The production and exportation of artemisinin-derived drugs in China: current status and existing challenges

Malar J. 2016 Jul 15;15:365. doi: 10.1186/s12936-016-1422-3.

Abstract

Background: As the discoverer and a major manufacturer of artemisinin, China has made valuable contributions to malaria control and the global market of artemisinin-derived drugs. This study aims to explore the production and export status of artemisinin-derived drugs in China during 2011 and 2014 to provide a clear understanding of China's participation in this field and also to provide guidance for its future role on global malaria control.

Methods: Production and exportation data were obtained from the Ministry of Industry and Information Technology (MIIT) database of the People's Republic China and monthly reports of the General Administration of Customs of China, respectively. The production volume, export volume, export value, and export area of artemisinin and its derivatives (artemether, artesunate, dihydroartemisinin), including both active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs), were descripted and analysed by Microsoft Excel.

Results: Between 2011 and 2013, the total production volume of artemisinin-derived APIs and FPPs reached 543.41 metric tons (MT) and 14.79 MT, respectively. The total export value and volume of artemisinin-derived APIs during 2012 and 2014 was US$ 211.39 million and 338.53 MT; the total export value and volume of FPPs was US$ 227.17 million and 4401.44 MT. Compared with the sharply decreasing trend of API exports each year, the export value of FPPs kept at a more stable level, with 14.66 % increase in 2013 and 5.31 % decrease in 2014. As for exportation areas, India was the largest purchaser of APIs, accounting for nearly a half of the total amount, while FPPs mainly exported to African countries.

Conclusions: Exports of artemisinin derivatives for China have been transforming from API-dominated to FPP-dominated. However, the exportation of artemisinin-derived drugs in China still face the challenges of small market share in the global FPP market and indirect sale of FPPs through a third country due to the deficiency in obtaining relevant certification into global market.

Keywords: Active pharmaceutical ingredients; Artemisinin; China; Export value; Finished pharmaceutical products; Prequalification certification; Production volume.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antimalarials / chemical synthesis*
  • Antimalarials / supply & distribution*
  • Artemisinins / chemical synthesis*
  • Artemisinins / supply & distribution*
  • China
  • Commerce
  • Humans

Substances

  • Antimalarials
  • Artemisinins