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Pharmaceutical contract manufacturing and API sourcing in Russia, Ukraine and the Baltic states 2011
Pharmaceutical contract manufacturing and API sourcing in Russia, Ukraine and the Baltic states 2011

June 2011
Pages: 145
Delivery: PDF


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The main aim of the report is to localise the most attractive companies for contract manufacturing and API sourcing in Russia, Ukraine and the Baltic states. Contract manufacturing is defined as the outsourcing of pharmaceutical production of finished dosage forms; API sourcing means buying API substances from other companies. The report also provides SWOT analysis of pharmaceutical outsourcing in the relevant countries, the region as a whole, key drivers and impediments of contract manufacturing in each country, and current and future trends in contract manufacturing.

Why a report on API sourcing?

  • There are many interesting companies in the region offering API and contract manufacturing
  • The region is increasingly competitive to China and India
  • Sourcing and contract manufacturing are more and more popular today
  • We want to show the complexity of the offers of such companies and help potential clients find partners in the region

Key topics

  • SWOT analysis of pharmaceutical contract manufacturing and API sourcing in the analysed countries
  • Key drivers and impediments of contract manufacturing and API sourcing in the analysed countries
  • Comparison of the region to other regions in the worlds, such as the Far East.
  • Which countries are the most attractive and why
  • Key drivers and impediments of contract manufacturing in each country
  • Possibilities of manufacturing of chemical-based drugs
  • Possibilities of manufacturing of biological drugs
  • Possibilities of manufacturing API
  • Current and future trends in contract manufacturing
  • Detailed profiles of the most attractive companies for outsourcing, in particular their specialisation and experience in contract manufacturing, financial information, contact details, product manufactured within contract manufacturing, additional services offered, certificates, production capacity experience
  • Regulatory changes influencing contract manufacturing/API sourcing in the analysed countries and overview of the countries macroeconomic reality

Questions the report answers:

  • What are the dangers and advantages of cooperating with companies from the analysed countries?
  • Which company is the best partner for contract manufacturing or API sourcing in the analysed countries?

Report strengths

  • Detailed profiles of companies / potential partners, from the perspective of their contract manufacturing and API sourcing offer
  • SWOT analysis of the analysed countries, from the perspective of their contract manufacturing and API sourcing offer

Who will find this report useful?

  • Anyone analysing the offers of potential partners for contract manufacturing and API sourcing
  • Anyone gauging the potential of firms in contract manufacturing and API sourcing
  • Anyone making a preliminary assessment of potential partners for a pharma firm

Market commentary by expert

Over the past two years in Russia and Ukraine, producers of pharmaceutical substances and those engaged in contract manufacturing have observed a slow uptrend. Previously those countries tried to be independent or be supplied from factories located in former Soviet Republics, such as the Baltic states. Now they have changed their market strategies and increasingly want to provide services to firms in Western countries. Their offers might be competitive to Indian and Chinese companies, as firms from the analysed region are today endeavouring to comply with internationally recognized standards, such as GMP.

Monika Stefanczyk, Head Pharmaceutical Market Analyst

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  1. Report methodology p. 11

  2. Executive summary p. 15

  3. General overview of contract manufacturing and API sourcing in the region analysed p. 21

    • Key recent trends and events in contract manufacturing and API sourcing in the region analysed p. 21
      • Key recent trends p. 21
      • Key recent events p. 22
    • Comparison of CEE region with other competitive regions p. 23
      • Comparison with Far East (India and China) p. 23
        • Key drivers of contract manufacturing and API sourcing in Russia, Ukraine and the Baltic states in comparison with China and India p. 23
        • Key obstacles to contract manufacturing and API sourcing in comparison with China and India p. 24
      • Comparison with Western Europe p. 25
        • Key drivers of contract manufacturing and API sourcing in comparison with Western Europe p. 25
        • Key obstacles to contract manufacturing and API sourcing in comparison with Western Europe p. 25
    • Possibility of contract manufacturing and API sourcing in particular countries p. 26

  4. Russia p. 27

    • Main characteristics of, and current trends in, API manufacturing and manufacturing under contract p. 27
    • Key drivers of, and obstacles to, contract manufacturing and API sourcing p. 31
      • Key drivers of contract manufacturing and API sourcing p. 31
      • Key obstacles to contract manufacturing and API sourcing p. 34
    • Profiles of key companies offering contract manufacturing services and API p. 36

  5. Ukraine p. 79

    • Main characteristics of, and current and anticipated trends in, API manufacturing and manufacturing under contract p. 79
    • Key drivers of, and obstacles to, contract manufacturing and API sourcing p. 81
      • Key drivers of contract manufacturing and API sourcing p. 81
      • Key obstacles to contract manufacturing and API sourcing p. 81
    • Profiles of key companies offering contract manufacturing services and API p. 83

  6. Estonia p. 101

    • Main characteristics of, and current trends in, API manufacturing and manufacturing under contract p. 101
    • Key drivers of, and obstacles, to contract manufacturing and API sourcing p. 102
      • Key drivers of contract manufacturing and API sourcing p. 102
      • Key obstacles to contract manufacturing and API sourcing p. 103
    • Profiles of key companies offering contract manufacturing services and API p. 103

  7. Latvia p. 107

    • Main characteristics of, and current trends in, API manufacturing and manufacturing under contract p. 107
    • Key drivers of, and obstacles, to contract manufacturing and API sourcing p. 108
      • Key drivers of contract manufacturing and API sourcing p. 108
      • Key obstacles to contract manufacturing and API sourcing p. 108
    • Profiles of key companies offering contract manufacturing services and API p. 110

  8. Lithuania p. 121

    • Main characteristics of, and current trends in, API manufacturing and manufacturing under contract p. 121
    • Key drivers of, and obstacles to, contract manufacturing and API sourcing p. 122
      • Key drivers of contract manufacturing and API sourcing p. 122
      • Key obstacles to contract manufacturing and API sourcing p. 122
    • Profiles of key companies offering contract manufacturing services and API p. 123

  9. Legal environment p. 131

    • GMP rules p. 131
      • General prevalence of GMP rules p. 131
      • PIC/S member state obligations p. 131
      • GMP GMP in API manufacturing p. 132
    • REACH Regulation p. 132
    • Changes anticipated in EU legislation – draft Directive 2001/83/EC p. 134

  10. Business climate in the countries analysed p. 135

    • Individual competitive advantages of countries analysed p. 135
    • Degree of sophistication of the production process in CEE countries p. 136
    • Import and export indicators p. 136
      • Length of procedures p. 136
      • Number of documents required p. 138
      • Costs p. 139

  11. List of graphs p. 141

  12. List of tables p. 142

  13. About PMR p. 143

  14. Contact PMR p. 144

List of graphs

  1. Comparison of potential of Russian, Indian and Chinese API companies, 2008
  2. Value (RUB m) and y-o-y change in pharmaceuticals manufactured by outsourcing companies in Russia, 2005-H1 2010
  3. Price categories of pharmaceuticals manufactured by outsourcing companies in Russia, H1 2010
  4. Location of CMOs and API producers in Russia, 2011
  5. Location of CMOs and API producers in Ukraine, 2011
  6. Location of CMOs and API producers in Estonia, 2011
  7. Location of CMOs and API producers in Latvia, 2011
  8. Location of CMOs and API producers in Lithuania, 2011
  9. Nature of country’s competitive advantage in countries analysed, 2011
  10. Sophistication of production process in countries analysed, 2011
  11. Length of export process in countries analysed in comparison with other countries (days), 2011
  12. Length of import process in countries analysed in comparison with other countries (days), 2011
  13. Documents required for export process in countries analysed in comparison with other countries (number of documents), 2011
  14. Import documents required in CEE countries in comparison with other countries (number of documents), 2011
  15. Export costs in countries analysed in comparison with other countries ($ per container), 2011
  16. Import costs in countries analysed in comparison with other countries ($ per container), 2011

List of tables

  1. The possibility of contract manufacturing of dietary supplements, biotech products and other finished dosage forms in addition to the sourcing of API and other pharmaceutical ingredients in Russia, Ukraine and the Baltic states, 2011
  2. Documents which regulate GMP in Russia in comparison with the US and the EU, 2011
  3. List of 57 strategically important drugs to be made locally in Russia from 2015
  4. Top 10 API sold by Pharmstandard, 2010
  5. Main characteristics of Pharmstandard facilities in Russia, 2009-2010
  6. Total production capacity of Stada in Russia, 2009
Pharmaceutical contract manufacturing and API sourcing in Russia, Ukraine and the Baltic states 2011

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