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インドの医薬品業界:世界市場における新しい時代の到来

Indian Pharmaceutical Industry 2013: Coming of Age in a Global Market

発行 Espicom Business Intelligence 商品コード 121787
出版日 ページ情報 英文 164 Pages
納期: 即日から翌営業日
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インドの医薬品業界:世界市場における新しい時代の到来 Indian Pharmaceutical Industry 2013: Coming of Age in a Global Market
出版日: 2013年01月29日 ページ情報: 英文 164 Pages
概要

当レポートでは、インドの医薬品業界の現状、制度的背景、将来の発展見通しについて調査分析し、主要医薬品企業20社の企業戦略、主要製品、製品開発動向、財務状況などの分析もまとめ、概略下記の構成でお届けいたします。

はじめに

インドの医薬品業界

  • 概要
    • インドの事業
    • 販売収益
    • ジェネリック開発:必要から生まれた自然のなりゆき?
  • 国内市場
  • バイオテクノロジー・バイオシミラー
    • 規制
      • バイオテクノロジー産業のパートナーシッププログラム
      • インドは国立バイオシミラーセンターの設立計画を発表
    • バイオシミラーとインド企業
  • 国際市場
    • 米国
      • 公認ジェネリック医薬品
      • インド企業のFDA ANDA承認
    • 欧州
    • 新興市場
      • ブラジル
      • ロシア
      • 南アフリカ
    • 世界貿易
  • 外資による買収

企業プロファイル

  • Alembic
    • 企業戦略
    • 国内製剤
    • 財務実績
  • Aurobindo Pharma
  • Biocon
  • Cipla
  • Claris Lifesciences
  • Dr. Reddy's
  • ELDER PHARMACEUTICALS
  • Glenmark
  • Jubilant Organosys
  • Lupin
  • NATCO PHARMA
  • Orchid Chemicals & Pharmaceuticals
  • PANACEA BIOTEC
  • Piramal Healthcare
  • Ranbaxy
  • Strides Arcolab
  • Sun Pharma
  • Torrent Pharmaceuticals
  • Wockhardt
  • Zydus Cadila

情報ソース

図表

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目次
Product Code: 978-1-909584-21-1

Abstract

Following a patchy performance in 2010/11, many observers questioned what the future might hold for the mainly generic Indian pharmaceutical companies, as health funders put downward pressure on generic prices. However, the industry has bounced back to profit, but the question is “what's next”?

The 20 companies examined in this report had combined sales of more than US$17.4 billion in their most recently reported fiscal year, which generally concluded on 31st March 2012. Ranbaxy reported revenue of Rs.99,769 million (US$2,145 million) for the calendar year ended 31st December 2011, making it the leading company in terms of revenue. Of the companies listed, 18 reported improved sales over 2010/11.

New Guidance on Biosimilar Manufacture

In 2012, new “Guidelines on Similar Biologics” were published. The Guidelines were prepared by the Central Drugs Standard Control Organisation and the Department of Biotechnology, and lay down the regulatory pathway for a biologic claiming to be similar to an already authorised reference biologic. The Guidelines apply to both locally-developed and imported products, although the precise approval process differs in each case. The document notes that a reduction in testing and data requirements at the preclinical and clinical level is likely to be possible for a biosimilar, however, ‘it is essential that the testing of the similar biologic be sufficient to ensure that the product meets acceptable levels of safety, efficacy and quality to ensure public health'.

A number of Indian companies are active in the biologics segment of the pharmaceutical market. Leading indigenous biotechnology companies include Biocon and Panacea Biotech, which ranked first and third in terms of revenue in the BioSpectrum-ABLE Biotech Industry Survey 2010. The Serum Institute of India was in second place. Unsurprisingly, the Indian biotech industry has its sights set on the regulated biosimilars markets of the EU and US. However, no Indian company has yet achieved a biosimilar approval in the EU and the US market remains in its infancy. A more realistic target for most companies, at least for the time being, is the domestic and emerging markets for biosimilars.

Where have all the outbound mergers gone?

Many Indian companies have pursued an aggressive acquisition policy in order to accelerate market growth or acquire manufacturing capacity. Prior to the economic downturn in 2008, this policy could be clearly seen with 10 acquisition/controlling stake deals announced in the year. Pressure on prices and variable performance have firmly put a lid on this activity, Sun Pharma's eventual control of Taro being one of the few deals to go through since. Inward investment has equally been affected as interest in Indian companies has cooled. Matrix - one of the more acquisitive companies - was purchased in 2007 by Mylan. Now rebranded Mylan Laboratories, one of the better known names in India pharma has now gone.

Focus on...current and future markets

India's domestic market: not achieving necessary growth

With a population of over one billion and a growing middle class in excess of 300 million people with disposable income and increasing healthcare expectations, the domestic formulations market has enormous potential for growth. But India is a country of wide economic divide and while a growing number of people can afford to pay for good quality private healthcare, for the bulk of its vast rural population all but basic healthcare provision will remain out of reach for the foreseeable future. However, domestic pharmaceutical companies are reporting increased penetration in smaller towns and rural areas. Rising household income and improvements in health infrastructure and delivery systems will continue to support long-term growth in the pharmaceutical market. Nevertheless, India's domestic market will not grow at the required rate to sustain the industry's revenue needs and production capacity and so Indian pharma companies will remain export focused in the medium term.

INTERNATIONAL DEVELOPMENTS

US Market: the prize market for Indian companies

The USA remains the largest generic market and the most sought after target for Indian companies involved in the generic business, and market growth has been sustained in recent years by a large number of patent expirations. As the Indian majors have gained experience in the US, they have been able to exploit opportunities provided by Paragraph IV filings and specialty generics with fewer competitors. Over the last decade the number of ANDAs approved increased dramatically. During the three year period between January 2002 and December 2004, the FDA approved 72 ANDAs for Indian pharmaceutical companies and their US subsidiaries and the numbers have increased year-on-year, to peak at 132 in 2008. Since then, the number of annual approvals has dropped slightly, to 119 in 2011 and 127 in 2012.

UK: One of Europe's strongest generics markets

Over 80% of prescriptions in the mature UK market are fulfilled generically. The UK has always been a focus for Indian companies with nine companies running 11 manufacturing sites. Between January 2009 and January 2010, Indian companies had more than 260 marketing authorisations approved by the UK's Medicines and Healthcare Regulatory Agency (MHRA) for a wide range of products. During this period, Ranbaxy received 55 approvals; Dr Reddy's received 54; Aurobindo received 39; and Lupin received 25.

Europe: wider generic adoption is good news for Indian companies

The UK and Germany have been promoting generic use as a way of containing healthcare costs for years and a number of Indian companies are active in these markets. Others, such as France, Italy and Spain, have more recently begun to explore the use of generics to curtail burgeoning drug bills. Government initiatives have been introduced to increase the use of generics and reduce prices as part of wider austerity measures. These generic markets are still relatively small but growing and there are a number of Indian companies currently monitoring them. When will they act and will prevaricating harm their long-term potential?

Russia: an import dependent market which is to the advantage of Indian companies

Russia is an important market for India's pharmaceutical industry. In 2012, the Russian pharmaceutical market was estimated at US$26,551 million at retail prices. The market is characterised by strong import growth which rose by a CAGR of 18.7% in US dollar terms over the 2007-11 period. The heavy reliance on imports has been to Indian companies' benefit and India's pharmaceutical exports to Russia amounted to US$534 million in 2011, of which US$517 million were retail formulations - this makes Russia India's second most important export market after the USA. Among the leaders in this trade were Dr Reddy's in gastrointestinal, cardiovascular and anti-infective drugs, while the leading areas for the company with biosimilars are immunology and oncology. Glenmark Russia is among the top 20 pharmaceutical companies in the dermatology segment and one of the fastest growing pharmaceutical companies in Russia.

South Africa

The generics market in South Africa has grown markedly in recent years as the government has continued to promote the low-cost sector as a means of improving access to medicines for the country's vast poor population. India's exports to South Africa amounted to US$310 million in 2011, of which US$267 million were retail formulations. To illustrate Indian company success, Lupin stated in its 2012 annual report that it was one of the fastest growing of the top ten companies in South Africa, recording growth of 40% in revenues to Rs.2,554 million (US$55 million) from its subsidiary, Pharma Dynamics. The company ranked fifth among generic pharmaceutical companies in South Africa.

India as a research base: balancing need and research investment

India's acknowledged strengths make it an ideal regional base, particularly for R&D and for commercialisation in select markets in which India already has a significant presence. With its vast population, comparatively low cost, fast turnaround and expertise in statistical analysis, India is also an attractive base for Phase III clinical trials.

Several multinationals are already using or plan to use India as a base for clinical research, particularly for specific diseases with a significant local patient base, such as tuberculosis. Companies such as GSK and Eli Lilly have been collaborating with domestic companies for R&D, while others have been utilising Indian contract research organisations. In the future, it is likely that an increasing number of companies will set up research centres in India and use the country as a hub for multi-centric global trials. Others will take advantage of the services offered by India's emerging CROs.

The Foreign Direct Investment (FDI) policy, introduced in 2001, allows 100% FDI in the pharmaceutical industry. By 2011, however, the move aimed at encouraging foreign investment had become a cause for concern and the FDI policy was placed under review.

The Ministry of Health fears that continued takeover of Indian pharmaceutical companies by multinationals will adversely affect the domestic industry and push prices up, leading to essential medicines becoming more expensive. This could impact public health programmes, including the Universal Immunisation Programme.

According to a September 2011 report in the online version of The Hindu, the Ministry has recommended that prior approval of the Foreign Investment Promotion Board be made mandatory and that steps should be taken to channel foreign investment into green-field projects. The report states that, since 2001 when 100% FDI was first allowed in the pharmaceutical sector, just 10% has gone to green-field projects. At the government's request, Ernst & Young is conducting a study on the impact of the recent takeover of Indian pharmaceutical companies, and its report is deemed likely to be placed before the Economic Advisory Council to the Prime Minister.

Opinion driven analysis - available now!

The Indian Pharmaceutical Industry 2013: Coming of Age in a Global Market is a new, insightful and data-rich management report packed with facts and statistics. Published in January 2013 and extending to 164 pages, the report provides a complete and detailed review of the Indian market and the 20 companies that are leading the way.

About the Author

The report has been researched and written by experienced independent market analyst, Karen Holmes. Karen has over 17 years pharmaceutical and healthcare market analysis experience. Among her many reports for Espicom, are:

  • Hospital Generic Drugs: Prospects for Generics and Biosimilars
  • Orphan Drugs: Market Environment, Products and Companies
  • Understanding India's Regional Health Markets
  • The Complete Guide to Companion Diagnostics

More Information

With a particular focus on 20 leading companies, this report examines the evolution of the Indian pharmaceutical majors in the new era and asks...

  • How has product patent regulation affected the domestic industry?
  • What are the key European markets for the industry now and in the future?
  • US: how well are Indian companies developing this prize market?
  • How well placed is the industry with respect to the growing market for biosimilars?
  • What has underpinned the resurgence of Indian companies' performance?
  • What are the different strategies being adopted by companies with an eye to the future?

Highly detailed appraisal of:

  • Alembic
  • Auribindo Pharma
  • Biocon
  • Cipla
  • Claris Lifesciences
  • Dr Reddy's
  • Elder Pharmaceuticals
  • Glenmark Pharmaceuticals
  • Jubilant Life Sciences
  • Lupin
  • Natco Pharma
  • Orchid
  • Panacea Biotec
  • Piramal Enterprises
  • Ranbaxy
  • Strides Arcolab
  • Sun Pharma
  • Torrent Pharmaceuticals
  • Wockhardt
  • Zydus Cadila

Table of Contents

FOREWORD

THE INDIAN PHARMACEUTICAL INDUSTRY

  • Overview
    • Indian Operations
    • Sales Revenue
    • Generic development: a natural progression born out of necessity?
  • Domestic Market
  • Biotechnology and Biosimilars
    • Regulation
      • Biotechnology Industry Partnership Programme
      • India announces plans to establish a National Biosimilar Centre
    • Biosimilars and Indian Companies
  • International Markets
    • The United States
      • Authorised generics
      • Indian Companies' FDA ANDA Approvals
    • Europe
    • Emerging Markets
      • Brazil
      • Russia
      • South Africa
    • Global Exports
  • Foreign Acquisitions

COMPANY PROFILES

  • ALEMBIC
    • Corporate Strategy
      • Manufacturing Capabilities
      • R&D
      • Key Markets
      • Products
    • Domestic Formulations
      • APIs
      • International Formulations
      • Generics
    • Financial Performance
  • AUROBINDO PHARMA
    • Corporate Strategy
      • Manufacturing Capabilities
      • Licensing and Supply Agreements
      • R&D
      • Key Markets
    • Products
      • APIs
      • Domestic Formulations
      • International Generics
    • Financial Performance
  • BIOCON
    • Corporate Strategy
    • Manufacturing
    • R&D
      • Insugen
      • Biosimilar insulin glargine
      • Oral insulin development
      • Monoclonal Antibodies
    • Recent Company News
      • Biocon & BMS sign option agreement for IN-105
      • Biocon & Pfizer conclude commercialisation agreement
    • Products
      • APIs
      • Domestic Formulations
      • International Formulations
    • Financial Performance
  • CIPLA
    • Corporate Strategy
      • Manufacturing
      • R&D
      • Key Markets
      • Recent Company News
        • Cipla reduces prices of some cancer drugs
        • Cipla proposes to buy stake in Cipla Medpro
        • DNDi enters antiretroviral collaboration with Cipla
    • Products
      • APIs
      • Domestic Formulations
      • International Generics
    • Financial Performance
  • CLARIS LIFESCIENCES
    • Corporate Strategy
      • Manufacturing
      • R&D
      • Key Markets
      • Recent Company News
        • Claris Lifesciences enters into a joint venture with Otsuka and Mitsui
        • Claris Lifesciences receives FDA response to Warning Letter; intends to supply itself in US
    • Products
      • Domestic Formulations
      • International Generics
    • Financial Performance
  • DR REDDY'S
    • Corporate Strategy
      • Manufacturing
      • R&D
      • Key Markets
      • Recent Company News
        • Dr Reddy's launches Pamorelin LA in India
        • Dr Reddy's makes public offer for OctoPlus
        • Merck and Dr Reddy's enter biosimilars collaboration
    • Products
      • APIs
      • Domestic Formulations
      • International Generics
    • Financial Performance
  • ELDER PHARMACEUTICALS
    • Corporate Strategy
      • Manufacturing
      • R&D
    • Products
    • Financial Performance
  • GLENMARK
    • Corporate Strategy
      • Manufacturing
      • R&D
        • New Chemical Entities
        • Biologics
      • Key Markets
      • Recent Company News
        • Glenmark settles OC litigation with Janssen
        • ICDR rules in favour of Glenmark regarding crofelemer agreement
    • Products
      • APIs
      • Domestic Formulations
      • International Generics
    • Financial Performance
  • JUBILANT LIFE SCIENCES
    • Corporate Strategy
      • Manufacturing
      • R&D
      • Recent Company News
        • JDI/Positron strategic tie-up set to boost PET scanner capabilities
        • Jubilant SEZ facility is inaugurated
        • Jubilant/Mnemosyne enter drug-discovery collaboration
        • Early milestones delivered in Jubilant/Endo collaborative discovery programme
    • Products
      • APIs
      • International Generics
    • Financial Performance
  • LUPIN
    • Corporate Strategy
      • Manufacturing
      • R&D
      • Key Markets
      • Recent Company News
        • Santarus/Depomed enter Glumetza settlement arrangement with Lupin
        • Lupin and Eli Lilly collaborate on diabetes products
    • Products
      • APIs
      • Domestic Formulations
      • International Formulations
    • Financial Performance
  • NATCO PHARMA
    • Corporate Strategy
      • Manufacturing
      • R&D
      • Key Markets
      • Recent Company News
        • IPAB dismisses AstraZeneca's patent plea
        • Natco granted sorafenib compulsory licence
        • Natco signs biosimilars agreement with Mabxience
    • Products
      • Domestic Formulations
      • International Generics
    • Financial Performance
  • ORCHID CHEMICALS & PHARMACEUTICALS
    • Corporate Strategy
      • Manufacturing
      • R&D
      • Key Markets
      • Recent Company News
        • Orchid exits its China joint venture
        • Hospira to acquire API and R&D facilities from Orchid
        • Orchid's drug-discovery initiative with Merck advances
    • Products
      • APIs
      • Domestic Formulations
      • International Generics
    • Financial Performance
  • PANACEA BIOTEC
    • Corporate Strategy
      • Manufacturing
      • R&D
      • Key Markets
      • Recent Company News
        • Panacea enters US generic alliance with Kremers Urban
        • Osmotica & Panacea sign strategic alliance agreement
        • Panacea inaugurates oncology production unit
    • Products
    • Financial Performance
  • PIRAMAL ENTERPRISES
    • Corporate Strategy
    • Manufacturing
    • R&D
    • Key Markets
    • Recent Company News
      • Strategic alliance with Fujifilm Diosynth Biotechnologies
      • Piramal/Baxter settle patent litigation over generic Suprane
    • Products
      • APIs
      • Domestic Formulations
      • International Formulations
    • Financial Performance
  • RANBAXY
    • Corporate Strategy
      • Manufacturing
      • R&D
      • Key Markets
      • Recent Company News
        • Ranbaxy approved to set up new manufacturing facility in Malaysia
        • Ranbaxy requests withdrawal of 27 ANDAs
        • Daiichi Sankyo/Ranbaxy launch hybrid business in Venezuela
        • Synriam launched in India
    • Products
      • APIs
      • Domestic Formulations
      • Ranbaxy/Daiichi Sankyo Global Partnership
      • International Generics
    • Financial Performance
  • STRIDES ARCOLAB
    • Corporate Strategy
    • Manufacturing
    • R&D
    • Key Markets
    • Recent Company News
      • Lilly/Strides collaborate to deliver branded generic cancer drugs in emerging markets
      • Phosphagenics licenses injectable antibiotic to Agila
      • Strides' Polish sterile injectable facility gains US FDA approval
      • Agila to enter the Canadian injectable market
      • Strides acquires FDA-approved sterile formulations facility
  • Products
    • Domestic Formulations
    • International Generics
  • Financial Performance
  • SUN PHARMA
    • Corporate Strategy
      • Manufacturing
      • R&D
      • Key Markets
      • Recent Company News
        • Caraco to acquire URL Pharma
        • DUSA to be acquired by Sun
        • Sun to take Taro private
    • Products
      • APIs
      • Domestic Formulations
      • International Generics
    • Financial Performance
  • TORRENT PHARMACEUTICALS
    • Corporate Strategy
      • Manufacturing
      • R&D
      • Key Markets
    • Products
      • Domestic Formulations
      • International Generics
    • Financial Performance
  • WOCKHARDT
    • Corporate Strategy
      • Manufacturing
      • R&D
      • Key Markets
    • Products
      • APIs
      • Domestic Formulations
      • International Generics
    • Financial Performance
  • ZYDUS CADILA
    • Corporate Strategy
      • Manufacturing
      • R&D
      • Key Markets
      • Recent Company News
        • Microbix licenses Kinlytic rights to Zydus to aid North American re-launch
        • Karo Bio/Zydus Cadila collaboration expires
        • Zydus Cadila acquires Biochem
    • Products
      • APIs
      • Domestic Formulations
      • International Generics
    • Financial Performance

SOURCES

  • Espicom Sources
  • Others

List of Tables

  • Company Sales, 2010/11-2011/12
  • FDA ANDA Approvals, 2002-2012 (Number)
  • Indian Pharmaceutical Companies' US Subsidiaries
  • FDA ANDA Approvals, 2011-2012
  • Indian Pharmaceutical Companies' EU Subsidiaries
  • Indian Companies' EMA Authorisations
  • Indian Company Registrations of Generic Medicines in Brazil, October 2012
  • Pharmaceutical Exports Summary, 1995-2011 (US$000s)
  • Retail Medicament Exports, 2001-2011 (US$000s)
  • Indian Companies' Foreign Acquisitions
  • Foreign Acquisitions of Indian Pharmaceutical Companies, 2007-2012
  • Alembic Manufacturing Facilities
  • Alembic FDA ANDA Approvals, 2009-2012
  • Alembic Financial Results 2008-2012
  • Aurobindo Pharma Key Manufacturing Facilities
  • Aurobindo Pharma Key Subsidiaries
  • Aurobindo Pharma Regulatory Filing Status
  • Aurobindo Pharma ANDA Approvals, 2004-2012
  • Cephazone Pharma FDA ANDA Approval, 2007
  • Aurobindo ANVISA Registrations, October 2012
  • Aurobindo Pharma Financial Results, 2008-2012
  • Biocon Financial Results from Continuing Operations, 2008-2012
  • Cipla Manufacturing Facilities
  • Cipla FDA ANDA Approvals
  • Cipla Financial Results, 2008-2012
  • Claris Lifesciences Key Subsidiaries
  • Claris Lifesciences: FDA ANDA Approvals, 2008
  • Claris Lifesciences Financial Results, 2009-2011
  • Dr Reddy's Manufacturing Facilities
  • Dr Reddy's: Regional Headquarters and Key Subsidiaries
  • Top 10 Brands in India, 2011-2012
  • Dr Reddy's FDA ANDA Approvals, 2002-2012
  • Dr Reddy's Financial Results, 2008-2012
  • Elder Pharmaceuticals Manufacturing Facilities
  • Elder Pharmaceuticals Financial Results, 2008-2012
  • Glenmark Pharmaceuticals Manufacturing Facilities
  • Glenmark Generics Manufacturing Facilities
  • Glenmark Key Subsidiaries
  • Glenmark FDA ANDA Approvals, 2006-2012
  • Glenmark EMA Approvals
  • Glenmark ANVISA Registrations, October 2012
  • Glenmark Financial Results, 2008-2012
  • Jubilant Life Sciences Manufacturing Facilities
  • Jubilant Cadista FDA ANDA Approvals 2004-2012
  • Jubilant Life Sciences Financial Results, 2011-2012
  • Lupin Manufacturing Facilities
  • Lupin FDA ANDA Approvals, 2003-2012
  • Lupin Financial Results, 2008-2012
  • Natco Pharma Manufacturing Facilities
  • Natco Pharma FDA ANDA Approvals
  • Natco Pharma Financial Results, 2008-2012
  • Orchid Manufacturing Facilities
  • Orchid Key Subsidiaries
  • Orchid Leading Brands
  • Orchid FDA ANDA Approvals, 2005-2012
  • Orchid Financial Results 2008-2012
  • Panacea Biotec Financial Results, 2008-2012
  • Piramal Healthcare Manufacturing Facilities
  • Piramal Enterprises Financial Results, 2011-2012
  • Ranbaxy Manufacturing Facilities
  • Ranbaxy Regional Headquarters & Key Subsidiaries
  • Ranbaxy Laboratories FDA ANDA Approvals, 2002-2012
  • Ranbaxy ANVISA Registrations, October 2012
  • Ranbaxy Financial Results, 2007-2011
  • Strides Arcolab Manufacturing Facilities
  • Strides Arcolab Key Subsidiaries
  • Sagent Strides FDA ANDA Approvals
  • Strides Arcolab FDA ANDA Approvals
  • Strides Arcolab Financial Results, 2007-2011
  • Sun Pharma Manufacturing Facilities
  • Sun Pharma Key Subsidiaries
  • Sun Pharma FDA ANDA Approvals, 2006-2012
  • Caraco Pharmaceutical ANDA Approvals, 2002-2008
  • Sun Pharma EMA Marketing Authorisations
  • Sun Pharma Financial Results, 2008-2012
  • Torrent Manufacturing Facilities
  • Torrent Key Subsidiaries
  • Torrent FDA ANDA Approvals, 2007-2012
  • Torrent ANVISA Registrations, October 2012
  • Torrent Financial Results, 2008-2012
  • Wockhardt Manufacturing Facilities
  • Wockhardt Key Subsidiaries
  • Wockhardt FDA ANDA Approvals, 2003-2012
  • Wockhardt Financial Results, 2010-2012
  • Zydus Cadila Manufacturing Facilities
  • Zydus Cadila Key Subsidiaries
  • Zydus ANDA Approvals, 2005-2012
  • Zydus ANVISA Registrations, October 2012
  • Zydus Cadila Financial Results, 2008-2012

List of Figures

  • Total Pharmaceutical Exports, 1995-2011 (US$000s)
  • Exports of Raw Materials, 1995-2011 (US$000s)
  • Exports of Retail Medicaments, 1995-2011 (US$000s)
  • Pharmaceutical Exports by Destination, 2011 (%)
  • Exports of Retail Medicaments by Category, 2001 (%)
  • Exports of Retail Medicaments by Category, 2011 (%)
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