OUTSOURCING SUPPLY OPERATIONS


US Pharmacopeia report  


A report on global API supply chain vulnerabilities indicates the outsized importance of, and dependency on, overseas manufacturers, asserts Darcy Jimenez.


T


he United States Pharmacopeia (USP) has launched a Medicine Supply Vulnerability Insights Series


to identify and highlight weaknesses   The USP’s insights are sourced from its global Medicine Supply Map, which makes use of more than 40 external datasets and 250m data points to quantify risk and resilience in the  


develops and sets standards in compounding, biologics, pharmaceutical manufacturing, and   highlight the US’s reliance on large Indian manufacturers for APIs. Over 80% of all APIs for essential medicines used in the US have no


domestic manufacturing source, with the US relying heavily on API manufacturing sites in India and China for crucial ingredients. According to the USP, of the 342 manufacturing facilities worldwide with more than 10 active US-approved API products, more than half are based in India. Of those with more than 30 active US-approved API products, India accounts for 65%.


 The US’s reliance on overseas API manufacturers means its supplies of essential medicines – from antibiotics to painkillers – are precarious. A study published last year by the Center for Analytics and Business Insights (CABI) at Washington University’s Olin Business School revealed that less than 5% of large- scale API manufacturing sites are in the US.


14 | Clinical Trial Supply Handbook


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