed 303 active pharmaceutical ingredients.The report is an information source with the sole aim ofimproving market transparency and encouraging price andquality competition for the benefit of all market players. Itcovers the main trading centres in Europe and Asia anddraws information from a network of price informationproviders.

INTRODUCTION


8

Figure 3. Price trends of various active pharmaceutical ingredients used in manufacturingantiretroviral medicines.

The prices of active pharmaceutical ingredients used in manufacturing antiretrovirals have been significantly reducedduring the last two years as shown in the graph below.

As part of its effort to provide information to improvemarket transparency, MNS reports are now directly avail-able on-line through ITC’s latest market analysis tool, Prod-uct Map, www.p-maps.org, a subscription based service.Subscribers from least developed countries and WHORegional Offices receive printed copies free-of-charge. The

Product Map on Pharmaceuticals combines quantitativemarket information in relation to international trade sta-tistics and macroeconomic indicators, qualitative marketintelligence - such as market briefs and published marketstudies - and networking links to key market players in thepharmaceuticals industry.

9


2. Diagnostics

ARVs have to be used with appropriate and cost-effectivediagnostics. Diagnostic technologies are important tomonitor the progression of the disease, the safety andefficacy of the treatment and the development ofresistance.

Since 1988, WHO has provided objective assessmentsof commercially available HIV test kits. This ongoing evalu-ation programme is coordinated by the WHO Departmentof Essential Health Technologies in collaboration with theUNAIDS Secretariat.

In 1989, WHO established a HIV test kit bulk-procurementscheme, which is now operated in collaboration with otherUN agencies. The aim is to provide national AIDS pro-grammes, blood transfusion services, large hospitals, non-governmental organizations, reference laboratories, UNagencies, donor-supported AIDS projects, and regulatoryauthorities in developing countries with high quality testsat reasonable cost. All HIV tests available through thescheme have been successfully evaluated by the WHOevaluation programme and meet specific, rigorous crite-ria. Manufacturers of test kits that have met the criteriaare invited to make their quotations in a selective tenderprocess. In addition to the assay performance other as-pects such as production capacity, distribution and serv-ice networks, patent issues, shelf life and storageconditions, are considered. This process has enabled theUN agencies to offer high quality tests at reduced prices,resulting in considerable annual savings to countries.

The test kits listed in chapter 4 are reviewed annually andcover the three broad categories, including simple/rapidtests, ELISA tests and supplemental tests.

The demand for simple/rapid HIV tests has increased anda wide range of high quality simple/rapid tests are avail-able. These are easy-to-use tests that require little or noequipment and limited training to perform and can provideaccurate same-day results. This makes them particularlysuitable for use in voluntary counselling and testing (VCT)centres and in antenatal clinics for prevention of motherto child transmission of HIV. When initial tests are reac-tive for HIV, confirmation of the test results is needed torule out any false positive results.

The existing systems for assessment and procurementof HIV test kits are being expanded to include technolo-gies used to monitor ARV therapy (CD4+ counts and viralload) and drug resistance.

An overview of types of CD4+ T-cell enumeration tech-nologies available are given in Annex 1A, whilst informa-tion on HIV viral load technologies is given in Annex 1B.Please note that this information is regularly updated anda v a i l a b l e a t : h t t p : / / w w w . w h o . i n t / e h t / M a i n_areas_of_work/BTS/HIV_Diagnostics/HIV_Test_Kit_Evaluation.htm#Reports

Additional documents with relevant information related todiagnostics are listed in Annex 3.


10

3. Access to quality HIV/AIDSmedicines

3.1 Prequalification project

The Procurement, Quality and Sourcing Project was initi-ated by WHO in collaboration with other United NationsOrganizations (UNAIDS Secretariat, UNICEF, and UNFPA,supported by the World Bank) in March 2001, as part of aUN-wide strategy to improve access to HIV-related treat-ment.

This project evaluates pharmaceutical products accord-ing to WHO recommended standards of safety, efficacyand quality and compliance with good manufacturing prac-tices (GMP). The prequalification process follows a stand-ard procedure developed through WHO ’s ExpertCommittee on Specifications for Pharmaceutical Prepa-rations. Assessment of product dossiers submitted bycompanies and GMP inspections are followed promptlyby feedback to the companies concerned. A medicine isadded to the list of prequalified products only when theproducts and manufacturing sites meet the required stand-ards. A list of HIV-related products/manufacturers thathave been found acceptable, in principle, for procurementby UN agencies is available on the web sites of collabo-rating UN agencies.

As of January 2004, 265 product dossiers for variousproducts and dosage forms from over 40 manufacturerswere received: 95 of these products, from 26 manufac-turing sites have been fully reviewed and listed asprequalified products. The remaining products are cur-rently under review. The products evaluated are ARVs (in-cluding fixed dose combinations), and medicines for thetreatment of opportunistic infections and cancers. A listof products evaluated under this project is regularly up-dated through the websites of collaborating UN agencies.Interested readers are advised to consult these sites forthe latest versions, or to access the list via the WHOwebsite: http://mednet3.who.int/prequal/.

This report is a pricing service, not a prequalification serv-ice. Every effort has been made to ensure the accuracyof the price information presented here and screening ofthe products included in this survey has been carried outas indicated on page 3. However, this screening in noway constitutes an in depth review of product quality. Prod-ucts that have been prequalified are marked in Annex 2B

of this report in bold and with an asterisk (*). Other prod-ucts listed in this document should, in relation to purchase,be subject to prequalification review as indicated in theWHO General Procedure for Prequalification of Suppliersof Pharmaceutical Products. Manufacturers are encour-aged to apply for WHO prequalification for their HIV-re-lated products.

In scaling up access to ARVs, it is not only the quantity ofmedicines that is important, but also their quality. ThePrequalification Project will guide potential buyers or pro-curement agencies by providing them with a current, reli-able and standardised inventory to select from whenpurchasing these life-saving medicines.

3.2 Product registration

In order to guide procurement, governments must ensurethey have strong national drug regulatory authorities(DRAs) with a clear mandate and legal authority,appropriate organizational structure, adequate number ofqualified staff, sufficient resources and a sustainablefinancing mechanism.

The primary objective of DRAs is to safeguard public healthby ensuring that all medicines circulating in the marketsmeet appropriate standards of safety, quality and efficacy.Safety aspects cover potential or actual harmful effects;quality relates to development and manufacture; andefficacy is a measure of the beneficial effect of themedicine on patients.

To assist procurement agencies with regulatory aspectsof medicine importation and procurement, Annex 2A pro-vides information on countries in which the majority ofproducts listed in this report are currently registered. Thisinformation is provided by manufacturing companies andis subject to change.

To improve the accuracy of this publication, DRAs arestrongly encouraged to submit any known changes orcorrections to the data provided, either by email [email protected]; or by fax to UNICEF Supply Division inCopenhagen, Denmark +45 35269421.


11

Table 1. Anti-infective medicines

Manufacturer Indicative prices, US$ List prices, US$

No No

of of

Anthelminthics manuf countries unit max min median 25th perc Brazil Spain

albendazole

chewable tablet, 400 mg 10 5 tab 0.180 0.015 0.036 0.022 0.048 1.317

Antibacterials,beta lactam medicines

benzathine benzylpenicillin

powder for injection, 1 1 vial 0.257 0.257 0.257 0.257 none n/a1.44 g (=2.4 million IU) in 24-ml vial

powder for injection, 3 3 vial 1.660 0.150 0.170 0.160 none 2.8711.44 g (=2.4 million IU) in 5-ml vial

benzylpenicillin

powder for injection, 3 g (=5 million IU) 3 3 vial 0.346 0.150 0.180 0.165 0.619 1.211(as sodium or potassium salt) in vial

powder for injection, 600 mg 1 1 vial 0.268 0.268 0.268 0.268 none n/a(=1 million IU) (as potasium salt) in vial

cefixime

paediatric oral suspension, 3 3 ml 0.201 0.025 0.034 0.030 none 1.856100 mg/5 ml

paediatric oral suspension, 1 1 ml 0.108 0.108 0.108 0.108 none n/a40 mg/5 ml

powder for injection, – – vial – – – – none n/a250 mg (as sodium salt)*

tablet, 200 mg 3 2 tab 1.213 0.315 0.375 0.345 none 0.935


ceftriaxone

powder for injection, 18 12 1g vial 12.680 0.600 1.086 0.852 0.687 8.2471 g (as sodium salt) in vial

powder for injection, 13 8 vial 2.809 0.230 0.775 0.650 none 2.684250 mg (as sodium salt) in vial

powder for injection, 11 8 vial 8.140 0.320 0.825 0.756 none 4.322500 mg (as sodium salt) in vial

procaine benzylpenicillin

powder for injection, 3 3 vial 0.237 0.144 0.170 0.157 none n/a3 g (=3 million IU) in vial


* No price informationnone - no purchase has been made for this product, therefore no minimum price payable is availablen/a - not available

4. Prices of medicinesand diagnostics

4.1 Medicines


12


No No

of ofOther antibacterials manuf countries unit max min median 25th perc Brazil Spain

azithromycin

oral suspension, 2 2 ml 0.200 0.040 0.120 0.080 0.078 0.310200 mg/5 ml (dihydrate)

capsule/tablet, 250 mg (dihydrate) 8 4 caps/tab 0.532 0.117 0.198 0.147 none 1.685

capsule/tablet, 500 mg (dihydrate) 8 5 caps/tab 1.500 0.250 0.470 0.308 0.447 4.120

capreomycin

powder for injection, 1 g in vial 2 2 1g vial 5.000 5.000 5.000 5.000 none 2.730

chloramphenicol

oily suspension for injection, 1 1 amp 0.620 0.620 0.620 0.620 none n/a0.5 g/ml (as sodium succinate)in 2-ml ampoule

oral suspension, 1 1 ml 0.006 0.006 0.006 0.006 none n/a150 mg/5 ml (as palmitate)

powder for injection, 5 4 1g vial 0.680 0.175 0.231 0.200 0.371 1.0551 g (sodium succinate) in vial

ciprofloxacin

tablet, 250 mg (as hydrochloride) 29 16 tab 0.605 0.011 0.041 0.018 0.048 0.227


clarithromycin

oral suspension, 125 mg/5 ml* – – ml – – – – none n/a

powder for injection, 500 mg 1 1 vial 0.700 0.700 0.700 0.700 none 23.346

tablet, 250 mg 15 10 tab 0.434 0.105 0.170 0.151 0.296 0.600

clindamycin

capsule, 150 mg 2 2 caps 0.113 0.036 0.075 0.055 0.660 0.164

injection, 150 mg/ml 1 1 amp 1.848 1.848 1.848 1.848 0.464 1.506(as phosphate) in 2-ml ampoule

cycloserine

capsule, 250 mg 2 2 caps 0.600 0.466 0.533 0.500 none n/a

doxycycline

capsule/tablet, 100 mg (hydrochloride) 15 10 caps/tab 0.114 0.007 0.015 0.011 0.052 0.112

erythromycin

powder for injection, – – vial – – – – none n/a500 mg (as lactobionate) in vial*

powder for oral suspension, 10 9 ml 0.899 0.005 0.011 0.008 0.010 n/a125 mg (as stearate or ethylsuccinate)

capsule/tablet, 250 mg 19 10 caps/tab 0.068 0.020 0.031 0.026 none 0.099(as stearate or ethylsuccinate)

capsule/tablet, 500 mg 12 7 caps/tab 0.126 0.040 0.051 0.046 0.099 0.202(as stearate or ethylsuccinate)


13


No No

of ofOther antibacterials manuf countries unit max min median 25th perc Brazil Spain

gentamicin

injection, 10 mg (as sulfate) in 2-ml vial 4 4 vial 0.295 0.045 0.073 0.045 0.072 n/a

injection, 40 mg (as sulfate) in 2-ml vial 7 4 vial 0.319 0.047 0.058 0.056 0.065 0.615

metronidazole

injection, 500 mg in 100-ml vial 6 6 vial 2.880 0.300 1.268 0.827 0.189 3.039

Suppository, 1 g 1 1 sup 0.450 0.450 0.450 0.450 none n/a

Suppository, 500 mg* – – sup – – – – none n/a

ofloxacin

IV infusion, 2 mg/ml (hydrochloride) 1 1 ml 0.032 0.032 0.032 0.032 none 17.828


tablet, 400 mg 5 4 tab 0.661 0.062 0.100 0.082 1.014 n/a

rifabutin

capsule, 150 mg 1 1 caps 0.753 0.753 0.753 0.753 none 2.813

silver nitrate

solution (eye drops), 1% 1 1 ml 0.070 0.070 0.070 0.070 none n/a

spectinomycin

powder for injection, 2 g 3 3 vial 4.000 2.747 3.750 3.249 none n/a(as hydrochloride) in vial

sulfadiazine

injection, 250 mg – – amp – – – – none n/a(sodium salt) in 4-ml ampoule*

tablet, 500 mg 4 4 tab 0.298 0.037 0.060 0.037 0.018 0.075

sulfamethoxazole+trimethoprim

injection, 80+16 mg/ml – – amp – – – – none 0.789in 5-ml ampoule*

oral suspension, 200+40 mg/5 ml 15 9 ml 0.137 0.003 0.006 0.005 0.002 0.022

tablet, 100+20 mg 9 7 tab 0.187 0.004 0.006 0.005 none 0.026

tablet, 400+80 mg 23 13 tab 0.187 0.005 0.010 0.008 0.016 0.049

tablet, 800+160 mg 11 9 tab 0.100 0.009 0.019 0.015 0.069 0.129

tetracycline

tablet, 500 mg 3 3 tab 0.021 0.014 0.014 0.014 0.031 n/a

4. PRICES OF MEDICINES AND DIAGNOSTICS



14


No No

of ofAntifilarials manuf countries unit max min median 25th perc Brazil Spain

crotamiton

cream/lotion 10% 1 1 ml 0.010 0.010 0.010 0.010 none 0.665

ivermectin

scored tablet, 3 mg* – – tab – – – – none n/a

scored tablet, 6 mg* – – tab – – – – none n/a

lindane

cream, lotion or powder 0.3%* – – tube – – – – none n/a

permethrin

cream, 5%* – – tube – – – – none 9.201

lotion, 1% – – tube – – – – none n/a

Antifungal medicines

amphotericin B

liposomal IV infusion, 5 mg/ml* – – vial – – – – none 172.950

liposomal IV infusion, – – vial – – – – none 76.089powder for reconstitution 50 mg*

powder for injection, 50 mg in vial 2 2 vial 9.000 5.181 7.091 6.136 2.426 2.567

clotrimazole

cream, 1% 11 10 gram 0.240 0.007 0.027 0.018 0.653 1.622

pessary, 500 mg 2 2 pess 0.600 0.026 0.313 0.170 none 2.196

fluconazole


capsule, 150 mg 9 4 caps 1.840 0.034 0.500 0.280 0.151 4.303


oral suspension, 50 mg/5 ml* – – ml – – – – none n/a

solution for injection, 5 2 ml 0.042 0.029 0.033 0.029 0.014 n/a2 mg/ml in ampoule

itraconazole

capsule, 100 mg 3 3 caps 0.640 0.128 0.500 0.314 0.292 1.539

oral solution, 10 mg/ml* – – ml – – – – none 2.126

ketoconazole

cream, 2% 7 5 gram 0.227 0.014 0.044 0.022 none 3.831

oral suspension, 100 mg/5 ml* – – ml – – – – none 0.087



15


No No

of ofAntifungal medicines manuf countries unit max min median 25th perc Brazil Spain

miconazole

cream/ointment 2% 5 5 tube 1.176 0.350 0.418 0.400 none n/a(as nitrate) 15 g tube

cream/ointment 2% 8 5 tube 0.980 0.130 0.435 0.394 0.618 2.395(as nitrate) 30 g tube

nystatin

lozenge, 100,000 IU* – – loz – – – –- none n/a

pessary, 100,000 IU 5 4 pess 0.030 0.017 0.024 0.021 none 0.071

tablet, 100,000 IU 2 2 tab 0.025 0.022 0.024 0.023 none 0.000

tablet, 500,000 IU 7 4 tab 0.069 0.022 0.036 0.030 none 0.081

Antiprotozoal medicines

pentamidine

powder for injection, 1 1 vial 9.000 9.000 9.000 9.000 none n/a200 mg (isetionate) in vial

tablet, 200 mg* – – tab – – – – none n/a

tablet, 300 mg* – – tab – – – – none n/a

powder for injection, 4 4 vial 48.400 9.980 18.350 11.495 36.948 10.739300 mg (isetionate) in vial

pyrimethamine

tablet, 25 mg 2 2 tab 0.050 0.045 0.048 0.046 0.017 0.079

tinidazole

tablet, 2 g* – – tab – – – – none n/a


Antiviral medicines

aciclovir

cream, 5% 4 3 gram 0.986 0.037 0.450 0.039 0.409 1.424

powder for injection, 3 3 vial 14.286 2.000 3.451 2.726 1.457 4.923250 mg (as sodium salt) in 10-ml vial

tablet, 200 mg 14 10 tab 0.540 0.030 0.054 0.039 0.086 0.699

tablet, 400 mg 12 8 tab 0.565 0.048 0.084 0.062 none n/a


cidofovir

IV infusion, 75 mg/ml in vial* – – vial – – – – none n/a

famciclovir

tablet, 125 mg* – – tab – – – – none 3.095





16


No No

of of

Antiviral medicines manuf countries unit max min median 25th perc Brazil Spain

foscarnet sodium

IV infusion, 24 mg/ml – – vial – – – – none 40.326

ganciclovir

capsule, 250 mg* – – caps – – – – none 4.027

capsule, 500 mg* – – caps – – – – none n/a

powder for IV infusion, 500 mg in vial 1 1 vial 42.520 42.520 42.520 42.520 17.337 24.874

imiquimod

cream, 5%* – – tube – – – – none n/a

podofilox

cream, 0.15%* – – tube – – – – none 17.182

solution or gel, 0.5%* – – tube – – – – none 11.040

podophyllum resin

solution, 10-25%* – – ml – – – – none n/a

valacyclovir


valganciclovir


Antiviral medicines – Antiretrovirals

abacavir (ABC)

syrup, 20 mg/ml 1 1 ml 0.131 0.131 0.131 0.131 none 0.333


didanosine (ddI)

buffered chewable tablet, 100 mg 8 6 tab 0.376 0.179 0.298 0.241 0.317 1.370

buffered chewable tablet, 25 mg 5 5 tab 0.286 0.083 0.108 0.083 none 0.342

syrup, 2 g 2 2 ml 0.171 0.125 0.148 0.137 none 27.402

unbuffered enteric coated capsule, – – caps – – – – none 2.139125 mg*

unbuffered enteric coated capsule, 2 1 caps 0.666 0.648 0.657 0.653 none 3.923250 mg

unbuffered enteric coated capsule, 2 1 caps 1.008 0.928 0.968 0.948 none 5.596400 mg

efavirenz (EFZ)

capsule, 50 mg* – – caps – – – – none n/a

capsule, 200 mg 4 2 caps 2.001 0.490 0.540 0.518 none n/a

tablet, 600 mg 3 1 tab 1.582 1.300 1.467 1.384 2.182 n/a


17


No No

of of

Antiviral medicines-Antiretrovirals manuf countries unit max min median 25th perc Brazil Spain

indinavir (IDV)


capsule, 400 mg 6 3 caps 1.058 0.301 0.341 0.308 0.404 1.934

lamivudine (3TC)

syrup, 50 mg/5 ml 3 3 ml 0.028 0.025 0.025 0.025 0.035 0.208

tablet, 150 mg 13 8 tab 1.531 0.086 0.150 0.124 0.237 3.129


nelfinavir (NFV)

capsule, 250 mg 6 4 caps 1.340 0.269 0.520 0.311 0.611 1.453

powder for suspension, 50 mg/g* – – g – – – – none 0.466

nevirapine (NVP)

syrup, 50 mg/5 ml 3 2 ml 0.100 0.015 0.031 0.023 0.143 0.225


saquinavir (SQV)


stavudine (d4T)



capsule, 30 mg 11 7 caps 0.140 0.047 0.068 0.065 0.093 2.830

capsule, 40 mg 15 10 caps 2.101 0.058 0.101 0.079 0.182 2.925

syrup, 1 mg/ml 3 3 ml 0.050 0.011 0.048 0.049 none 0.596

tenofovir (TDF)


zalcitabine (ddC)

tablet, 0.375 mg 1 1 tab 0.402 0.402 0.402 0.402 none n/a

tablet, 0.75 mg 2 2 tab 0.865 0.761 0.813 0.787 none 1.757

zidovudine (AZT or ZDV)

capsule, 100 mg 14 10 caps 0.617 0.084 0.142 0.113 0.114 1.097



injection, 10 mg/ml in 20-ml vial 1 1 vial 5.000 5.000 5.000 5.000 1.443 8.532

oral solution, 50 mg/5 ml 3 3 ml 0.036 0.019 0.026 0.023 0.015 0.085




18


No No

Antiviral medicines - Antiretrovirals of of(combinations) manuf countries unit max min median 25th perc Brazil Spain

3TC/AZT

tablet, 300/150 mg 11 7 tab 2.951 0.278 0.384 0.328 0.471 8.036

3TC/D4T/NVP

tablet, 150/30/200 mg 1 1 tab 0.431 0.431 0.431 0.431 none n/a


ABC/3TC/ZDV

tablet, 300/150/300 mg 2 2 tab 2.294 1.700 1.997 1.849 none 13.566

AZT/3TC/NVP


lopinavir/ritonavir (LPV/r)

oral solution, 20+80 mg/ml* – – ml – – – – none 8.060

capsule, 133.3+33.3 mg* – – caps – – – – none 2.687

Table 2. Antineoplastic medicines


No No

of ofCytotoxic medicines manuf countries unit max min median 25th perc Brazil Spain

bleomycin

powder for injection, 15 mg 2 2 vial 21.000 18.000 19.500 18.750 22.515 13.930(as sulfate) in vial

calcium folinate (leucovorin)


doxorubicine HCl

powder for injection, 10 mg in 5-ml vial 4 4 vial 23.720 3.000 7.660 5.063 3.196 7.286

powder for injection, 50 mg in 25-ml vial 4 4 vial 111.111 14.000 29.525 17.675 14.739 31.858

etoposide

capsule, 100 mg* – – caps – – – – none 11.566

injection, 20 mg/ml in 5-ml ampoule 5 3 amp 31.211 1.723 9.850 5.000 2.921 2.492

methotrexate

injection, 25 mg/ml 2 2 vial 18.100 1.400 9.750 5.575 2.062 3.603(as sodium salt) in 2-ml vial

powder for injection, 3 3 vial 4.310 2.000 3.360 2.680 none 3.77250 mg (as sodium salt) in 2-ml vial

tablet, 2.5 mg 4 3 tab 0.188 0.031 0.068 0.057 none 0.056

vinblastine

powder for injection, 3 2 vial 14.260 1.400 2.347 1.874 11.684 6.81510 mg (sulfate) in 10-ml vial

19


No No

of of

Cytotoxic medicines manuf countries unit max min median 25th perc Brazil Spain

vincristine

injection, 1 mg/ml (sulfate) in vial 3 3 vial 4.500 0.674 3.080 1.877 2.405 n/a

powder for injection, 1 1 vial 2.000 2.000 2.000 2.000 2.405 5.4681 mg (sulfate) in 1-ml vial

vinorelbine

injection concentrate 10 mg/ml in vial 1 1 ml 16.480 16.480 16.480 16.480 143.086 21.352

Table 3. Medicines used for the treatmentof mental and substance use disorders


No No

Medicines used of ofin depressive disorders manuf countries unit max min median 25th perc Brazil Spain

amitriptyline


fluoxetine

tablet, 20 mg 10 7 tab 0.491 0.015 0.078 0.040 0.034 0.221

Medicines used in generalizedanxiety and sleep disorders

lorazepam

injection, 4 mg/ml in ampoule* – – amp – – – – none n/a


methotrimepazine /methotrimepazine/levomepromazine

injection, 25 mg/ml in ampoule – – amp – – – – none 0.181

tablet, 25 mg 2 2 tab 0.108 0.033 0.071 0.052 0.038 0.059

Medicines used in the treatmentof opioid dependence

buprenorphine

sublingual tablet, – – tab – – – – none 0.370200 mcg (hydrochloride)*

sublingual tablet, – – tab – – – – none n/a400 mcg (hydrochloride)*

naltrexone HCl





20

Table 4. Analgesics


No No

of ofOpioid analgesics manuf countries unit max min median 25th perc Brazil Spain

codeine

tablet, 30 mg (phosphate) 5 5 tab 0.066 0.020 0.034 0.030 0.232 0.100

methadone


morphine

injection, 10 mg/ml 6 4 amp 1.998 0.271 0.470 0.311 0.495 0.231(sulfate or HCl), in 1-ml ampoule

oral solution, 4 2 ml 1.000 0.055 0.058 0.056 none n/a10 mg/5 ml (sulfate or HCl)

tablet, modified release, 10 mg (sulfate) – – tab – – – – none 0.137

pethidine

injection, 50 mg/ml 4 3 amp 0.450 0.284 0.370 0.334 0.344 n/a(hydrochloride) in 1-ml ampoule

injection, 50 mg/ml 7 6 amp 1.773 0.258 0.505 0.392 none 0.598(hydrochloride) in 2-ml ampoule



Table 5. Gastrointestinal medicines


No No

Antacids and other of of

antiulcer medicines manuf countries unit max min median 25th perc Brazil Spain

omeprazole

capsule, 10 mg 8 6 caps 0.312 0.014 0.070 0.050 0.028 n/a

capsule, 20 mg 19 9 caps 1.046 0.011 0.093 0.030 0.034 0.210


powder for injection, 1 1 vial 3.000 3.000 3.000 3.000 1.371 9.58440 mg (as sodium salt) in vial

powder for IV infusion, 2 2 vial 3.000 1.950 2.475 2.213 none n/a40 mg (as sodium salt) in vial


2121


No No

of ofAntiemetic medicines manuf countries unit max min median 25th perc Brazil Spain

dimenhydrinate


metoclopramide

injection 5 mg/ml in 2-ml ampoule 5 5 amp 0.219 0.055 0.112 0.108 0.062 0.177


prochlorperazine

injection, 12.5 mg/ml 2 2 ml 0.359 0.130 0.245 0.187 none n/a


Laxatives

docusate sodium

capsule, 100 mg* – – tab – – – – none n/a




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26

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27

Man

ufac

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Fax

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site

Prod

ucts

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tis L

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cons

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), st

avud

ine

(d4T

), zi

dovu

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(AZT

or

ZDV)

Repu

blic

of K

orea

5. LIST OF MANUFACTURERS - MEDICINES AND DIAGNOSTICS


28

Man

ufac

ture

rAd

dres

sTe

leph

one

Fax

E-m

ail/

Web

site

Prod

ucts

Cipl

a Lt

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ella

sis

Road

+91

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BC),

acic

lovi

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azi

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Indi

ace

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side

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V), l

amiv

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TC),

met

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lfina

vir

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pine

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stat

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dine

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nbla

stin

e, v

incr

istin

e,zi

dovu

dine

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or

ZDV)

.

CLAR

IS L

ifesc

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tdCo

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in,

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Edifi

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Cona

ta 2

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ww

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pen

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CH-4

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cin,

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29

Man

ufac

ture

rAd

dres

sTe

leph

one

Fax

E-m

ail/

Web

site

Prod

ucts

Gla

xo S

mith

Klin

eG

SK H

ouse

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baca

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reat

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t Roa

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lam

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TW8

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Gle

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arm

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Ashr

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d ra

pid

less

hum

an e

rror

, low

bio

-haz

ard

risk,

Qui

ck r

esul

ts,

Abso

lute

CD

4 an

d CD

8 co

unts

Abso

lute

CD

4 an

d CD

8 co

unts

,EQ

A av

aila

ble

Qui

ck re

sults

, EQ

A av

aila

ble

Dis

adva

ntag

esEx

pens

ive

reag

ents

,CD

4% a

mon

g ly

mph

ocy t

es10

sam

ples

pro

cess

ed a

t a ti

me,

6 sa

mpl

es p

roce

ssed

at a

tim

e,12

sam

ples

pro

cess

ed a

t a ti

me,

not

repo

rted

,Su

bjec

tivity

in v

isua

l cou

ntin

g,Su

bjec

tivity

in v

isua

l cou

ntin

g,CD

4% a

mon

g ly

mph

ocy t

esIn

stru

men

t not

pro

ven

inCD

4% a

mon

g ly

mph

ocy t

es o

r CD

8 co

unts

CD4%

am

ong

lym

phoc

y tes

not

rep

orte

d a

n in

depe

nden

t mul

ti-ce

ntre

stu

dy n

ot re

port

ed.

No

EQA

avai

labl

e n

ot re

port

ed.

No

EQA

avai

lab

MAb

– m

onoc

lona

l ant

ibod

y; E

QA

– ex

t ern

al q

ualit

y as

sess

men

ta T

he a

naly

sis

of c

orre

lat io

n us

ing

linea

r re

gres

sion

is n

ot a

ppro

pria

t e t o

st u

dy m

etho

d co

mpa

rison

. Ins

t ead

, the

ana

lysi

s of

agr

eem

ent s

houl

d be

per

form

ed. U

nfor

t una

t ely

, non

e of

t he

publ

ishe

d st

udie

s ha

sus

ed t

his

anal

ysis

t o c

ompa

re t h

ese

met

hods

wit h

flow

cyt

omet

ry. T

here

fore

, her

e t h

e r

valu

es a

re s

t ill r

epor

t ed.

b D

epen

ding

on

if a

light

or

fluor

esce

nce

mic

rosc

ope

is u

sed.

c Rea

gent

cos

t may

dec

reas

e su

bst a

ntia

lly in

t he

near

fut u

re.



38

B an

d N

K ce

lls –

sub

sets

of l

ymph

ocy t

es; Q

C –

qual

ity c

ontr

ol; E

QA

– ex

tern

al q

ualit

y as

sess

men

ta A

ny fl

ow c

y tom

eter

from

any

of t

he th

ree

man

ufac

ture

rs c

an o

pera

te w

ith th

is m

etho

d to

pro

vide

abs

olut

e co

unts

. The

resu

lts o

f flo

w c

y tom

etry

are

com

bine

d w

ith th

ose

from

hae

mat

olog

y to

cal

cula

te a

bsol

ute

coun

ts.

b Vol

umet

ric in

stru

men

ts h

ave

the

inhe

rent

har

dwar

e pr

oper

ty o

f mea

surin

g th

e vo

lum

e of

the

sam

ple,

pro

vidi

ng d

irect

abs

olut

e co

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with

out t

he u

se o

f hae

mat

olog

y an

aly s

ers

or b

eads

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ny fl

ow c

y tom

eter

from

any

of t

he th

ree

man

ufac

ture

rs c

an o

pera

te w

ith th

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etho

d to

pro

vide

abs

olut

e co

unts

.d I

nstr

umen

ts fr

om th

is m

anuf

actu

rer,

incl

udin

g th

e Cy

Flow

, rem

ain

to b

e va

lidat

ed a

s vo

lum

etric

abs

olut

e CD

4 T

cell

coun

ters

by

inde

pend

ent i

nves

tigat

ors

in m

ultic

entr

ic s

tudi

es.

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w c

yto

met

ry

Para

met

erD

oubl

e-pl

atfo

rma

Sing

le-p

latf

orm

Volu

met

ricb

Bea

d-ba

sedc

Inst

rum

ents

, Man

ufac

ture

rsFl

ow c

ytom

eter

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cyt

omet

erFl

ow c

ytom

eter

Part

ec G

mbH

(M

unst

er, G

erm

any)

dPa

rtec

Gm

bH (

Mun

ster

, Ger

man

y)d

Bect

on D

icki

nson

(CA,

USA

)Be

cton

Dic

kins

on (

CA,U

SA)

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va T

echn

olog

ies

(CA,

USA)

Coul

ter

Corp

orat

ion

(FL,

USA

)Co

ulte

r Co

rpor

atio

n (F

L, U

SA)

Cos

t of

inst

rum

ent

(US$

)20

000

– 9

5 00

020

000

– 7

0 00

020

000

– 9

5 00

0

Cos

t of

rea

gent

s/te

st (

US$

)3

– 11

2 –

108

– 25

Spec

imen

Who

le b

lood

Who

le b

lood

Who

le b

lood

Res

ults

Abso

lute

CD

4 co

unt

Abso

lute

CD

4 co

unt

Abso

lute

CD

4 co

unt

Abso

lute

CD

8 co

unt

Abso

lute

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lute

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8 co

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and

CD

8% a

mon

g ly

mph

ocy t

esCD

4% a

nd C

D8%

am

ong

lym

phoc

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CD4%

and

CD

8% a

mon

g ly

mph

ocy t

esCD

4/CD

8 ra

tioCD

4/CD

8 ra

tioCD

4/CD

8 ra

tioB

and

NK

cells

are

pos

sibl

eB

and

NK

cells

are

pos

sibl

eB

and

NK

cells

are

pos

sibl

e

Thro

ughp

ut (

sam

ples

/day

)Up

to 2

00Up

to 5

0Up

to 2

00

Adva

ntag

esAc

cura

te p

ipet

ting

less

cru

cial

No

need

for

extr

a be

ads

or h

aem

atol

ogy

anal

y ser

No

need

for

haem

atol

ogy

anal

y ser

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tube

ass

ay p

ossi

ble

with

out Q

C pr

oble

ms

or

haem

atol

ogy

anal

y ser

Prot

ocol

s fo

r ag

ed s

ampl

es a

vaila

ble

EQA

avai

labl

eEQ

A av

aila

ble

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avai

labl

e

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adva

ntag

esRe

quire

s th

e us

e of

a h

aem

atol

ogy

anal

y ser

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ires

accu

rate

pip

ettin

g te

chni

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rate

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ettin

g te

chni

que

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e pr

one

to c

leric

al e

rror

sIn

tern

al Q

C fo

r pi

petti

ng re

quire

s tw

o tu

bes

assa

yIn

tern

al Q

C fo

r pi

petti

ng re

quire

s tw

o tu

bes

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h sa

mpl

es n

eede

d in

ord

er to

Inst

rum

ents

not

yet

pro

ven

in a

n in

depe

nden

t a

ssay

obt

ain

abso

lute

cou

nts

mul

ti ce

ntre

stu

dyBe

ads

are

expe

nsiv

e an

d re

quire

car

eful

han

dlin

g

3939

ANN

EX 1

B

Su

mm

ary

of

mai

n c

har

acte

rist

ics

of

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al L

oad

Tec

hn

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gies

(nuc

leic

aci

d ba

sed)

Com

pany

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ttR

oche

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erbi

oMér

ieux

bioM

érie

uxPr

imag

en

Assa

y N

ame

LcX

® H

IV R

NA

Ampl

icor

HIV

-1Ve

rsan

t® H

IV-1

Nuc

liSen

s®N

ucliS

ens

Easy

Q®

Ret

inaTM

Qua

ntita

tive

Mon

itor®

Tes

tR

NA

3.0

Assa

yH

IV-1

-QT

HIV

-1R

ainb

ow

Type

of

assa

yRT

-PCR

RT-P

CRbD

NA

NAS

BAN

ASBA

NAS

BA

Dyn

amic

Ran

ge50

– 1

000

000

50 –

750

000

75 –

500

000

50 –

1 0

00 0

0050

– 3

000

000

500

– 50

000

000

(cop

ies/

ml)

Spec

imen

Typ

ePl

asm

aPl

asm

a, d

ried

bloo

dPl

asm

aPl

asm

a, s

erum

, drie

dPl

asm

a, s

erum

, drie

dPl

asm

a, s

erum

, who

le b

lood

,sp

ots

bloo

d sp

ots

bloo

d sp

ots

drie

d bl

ood

spot

s

Spec

imen

vol

ume

200

– 1

000

µl10

0 –

500

µl1

000

– 2

000

µl10

– 2

000

µl

10 –

2 0

00 µ

l20

0 µl

Area

of

HIV

Pol

Gag

Pol

Gag

Gag

LTR

geno

me

ampl

ified

HIV

-1 s

ubty

pes

Gro

up M

(sub

type

s A-

G)

All,

plus

som

e HI

V-2

Gro

up M

(sub

type

s A-

G)

All

All

All

ampl

ified

and

Gro

up O

Tim

e fo

r re

sult

5 ho

urs

6 –

7 ho

urs

22 h

ours

2 ho

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1.5

hour

s

Cos

t/te

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– 7

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ber

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yer

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rifug

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Heat

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agem

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com

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qua

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r al

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40

Com

pany

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ttR

oche

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erbi

oMér

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érie

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imag

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pmen

t C

ost

($U

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10 0

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er14

0 00

013

0 00

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000

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00Am

plip

rep

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em A

naly

zer

30 0

00

(non

-nuc

leic

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pany

Cav

idi

Perk

in E

lmer

Inno

gene

tics

ExaV

irTM

Load

Qua

ntita

tive

HIV

-1 p

24 U

ltra

ELIS

AAs

say

Nam

eH

IV-R

T Lo

ad K

itEL

AST

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A am

plifi

catio

n sy

stem

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test

TM

Type

of

Assa

yEn

zym

e im

mun

oass

ay fo

r qu

antit

atio

n of

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me

imm

unoa

ssay

for

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titat

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ofEn

zym

e im

mun

oass

ay fo

r qu

antit

atio

n of

RT a

ctiv

ityp2

4 an

tigen

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antig

en

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amic

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ge75

0 –

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000

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es/m

l40

0 co

pies

/ml

7 pg

/ml –

250

(50

– 20

0 00

0 co

pies

/ml)

Spec

imen

Typ

ePl

asm

aPl

asm

a, s

erum

or

cell

cultu

re s

uper

nata

ntPl

asm

a, s

erum

or

cell

cultu

re s

uper

nata

nt

Spec

imen

Vol

ume

1000

µl

100

µl10

0 µl

Area

of

HIV

Gen

ome

Sele

cted

RT a

ctiv

ityp2

4 an

tigen

p24

antig

enfo

r Am

plifi

catio

n

HIV

-1 S

ubty

pes

Ampl

ified

All,

plus

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V-1

All,

plus

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-2

Tim

e fo

r R

esul

t24

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rs2.

30 h

ours

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urs

Cos

t/Te

st (

US$

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Num

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of S

ampl

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t R

equi

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bato

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), EL

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A re

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, com

pute

rRe

frig

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ost

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p pa

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clud

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000

– 9

000

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l tes

ts re

quire

pip

ette

s, v

orte

x m

ixer

s

41

ANNEX 2A

Registration status ofproducts included in thesources and prices surveyIf the products you require are not listed as registered in your country, this does not mean they cannot be purchased.Please contact the manufacturer to find out if they are able to supply to your country, and contact your Drug RegulatoryAuthority for quality assurance and importation issues. It is also advisable to check if products of interest have beenauthorised for marketing in countries that have a strong regulatory system such as the United Kingdom or South Africa.

Country/ RegistrationMedicine Name (INN) Dosage form & strength Manufacturer status

Afghanistan

benzylpenicillin powder for injection, Alembic Ltd. Completed3 g (=5 million IU) (as sodium orpotassium salt) in vial

cefixime paediatric oral suspension, 100 mg/5 ml Bilim Pharmaceutical Ind. Completed

ceftriaxone powder for injection, 1 g (as sodium salt) in vial Bilim Pharmaceutical Ind. Completed

clarithromycin tablet, 250 mg Bilim Pharmaceutical Ind. Completed

gentamicin injection, 40 mg (as sulfate) in 2-ml vial Neon Laboratories Ltd. Completed

nelfinavir (NFV) capsule, 250 mg F. Hoffmann-La Roche Ltd. Completed

procaine benzylpenicillin powder for injection, 3 g (=3 million IU) in vial Alembic Ltd. Completed

saquinavir (SQV) capsule, 200 mg F. Hoffmann-La Roche Ltd. Completed

sulfamethoxazole+trimethoprim tablet, 400+80 mg IPCA Laboratories Ltd. Completed

Albania

aciclovir cream, 5% Ecobi Farmaceutici S.a.s Completed

amitriptyline tablet, 25 mg (as hydrochloride) Remedica Ltd. Completed

benzathine benzylpenicillin powder for injection, Alembic Ltd. Completed1.44 g (=2.4 million IU) in 5-ml vial

calcium folinate (leucovorin) tablet, 15 mg Ecobi Farmaceutici S.a.s. Completed

chloramphenicol powder for injection, 1 g (sodium succinate) Sanavita Aktiengesellschaft & Co. Completedin vial

ciprofloxacin tablet, 250 mg (as hydrochloride) Alembic Ltd. Completed

clotrimazole cream, 1% Purna Pharmaceuticals NV Completed

ketoconazole tablet, 200 mg Remedica Ltd. Completed

methotrexate tablet, 2.5 mg Remedica Ltd. Completed

miconazole cream/ointment 2% (as nitrate) 30 g tube Ecobi Farmaceutici S.a.s. Completed

sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Ecobi Farmaceutici S.a.s. Completed

zidovudine (AZT or ZDV) capsule, 250 mg Glaxo SmithKline Completed

Algeria

aciclovir cream, 5% Ecobi Farmaceutici S.a.s. Completed

azithromycin tablet/capsule, 250 mg (dihydrate) Aleppo Pharmaceutical Industries (Alpha) Completed

bleomycin powder for injection, 15 mg (as sulfate) in vial Aventis Intercontinental Completed

cefixime paediatric oral suspension, 40 mg/5 ml Aventis Intercontinental Completed

ceftriaxone powder for injection, 250 mg (as sodium salt) Aleppo Pharmaceutical Industries (Alpha) Completedin vial



42

Algeria

ciprofloxacin tablet, 500 mg (as hydrochloride) Aleppo Pharmaceutical CompletedIndustries (Alpha)

indinavir (IDV) capsule, 400 mg Cipla Ltd. Completed

ketoconazole tablet, 200 mg Intas Pharmaceuticals Ltd Completed

lamivudine (3TC) syrup, 50 mg/5 ml Cipla Ltd. Completed

methotrexate powder for injection, Aventis Intercontinental Completed50 mg (as sodium salt) in 2-ml vial

methotrimepazine/ tablet, 25 mg Aventis Intercontinental Completedlevomepromazine

metronidazole injection, 500 mg in 100-ml vial Aventis Intercontinental Completed


ofloxacin tablet, 200 mg Aventis Intercontinental Completed

omeprazole capsule, 20 mg Mepha Ltd Completed

sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Aspen Pharmacare Completed

zidovudine (AZT or ZDV) injection, 10 mg/ml in 20-ml vial Glaxo SmithKline Completed

Angola



Argentina

3TC/AZT tablet, 300/150 mg Donato y Zurlo S.A. Completed

abacavir (ABC) syrup, 20 mg/ml Glaxo SmithKline Completed

ABC/3TC/ZDV tablet, 300/150/300 mg Glaxo SmithKline Completed

aciclovir powder for injection, Lab. Filaxis International S.A. Completed250 mg (as sodium salt) in 10-ml vial

calcium folinate (leucovorin) tablet, 15 mg Lab. Filaxis International S.A. Completed

ciprofloxacin tablet, 250 mg (as hydrochloride) Bayer Healthcare AG Completed

didanosine (ddI) buffered chewable tablet, 100 mg Donato y Zurlo S.A. Completed

doxorubicine HCl powder for injection, 10 mg in 5-ml vial Lab. Filaxis International S.A. Completed

efavirenz (EFZ) capsule, 200 mg Lab. Filaxis International S.A. Completed

etoposide injection, 20 mg/ml in 5-ml ampoule Lab. Filaxis International S.A. Completed

ganciclovir powder for IV infusion, 500 mg in vial Lab. Filaxis International S.A. Completed

indinavir (IDV) capsule, 200 mg Donato y Zurlo S.A. Completed

lamivudine (3TC) syrup, 50 mg/5 ml Donato y Zurlo S.A. Completed

methotrexate powder for injection, Aventis Intercontinental Completed50 mg (as sodium salt) in 2-ml vial



nelfinavir (NFV) capsule, 250 mg Donato y Zurlo S.A. Completed

nevirapine (NVP) syrup, 50 mg/5 ml Boehringer Ingelheim Gmbh Completed

nevirapine (NVP) tablet, 200 mg Boehringer Ingelheim Gmbh Completed

nevirapine (NVP) tablet, 200 mg Lab. Filaxis International S.A. Completed

pentamidine powder for injection, 300 mg (isetionate) in vial Lab. Filaxis International S.A. Completed

stavudine (d4T) capsule, 30 mg Donato y Zurlo S.A. Completed

vinblastine powder for injection, 10 mg (sulfate) in 10-ml vial Lab. Filaxis International S.A. Completed


43


Argentina

vincristine injection, 1 mg/ml (sulfate) in vial Lab. Filaxis International S.A. Completed

vinorelbine injection concentrate 10 mg/ml in vial Lab. Filaxis International S.A. Completed

zalcitabine (ddC) tablet, 0.75 mg Lab. Filaxis International S.A. Completed

zidovudine (AZT or ZDV) capsule, 100 mg Donato y Zurlo S.A. Completed

Armenia

aciclovir cream, 5% Cipla Ltd. Completed

azithromycin tablet/capsule, 250 mg (dihydrate) Cipla Ltd. Completed


gentamicin injection, 40 mg (as sulfate) in 2-ml vial Sanavita Aktiengesellschaft & Co. Completed

metronidazole injection, 500 mg in 100-ml vial Demo S.A., Pharmaceutical Industry Completed

ofloxacin tablet, 200 mg Intas Pharmaceuticals Ltd Completed

omeprazole capsule, 20 mg Cipla Ltd. Completed

Aruba

3TC/AZT tablet, 300/150 mg Glaxo SmithKline Completed



lamivudine (3TC) syrup, 50 mg/5 ml Glaxo SmithKline Completed



Australia

aciclovir tablet, 400 mg Ranbaxy Laboratories Ltd Completed


clotrimazole cream, 1% Cipla Ltd. Completed



Austria

ciprofloxacin tablet, 250 mg (as hydrochloride) Alpharma Completed

clarithromycin tablet, 250 mg Alpharma Completed



Azerbaijan



fluconazole capsule, 150 mg Bilim Pharmaceutical Ind. Completed




Bahrain



ANNEX 2A. REGISTRATION STATUS OF PRODUCTS INCLUDED IN THE SOURCES AND PRICES SURVEY


44


Bahrain

ceftriaxone powder for injection, Ranbaxy Laboratories Ltd Completed250 mg (as sodium salt) in vial







zidovudine (AZT or ZDV) oral solution, 50 mg/5 ml Glaxo SmithKline Completed

Bangladesh

azithromycin tablet/capsule, 250 mg (dihydrate) The Acme Laboratories Ltd. Completed

ceftriaxone powder for injection, 1 g (as sodium salt) in vial Aventis Ltd. Completed

ciprofloxacin tablet, 250 mg (as hydrochloride) Aventis Ltd. Completed

clarithromycin tablet, 250 mg The Acme Laboratories Ltd. Completed

clotrimazole cream, 1% The Acme Laboratories Ltd. Completed

doxycycline capsule/tablet, 100 mg (hydrochloride) The Acme Laboratories Ltd. Completed

erythromycin powder for oral suspension, Aventis Ltd. Completed125 mg (as stearate or ethylsuccinate)

lamivudine (3TC) tablet, 150 mg Glaxo SmithKline Completed

metoclopramide injection 5 mg/ml in 2-ml ampoule Aventis Ltd. Completed


nystatin pessary, 100,000 IU The Acme Laboratories Ltd. Completed

omeprazole capsule, 10 mg Aventis Ltd. Completed

prochlorperazine injection, 12.5 mg/ml Aventis Ltd. Completed


sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Aventis Ltd. Completed

vinblastine powder for injection, 10 mg (sulfate) in 10-ml vial Cipla Ltd. Completed

vincristine injection, 1 mg/ml (sulfate) in vial Cipla Ltd. Completed


Belarus


ceftriaxone powder for injection, 1 g (as sodium salt) in vial Ranbaxy Laboratories Ltd Completed


fluconazole capsule, 50 mg Cipla Ltd. Completed





omeprazole capsule, 20 mg Intas Pharmaceuticals Ltd Completed

Belgium


ciprofloxacin tablet, 250 mg (as hydrochloride) Ranbaxy Laboratories Ltd Completed

etoposide injection, 20 mg/ml in 5-ml ampoule Neon Antibiotics PVT. Ltd. In Process

45


Belgium

ketoconazole cream, 2% Gracure Pharmaceuticals Ltd. Completed






Benin




ceftriaxone powder for injection, 1 g (as sodium salt) in vial Mepha Ltd Completed

ciprofloxacin tablet, 250 mg (as hydrochloride) Cipla Ltd. Completed

erythromycin tablet/capsule, Phyto-Riker Pharmaceuticals Ltd. Completed250 mg (as stearate or ethylsuccinate)


lamivudine (3TC) tablet, 150 mg Ranbaxy Laboratories Ltd Completed





nevirapine (NVP) tablet, 200 mg Ranbaxy Laboratories Ltd Completed

ofloxacin IV infusion, 5 mg/ml (hydrochloride) Aventis Intercontinental Completed



zidovudine (AZT or ZDV) tablet, 300 mg Ranbaxy Laboratories Ltd Completed

Bhutan



Bolivia




dimenhydrinate tablet, 50 mg Laboratorios Cinfa S.A. Completed

gentamicin injection, 40 mg (as sulfate) in 2-ml vial Intas Pharmaceuticals Ltd Completed

omeprazole capsule, 20 mg Alembic Ltd. Completed


Bosnia and Herzegovina





46


Botswana



erythromycin tablet/capsule, Hovid SDN. BHN. Completed250 mg (as stearate or ethylsuccinate)

fluconazole capsule, 200 mg Remedica Ltd. Completed







Brazil

3TC/AZT tablet, 300/150 mg Far Manguinhos Completed

3TC/AZT tablet, 300/150 mg Strides Arcolab Ltd. Completed



aciclovir powder for injection, Lab. Filaxis International S.A. Completed250 mg (as sodium salt) in 10-ml vial


ceftriaxone powder for injection, 1 g (as sodium salt) in vial Cheil Jedang Corp. Completed

ceftriaxone powder for injection, 1 g (as sodium salt) in vial Strides Arcolab Ltd. Completed

chloramphenicol powder for injection, 1 g (sodium succinate) in vial Strides Arcolab Ltd. Completed


ciprofloxacin tablet, 250 mg (as hydrochloride) Strides Arcolab Ltd. Completed

ciprofloxacin tablet, 500 mg (as hydrochloride) Strides Arcolab Ltd. Completed

clarithromycin powder for injection, 500 mg Strides Arcolab Ltd. Completed

clarithromycin tablet, 250 mg Strides Arcolab Ltd. Completed

clarithromycin tablet, 250 mg Ranbaxy Laboratories Ltd Completed

clindamycin injection, 150 mg/ml (as phosphate) Strides Arcolab Ltd. Completedin 4-ml ampoule

didanosine (ddI) buffered chewable tablet, 100 mg Far Manguinhos Completed



fluconazole capsule, 50 mg CLARIS Lifesciences Ltd. Completed

fluoxetine capsule, 20 mg Ranbaxy Laboratories Ltd Completed

indinavir (IDV) capsule, 400 mg Far Manguinhos Completed

ketoconazole tablet, 200 mg Far Manguinhos Completed

ketoconazole tablet, 200 mg Strides Arcolab Ltd. Completed

lamivudine (3TC) syrup, 50 mg/5 ml Far Manguinhos Completed

lamivudine (3TC) tablet, 150 mg Strides Arcolab Ltd. Completed

methotrexate powder for injection, Lab. Filaxis International S.A. Completed50 mg (as sodium salt) in 2-ml vial

metoclopramide injection 5 mg/ml in 2-ml ampoule CLARIS Lifesciences Ltd. Completed



47


Brazil

nevirapine (NVP) tablet, 200 mg Far Manguinhos Completed

nevirapine (NVP) tablet, 200 mg Strides Arcolab Ltd. Completed

ofloxacin tablet, 200 mg Ranbaxy Laboratories Ltd Completed


omeprazole capsule, 20 mg Strides Arcolab Ltd. Completed

pentamidine powder for injection, 300 mg (isetionate) in vial Aventis Intercontinental Completed

stavudine (d4T) capsule, 30 mg Far Manguinhos Completed

stavudine (d4T) capsule, 30 mg Strides Arcolab Ltd. Completed


sulfadiazine tablet, 500 mg Far Manguinhos Completed

sulfamethoxazole+trimethoprim tablet, 400+80 mg Far Manguinhos Completed

sulfamethoxazole+trimethoprim tablet, 400+80 mg Strides Arcolab Ltd. Completed





zidovudine (AZT or ZDV) capsule, 100 mg Far Manguinhos Completed

Bulgaria

ceftriaxone powder for injection, Lupin Ltd. Completed250 mg (as sodium salt) in vial




fluconazole capsule, 150 mg Ranbaxy Laboratories Ltd Completed

Burkina Faso





ciprofloxacin tablet, 250 mg (as hydrochloride) Mepha Ltd Completed

ketoconazole tablet, 200 mg Bilim Pharmaceutical Ind. Completed










Burundi

3TC/AZT tablet, 300/150 mg Cipla Ltd. Completed

3TC/d4T/NVP tablet, 150/30/200 mg Ranbaxy Laboratories Ltd Completed



48


Burundi

efavirenz (EFZ) tablet, 600 mg Ranbaxy Laboratories Ltd Completed




nevirapine (NVP) tablet, 200 mg Cipla Ltd. Completed


stavudine (d4T) capsule, 30 mg Cipla Ltd. Completed

zidovudine (AZT or ZDV) oral solution, 50 mg/5 ml Cipla Ltd. Completed

Cambodia

3TC/AZT tablet, 300/150 mg Aurobindo Pharma Ltd. In Process

3TC/d4T/NVP tablet, 150/40/200 mg The Government Pharmaceutical CompletedOrganization


albendazole chewable tablet, 400 mg IPCA Laboratories Ltd. Completed

azithromycin tablet/capsule, 250 mg (dihydrate) Alembic Ltd. Completed

ceftriaxone powder for injection, 1 g (as sodium salt) in vial Cheil Jedang Corp. In Process

chloramphenicol powder for injection, 1 g (sodium succinate) in vial Neon Laboratories Ltd. In Process

ciprofloxacin tablet, 250 mg (as hydrochloride) Lyka Labs Ltd. Completed


clotrimazole cream, 1% SM Pharmaceuticals Sdn Bhd Completed

didanosine (ddI) buffered chewable tablet, 100 mg Aurobindo Pharma Ltd. Completed

doxycycline capsule/tablet, 100 mg (hydrochloride) Remedica Ltd. Completed

erythromycin tablet/capsule, Lyka Labs Ltd. Completed250 mg (as stearate or ethylsuccinate)



indinavir (IDV) capsule, 400 mg Ranbaxy Laboratories Ltd Completed

ketoconazole tablet, 200 mg Hovid SDN. BHN. In Process

lamivudine (3TC) syrup, 50 mg/5 ml Aurobindo Pharma Ltd. Completed





nystatin pessary, 100,000 IU SM Pharmaceuticals Sdn Bhd Completed


omeprazole capsule, 20 mg Hovid SDN. BHN. Completed


stavudine (d4T) capsule, 30 mg Aurobindo Pharma Ltd. Completed

sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Aurobindo Pharma Ltd. Completed

zidovudine (AZT or ZDV) capsule, 100 mg Aurobindo Pharma Ltd. Completed

Cameroon

3TC/AZT tablet, 300/150 mg Ranbaxy Laboratories Ltd Completed



49


Cameroon

albendazole chewable tablet, 400 mg Cipla Ltd. Completed

benzathine benzylpenicillin powder for injection, Aventis Intercontinental Completed1.44 g (=2.4 million IU) in 5-ml vial





erythromycin powder for oral suspension, Beltapharm SpA Completed125 mg (as stearate or ethylsuccinate)


ketoconazole tablet, 200 mg Beltapharm SpA Completed

lamivudine (3TC) tablet, 150 mg Cipla Ltd. Completed

methotrexate injection, 25 mg/ml (as sodium salt) in 2-ml vial Aventis Intercontinental Completed

miconazole cream/ointment 2% (as nitrate) 15 g tube Beltapharm SpA Completed

naltrexone HCl tablet, 50 mg Lachifarma, SRL Completed








sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Lachifarma, SRL Completed

tetracycline tablet, 250 mg Phyto-Riker Pharmaceuticals Ltd. Completed

zidovudine (AZT or ZDV) tablet, 300 mg Cipla Ltd. Completed

Canada




Cape Verde



Central African Republic (the)


3TC/d4T/NVP tablet, 150/40/200 mg Cipla Ltd. Completed











50


Central African Republic (the)




Chad


3TC/d4T/NVP tablet, 150/40/200 mg Strides Arcolab Ltd. Completed









stavudine (d4T) capsule, 30 mg Ranbaxy Laboratories Ltd Completed


Chile




aciclovir cream, 5% IVAX Pharmaceuticals Mexico, CompletedS.A. de C.V.

benzylpenicillin powder for injection, Alembic Ltd. Completed3 g (=5 million IU)(as sodium or potassium salt) in vial

ceftriaxone powder for injection, 1 g (as sodium salt) in vial IVAX Pharmaceuticals Mexico, CompletedS.A. de C.V.


clarithromycin tablet, 250 mg IVAX Pharmaceuticals Mexico, CompletedS.A. de C.V.


fluconazole solution for injection, 2 mg/ml in ampoule CLARIS Lifesciences Ltd. Completed

fluoxetine tablet, 20 mg IVAX Pharmaceuticals Mexico, CompletedS.A. de C.V.

itraconazole capsule, 100 mg IVAX Pharmaceuticals Mexico, CompletedS.A. de C.V.

ketoconazole cream, 2% IVAX Pharmaceuticals Mexico, CompletedS.A. de C.V.




miconazole cream/ointment 2% (as nitrate) 40 g tube IVAX Pharmaceuticals Mexico, CompletedS.A. de C.V.



51


Chile

omeprazole capsule, 10 mg IVAX Pharmaceuticals Mexico, CompletedS.A. de C.V.


sulfamethoxazole+trimethoprim tablet, 100+20 mg IVAX Pharmaceuticals Mexico, CompletedS.A. de C.V.



China





calcium folinate (leucovorin) tablet, 15 mg Medac GmbH, International Operations Completed

ceftriaxone powder for injection, Lupin Ltd.. Completed250 mg (as sodium salt) in vial







Hong Kong




aciclovir tablet, 200 mg Hovid SDN. BHN. Completed

ceftriaxone powder for injection, 1 g (as sodium salt) in vial Demo S.A., Pharmaceutical Industry Completed





erythromycin powder for oral suspension, Hovid SDN. BHN. Completed125 mg (as stearate or ethylsuccinate)


fluoxetine capsule, 20 mg Remedica Ltd. Completed

itraconazole capsule, 100 mg Intas Pharmaceuticals Ltd Completed

ketoconazole tablet, 200 mg Aspen Pharmacare In Process


metoclopramide tablet, 10 mg (as hydrochloride) Aspen Pharmacare Completed

miconazole cream/ointment 2% (as nitrate) 15 g tube Hovid SDN. BHN. Completed



nystatin pessary, 100,000 IU Pharmadrug Completed

ofloxacin tablet, 200 mg Hovid SDN. BHN. Completed




52


China

Macau


azithromycin tablet/capsule, 250 mg (dihydrate) Cipla Ltd. Completed

erythromycin powder for oral suspension, Purna Pharmaceuticals NV Completed125 mg (as stearate or ethylsuccinate)




metoclopramide tablet, 10 mg (as hydrochloride) Genepharm SA Completed

ofloxacin tablet, 200 mg Cipla Ltd. Completed

omeprazole capsule, 20 mg Laboratorios Cinfa S.A. In Process

Taiwan





clotrimazole cream, 1% Aspen Pharmacare Completed






Colombia
















zalcitabine (ddC) tablet, 0.75 mg Lab. Filaxis International S.A. Completed


Comoros (the)



53


Congo (the)












methotrimepazine / tablet, 25 mg Aventis Intercontinental Completedlevomepromazine










zidovudine (AZT or ZDV) capsule, 100 mg Cipla Ltd. Completed

Costa Rica


abacavir (ABC) tablet, 300 mg Glaxo SmithKline Completed


aciclovir cream, 5% Apotex Mexico (Protein, S.A. de C.V.) Completed


ciprofloxacin tablet, 250 mg (as hydrochloride) Apotex Mexico (Protein, S.A. de C.V.) Completed


didanosine (ddI) buffered chewable tablet, 100 mg Apotex Mexico (Protein, S.A. de C.V.) Completed




fluoxetine capsule, 20 mg Apotex Mexico (Protein, S.A. de C.V.) Completed


indinavir (IDV) capsule, 400 mg Aurobindo Pharma Ltd. Completed


ketoconazole cream, 2% Apotex Mexico (Protein, S.A. de C.V.) Completed




54


Costa Rica


metoclopramide injection 5 mg/ml in 2-ml ampoule Aspen Pharmacare Completed

metronidazole injection, 500 mg in 100-ml vial Aspen Pharmacare Completed





omeprazole capsule, 10 mg Apotex Mexico (Protein, S.A. de C.V.) Completed

pethidine injection, 50 mg/ml (hydrochloride) Aspen Pharmacare Completedin 2-ml ampoule

stavudine (d4T) capsule, 40 mg Apotex Mexico (Protein, S.A. de C.V.) Completed

sulfamethoxazole+trimethoprim tablet, 100+20 mg Apotex Mexico (Protein, S.A. de C.V.) Completed

zidovudine (AZT or ZDV) capsule, 100 mg Apotex Mexico (Protein, S.A. de C.V.) Completed

Côte D’Ivoire






cefixime tablet, 200 mg Aventis Intercontinental Completed


ciprofloxacin tablet, 250 mg (as hydrochloride) IPCA Laboratories Ltd. Completed










omeprazole capsule, 20 mg Aurobindo Pharma Ltd. Completed


zidovudine (AZT or ZDV) capsule, 100 mg Combino Pharm, S.L. Completed

Croatia

benzylpenicillin powder for injection, Pliva d.d. Completed600 mg (=1 million IU) (as potasium salt) in vial






55


Cuba




Cyprus

aciclovir tablet, 200 mg Genepharm SA Completed


cefixime tablet, 400 mg Genepharm SA Completed



clarithromycin tablet, 250 mg Remedica Ltd. Completed

clotrimazole cream, 1% Remedica Ltd. Completed


erythromycin powder for oral suspension, Remedica Ltd. Completed125 mg (as stearate or ethylsuccinate)

fluconazole capsule, 200 mg Remedica Ltd. Completed

fluoxetine tablet, 20 mg Genepharm SA Completed



metoclopramide tablet, 10 mg (as hydrochloride) Remedica Ltd. Completed




ofloxacin tablet, 200 mg Genepharm SA Completed

omeprazole capsule, 20 mg Genepharm SA Completed

pethidine injection, 50 mg/ml (hydrochloride) Martindale Pharmaceuticals Ltd. Completedin 1-ml ampoule

prochlorperazine tablet, 5 mg Remedica Ltd. Completed

sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Remedica Ltd. Completed

tinidazole tablet, 500 mg Remedica Ltd. Completed

Czech Republic (the)


ceftriaxone powder for injection, 1 g (as sodium salt) in vial Lupin Ltd.. Completed







Democratic Republicof the Congo (the)



azithromycin tablet/capsule, 250 mg (dihydrate) Lyka Labs Ltd. Completed

ceftriaxone powder for injection, 1 g (as sodium salt) in vial Lyka Labs Ltd. Completed



56


Democratic Republicof the Congo (the)

ciprofloxacin tablet, 250 mg (as hydrochloride) Lyka Labs Ltd. Completed

erythromycin tablet/capsule, Lyka Labs Ltd. Completed250 mg (as stearate or ethylsuccinate)


metoclopramide tablet, 10 mg (as hydrochloride) IPCA Laboratories Ltd. Completed






sulfamethoxazole+trimethoprim tablet, 100+20 mg Lyka Labs Ltd. Completed


Denmark

aciclovir tablet, 200 mg Alpharma Completed





metronidazole suppository, 1 g Aventis Intercontinental Completed





silver nitrate solution (eye drops), 1% Gracure Pharmaceuticals Ltd. Completed

sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Scanpharm A/S Completed

Djibouti



Dominica





Dominican Republic (the)






57


Dominican Republic (the)





efavirenz (EFZ) capsule, 200 mg Aurobindo Pharma Ltd. Completed



fluoxetine capsule, 20 mg IVAX Pharmaceuticals Mexico, In ProcessS.A. de C.V.





metoclopramide tablet, 10 mg (as hydrochloride) Apotex Mexico (Protein, S.A. de C.V.) Completed

miconazole cream/ointment 2% (as nitrate) 20 g tube Apotex Mexico (Protein, S.A. de C.V.) Completed






sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Apotex Mexico (Protein, S.A. de C.V.) Completed


Ecuador












Egypt




methotrexate tablet, 2.5 mg Aventis Intercontinental Completed





58


Egypt



El Salvador





amphotericin B powder for injection, 50 mg in vial Neon Antibiotics PVT. Ltd. In Process













nystatin tablet, 500,000 IU Apotex Mexico (Protein, S.A. de C.V.) Completed




sulfamethoxazole+trimethoprim tablet, 100+20 mg Hovid SDN. BHN. Completed


Equatorial Guinea



Eritrea

albendazole chewable tablet, 400 mg Shiba Pharmaceuticals & Chemicals Ltd. In Process

azithromycin oral suspension, 200 mg/5 ml (dihydrate) Shiba Pharmaceuticals & Chemicals Ltd. In Process

ciprofloxacin tablet, 250 mg (as hydrochloride) Shiba Pharmaceuticals & Chemicals Ltd. In Process

clindamycin capsule, 150 mg Shiba Pharmaceuticals & Chemicals Ltd. In Process

doxycycline capsule/tablet, 100 mg (hydrochloride) Shiba Pharmaceuticals & Chemicals Ltd. In Process

erythromycin powder for oral suspension, Shiba Pharmaceuticals & Chemicals Ltd. In Process125 mg (as stearate or ethylsuccinate)

fluconazole capsule, 150 mg Shiba Pharmaceuticals & Chemicals Ltd. In Process


ofloxacin tablet, 200 mg Shiba Pharmaceuticals & Chemicals Ltd. In Process

59


Eritrea

omeprazole capsule, 10 mg Shiba Pharmaceuticals & Chemicals Ltd. In Process

pyrimethamine tablet, 25 mg Shiba Pharmaceuticals & Chemicals Ltd. In Process


sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Shiba Pharmaceuticals & Chemicals Ltd. In Process

Estonia


ciprofloxacin tablet, 250 mg (as hydrochloride) Lupin Ltd.. Completed





Ethiopia




ceftriaxone powder for injection, Lupin Ltd.. Completed250 mg (as sodium salt) in vial

ciprofloxacin tablet, 250 mg (as hydrochloride) IPCA Laboratories Ltd. In Process


clindamycin capsule, 150 mg Bilim Pharmaceutical Ind. In Process




fluconazole capsule, 150 mg IPCA Laboratories Ltd. In Process









ofloxacin tablet, 200 mg Hovid SDN. BHN. In Process

omeprazole capsule, 10 mg Aurobindo Pharma Ltd. In Process




sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml IPCA Laboratories Ltd. In Process



European Union





60


European Union




morphine injection, 10 mg/ml Molteni Farmaceutici Completed(sulfate or HCl), in 1-ml ampoule




Fiji

aciclovir tablet, 200 mg SM Pharmaceuticals Sdn Bhd Completed



sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml SM Pharmaceuticals Sdn Bhd Completed

Finland








France




ceftriaxone powder for injection, 1 g (as sodium salt) in vial Panpharma Completed

didanosine (ddI) buffered chewable tablet, 100 mg Bristol-Myers Squibb ( FR) Completed



metoclopramide injection 5 mg/ml in 2-ml ampoule Lab. Renaudin Completed


morphine injection, 10 mg/ml Lab. Renaudin Completed(sulfate or HCl), in 1-ml ampoule





pethidine injection, 50 mg/ml (hydrochloride) in 2-ml ampoule Lab. Renaudin Completed

stavudine (d4T) capsule, 15 mg Bristol-Myers Squibb ( FR) Completed

61


Gabon























Gambia (the)





Georgia




clarithromycin tablet, 250 mg Intas Pharmaceuticals Ltd Completed


doxycycline capsule/tablet, 100 mg (hydrochloride) Sanavita Aktiengesellschaft & Co. Completed





miconazole cream/ointment 2% (as nitrate) 30 g tube Purna Pharmaceuticals NV Completed





62


Georgia




Germany


calcium folinate (leucovorin) tablet, 15 mg Medac GmbH, International Operations Completed




doxorubicine HCl powder for injection, 10 mg in 5-ml vial Medac GmbH, International Operations Completed


etoposide injection, 20 mg/ml in 5-ml ampoule Medac GmbH, International Operations Completed


gentamicin injection, 40 mg (as sulfate) in 2-ml vial Rotexmedica Completed

metronidazole injection, 500 mg in 100-ml vial Rotexmedica Completed





sulfadiazine tablet, 500 mg Heyl Chemisch.-pharmazeutische CompletedFabrik GmbH & Co KG

sulfamethoxazole+trimethoprim tablet, 400+80 mg Alpharma Completed

Ghana







azithromycin oral suspension, 200 mg/5 ml (dihydrate) Cipla Ltd. Completed

cefixime tablet, 200 mg Cipla Ltd. Completed

ciprofloxacin tablet, 250 mg (as hydrochloride) Lupin Ltd.. Completed


fluconazole capsule, 200 mg IPCA Laboratories Ltd. Completed










63


Ghana


sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Hovid SDN. BHN. Completed



Greece

aciclovir tablet, 200 mg Genepharm SA Completed

cefixime tablet, 400 mg Genepharm SA Completed


ciprofloxacin tablet, 250 mg (as hydrochloride) Demo S.A., Pharmaceutical Industry Completed

clarithromycin tablet, 250 mg Genepharm SA Completed

fluconazole solution for injection, 2 mg/ml in ampoule Genepharm SA Completed

fluoxetine tablet, 20 mg Genepharm SA Completed







omeprazole capsule, 20 mg Demo S.A., Pharmaceutical Industry Completed


spectinomycin powder for injection, 2 g (as hydrochloride) in vial Demo S.A., Pharmaceutical Industry Completed

Guadeloupe

ceftriaxone powder for injection, IVAX Pharmaceuticals Mexico, Completed500 mg (as sodium salt) in vial S.A. de C.V.

Guatemala

3TC/AZT tablet, 300/150 mg Aurobindo Pharma Ltd. Completed




albendazole chewable tablet, 400 mg Beltapharm SpA Completed













64


Guatemala




nelfinavir (NFV) capsule, 250 mg Aurobindo Pharma Ltd. Completed










Guinea


















Guinea-Bissau



Guyana

3TC/AZT tablet, 300/150 mg New GPC Inc Completed

3TC/d4T/NVP tablet, 150/40/200 mg New GPC Inc Completed

aciclovir tablet, 800 mg Remedica Ltd. Completed

indinavir (IDV) capsule, 200 mg New GPC Inc Completed


65


Guyana

lamivudine (3TC) tablet, 150 mg New GPC Inc Completed

nevirapine (NVP) tablet, 200 mg New GPC Inc Completed


stavudine (d4T) capsule, 30 mg New GPC Inc Completed

zidovudine (AZT or ZDV) capsule, 100 mg New GPC Inc Completed

Haiti




ciprofloxacin tablet, 250 mg (as hydrochloride) IVAX Pharmaceuticals Mexico, CompletedS.A. de C.V.








lamivudine (3TC) tablet, 150 mg Aurobindo Pharma Ltd. Completed





nevirapine (NVP) tablet, 200 mg Aurobindo Pharma Ltd. Completed









Honduras







66


Honduras





erythromycin powder for oral suspension, Alembic Ltd. Completed125 mg (as stearate or ethylsuccinate)












sulfamethoxazole+trimethoprim tablet, 100+20 mg Aurobindo Pharma Ltd. Completed


Hungary





Iceland






India



abacavir (ABC) tablet, 300 mg Cipla Ltd. Completed

ABC/3TC/ZDV tablet, 300/150/300 mg Ranbaxy Laboratories Ltd Completed



amitriptyline tablet, 25 mg (as hydrochloride) Gracure Pharmaceuticals Ltd. Completed

67

India

amphotericin B powder for injection, 50 mg in vial Neon Antibiotics PVT. Ltd. Completed

azithromycin oral suspension, 200 mg/5 ml (dihydrate) Alembic Ltd. Completed

AZT/3TC/NVP tablet, 300/150/200 mg Aurobindo Pharma Ltd. Completed


benzylpenicillin powder for injection, 3 g (=5 million IU) Alembic Ltd. Completed(as sodium or potassium salt) in vial

bleomycin powder for injection, 15 mg (as sulfate) in vial Neon Antibiotics PVT. Ltd. Completed

capreomycin powder for injection, 1 g in vial Neon Antibiotics PVT. Ltd. Completed

cefixime paediatric oral suspension, 100 mg/5 ml Cipla Ltd. Completed

ceftriaxone powder for injection, 1 g (as sodium salt) in vial Alembic Ltd. Completed




chloramphenicol oral suspension, 125 mg/5 ml (as palmitate) Gracure Pharmaceuticals Ltd. Completed



clarithromycin tablet, 250 mg Alembic Ltd. Completed

clotrimazole cream, 1% Cipla Ltd. Completed


doxorubicine HCl powder for injection, 10 mg in 5-ml vial Neon Antibiotics PVT. Ltd. Completed

doxycycline capsule/tablet, 100 mg (hydrochloride) Cipla Ltd. Completed

efavirenz (EFZ) capsule, 200 mg Aurobindo Pharma Ltd. Completed

erythromycin powder for oral suspension, Alembic Ltd. Completed125 mg (as stearate or ethylsuccinate)

etoposide capsule, 50 mg Cipla Ltd. Completed

fluconazole capsule, 50 mg Alembic Ltd. Completed


gentamicin injection, 10 mg (as sulfate) in 2-ml vial Gracure Pharmaceuticals Ltd. Completed


indinavir (IDV) capsule, 400 mg Strides Arcolab Ltd. Completed

itraconazole capsule, 100 mg Glenmark Pharmaceuticals Ltd Completed

ketoconazole cream, 2% Gracure Pharmaceuticals Ltd. Completed


lamivudine (3TC) tablet, 150 mg Strides Arcolab Ltd. Completed

methotrexate injection, 25 mg/ml (as sodium salt) in 2-ml vial Cipla Ltd. Completed


miconazole cream/ointment 2% (as nitrate) 30 g tube Gracure Pharmaceuticals Ltd. Completed

naltrexone HCl tablet, 50 mg Intas Pharmaceuticals Ltd Completed


nevirapine (NVP) syrup, 50 mg/5 ml Aurobindo Pharma Ltd. Completed


nystatin pessary, 100,000 IU Cipla Ltd. Completed






68


India

pentamidine powder for injection, 200 mg (isetionate) in vial Neon Antibiotics PVT. Ltd. Completed

pethidine injection, 50 mg/ml (hydrochloride) Neon Laboratories Ltd. Completedin 1-ml ampoule


pyrimethamine tablet, 25 mg Gracure Pharmaceuticals Ltd. Completed

rifabutin capsule, 150 mg Lupin Ltd.. Completed

silver nitrate solution (eye drops), 1% Gracure Pharmaceuticals Ltd. Completed

spectinomycin powder for injection, 2 g (as hydrochloride) in vial Neon Antibiotics PVT. Ltd. Completed





tetracycline tablet, 500 mg Gracure Pharmaceuticals Ltd. Completed

tinidazole tablet, 500 mg Gracure Pharmaceuticals Ltd. Completed




zidovudine (AZT or ZDV) tablet, 300 mg Strides Arcolab Ltd. Completed

Indonesia







metoclopramide tablet, 10 mg (as hydrochloride) Alpharma Completed






Iran (Islamic Republic of)






Iraq

aciclovir tablet, 200 mg Cipla Ltd. Completed


azithromycin oral suspension, 200 mg/5 ml (dihydrate) Aleppo Pharmaceutical Industries (Alpha) In Process


69


Iraq


ceftriaxone powder for injection, Aleppo Pharmaceutical Industries (Alpha) Completed250 mg (as sodium salt) in vial

ciprofloxacin tablet, 250 mg (as hydrochloride) Aleppo Pharmaceutical Industries (Alpha) In Process


clotrimazole cream, 1% Pharmadrug Completed







ofloxacin tablet, 200 mg Cipla Ltd. In Process


pethidine injection, 50 mg/ml (hydrochloride) in 2-ml ampoule Aspen Pharmacare Completed







Ireland










pethidine injection, 50 mg/ml (hydrochloride) in 1-ml ampoule Martindale Pharmaceuticals Ltd. Completed

Israel

ceftriaxone powder for injection, 1 g (as sodium salt) in vial Rekah Pharmaceutical Group Completed


codeine tablet, 30 mg (phosphate) Rekah Pharmaceutical Group Completed

doxycycline capsule/tablet, 100 mg (hydrochloride) Rekah Pharmaceutical Group Completed







70


Israel


sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Rekah Pharmaceutical Group Completed

Italy

aciclovir cream, 5% Ecobi Farmaceutici S.a.s. Completed

calcium folinate (leucovorin) tablet, 15 mg Ecobi Farmaceutici S.a.s. Completed


ketoconazole tablet, 200 mg Beltapharm SpA Completed


morphine injection, 10 mg/ml (sulfate or HCl), Molteni Farmaceutici Completedin 1-ml ampoule




pethidine injection, 50 mg/ml (hydrochloride) Molteni Farmaceutici Completedin 2-ml ampoule

sulfadiazine tablet, 500 mg Ecobi Farmaceutici S.a.s. Completed


Jamaica





amitriptyline tablet, 25 mg (as hydrochloride) Intas Pharmaceuticals Ltd Completed


ciprofloxacin tablet, 250 mg (as hydrochloride) Intas Pharmaceuticals Ltd Completed













Japan


Jordan




71


Jordan


erythromycin tablet/capsule, 250 mg Hovid SDN. BHN. Completed(as stearate or ethylsuccinate)









Kazakhstan


benzathine benzylpenicillin powder for injection, Sanavita Aktiengesellschaft & Co. Completed1.44 g (=2.4 million IU) in 24-ml vial

benzylpenicillin powder for injection, 3 g (=5 million IU) Sanavita Aktiengesellschaft & Co. Completed(as sodium or potassium salt) in vial











procaine benzylpenicillin powder for injection, 3 g (=3 million IU) in vial Sanavita Aktiengesellschaft & Co. Completed


Kenya








benzathine benzylpenicillin powder for injection, 1.44 g (=2.4 million IU) Alembic Ltd. Completedin 5-ml vial


ciprofloxacin tablet, 250 mg (as hydrochloride) Aurobindo Pharma Ltd. Completed


clotrimazole cream, 1% Gracure Pharmaceuticals Ltd. Completed

erythromycin tablet/capsule, Alembic Ltd. Completed250 mg (as stearate or ethylsuccinate)



72


Kenya

etoposide injection, 20 mg/ ml in 5 ml ampoule Cipla Ltd. Completed
















Kiribati



Kuwait












Kyrgyzstan

benzathine benzylpenicillin powder for injection, 1.44 g (=2.4 million IU) Sanavita Aktiengesellschaft & Co. Completedin 24-ml vial

benzylpenicillin powder for injection, 3 g (=5 million IU) Sanavita Aktiengesellschaft & Co. Completed(as sodium or potassium salt) in vial





73


Lao People’s DemocraticRepublic (the)






Latvia





doxycycline capsule/tablet, 100 mg (hydrochloride) Intas Pharmaceuticals Ltd Completed





Lebanon


benzathine benzylpenicillin powder for injection, 1.44 g (=2.4 million IU) Aventis Intercontinental Completed in 5-ml vial

ceftriaxone powder for injection, 1 g (as sodium salt) in vial Aleppo Pharmaceutical Industries (Alpha) Completed

ciprofloxacin tablet, 250 mg (as hydrochloride) Aleppo Pharmaceutical Industries (Alpha) Completed


methotrexate powder for injection, 50 mg (as sodium salt) Aventis Intercontinental Completedin 2-ml vial





pethidine injection, 50 mg/ml (hydrochloride) Lab. Renaudin Completedin 2-ml ampoule


Lesotho



Liberia






Libyan Arab Jamahiriya (the)




74


Lithuania








Luxembourg








Madagascar

benzathine benzylpenicillin powder for injection, 1.44 g (=2.4 million IU) Aventis Intercontinental Completedin 24-ml vial














pethidine injection, 50 mg/ml (hydrochloride) Lab. Renaudin Completedin 2-ml ampoule




Malawi






75


Malawi






erythromycin tablet/capsule, Alembic Ltd. Completed250 mg (as stearate or ethylsuccinate)







nevirapine (NVP) syrup, 50 mg/5 ml Aurobindo Pharma Ltd. Completed










Malaysia







chloramphenicol powder for injection, 1 g (sodium succinate) in vial SM Pharmaceuticals Sdn Bhd Completed


clarithromycin tablet, 250 mg Alpharma In Process


crotamiton cream/lotion 10% SM Pharmaceuticals Sdn Bhd Completed

doxycycline capsule/tablet, 100 mg (hydrochloride) Hovid SDN. BHN. Completed


etoposide injection, 20 mg/ml in 5-ml ampoule Cipla Ltd. Completed




itraconazole capsule, 100 mg SM Pharmaceuticals Sdn Bhd Completed

ketoconazole tablet, 200 mg Hovid SDN. BHN. Completed



76


Malaysia












tetracycline tablet, 500 mg Hovid SDN. BHN. Completed




Maldives

erythromycin tablet/capsule, 500 mg Alembic Ltd. Completed(as stearate or ethylsuccinate)



Mali







ciprofloxacin tablet, 250 mg (as hydrochloride) Gracure Pharmaceuticals Ltd. Completed

doxycycline capsule/tablet, 100 mg (hydrochloride) Gracure Pharmaceuticals Ltd. Completed

erythromycin tablet/capsule, 250 mg Gracure Pharmaceuticals Ltd. Completed(as stearate or ethylsuccinate)













77


Mali




Malta







Mauritania












Mauritius








erythromycin tablet/capsule, 250 mg SM Pharmaceuticals Sdn Bhd Completed(as stearate or ethylsuccinate)





metoclopramide tablet, 10 mg (as hydrochloride) Aspen Pharmacare Completed









78


Mauritius





zidovudine (AZT or ZDV) tablet, 300 mg Glaxo SmithKline Completed

Mexico











dimenhydrinate tablet, 50 mg Apotex Mexico (Protein, S.A. de C.V.) Completed


erythromycin tablet/capsule, 250 mg Strides Arcolab Ltd. Completed(as stearate or ethylsuccinate)

erythromycin tablet/capsule, 500 mg Strides Arcolab Ltd. Completed(as stearate or ethylsuccinate)







methotrexate powder for injection, 50 mg (as sodium salt) Lab. Filaxis International S.A. Completedin 2-ml vial

metoclopramide tablet, 10 mg (as hydrochloride) Apotex Mexico (Protein, S.A. de C.V.) Completed











zalcitabine (ddC) tablet, 0.375 mg Apotex Mexico (Protein, S.A. de C.V.) Completed


79


Mongolia


clindamycin capsule, 150 mg Bilim Pharmaceutical Ind. Completed

doxorubicine HCl powder for injection, 10 mg in 5-ml vial Neon Antibiotics PVT. Ltd. In Process


methotrexate injection, 25 mg/ml (as sodium salt) in 2-ml vial Neon Antibiotics PVT. Ltd. Completed

Morocco














Mozambique

3TC/AZT tablet, 300/150 mg Ranbaxy Laboratories Ltd Completed





zidovudine (AZT or ZDV) capsule, 100 mg Ranbaxy Laboratories Ltd Completed

Myanmar







ceftriaxone powder for injection, 1 g (as sodium salt) in vial Alembic Ltd. In Process

chloramphenicol oral suspension, 125 mg/5 ml (as palmitate) Gracure Pharmaceuticals Ltd. Completed








80


Myanmar




gentamicin injection, 40 mg (as sulfate) in 2-ml vial Neon Laboratories Ltd. In Process


ketoconazole tablet, 200 mg Hovid SDN. BHN. In Process


metoclopramide injection 5 mg/ml in 2-ml ampoule Aventis Ltd. Completed





nevirapine (NVP) syrup, 50 mg/5 ml Cipla Ltd. Completed







sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Aventis Ltd. Completed



vincristine injection, 1 mg/ml (sulfate) in vial Cipla Ltd. In Process


Namibia

gentamicin injection, 40 mg (as sulfate) in 2-ml vial Aspen Pharmacare Completed





Nepal

azithromycin tablet/capsule, 250 mg (dihydrate) The Acme Laboratories Ltd. Completed


ciprofloxacin tablet, 250 mg (as hydrochloride) Gracure Pharmaceuticals Ltd. Completed

clarithromycin tablet, 250 mg The Acme Laboratories Ltd. Completed


gentamicin injection, 40 mg (as sulfate) in 2-ml vial Neon Laboratories Ltd. In Process


omeprazole capsule, 20 mg Gracure Pharmaceuticals Ltd. Completed

pethidine tablet, 50 mg Martindale Pharmaceuticals Ltd. Completed


81


Netherlands (the)


albendazole chewable tablet, 400 mg Remedica Ltd. Completed




clotrimazole pessary, 500 mg Gracure Pharmaceuticals Ltd. Completed

erythromycin powder for oral suspension, Gracure Pharmaceuticals Ltd. Completed125 mg (as stearate or ethylsuccinate)




miconazole cream/ointment 2% (as nitrate) 30 g tube Gracure Pharmaceuticals Ltd. Completed




omeprazole capsule, 20 mg Gracure Pharmaceuticals Ltd. Completed



pyrimethamine tablet, 25 mg Gracure Pharmaceuticals Ltd. Completed


Netherlands Antilles








New Zealand


ceftriaxone powder for injection, 1 g (as sodium salt) in vial Laboratorio Reig Jofre S.A. Completed




Nicaragua










82


Nicaragua















Niger (the)






erythromycin tablet/capsule, 250 mg Phyto-Riker Pharmaceuticals Ltd. Completed(as stearate or ethylsuccinate)









Nigeria








efavirenz (EFZ) capsule, 200 mg Cipla Ltd. Completed



83


Nigeria












Norway








Oman


ceftriaxone powder for injection, 250 mg Ranbaxy Laboratories Ltd Completed(as sodium salt) in vial



erythromycin tablet/capsule, 250 mg Remedica Ltd. Completed(as stearate or ethylsuccinate)








sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Remedica Ltd. Completed


Pakistan









84


Panama



aciclovir tablet, 200 mg Apotex Mexico (Protein, S.A. de C.V.) Completed







erythromycin powder for oral suspension, 125 mg Beltapharm SpA Completed(as stearate or ethylsuccinate)












sulfamethoxazole+trimethoprim tablet, 400+80 mg Apotex Mexico (Protein, S.A. de C.V.) Completed


Papua New Guinea

aciclovir tablet, 200 mg SM Pharmaceuticals Sdn Bhd Completed




Paraguay










85


Peru




aciclovir cream, 5% Gracure Pharmaceuticals Ltd. Completed

albendazole chewable tablet, 400 mg Gracure Pharmaceuticals Ltd. Completed




ceftriaxone powder for injection, 1 g (as sodium salt) in vial Aurobindo Pharma Ltd. Completed

chloramphenicol powder for injection, 1 g (sodium succinate) in vial Neon Laboratories Ltd. Completed






gentamicin injection, 40 mg (as sulfate) in 2-ml vial Gracure Pharmaceuticals Ltd. Completed











tetracycline tablet, 500 mg Gracure Pharmaceuticals Ltd. Completed


Philippines (the)










metoclopramide tablet, 10 mg (as hydrochloride) The Acme Laboratories Ltd. Completed






86


Poland




fluconazole capsule, 50 mg Pliva d.d. Completed






Portugal







omeprazole capsule, 10 mg Laboratorios Andr—maco S.A. Completed


Qatar









Republic of Korea (the)

3TC/AZT tablet, 300/150 mg Cheil Jedang Corp. Completed

3TC/d4T/NVP tablet, 150/40/200 mg Cheil Jedang Corp. Completed


aciclovir tablet, 200 mg Samchully Pharm. Co., Ltd. Completed

capreomycin powder for injection, 1 g in vial Cheil Jedang Corp. Completed



cycloserine capsule, 250 mg Cheil Jedang Corp. Completed

lamivudine (3TC) tablet, 150 mg Cheil Jedang Corp. Completed

metronidazole injection, 500 mg in 100-ml vial Cheil Jedang Corp. Completed



nevirapine (NVP) tablet, 200 mg Cheil Jedang Corp. Completed

stavudine (d4T) capsule, 40 mg Cheil Jedang Corp. Completed

zidovudine (AZT or ZDV) capsule, 100 mg Cheil Jedang Corp. Completed

87


Republic of Moldova (the)











Romania










ofloxacin tablet, 200 mg Genepharm SA Completed

omeprazole capsule, 10 mg Genepharm SA Completed

Russian Federation (the)



benzathine benzylpenicillin powder for injection, 1.44 g (=2.4 million IU) Aventis Intercontinental Completed in 5-ml vial

capreomycin powder for injection, 1 g in vial Cheil Jedang Corp. In Process




cycloserine capsule, 250 mg Cheil Jedang Corp. In Process














88

Russian Federation (the)






Rwanda



Samoa



Sao Tome and Principe



Saudi Arabia











Senegal



3TC/d4T/NVP tablet, 150/40/200 mg Strides Arcolab Ltd. Completed











indinavir (IDV) capsule, 400 mg Strides Arcolab Ltd. Completed


89


Senegal

















Serbia and Montenegro


ceftriaxone powder for injection, Demo S.A., Pharmaceutical Industry Completed250 mg (as sodium salt) in vial






Sierra Leone












zidovudine (AZT or ZDV) oral solution, 50 mg/5 ml Cipla Ltd. Completed

Singapore






90


Singapore

aciclovir tablet, 200 mg Beacons Pharmaceuticals Pte Ltd. Completed




clotrimazole cream, 1% Beacons Pharmaceuticals Pte Ltd. Completed

codeine tablet, 30 mg (phosphate) Beacons Pharmaceuticals Pte Ltd. Completed

dimenhydrinate tablet, 50 mg Beacons Pharmaceuticals Pte Ltd. Completed

doxycycline capsule/tablet, 100 mg (hydrochloride) Beacons Pharmaceuticals Pte Ltd. Completed

erythromycin powder for oral suspension, 125 mg Beacons Pharmaceuticals Pte Ltd. Completed(as stearate or ethylsuccinate)


ketoconazole cream, 2% Beacons Pharmaceuticals Pte Ltd. Completed



miconazole cream/ointment 2% (as nitrate) 15 g tube Beacons Pharmaceuticals Pte Ltd. Completed





sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Beacons Pharmaceuticals Pte Ltd. Completed



Slovakia

ceftriaxone powder for injection, 250 mg Lupin Ltd.. Completed(as sodium salt) in vial


Slovenia




Solomon Islands



Somalia



South Africa




aciclovir tablet, 200 mg Aspen Pharmacare Completed

amitriptyline tablet, 25 mg (as hydrochloride) Aspen Pharmacare Completed

91


South Africa


ciprofloxacin tablet, 250 mg (as hydrochloride) Aspen Pharmacare Completed


codeine tablet, 30 mg (phosphate) Aspen Pharmacare Completed

cycloserine capsule, 250 mg Cheil Jedang Corp. In Process

didanosine (ddI) buffered chewable tablet, 100 mg Bristol-Myers Squibb (SA) Completed

doxycycline capsule/tablet, 100 mg (hydrochloride) Aspen Pharmacare Completed

erythromycin tablet/capsule, 250 mg SM Pharmaceuticals Sdn Bhd Completed(as stearate or ethylsuccinate)


fluoxetine capsule, 20 mg Aspen Pharmacare Completed

gentamicin injection, 10 mg (as sulfate) in 2-ml vial Aspen Pharmacare Completed

ketoconazole cream, 2% Aspen Pharmacare In Process




morphine injection, 10 mg(hydrochloride) in 1-ml ampoule Aspen Pharmacare Completed





ofloxacin tablet, 200 mg Aspen Pharmacare Completed


prochlorperazine tablet, 5 mg Aspen Pharmacare Completed


stavudine (d4T) capsule, 20 mg Aspen Pharmacare Completed



Spain

aciclovir powder for injection, 250 mg (as sodium salt) Alpharma Completedin 10-ml vial

amphotericin B powder for injection, 50 mg in vial Combino Pharm, S.L. Completed

azithromycin tablet/capsule, 500 mg (dihydrate) Laboratorio Reig Jofre S.A. Completed


ciprofloxacin tablet, 250 mg (as hydrochloride) Laboratorios Cinfa S.A. Completed

clarithromycin tablet, 250 mg Orios Juventus S.A. Completed

clindamycin injection, 150 mg/ml (as phosphate) Combino Pharm, S.L. Completedin 2-ml ampoule


fluconazole solution for injection, 2 mg/ml in ampoule Laboratorio Reig Jofre S.A. Completed

fluoxetine capsule, 20 mg Combino Pharm, S.L. Completed






92


Spain

omeprazole capsule, 20 mg Laboratorios Andr—maco S.A. Completed

pentamidine powder for injection, 300 mg (isetionate) in vial Combino Pharm, S.L. Completed

sulfadiazine tablet, 500 mg Laboratorio Reig Jofre S.A. Completed


Sri Lanka


aciclovir powder for injection, 250 mg (as sodium salt) Hovid SDN. BHN. In Processin 10-ml vial


amphotericin B powder for injection, 50 mg in vial Neon Antibiotics PVT. Ltd. In Process


bleomycin powder for injection, 15 mg (as sulfate) in vial Neon Antibiotics PVT. Ltd. In Process







erythromycin powder for oral suspension, 125 mg Alembic Ltd. Completed(as stearate or ethylsuccinate)

etoposide injection, 20 mg/ml in 5-ml ampoule Cipla Ltd. In Process


gentamicin injection, 40 mg (as sulfate) in 2-ml vial Neon Laboratories Ltd. Completed



methotrexate injection, 25 mg/ml (as sodium salt) in 2-ml vial Neon Antibiotics PVT. Ltd. Completed




omeprazole capsule, 20 mg Alembic Ltd. In Process

pethidine injection, 50 mg/ml (hydrochloride) Neon Laboratories Ltd. In Processin 1-ml ampoule





vincristine powder for injection, 1 mg (sulfate) in 1-ml vial Neon Antibiotics PVT. Ltd. In Process


Sudan (the)




azithromycin oral suspension, 200 mg/5 ml (dihydrate) Aleppo Pharmaceutical Industries (Alpha) In Process


93


Sudan (the)

ciprofloxacin tablet, 250 mg (as hydrochloride) Aleppo Pharmaceutical Industries (Alpha) In Process

clarithromycin tablet, 250 mg Intas Pharmaceuticals Ltd In Process


doxycycline capsule/tablet, 100 mg (hydrochloride) Remedica Ltd. In Process

erythromycin powder for oral suspension, 125 mg Hovid SDN. BHN. In Process(as stearate or ethylsuccinate)


fluconazole capsule, 50 mg Cipla Ltd. In Process







omeprazole capsule, 10 mg Genepharm SA In Process






Suriname


chloramphenicol powder for injection, 1 g (sodium succinate) in vial Sanavita Aktiengesellschaft & Co. Completed




sulfamethoxazole+trimethoprim tablet, 400+80 mg Sanavita Aktiengesellschaft & Co. Completed

Swaziland



Sweden








Switzerland





94


Switzerland


nelfinavir (NFV) capsule, 250 mg Hoffmann-La Roche Completed





saquinavir (SQV) capsule, 200 mg Hoffmann-La Roche Completed

Syrian Arab Republic (the)



ceftriaxone powder for injection, 250 mg Aleppo Pharmaceutical Industries (Alpha) Completed(as sodium salt) in vial



Thailand


3TC/d4T/NVP tablet, 150/40/200 mg The Government Pharmaceutical CompletedOrganization



aciclovir tablet, 200 mg Cipla Ltd. Completed

amitriptyline tablet, 25 mg (as hydrochloride) The Government Pharmaceutical CompletedOrganization




dimenhydrinate tablet, 50 mg The Government Pharmaceutical CompletedOrganization




ketoconazole tablet, 200 mg The Government Pharmaceutical CompletedOrganization







stavudine (d4T) capsule, 30 mg The Government Pharmaceutical CompletedOrganization

sulfamethoxazole+trimethoprim tablet, 400+80 mg The Government Pharmaceutical CompletedOrganization


95


The former Yugoslav Republicof Macedonia



Togo




















Trinidad and Tobago






clarithromycin tablet, 250 mg Ranbaxy Laboratories Ltd In Process

fluconazole capsule, 50 mg Ranbaxy Laboratories Ltd Completed















96


Trinidad and Tobago




Tunisia








methotrexate tablet, 2.5 mg Aventis Intercontinental Completed


morphine injection, 10 mg/ml (sulfate or HCl), Lab. Renaudin Completedin 1-ml ampoule



Turkey







clindamycin capsule, 150 mg Bilim Pharmaceutical Ind. Completed








Turkmenistan





Tuvalu



97


Uganda










doxycycline capsule/tablet, 100 mg (hydrochloride) Aspen Pharmacare Completed

















sulfamethoxazole+trimethoprim tablet, 400+80 mg Aspen Pharmacare Completed


Ukraine



abacavir (ABC) tablet, 300 mg Ranbaxy Laboratories Ltd Completed

aciclovir powder for injection, 250 mg (as sodium salt) Neon Antibiotics PVT. Ltd. In Processin 10-ml vial


bleomycin powder for injection, 15 mg (as sulfate) in vial Neon Antibiotics PVT. Ltd. In Process




didanosine (ddI) buffered chewable tablet, 100 mg Ranbaxy Laboratories Ltd Completed


efavirenz (EFZ) capsule, 200 mg Ranbaxy Laboratories Ltd Completed



98


Ukraine




itraconazole capsule, 100 mg Glenmark Pharmaceuticals Ltd Completed








omeprazole capsule, 20 mg Intas Pharmaceuticals Ltd In Process




vincristine powder for injection, 1 mg (sulfate) in 1-ml vial Neon Antibiotics PVT. Ltd. In Process

zidovudine (AZT or ZDV) capsule, 100 mg Ranbaxy Laboratories Ltd Completed

United Arab Emirates (the)





ciprofloxacin tablet, 250 mg (as hydrochloride) Bayer Healthcare AG In Process



erythromycin powder for oral suspension, 125 mg Shiba Pharmaceuticals & Chemicals Ltd. In Process(as stearate or ethylsuccinate)






omeprazole capsule, 10 mg Mepha Ltd In Process




United Kingdom (the)





amitriptyline tablet, 25 mg (as hydrochloride) Pharmchem International Ltd. Completed

azithromycin tablet/capsule, 500 mg (dihydrate) Pharmchem International Ltd. Completed

99


United Kingdom (the)

benzathine benzylpenicillin powder for injection, 1.44 g (=2.4 million IU) Pharmchem International Ltd. Completedin 5-ml vial

benzylpenicillin powder for injection, 3 g (=5 million IU) Pharmchem International Ltd. Completed(as sodium or potassium salt) in vial


ceftriaxone powder for injection, 1 g (as sodium salt) in vial Pharmchem International Ltd. Completed

chloramphenicol oily suspension for injection, 0.5 g/ml Pharmchem International Ltd. Completed(as sodium succinate) in 2-ml ampoule



clotrimazole cream, 1% Pharmchem International Ltd. Completed

codeine tablet, 30 mg (phosphate) Pharmchem International Ltd. Completed

doxorubicine HCl powder for injection, 10 mg in 5-ml vial Medac GmbH, International Operations Completed

doxycycline capsule/tablet, 100 mg (hydrochloride) Pharmchem International Ltd. Completed

erythromycin powder for oral suspension, 125 mg Pharmchem International Ltd. Completed(as stearate or ethylsuccinate)


fluoxetine capsule, 20 mg Pharmchem International Ltd. Completed

gentamicin injection, 10 mg (as sulfate) in 2-ml vial Pharmchem International Ltd. Completed

ketoconazole tablet, 200 mg Pharmchem International Ltd. Completed


methadone tablet, 5 mg Pharmchem International Ltd. Completed


miconazole cream/ointment 2% (as nitrate) 15 g tube Pharmchem International Ltd. Completed

morphine injection, 10 mg(hydrochloride) in 1-ml ampoule Martindale Pharmaceuticals Ltd. Completed





pethidine injection, 50 mg/ml (hydrochloride) in 1-ml ampoule Martindale Pharmaceuticals Ltd. Completed

procaine benzylpenicillin powder for injection, 3 g (=3 million IU) in vial Pharmchem International Ltd. Completed

spectinomycin powder for injection, 2 g (as hydrochloride) in vial Pharmchem International Ltd. Completed

sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Alpharma Completed

tetracycline tablet, 500 mg Pharmchem International Ltd. Completed

vincristine injection, 1 mg/ml (sulfate) in vial Pharmchem International Ltd. Completed


United Republic of Tanzania (the)





albendazole chewable tablet, 400 mg Beltapharm SpA In Process


azithromycin oral suspension, 200 mg/5 ml (dihydrate) Alembic Ltd. In Process




100


United Republic of Tanzania (the)


ciprofloxacin tablet, 250 mg (as hydrochloride) Aurobindo Pharma Ltd. In Process



clotrimazole pessary, 500 mg Gracure Pharmaceuticals Ltd. Completed

doxycycline capsule/tablet, 100 mg (hydrochloride) Intas Pharmaceuticals Ltd In Process


erythromycin powder for oral suspension, 125 mg Beltapharm SpA In Process(as stearate or ethylsuccinate)

fluconazole capsule, 150 mg IPCA Laboratories Ltd. In Process









ofloxacin tablet, 200 mg Cipla Ltd. In Process







USA





ceftriaxone powder for injection, 250 mg (as sodium salt) Lupin Ltd.. Completedin vial







Uruguay






101

Uruguay




methotrexate powder for injection, 50 mg (as sodium salt) Lab. Filaxis International S.A. Completedin 2-ml vial









Uzbekistan






erythromycin tablet/capsule, 250 mg Sanavita Aktiengesellschaft & Co. Completed(as stearate or ethylsuccinate)




nystatin pessary, 100,000 IU The Acme Laboratories Ltd. Completed



sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Sanavita Aktiengesellschaft & Co. Completed

Vanuatu



Venezuela









fluoxetine capsule, 20 mg Laboratorios Cinfa S.A. In Process





102


Venezuela







omeprazole capsule, 20 mg Laboratorios Cinfa S.A. In Process



Viet Nam



albendazole chewable tablet, 400 mg Strides Arcolab Ltd. Completed

azithromycin oral suspension, 200 mg/5 ml (dihydrate) Alembic Ltd. Completed

cefixime tablet, 200 mg Lyka Labs Ltd. In Process

ceftriaxone powder for injection, 1 g (as sodium salt) in vial Alembic Ltd. In Process






ketoconazole tablet, 200 mg Remedica Ltd. In Process













Yemen



azithromycin oral suspension, 200 mg/5 ml (dihydrate) Aleppo Pharmaceutical Industries (Alpha) Completed




clindamycin capsule, 150 mg Shiba Pharmaceuticals & Chemicals Ltd. Completed

doxycycline capsule/tablet, 100 mg (hydrochloride) Shiba Pharmaceuticals & Chemicals Ltd. Completed

103

Yemen

erythromycin powder for oral suspension, 125 mg Hovid SDN. BHN. Completed(as stearate or ethylsuccinate)




miconazole cream/ointment 2% (as nitrate) 15 g tube Lachifarma, SRL Completed








pyrimethamine tablet, 25 mg Shiba Pharmaceuticals & Chemicals Ltd. Completed


sulfamethoxazole+trimethoprim oral suspension, 200+40 mg/5 ml Aurobindo Pharma Ltd. Completed


Zambia


















Zimbabwe










104

Zimbabwe




doxycycline capsule/tablet, 100 mg (hydrochloride) Intas Pharmaceuticals Ltd Completed




lamivudine (3TC) tablet, 150 mg IPCA Laboratories Ltd. Completed







ofloxacin tablet, 200 mg Remedica Ltd. Completed



sulfamethoxazole+trimethoprim tablet, 400+80 mg Aspen Pharmacare Completed



105

Table 1. Anti-infective medicines

Anthelminthics Manufacturer

albendazole

chewable tablet, 400 mg Artesan Pharma GmbH & Co. KG, Beltapharm SpA, CiplaLtd., Gracure Pharmaceuticals Ltd., IPCA Laboratories Ltd.,Lachifarma SRL, Lyka Labs Ltd., Remedica Ltd., ShibaPharmaceuticals & Chemicals Ltd., Strides Arcolab Ltd.

Antibacterials, beta lactam medicines

benzathine benzylpenicillin

powder for injection, 1.44 g (=2.4 million IU) in 24–ml vial Sanavita Aktiengesellschaft & Co.

powder for injection, 1.44 g (=2.4 million IU) in 5–ml vial Alembic Ltd., Aventis Intercontinental,Pharmchem International Ltd.

benzylpenicillin

powder for injection, 3 g (=5 million IU) Alembic Ltd., Pharmchem International Ltd., Sanavita(as sodium or potassium salt) in vial Aktiengesellschaft & Co.

powder for injection, 600 mg (=1 million IU) Pliva d.d.(as potasium salt) in vial

cefixime

paediatric oral suspension, 100 mg/5 ml Aventis Intercontinental, Bilim Pharmaceutical Ind.,Lyka Labs Ltd.

paediatric oral suspension, 40 mg/5 ml Aventis Intercontinental

tablet, 200 mg Aventis Intercontinental, Cipla Ltd., Lyka Labs Ltd.

tablet, 400 mg Bilim Pharmaceutical Ind., Genepharm SA

ceftriaxone

powder for injection, 1 g (as sodium salt) in vial Alembic Ltd., Aurobindo Pharma Ltd., Aventis Ltd., BilimPharmaceutical Ind.,Cheil Jedang Corp., Cipla Ltd., DemoS.A., Pharmaceutical Industry, IVAX Pharmaceuticals Mexico,(S.A. de C.V.), Laboratorio Reig Jofre S.A., Lyka Labs Ltd.,Mepha Ltd., Neon Laboratories Ltd., Panpharma,Pharmchem International Ltd., Pliva d.d., RanbaxyLaboratories Ltd., Rekah Pharmaceutical Group,Strides Arcolab Ltd.

powder for injection, 250 mg (as sodium salt) in vial Aleppo Pharmaceutical Industries (Alpha), Aurobindo PharmaLtd., Aventis Ltd., Cheil Jedang Corp., Cipla Ltd., CombinoPharm, S.L., Demo S.A., *Hoffman-La Roche Ltd, Pharma-ceutical Industry, Lupin Ltd., Mepha Ltd., Neon LaboratoriesLtd., Pharmchem International Ltd., Ranbaxy LaboratoriesLtd., Strides Arcolab Ltd.

ANNEX 2B

Sources of medicinesPrequalified16 sources of specific products are marked in bold with an asterisk

16 Procurement Quality and Sourcing Project, list of manufacturers and suppliers http://mednet3.who.int/prequal/hiv/hiv-suppliers.doc



106

Antibacterials, beta lactam medicines Manufacturer

ceftriaxone

powder for injection, 500 mg (as sodium salt) in vial Aurobindo Pharma Ltd., Aventis Ltd., Bilim PharmaceuticalInd., Cheil Jedang Corp., Cipla Ltd., Demo S.A.,*Hoffman-La Roche Ltd., Pharmaceutical Industry,IVAX Pharmaceuticals Mexico (S.A. de C.V.), Lyka Labs Ltd.,Mepha Ltd., Pharmchem International Ltd., Strides Arcolab Ltd.

procaine benzylpenicillin

powder for injection, 3 g (=3 million IU) in vial Alembic Ltd., Pharmchem International Ltd.,Sanavita Aktiengesellschaft & Co., Strides Arcolab Ltd.

Antibacterials, others

azithromycin

oral suspension, 200 mg/5 ml (dihydrate) Alembic Ltd., Shiba Pharmaceuticals & Chemicals Ltd.

capsule/tablet, 250 mg (dihydrate) Alembic Ltd., Aleppo Pharmaceutical Industries (Alpha), Cipla Ltd.,IPCA Laboratories Ltd., Lyka Labs Ltd., Shiba Pharmaceuticals &Chemicals Ltd., Strides Arcolab Ltd., The Acme Laboratories Ltd.

capreomycin

powder for injection, 1 g in vial Cheil Jedang Corp., Neon Antibiotics PVT. Ltd.

chloramphenicol

oily suspension for injection,0.5 g/ml (as sodium succinate) Pharmchem International Ltd.in 2–ml ampoule

oral suspension, 150 mg/5 ml (as palmitate) Pharmchem International Ltd.

powder for injection, 1 g (sodium succinate) in vial Neon Laboratories Ltd., Pharmchem International Ltd.,Sanavita Aktiengesellschaft & Co., SM Pharmaceuticals Sdn Bhd,Strides Arcolab Ltd.

ciprofloxacin

tablet, 250 mg (as hydrochloride) Alembic Ltd., Alpharma, Apotex Mexico Protein, (S.A. de C.V.),tablet, 500 mg (as hydrochloride) Aspen Pharmacare, Aurobindo Pharma Ltd., Aventis Ltd., Bayertablet, 750 mg (as hydrochloride) Healthcare AG, Cheil Jedang Corp., *Cipla Ltd., Genepharm SA,

Glenmark Pharmaceuticals Ltd., Gracure Pharmaceuticals Ltd.,Intas Pharmaceuticals Ltd., IPCA Laboratories Ltd.,IVAX Pharmaceuticals Mexico (S.A. de C.V.),*Laboratorios Cinfa S.A., Lupin Ltd., Lyka Labs Ltd., MephaLtd., Orios Juventus S.A., Pharmchem International Ltd.,Phyto-Riker Pharmaceuticals Ltd., Pliva d.d.,*Ranbaxy Laboratories Ltd., Remedica Ltd.,Shiba Pharmaceuticals & Chemicals Ltd., SM PharmaceuticalsSdn Bhd, Strides Arcolab Ltd., The Acme Laboratories Ltd.

clarithromycin

powder for injection, 500 mg Strides Arcolab Ltd.

tablet, 250 mg Alembic Ltd., Alpharma, Bilim Pharmaceutical Ind., Genepharm SA,Intas Pharmaceuticals Ltd., IPCA Laboratories Ltd., IVAX Pharma-ceuticals Mexico, (S.A. de C.V.), Lyka Labs Ltd., Orios JuventusS.A., *Ranbaxy Laboratories Ltd., Remedica Ltd.,SM Pharmaceuticals Sdn Bhd, Strides Arcolab Ltd., The AcmeLaboratories Ltd., The Government Pharmaceutical Organization

107

Antibacterials, others Manufacturer

clindamycin

capsule, 150 mg Bilim Pharmaceutical Ind., Shiba Pharmaceuticals & Chemicals Ltd.

injection, 150 mg/ml (as phosphate) in 2–ml ampoule Combino Pharm, S.L.

injection, 150 mg/ml (as phosphate) in 4–ml ampoule Strides Arcolab Ltd.

cycloserine

capsule, 250 mg Cheil Jedang Corp., Pharmadrug

doxycycline

capsule/tablet, 100 mg (hydrochloride) Aspen Pharmacare, Beacons Pharmaceuticals Pte Ltd., Cipla Ltd.,Gracure Pharmaceuticals Ltd., Hovid SDN. BHN., Intas Pharmaceu-ticals Ltd., Pharmadrug, Pharmchem International Ltd., RekahPharmaceutical Group, Remedica Ltd., Sanavita Aktiengesellschaft& Co., Shiba Pharmaceuticals & Chemicals Ltd.,The Acme Laboratories Ltd.

erythromycin

powder for oral suspension, 125mg (as stearate or ethylsuccinate) Aventis Ltd., Beacons Pharmaceuticals Pte Ltd., Beltapharm SpA,Gracure Pharmaceuticals Ltd., Lachifarma SRL, Pharmadrug,Pharmchem International Ltd., Purna Pharmaceuticals NV,Remedica Ltd., Shiba Pharmaceuticals & Chemicals Ltd.

capsule/tablet, 250 mg (as stearate or ethylsuccinate) Alembic Ltd., Artesan Pharma GmbH & Co. KG, Aurobindo PharmaLtd., Aventis Ltd., Beacons Pharmaceuticals Pte Ltd., BeltapharmSpA, Cipla Ltd., Gracure Pharmaceuticals Ltd., Hovid SDN. BHN.,IPCA Laboratories Ltd., Lachifarma SRL, Lyka Labs Ltd.,Pharmchem International Ltd., Phyto-Riker Pharmaceuticals Ltd.,Remedica Ltd., Sanavita Aktiengesellschaft & Co., Shiba Pharma-ceuticals & Chemicals Ltd., SM Pharmaceuticals Sdn Bhd,Strides Arcolab Ltd.

capsule/tablet, 500 mg (as stearate or ethylsuccinate) Alembic Ltd., Artesan Pharma GmbH & Co. KG, Aventis Ltd., CiplaLtd., Gracure Pharmaceuticals Ltd., Hovid SDN. BHN., IPCALaboratories Ltd., Pharmchem International Ltd., Remedica Ltd.,Sanavita Aktiengesellschaft & Co., Shiba Pharmaceuticals &Chemicals Ltd., Strides Arcolab Ltd.

gentamicin

injection, 10 mg (as sulfate) in 2–ml vial Aspen Pharmacare, Intas Pharmaceuticals Ltd.,Pharmchem International Ltd., Rotexmedica

injection, 40 mg (as sulfate) in 2–ml vial Aspen Pharmacare, Gracure Pharmaceuticals Ltd., Intas Pharma-ceuticals Ltd., Neon Laboratories Ltd., Pharmchem InternationalLtd., Rotexmedica, Sanavita Aktiengesellschaft & Co.

metronidazole

injection, 500 mg in 100–ml vial Aspen Pharmacare, Aventis Intercontinental, Cheil Jedang Corp.,Demo S.A., Pharmaceutical Industry, Pharmchem InternationalLtd., Rotexmedica

suppository, 1 g Aventis Intercontinental

ANNEX 2B. SOURCES OF MEDICINES


108


ofloxacin

IV infusion, 2 mg/ml (hydrochloride) Genepharm SA

IV infusion, 5 mg/ml (hydrochloride) Aventis Intercontinental

tablet, 200 mg Aspen Pharmacare, Aventis Intercontinental, Cipla Ltd., GenepharmSA, Gracure Pharmaceuticals Ltd., Hovid SDN. BHN., IntasPharmaceuticals Ltd., IPCA Laboratories Ltd., Lyka Labs Ltd.,Ranbaxy Laboratories Ltd., Remedica Ltd., Shiba Pharmaceuticals& Chemicals Ltd., Strides Arcolab Ltd.

tablet, 400 mg Aspen Pharmacare, Cipla Ltd., Remedica Ltd.,Shiba Pharmaceuticals & Chemicals Ltd., Strides Arcolab Ltd.

rifabutin

capsule, 150 mg Lupin Ltd.

silver nitrate

solution (eye drops), 1% Gracure Pharmaceuticals Ltd.

spectinomycin

powder for injection, 2 g (as hydrochloride) in vial Demo S.A., Pharmaceutical Industry, Neon Antibiotics PVT. Ltd.,Pharmchem International Ltd.

sulfadiazine

tablet, 500 mg *Doms RecordatiNPI, Ecobi Farmaceutici S.a.s., Far Manguinhos,Heyl Chemisch.-pharmazeutische Fabrik GmbH & Co KG,Laboratorio Reig Jofre S.A., Strides Arcolab Ltd.

sulfamethoxazole+trimethoprim

oral suspension, 200+40 mg/5 ml Apotex Mexico Protein, (S.A. de C.V.), Aspen Pharmacare, AventisLtd., Beacons Pharmaceuticals Pte Ltd., Ecobi Farmaceutici S.a.s.,*Hoffman-La Roche Ltd, Hovid SDN. BHN., Lachifarma SRL,Pharmchem International Ltd., Remedica Ltd., Scanpharm A/S,Shiba Pharmaceuticals & Chemicals Ltd., SM PharmaceuticalsSdn Bhd, The Acme Laboratories Ltd.

tablet, 100+20 mg Artesan Pharma GmbH & Co. KG, Ecobi Farmaceutici S.a.s.,Gracure Pharmaceuticals Ltd., IVAX Pharmaceuticals Mexico, (S.A.de C.V.), Lachifarma SRL, Lyka Labs Ltd., Pharmchem Interna-tional Ltd., Rekah Pharmaceutical Group, Shiba Pharmaceuticals &Chemicals Ltd.

tablet, 400+80 mg Alpharma, Apotex Mexico Protein, (S.A. de C.V.), Artesan PharmaGmbH & Co. KG, Aspen Pharmacare, Aurobindo Pharma Ltd.,Aventis Ltd., Beacons Pharmaceuticals Pte Ltd., EcobiFarmaceutici S.a.s., Far Manguinhos, Gracure PharmaceuticalsLtd., *Hoffman-La Roche Ltd., Hovid SDN. BHN., IntasPharmaceuticals Ltd., IPCA Laboratories Ltd., IVAX Pharmaceuti-cals Mexico, (S.A. de C.V.), Pharmchem International Ltd.,Remedica Ltd., Sanavita Aktiengesellschaft & Co., Shiba Pharma-ceuticals & Chemicals Ltd., SM Pharmaceuticals Sdn Bhd, StridesArcolab Ltd. The Acme Laboratories Ltd., The GovernmentPharmaceutical Organization

tablet, 800+160 mg Alpharma, Apotex Mexico Protein, (S.A. de C.V.), AspenPharmacare, Aurobindo Pharma Ltd., Aventis Ltd.,*Hoffman-La Roche Ltd, Hovid SDN. BHN., Intas Pharmaceuti-cals Ltd., Pharmchem International Ltd., Rekah PharmaceuticalGroup, Shiba Pharmaceuticals & Chemicals Ltd.,Strides Arcolab Ltd.

NPI No price information

109


tetracycline

tablet, 500 mg Gracure Pharmaceuticals Ltd., Hovid SDN. BHN., PharmchemInternational Ltd.

Antifilarials

crotamiton

cream/lotion 10% SM Pharmaceuticals Sdn Bhd

Antifungal medicines

amphotericin B

powder for injection, 50 mg in vial Combino Pharm, S.L., Neon Antibiotics PVT. Ltd.

clotrimazole

cream, 1% Aspen Pharmacare, Beacons Pharmaceuticals Pte Ltd., Cipla Ltd.,Gracure Pharmaceuticals Ltd., Pharmadrug, PharmchemInternational Ltd., Purna Pharmaceuticals NV, Remedica Ltd., SMPharmaceuticals Sdn Bhd, The Acme Laboratories Ltd.,The Government Pharmaceutical Organization,

pessary, 500 mg Gracure Pharmaceuticals Ltd., Remedica Ltd.

fluconazole

capsule, 50 mg Cipla Ltd., Pliva d.d., *Ranbaxy Laboratories Ltd.

capsule, 150 mg Bilim Pharmaceutical Ind., Cipla Ltd., Gracure PharmaceuticalsLtd., Intas Pharmaceuticals Ltd., Pliva d.d., *Ranbaxy Labor-atories Ltd., Shiba Pharmaceuticals & Chemicals Ltd.

capsule, 200 mg Cipla Ltd., IPCA Laboratories Ltd., Pliva d.d.,*Ranbaxy Laboratories Ltd., Remedica Ltd.,Shiba Pharmaceuticals & Chemicals Ltd., The GovernmentPharmaceutical Organization

solution for injection, 2mg/ml in ampoule Genepharm SA, Laboratorio Reig Jofre S.A.

itraconazole

capsule, 100 mg Intas Pharmaceuticals Ltd., IVAX Pharmaceuticals Mexico,(S.A. de C.V.), SM Pharmaceuticals Sdn Bhd

ketoconazole

cream, 2% Apotex Mexico Protein, (S.A. de C.V.), Aspen Pharmacare,Beacons Pharmaceuticals Pte Ltd., Gracure Pharmaceuticals Ltd.,IVAX Pharmaceuticals Mexico, (S.A. de C.V.), Purna Pharmaceuti-cals NV

tablet, 200 mg Artesan Pharma GmbH & Co. KG, Aspen Pharmacare, BeltapharmSpA, Bilim Pharmaceutical Ind., Far Manguinhos, Gracure Pharma-ceuticals Ltd., Hovid SDN. BHN., Intas Pharmaceuticals Ltd., IVAXPharmaceuticals Mexico, (S.A. de C.V.), Lachifarma SRL,Pharmadrug, Pharmchem International Ltd., Remedica Ltd., SMPharmaceuticals Sdn Bhd, Strides Arcolab Ltd., The GovernmentPharmaceutical Organization



110

Antifungal medicines Manufacturer

miconazole

cream/ointment 2% (as nitrate) 15 g tube Beacons Pharmaceuticals Pte Ltd., Hovid SDN. BHN., LachifarmaSRL, Pharmchem International Ltd., Purna Pharmaceuticals NV

cream/ointment 2% (as nitrate) 20 g tube Apotex Mexico Protein, (S.A. de C.V.)

cream/ointment 2% (as nitrate) 30 g tube Beltapharm SpA, Ecobi Farmaceutici S.a.s., Gracure Pharmaceuti-cals Ltd., Lachifarma SRL, Pharmadrug, Pharmchem InternationalLtd., Purna Pharmaceuticals NV

cream/ointment 2% (as nitrate) 40 g tube IVAX Pharmaceuticals Mexico, (S.A. de C.V.)

nystatin

pessary, 100,000 IU Artesan Pharma GmbH & Co. KG, Cipla Ltd., Pharmadrug, SMPharmaceuticals Sdn Bhd, The Acme Laboratories Ltd.

tablet, 100,000 IU Artesan Pharma GmbH & Co. KG, Cipla Ltd.

tablet, 500,000 IU Apotex Mexico Protein, (S.A. de C.V.), Artesan Apotex MexicoProtein, (S.A. de C.V.), Artesan Pharma GmbH & Co. KG, CiplaLtd., Pharmadrug, Sanavita Aktiengesellschaft & Co., The AcmeLaboratories Ltd.

Antiprotozoal medicines

pentamidine

powder for injection, 200 mg (isetionate) in vial Neon Antibiotics PVT. Ltd.

powder for injection, 300 mg (isetionate) in vial Aventis Intercontinental, Combino Pharm, S.L., Lab.Filaxis International S.A., Neon Antibiotics PVT. Ltd.

pyrimethamine

tablet, 25 mg Gracure Pharmaceuticals Ltd., Shiba

tinidazole

tablet, 500 mg Gracure Pharmaceuticals Ltd., Intas Pharmaceuticals Ltd.,Remedica Ltd.

Antiviral medicines

aciclovir

cream, 5% *Cipla Ltd., Ecobi Farmaceutici S.a.s., Gracure PharmaceuticalsLtd., IVAX Pharmaceuticals Mexico, (S.A. de C.V.)

powder for injection, 250 mg (as sodium salt) in 10–ml vial Combino Pharm, S.L., Lab. Filaxis International S.A., NeonAntibiotics PVT. Ltd.

tablet, 200 mg Alpharma, Apotex Mexico Protein, (S.A. de C.V.), AspenPharmacare, Beacons Pharmaceuticals Pte Ltd., *Cipla Ltd.,Hovid SDN. BHN., IPCA Laboratories Ltd., IVAX PharmaceuticalsMexico, (S.A. de C.V.), Lab. Filaxis International S.A., Pharmadrug,*Ranbaxy Laboratories Ltd., Remedica Ltd., Samchully Pharm.Co., Ltd., SM Pharmaceuticals Sdn Bhd

tablet, 400 mg Alpharma, Aspen Pharmacare, Beacons Pharmaceuticals Pte Ltd.,*Cipla Ltd., Ecobi Farmaceutici S.a.s., Hovid SDN. BHN., IPCALaboratories Ltd., *Ranbaxy Laboratories Ltd., Remedica Ltd.,Samchully Pharm. Co., Ltd., SM Pharmaceuticals Sdn Bhd

tablet, 800 mg *Cipla Ltd., Combino Pharm, S.L., Ecobi Farmaceutici S.a.s.,IPCA Laboratories Ltd., Lab. Filaxis International S.A., LaboratoriosCinfa S.A., *Ranbaxy Laboratories Ltd., Remedica Ltd.

111

Antiviral medicines Manufacturer

ganciclovir

powder for IV infusion, 500 mg in vial *Hoffmann-La Roche Ltd., Lab. Filaxis International S.A.

Antiviral medicines – Antiretrovirals

abacavir (ABC)

syrup, 20 mg/ml *Glaxo SmithKline

tablet, 300 mg Cipla Ltd., *Glaxo SmithKline

didanosine (ddI)

buffered chewable tablet, 100 mg Apotex Mexico Protein, (S.A. de C.V.), Aurobindo Pharma Ltd.,*Bristol-Myers Squibb (FR), Bristol-Myers Squibb (SA), CiplaLtd., Donato y Zurlo S.A., Far Manguinhos, Ranbaxy LaboratoriesLtd., Strides Arcolab Ltd.

buffered chewable tablet, 25 mg Apotex Mexico Protein, (S.A. de C.V.),*Bristol-Myers Squibb (FR),Bristol-Myers Squibb ( SA), Cipla Ltd., Far Manguinhos,Strides Arcolab Ltd.

syrup, 2 g *Bristol-Myers Squibb ( FR), Bristol-Myers Squibb (SA)

unbuffered enteric coated capsule, 250 mg Bristol-Myers Squibb ( FR), Cipla Ltd., Ranbaxy Laboratories Ltd.

unbuffered enteric coated capsule, 400 mg Bristol-Myers Squibb ( FR), Cipla Ltd., Ranbaxy Laboratories Ltd.

efavirenz (EFZ)

capsule, 200 mg Aurobindo Pharma Ltd., Cipla Ltd., Lab. Filaxis International S.A.,Ranbaxy Laboratories Ltd.

tablet, 600 mg Aurobindo Pharma Ltd., Cipla Ltd., Ranbaxy Laboratories Ltd.

indinavir (IDV)

capsule, 200 mg Cipla Ltd., Donato y Zurlo S.A., *Hetero Drugs Ltd.NPI,New GPC Inc.

capsule, 400 mg Aurobindo Pharma Ltd., Cipla Ltd., Far Manguinhos, Lab. FilaxisInternational S.A., Strides Arcolab Ltd.,*Ranbaxy Laboratories Ltd.

lamivudine (3TC)

syrup, 50 mg/5 ml *Cipla Ltd., *Glaxo SmithKline,The Government Pharmaceutical Organization

tablet, 150 mg Aurobindo Pharma Ltd., Cheil Jedang Corp., *Cipla Ltd.,Donato y Zurlo S.A., Far Manguinhos, *Glaxo SmithKline,*Hetero Drugs Ltd.NPI, Intas Pharmaceuticals Ltd., IPCALaborato-ries Ltd., Lab. Filaxis International S.A., New GPC Inc,*Ranbaxy Laboratories Ltd., Strides Arcolab Ltd. ,The Government Pharmaceutical Organization

tablet, 300 mg Ranbaxy Laboratories Ltd.

nelfinavir (NFV)

capsule, 250 mg Aurobindo Pharma Ltd., Cipla Ltd., Donato y Zurlo S.A., F.*Hoffmann-La Roche Ltd., Lab. Filaxis International S.A.

powder for oral solution, 50 mg/g *Hoffmann-La Roche Ltd

nevirapine (NVP)

syrup, 50 mg/5 ml *Boehringer Ingelheim Gmbh, Cipla Ltd., The GovernmentPharmaceutical Organization




112

Antiviral medicines – Antiretrovirals Manufacturer

tablet, 200 mg Aurobindo Pharma Ltd., *Boehringer Ingelheim Gmbh , CheilJedang Corp.,*Cipla Ltd.,Far Manguinhos,*Hetero Drugs LtdNPI

Lab. Filaxis International S.A., New GPC Inc, *Ranbaxy Labora*Ranbaxy Laboratories Ltd., Strides Arcolab Ltd. ,The Government Pharmaceutical Organization

saquinavir (SQV)

(hard gel and soft gel) capsule, 200 mg *F. Hoffmann-La Roche Ltd.

stavudine (d4T)

capsule, 15 mg *Bristol-Myers Squibb ( FR),The Government Pharmaceutical Organization

capsule, 20 mg Aspen Pharmacare, *Bristol-Myers Squibb ( FR), Bristol-MyersSquibb ( SA), The Government Pharmaceutical Organization

capsule, 30 mg Aspen Pharmacare, Aurobindo Pharma Ltd., *Bristol-MyersSquibb ( FR), Bristol-Myers Squibb (SA), Cipla Ltd., Donato yZurlo S.A., Far Manguinhos, *Hetero Drugs Ltd§, New GPC Inc,*Ranbaxy Laboratories Ltd., Strides Arcolab Ltd.,The Government Pharmaceutical Organization

capsule, 40 mg Apotex Mexico Protein, (S.A. de C.V.), Aspen Pharmacare,Aurobindo Pharma Ltd., *Bristol-Myers Squibb ( FR), Bristol-Myers Squibb (SA), Cheil Jedang Corp., Cipla Ltd., Donato y ZurloS.A., Far Manguinhos, *Hetero Drugs LtdNPI, Lab. FilaxisInternational S.A., New GPC Inc, Ranbaxy Laboratories Ltd.,Samchully Pharm. Co., Ltd., Strides Arcolab Ltd.,The Government Pharmaceutical Organization

syrup, 1 mg/ml Bristol-Myers Squibb ( FR), Bristol-Myers Squibb (SA),The Government Pharmaceutical Organization

zalcitabine (ddC)

tablet, 0.375 mg Apotex Mexico Protein, (S.A. de C.V.), *Hoffman-La Roche Ltd

tablet, 0.75 mg Apotex Mexico Protein, (S.A. de C.V.), *Hoffman-La Roche Ltd,Lab. Filaxis International S.A.

zidovudine (AZT or ZDV)

capsule, 100 mg Apotex Mexico Protein, (S.A. de C.V.), Aurobindo Pharma Ltd.,Cheil Jedang Corp., *Cipla Ltd., *Combino Pharm, S.L.,Donato y Zurlo S.A., Far Manguinhos, *Glaxo SmithKline, IPCALaboratories Ltd., Lab. Filaxis International S.A., New GPC Inc,Ranbaxy Laboratories Ltd., Samchully Pharm. Co., Ltd., StridesArcolab Ltd. , The Government Pharmaceutical Organization

capsule, 250 mg Apotex Mexico Protein, (S.A. de C.V.), Cheil Jedang Corp.,*Combino Pharm, S.L., Donato y Zurlo S.A.,*Glaxo Smith Kline, Lab. Filaxis International S.A.,Samchully Pharm. Co., Ltd.

injection, 10 mg/ml in 20–ml vial *Glaxo SmithKline

oral solution, 50 mg/5 ml *Cipla Ltd., *Combino Pharm, S.L., *Glaxo SmithKline

tablet, 300 mg Aurobindo Pharma Ltd., *Cipla Ltd., *Combino Pharm, S.L.,*Glaxo SmithKline, *Hetero Drugs LtdNPI, New GPC Inc,*Ranbaxy Laboratories Ltd., Samchully Pharm. Co., Ltd.,Strides Arcolab Ltd., The Government Pharmaceutical Organization


113

Antiviral medicines - Antiretrovirals (combinations) Manufacturer

3TC/AZT

tablet, 300/150 mg Aurobindo Pharma Ltd., Cheil Jedang Corp., *Cipla Ltd.,Donato y Zurlo S.A., Far Manguinhos, *Glaxo SmithKline,*Hetero Drugs LtdNPI Lab. Filaxis International S.A.,New GPC Inc, *Ranbaxy Laboratories Ltd.,Strides Arcolab Ltd., The Government Pharmaceutical Organization

3TC/d4T/NVP

tablet, 150/30/200 mg *Ranbaxy Laboratories Ltd.

tablet, 150/40/200 mg Cheil Jedang Corp., *Cipla Ltd., New GPC Inc, *RanbaxyLaboratories Ltd., Strides Arcolab Ltd., The GovernmentPharmaceutical Organization

ABC/3TC/ZDV

tablet, 300/150/300 mg *Glaxo SmithKline, Ranbaxy Laboratories Ltd.

AZT/3TC/NVP

tablet, 300/150/200 mg Aurobindo Pharma Ltd., Cipla Ltd.

Table 2. Antineoplastic medicines

Cytotoxic medicines Manufacturer

bleomycin

powder for injection, 15 mg 15 mg (as sulfate) in vial Aventis Intercontinental, Neon Antibiotics PVT. Ltd.

calcium folinate (leucovorin)

tablet, 15 mg Ecobi Farmaceutici S.a.s., Lab. Filaxis International S.A.,Medac GmbH, International Operations

doxorubicine HCl

powder for injection, 10 mg in 5–ml vial Lab. Filaxis International S.A., Medac GmbH, InternationalOperations, Neon Antibiotics PVT. Ltd.,Pharmchem International Ltd.

powder for injection, 50 mg in 25–ml vial Lab. Filaxis International S.A., Medac GmbH, InternationalOperations, Neon Antibiotics PVT. Ltd.,Pharmchem International Ltd.

etoposide

injection, 20 mg/ ml in 5–ml ampoule Cipla Ltd., Intas Pharmaceuticals Ltd., Lab. Filaxis InternationalS.A., Medac GmbH, International Operations,Neon Antibiotics PVT. Ltd.

methotrexate

injection, 25 mg/ml (as sodium salt) in 2–ml vial Aventis Intercontinental, Neon Antibiotics PVT. Ltd.

powder for injection, 50 mg (as sodium salt) in 2–ml vial Aventis Intercontinental, Lab. Filaxis International S.A., NeonAntibiotics PVT. Ltd.

tablet, 2.5 mg Aventis Intercontinental, Cipla Ltd., Neon Antibiotics PVT. Ltd.,Remedica Ltd.

vinblastine

powder for injection, 10 mg (sulfate) in 10–ml vial *Cipla Ltd., Lab. Filaxis International S.A.,Neon Antibiotics PVT.Ltd.



114

Cytotoxic medicines Manufacturer

vincristine

injection, 1 mg/ml (sulfate) in vial *Cipla Ltd., Lab. Filaxis International S.A., PharmchemInternational Ltd.

powder for injection, 1 mg (sulfate) in 1–ml vial Neon Antibiotics PVT. Ltd.

vinorelbine

injection concentrate 10 mg/ml in vial

Table 3. Medicines used for the treatmentof mental and substance abuse disorders

Medicines used in depressive disorders Manufacturer

amitriptyline

tablet, 25 mg (as hydrochloride) Aspen Pharmacare, Gracure Pharmaceuticals Ltd., Intas Pharma-ceuticals Ltd., Pharmchem International Ltd., Remedica Ltd.,The Government Pharmaceutical Organization

fluoxetine

tablet, 20 mg Apotex Mexico Protein, (S.A. de C.V.), Aspen Pharmacare,CombinoPharm, S.L., Genepharm SA, IVAX Pharmaceuticals Mexico, (S.A.de C.V.), Laboratorios Cinfa S.A., Pharmchem International Ltd.,Ranbaxy Laboratories Ltd., Remedica Ltd.

Medicines used in generalized anxietyand sleep disorders

methotrimepazine/levomepromazine

tablet, 25 mg Aventis Intercontinental, Pharmadrug

Medicines used in treatment of opioid dependence

naltrexone HCl

tablet, 50 mg Intas Pharmaceuticals Ltd., Lachifarma SRL

Table 4. Analgesics

Opioid analgesics Manufacturer

codeine

tablet, 30 mg (phosphate) Aspen Pharmacare, Beacons Pharmaceuticals Pte Ltd.,Pharmchem International Ltd., Rekah Pharmaceutical Group,Remedica Ltd.

methadone

tablet, 5 mg Pharmchem International Ltd.

morphine

injection, 10 mg/ml (sulfate or HCl), in 1–ml ampoule Aspen Pharmacare, Lab. Renaudin, Martindale PharmaceuticalsLtd., Molteni Farmaceutici, Pharchem International Ltd.

oral solution, 10 mg/5 ml (sulfate or HCl) Molteni Farmaceutici, Pharmchem International Ltd.

115

Opioid analgesics Manufacturer

pethidine

injection, 50 mg/ml (hydrochloride) in 1–ml ampoule Aspen Pharmacare, Martindale Pharmaceuticals Ltd., NeonLaboratories Ltd., Pharmchem International Ltd.

injection, 50 mg/ml (hydrochloride) in 2–ml ampoule Aspen Pharmacare, Lab. Renaudin, Martindale PharmaceuticalsLtd., Molteni Farmaceutici, Neon Laboratories Ltd., Pharmadrug,Pharmchem International Ltd.

tablet, 50 mg Martindale Pharmaceuticals Ltd., Pharmchem International Ltd.

tablet, 100 mg Pharmchem International Ltd.

Table 5. Gastrointestinal medicines

Antacids and other antiulcer medicines Manufacturer

omeprazole

capsule, 10 mg Aventis Ltd., Cipla Ltd., IVAX Pharmaceuticals Mexico, (S.A. deC.V.), Lyka Labs Ltd., Mepha Ltd., Shiba Pharmaceuticals &Chemicals Ltd., SM Pharmaceuticals Sdn Bhd

capsule, 20 mg Alembic Ltd., Apotex Mexico Protein, (S.A. de C.V.), AurobindoPharma Ltd., Aventis Ltd., Cipla Ltd., Demo S.A., PharmaceuticalIndustry, Genepharm SA, Gracure Pharmaceuticals Ltd., HovidSDN. BHN., Intas Pharmaceuticals Ltd., IVAX PharmaceuticalsMexico, (S.A. de C.V.), Laboratorios Andr—maco S.A.,Laboratorios Cinfa S.A., Mepha Ltd., Remedica Ltd., ShibaPharmaceuticals & Chemicals Ltd., SM Pharmaceuticals Sdn Bhd,Strides Arcolab Ltd. , The Acme Laboratories Ltd.

capsule, 40 mg Aurobindo Pharma Ltd., Aventis Ltd., IVAX PharmaceuticalsMexico, (S.A. de C.V.), Laboratorios Andr—maco S.A., MephaLtd., Shiba Pharmaceuticals & Chemicals Ltd., The AcmeLaboratories Ltd.

powder for injection, 40 mg (as sodium salt) in vial Neon Antibiotics PVT. Ltd.,

powder for IV infusion, 40 mg (as sodium salt) in vial Genepharm SA, Neon Antibiotics PVT. Ltd.

Antiemetic medicines

dimenhydrinate

tablet, 50 mg Apotex Mexico Protein, (S.A. de C.V.), Beacons PharmaceuticalsPte Ltd., Laboratorios Cinfa S.A., The Government PharmaceuticalOrganization

metoclopramide

injection 5 mg/ml in 2–ml ampoule Aspen Pharmacare, Aventis Ltd., CLARIS Lifesciences Ltd., Lab.Renaudin, The Government Pharmaceutical Organization

tablet, 10 mg (as hydrochloride) Alpharma, Apotex Mexico Protein, (S.A. de C.V.), AspenPharmacare, Aventis Ltd., Genepharm SA, IPCA Laboratories Ltd.,Remedica Ltd., The Acme Laboratories Ltd.

prochlorperazine

injection, 12.5 mg/ml Aventis Ltd., Pharmadrug

tablet, 5 mg Aspen Pharmacare, Aventis Ltd., Remedica Ltd.

tablet, 10 mg Pharmadrug



116116

ANNEX 3

Further reading, referencesand contacts

http://dcc2.bumc.bu.edu/richardl/IH820/Resource_materials/Web_Resources/Levison-hiddencosts.doc

• A commitment to action for expanded access to HIV/AIDS treatment. International HIV Treatment AccessCoalition, WHO, Geneva, 2002 (WHO/HIV/2002.24).

http://www.who.int/hiv/pub/prev_care/who_hiv_2002_24.pdf

• Berwick D. “We All Have AIDS”: The case for reducingthe cost of HIV medicines to zero. British Medical Jour-nal, 2002, 324: 214–218.

• Guidelines on interaction with commercial enterprisesto achieve health outcomes. Annex to guidelines onworking with the private sector to achieve health out-comes. WHO, Geneva, 2000 (EB107/20).

http://www.who.int/gb/EB_WHA/PDF/EB107/ee20.pdf

• Guidelines for drug donations (interagency document).WHO, Geneva, 1999 (WHO/EDM/PAR/99.4).

http://www.who.int/medicines/docs/pagespublications/ supplypub.htm.

Treatment guidelines

• Antiretroviral drugs and the prevention of mother-to-child transmission of HIV infection in resource-limitedsettings. Draft document. WHO, Geneva, 2004.

http://www.who.int/3by5/publications/documents/pmtct/en/

• Integrated management of adolescent and adult illness(IMAI) modules. WHO, Geneva, 2004 (WHO/CDS/IMAI/2004.1).

http://www.who.int/3by5/publications/documents/imai/en/

• WHO Model Formulary 2004. WHO, Geneva, 2004.

http://mednet3.who.int/mf/intro.asp

• A public health approach for scaling up antiretroviral(ARV) treatment. A toolkit for programme managers.WHO, Geneva, 2003.

http://www.who.int/3by5/publications/documents/isbn9241591161/en/

General

• Two pills a day saving lives: Fixed-dose combinations(FDCs) of antiretroviral drugs. MSF, Geneva, 2004.

http://www.accessmed-msf.org/documents/factsheetfdc.pdf

• AIDS epidemic update. UNAIDS/WHO, Geneva, 2003.

http://www.unaids.org/Unaids/EN/Resources/Publications/Corporate+publications/AIDS+epidemic+update+-+December+2003.asp

• Treating 3 million by 2005: Making it happen. UNAIDS/WHO, Geneva, 2003.

http://www.who.int/3by5/publications/documents/isbn9241591129/en/

• Guidelines for price discounts of single-source phar-maceuticals (interagency document). WHO, Geneva,2003 (WHO/EDM/PAR/2003.3).

http://www.who.int/medicines/library/docseng_from_a_to_z.shtml#g

• Human capacity-building plan for scaling up HIV/AIDStreatment. WHO, Geneva, 2003.

http://www.who.int/3by5/publications/documents/capacity_building/en/

• Partnership work: the health service-community inter-face for the prevention, care and treatment of HIV/AIDS. Report of a WHO consultation, 5-6 December2002. WHO, Geneva, 2003.

http://www.who.int/hiv/pub/prev_care/hivpub43/en/

• Handbook on access to HIV/AIDS-related treatment. Acollection of information, tools and resources for NGOs,CBOs and PLWA groups. Joint publication UNAIDS, WHOand International AIDS Alliance, Geneva, 2003.

http://www.unaids.org/publications/documents/health/access/NGOtoolkit/index.html

http://www.who.int/hiv/pub/prev_care/pub29/en/

• Levison L Policy and programming options for reduc-ing the procurement costs of essential medication indeveloping countries. Boston University School of Pub-lic Health, 2003.

117

ANNEX 3. FURTHER READING, REFERENCES AND CONTACTS

• The selection and use of essential medicines. Reportof the WHO Expert Committee, 2003 (including the13th Model List of Essential Medicines). WHO,Geneva, 2003 (WHO Technical Report Series, No. 920).

http://www.who.int/medicines/organization/par/edl/expertcomm.shtml

• Saving mothers, saving families: The MTCT-Plus Initia-tive. Perspectives and practice in antiretroviral treat-ment. Case study. WHO, Geneva, 2003.

http://www.who.int/hiv/pub/prev_care/pub40/en/

• Guidelines for the management of sexually transmit-ted infections. WHO, Geneva, 2003.

http://www.who.int/hiv/pub/sti/pub6/en/

• Scaling up antiretroviral therapy in resource limited set-tings: Treatment guidelines for a public health approach.WHO, Geneva, 2003.

http://www.who.int/3by5/publications/documents/arv_guidelines/en/

• Emergency scale-up of antiretroviral therapy in re-source-limited settings: Technical and operational rec-ommendations to achieve 3 by 5. Report of the WHO/UNAIDS consultation,18-21 November 2003, Zambia.WHO, Geneva, 2003.

http://www.who.int/3by5/publications/documents/zambia/en/

• Provision of antiretroviral therapy in resource-limitedsettings: A review of experience up to August 2003.WHO and UK Department for International Development,2003.

http://www.who.int/3by5/publications/documents/dfid/en/

• Monitoring and evaluating of national ART programmesin the rapid scale-up to 3 by 5. Draft document. WHO,Geneva, 2003.

http://www.who.int/3by5/publications/documents/artindicators/en/

• Guidelines for surveillance of HIV drug resistance. Draftdocument for review. WHO, Geneva, 2003.

http://www.who.int/3by5/publications/documents/hivdrugsurveillance/en/

• HIV/AIDS care and treatment: A clinical course for peo-ple caring for people living with HIV/AIDS. Family HealthInternational, Arlington, VA, 2003.

http://www.fhi.org/en/HIVAIDS/Publications/manualsguidebooks/careandtreatmentclinicalcourse.htm

• AIDS Palliative Care: UNAIDS Technical Update, Octo-ber 2000.

http://www.unaids.org/publications/documents/care/general/JC-PalliCare-TU-E.pdf

Substance abuse

• Evidence for action: Effectiveness of community-basedoutreach in preventing HIV/AIDS among injecting drugusers. WHO, Geneva, 2004.

http://www.who.int/hiv/pub/prev_care/idu/en/

• Training guide for HIV prevention outreach to injectingdrug users. Workshop Manual. WHO, Geneva, 2004.

http://www.who.int/hiv/pub/prev_care/hivpubidu/en/

• Substitution maintenance therapy in the managementof opioid dependence and HIV/AIDS prevention. WHO/UNODC/UNAIDS position paper. WHO, Geneva, 2004.

http://www.who.int/substance_abuse/publications/psychoactives/en/

HIV testing

• Rapid HIV tests. Draft guidelines for use in HIV testingand counselling services in resource-constrained set-tings. WHO, Geneva, 2004.

http://www.who.int/hiv/pub/vct/rapidhivtests/en/

• Increasing access to HIV testing and counselling. Re-port of a WHO Consultation, 19-21 November 2002.WHO, Geneva, 2003.

http://www.who.int/hiv/pub/vct/pub36/en/

• The right to know. New approaches to HIV testing andcounselling. WHO, Geneva, 2003 (WHO/HIV/2003.08).


• Increasing Access to Knowledge of HIV Status. Con-clusions of a WHO Consultation, 3-4 December 2001.WHO, Geneva, 2002 (WHO/HIV/2002.09).


TB/HIV

• Interim policy on collaborative TB/HIV activities. WHO,Geneva, 2004 (WHO/HTM/HIV/2004.1).

http://www.who.int/hiv/pub/prev_care/tbhiv/en/

Procurement guides

• HIV/AIDS Medicines and related supplies: Contempo-rary context and procurement. Technical Guide. WorldBank, Washington, DC, 2004.

http://siteresources.worldbank.org/INTPROCUREMENT/Resources/Technical-Guide-HIV-AIDS.pdf

• Surmounting challenges: Procurement of antiretroviralmedicines in low- and middle-income countries, WHO/MSF, Geneva, 2003.

http://www.accessmed-msf.org/documents/procurementreport.pdf

• Managing Drug Supply. 3rd edition. WHO and Manage-ment Sciences for Health, Arlington, VA, 2003.

http://www.msh.org/what_MSH_does/cpm/resources.html#top

• Operational principles for good pharmaceutical procure-ment (interagency document). WHO, Geneva, 1999(WHO/EDM/PAR/99.5).

http://www.who.int/medicines/library/par/who-edm-par-99-5/who-edm-par-99-5.shtml

Intellectual Property rights andpharmaceuticals

• HIV/AIDS medicines and related supplies: Contempo-rary context and procurement. Technical guide. Chap-ter 2 and Annex B. World Bank, Washington, DC, 2004.

http://siteresources.worldbank.org/INTPROCUREMENT/Resources/Technical-Guide-HIV-AIDS.pdf

• Drug patents under the spotlight: sharing practicalknowledge about pharmaceutical patents. MSF, Ge-neva, 2003.

http://www.accessmed-msf.org/prod/publications.asp?scntid=225200385263&contenttype=PARA&

• Globalization, patents and drugs. An annotated bibli-ography. Health Economics and Drugs Series number9. WHO, Geneva, 2002 (EDM/PAR/2002.1).

http://www.who.int/medicines/library/par/who-edm-par-2001-1/who-edm-par-2001-1.htm

• Implications of the DOHA Declaration on the TRIPSAgreement and public health. WHO, Geneva, 2002(WHO/EDM/PAR/2002.3).

http://www.who.int/medicines/library/docseng_from_a_to_z.shtml#p

• Network for monitoring the impact of globalization and

TRIPS on access to medicines. Health Economics andDrugs Series number 11. WHO, Geneva, 2002 (WHO/EDM/PAR/2002.1).

http://www.who.int/medicines/library/docseng_from_a_to_z.shtml#n

• Globalization, TRIPS and access to pharmaceuticals.WHO Policy Perspectives on Medicines number 3.WHO, Geneva, 2001.

http://www.who.int/medicines/organization/ood/ood6pagers.shtml

• Patent situation of HIV/AIDS-related drugs in 80 coun-tries. UNAIDS/WHO, Geneva, 2000.

http://www.who.int/medicines/library/docseng_from_a_to_z.shtml#g

• Globalization and access to drugs: Perspectives onthe WTO/TRIPS Agreement. Health Economics andDrugs Series number 7 (revised). WHO, Geneva, 1998(WHO/DAP/98.9).

http://www.who.int/medicines/library/dap/who-dap-98-9-rev/who-dap-98-9.shtml

Pricing strategies

• Drug Price Information Services: What is WHO doingto improve drug price information? WHO InformationSheet.

http://www.who.int/medicines/organization/par/ipc/drugpriceinfo.shtml

• The Consumer Project on Technology. Fact sheet.

http://cptech.org/ip/health/econ/pricingstudies.html

• Medicine prices: a new approach to measurement.WHO and Health Action International, Geneva,2003(WHO/EDM/PAR/2003.2).

http://www.who.int/medicines/library/prices.shtml

• Cost-containment mechanisms for essential medicines,including antiretrovirals, in China. WHO, Geneva, 2003(WHO/EDM/PAR/2003.6).

http://www.who.int/medicines/library/docseng_from_a_to_z.shtml#c

• Overview of pharmaceutical pricing and reimbursementregulation in Europe. Panos Kanavos, LSE Health andSocial Care, 2001.

• Policies on pricing and reimbursement of medicines inEurope: Networking for information exchange amongpolicy makers. Annex: Comparative Review of DrugPrices. WHO Regional Office for Europe, Copenhagen,2000.


118

• Public-private roles in the pharmaceutical sector. Im-plications for equitable access and rational drug use.WHO, Geneva, 1997 (WHO/DAP/99.12).

http://www.who.int/medicines/library/dap/who-dap-97-12/who-dap-97-12.shtml

• Alternative drug pricing policies in the Americas.WHO, Geneva, 1995 (WHO/DAP/95.6).

http://www.who.int/medicines/library/dap/who-dap-95-6/who-dap-95-6.shtml

Websites

Partner sitesUNAIDS: www.unaids.org

UNICEF: www.unicef.org

WHO: www.who.int

MSF: www.msf.org

Others websites for information relatedto HIV/AIDSAIDS Education Global Information System:

http://www.aegis.com

AVERT (an international HIV/AIDS charity):

http://www.avert.org

DOTS-plus for multidrug resistant TB:

http://www.who.int/gtb/policyrd/DOTSplus.htm

Health Action International. http://www.haiweb.org:

International HIV/AIDS Alliance. http://www. aidsalliance .org/

John Snow Inc/DELIVER:

http://deliver.jsi.com

Management Sciences for Health:

http://www.msh.org/

Sexually Transmitted Infections:

http://www.who.int/hiv/pub/sti/en/

Stop TB Partnership:

http://www.stoptb.org

The Global Fund to Fight AIDS, Tuberculosisand Malaria:

http://www.theglobalfund.org/en/

The Global TB Drug Facility:

http://www.stoptb.org/GDF/

Contacts• For further information about suppliers or

products, please contact:

Sources of Medicines for HIV/AIDS SurveyPharmaceutical and Micronutrients TeamUNICEF Supply DivisionFax: +45 35 269421 E-mail: [email protected]

• For further information on HIV test kit evalua-tion or the bulk procurement scheme, contact:Essential Health and Technologies (EHT)World Health OrganizationFax +41 22 791 4836

• For any comments on this document, oradditional information that could be useful tothis project, please complete the feedbackform, Annex 5, and return it to:Sources of medicines for HIV/AIDS SurveyPharmaceutical and Micronutrient TeamUNICEF Supply DivisionUnicef plads Freeport DK-2100 CopenagenDenmarkFax: +45 35 269421Email: [email protected]

ANNEX 3. FURTHER READING, REFERENCES AND CONTACTS

119

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ANNEX 4.FURTHER READING, REFERENCES, AND CONTACTS

ANNEX 4

Untangling the web of pricereductions: a pricing guidefor the purchase of ARVsfor developing countries.

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Please fill out this form and fax it to UNICEF Supply Division +45 35 26 94 21, e-mail: [email protected], or post it to:UNICEF SD, Pharmaceutical and Micronutrient Group – HIV/AIDS Survey, Freeport DK-2100 Copenhagen Ø, Denmark

1. GENERAL INFORMATION

Your name

Occupation

Company name/Organization name

Address

Telephone Fax

Email (required)

Internet address

2. FEEDBACKWhat did you think of the publication in general?

■ Excellent, very useful ■ Good, quite useful ■ Satisfactory, reasonably useful

■ Poor, not useful—please indicate why:

What did you think of the medicines included in the publication?

■ Good selection of medicines

■ More medicines required, for example:

■ Fewer medicines required, remove:

What did you think of the pricing information?

■ Good, enough information on the prices of drugs of interest

■ Poor, not enough information

Have you contacted any of the manufacturers listed?

■ Yes ■ No

Other comments:

3. ENQUIRY■ I would like to participate in the next Survey (Manufacturing companies only)

■ I would like to receive more copies of the Publication

Other enquiry:

✁

Feedback and enquiry form


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Sources and prices of selected medicines and diagnostics ... · tarian aid organization that provides emergency medi-cal assistance to populations in danger in more than 80 countries,