International Journal of Drug Regulatory Affairs
  • Year: 2020
  • Volume: 8
  • Issue: 3

Active pharmaceutical ingredients (api) supply chain in Europe, United States, India, China and Canada

  • Author:
  • Mallikarjun Nagur1,, T.M. Pramod Kumar1, Sangamesh Basayya Puranik2
  • Total Page Count: 10
  • Page Number: 1 to 10

1Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Sri Shivarathreeshwara Nagara, Mysore, Karnataka, India, 570 015

2Head - Regulatory Affairs, Anthem Biosciences, Bangalore, Karnataka, India, 560099

*Corresponding author Tel.: +91-9449262039, E-mail address: mnagur613@gmail.com (Mallikarjun Nagur)

Online published on 24 May, 2021.

Abstract

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