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Russian Chemical Bulletin

, Volume 64, Issue 7, pp 1696–1699 | Cite as

The achievements and problems of the production of generic drug substances for pharmaceutical industry

  • Yu. V. Skornyakov
  • O. V. Skornyakova
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  • 38 Downloads

Abstract

The key achievements, problems, and prospects of the pharmaceutical industry in the Russian Federation concerning the development, synthesis, and purification of active pharmaceutical ingredients (generic drugs) are considered.

Key words

pharmaceutics active pharmaceutical ingredient generic drug manufacturer´s monograph 

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References

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    M. D. Mashkovskii, Lekarstvennye sredstva [Pharmaceutical products] Novaya volna, Moscow, 2010, 1216 pp. (in Russian).Google Scholar
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    Lekarstvennye preparaty v Rossii: spravochnik Vidal´ [Pharmaceutical products in Russia: a Vidal Handbook] Vidal´ rus., Moscow, 2014, 1600 pp. (in Russian).Google Scholar
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    Novel New Drugs 2013 Summary, US Food and Drug Administration, 2014.Google Scholar
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    Novel New Drugs 2014 Summary, US Food and Drug Administration, 2015.Google Scholar
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    European Pharmacopeia EP v. 8.0–8.8, 2014.Google Scholar
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    American Pharmacopeia USP38-NF 33, 2014.Google Scholar
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    WO Pat. 98/30227 Teva Pharmaceutical Industries Ltd.Google Scholar

Copyright information

© Springer Science+Business Media New York 2015

Authors and Affiliations

  1. 1.LLC KhimfarmresursMoscowRussian Federation
  2. 2.Department of ChemistryM. V. Lomonosov Moscow State UniversityMoscowRussian Federation

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