Active Pharmaceutical Ingredients (API) Supply chain in Europe, United States, India, China and Canada

  • Mallikarjun Nagur
  • T M Pramod Kumar
  • Sangamesh Basayya Puranik


The main objectives of the review of the study Active pharmaceutical ingredients supply chain in India, Europe, United States, China and Canada. Active pharmaceutical ingredient supply chain management is the integration, planning, and management of all of the processes across the system of resources from the earliest raw material supplier through the sourcing, logistics, manufacturing, and distribution networks to the customer. The base of supply chain management is the efficient integration and planning of demand and supply across companies. Planning is not only at the tactical level, but also at the strategic level. Majority of the countries follow the Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. Roughly 80% of active pharmaceutical ingredients and 40% of finished drug product are imported into the U.S. from overseas from India and China. The pharmaceutical active ingredients supply chain used to be seen as a tool to supply products to market in an effective way, where the emphasis was on security of supply. Recent changes in the operating environment mean that companies are revisiting the components of their supply chains and identifying ways of extracting additional benefits from them.

Keywords: Active pharmaceutical ingredients, Supply chain, Logistics, Cold-chain, GMP, FDASIA, GDUFA, OECD


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• Health Canada, Natural Health Products Program Quarterly Snapshot webpage. Accessed 6 November 2014 at http://www.hc‐‐mps/prod-natur/activit/qs‐at‐eng.php.

• Australian National Audit Office (2011), Audit Report No.3 2011‐12 Therapeu-tic Goods Regulation: Complementary Medicines, 2011, Commonwealth of Australia, p. 13.
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How to Cite
Nagur, M., T. M. Pramod Kumar, and S. Basayya Puranik. “Active Pharmaceutical Ingredients (API) Supply Chain in Europe, United States, India, China and Canada”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 3, Sept. 2020, pp. 1-10, doi:10.22270/ijdra.v8i3.323.