When to Onshore? A Framework for the Manufacturing of Active Pharmaceutical Ingredients
Open Access
Author:
Irvin, Emily
Area of Honors:
Supply Chain and Information Systems
Degree:
Bachelor of Science
Document Type:
Thesis
Thesis Supervisors:
Robert Alexander Novack, Thesis Supervisor John C Spychalski, Thesis Honors Advisor
Keywords:
Active Pharmaceutical Ingredients APIs Supply Chain Shortage Onshoring
Abstract:
On February 24, 2021, President Joseph Biden issued Executive Order 14017 stating that he intends to strengthen “America’s Supply Chains.” This involves an in-depth look at risks within the supply chain, specifically related to the production of active pharmaceutical ingredients (APIs). The goal of this research is to analyze API production, understand why certain drugs are in shortage, and develop a framework for when the US Government should onshore critical APIs. This framework will also offer alternative solutions to onshoring, such as stockpiles, subsidies, and advanced manufacturing practices. It is a commonly accepted statistic that seventy to eighty percent of APIs are produced overseas, and copious research has been done to analyze the impact of disasters abroad on the United States’ ability to provide critical medication to its citizens. This thesis will build on prior research through interviews and case studies to develop a final framework that the government may use to determine the feasibility of onshoring API production. The utilization of this framework in manufacturing decisions will lower the risk of API shortages along the supply chain in times of future disaster.
