Разработка и регистрация лекарственных средств (Jan 2019)

ACTIVE SUBSTANCES FOR DOMESTIC MANUFACTURER OF MEDICINES: PAST, PRESENT AND FUTURE

  • K. O. Sidorov,
  • A. A. Lin,
  • N. V. Marchenko

Journal volume & issue
Vol. 0, no. 4
pp. 298 – 302

Abstract

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At present, there is a tendency in Russia to switch domestic manufacturers of drugs from the system of purchases of chemical products to own production of active pharmaceutical ingredients. The article reviews the current state of production of active pharmaceutical substances in the Russian Federation. The historical milestones in the production of pharmaceutical substances in the Soviet Union and the current situation of this market are considered. In addition, it provides an overview of the current international practices of quality control of active pharmaceutical ingredients and formulated assumption about the future state of the purchase market of API in countries with a low level of the control system. The authors analyze the structure and price indicators of the Russian API market.

Keywords