U.S. Pharmacopeia Medicine Supply Map releases global API manufacturing findings

U.S. Pharmacopeia Medicine Supply Map releases global API manufacturing findings

Rockville, MD, March 16, 2022 – U.S. Pharmacopeia (USP), an independent scientific organization, announces the USP Medicine Supply Vulnerability Insights Series sourced from USP’s global Medicine Supply Map. The first of its kind, the USP Medicine Supply Map leverages insights derived from the use of USP quality standards in more than 22 thousand locations around the world, spanning 92 percent of generic medicines approved in the US.

The first findings in the USP Medicine Supply Map Vulnerability Insights Series show the significance of large Indian facilities in the manufacturing of active pharmaceutical ingredients (API).

Number of facilities with more than 30 active US-approved API products Number of facilities with more than 10 active US-approved API products
India 114 183
European Union 45 83
China 4 35
United States 3 19
Other 7 22

Source: U.S. Pharmacopeia Medicine Supply Map

The Medicine Supply Map aggregates more than 40 external datasets and 250 million data points to quantify risk and resilience in the upstream pharmaceutical supply chain. This comprehensive view results in insights that can aid in directing regulatory and industry actions to guard against over-concentrated sources of API, reduce disruptions, and inform public investment and policy reforms that build more supply resilience.

“As the U.S. considers legislation to improve supply chain resiliency, insights from the Medicine Supply Map can provide increased visibility to help decision-making,” explains Vimala Raghavendran, who heads USP’s Pharmaceutical Supply Chain Center.

The USP Medicine Supply Vulnerability Insights Series will look at the global distribution of APIs and risks associated with specific drug classes, from broadly used medicines such as antimicrobials and statins to those that are critically needed in small populations, such as pediatric oncology medications. Future findings will identify potential supply chain risks that could impact the availability of critical medicines.

“USP’s Medicine Supply Map is an innovative early warning system to help identify ingredient and finished product at risk of shortage so providers, manufacturers and governments can take actions to help prevent the shortage from occurring,” noted Ronald T. Piervincenzi, Ph.D., U.S. Pharmacopeia CEO. “Without visibility into the medicine supply chain, preparing for the next crisis is not possible.”

“To find an effective cure, you first need an accurate diagnosis,” said Dave Levin, M.D., Chief Medical and Information Officer of Phlow Corp, a U.S.-based, public benefit impact-driven pharmaceutical company. “The USP Medicine Supply Map is helping us identify upstream vulnerabilities in the supply chain for various essential medicines and determine those where Phlow’s capabilities in advanced manufacturing, can have the biggest impact.” The Medicine Supply Map will be discussed in upcoming USP Convention meetings to identify specific solutions to increase supply chain resilience, develop recommendations to improve the continuous cycle of preparedness, including implications for national stockpiles, and increase international cooperation among supply chain partners such as governments and manufacturers.

USP will also engage with its partners and stakeholders to inform the Medicines Supply Map. During an upcoming meeting of the USP Convention members representing manufacturers, patients, practitioners and North American regulators will explore actions to improve the function, composition, and accessibility of the healthcare infrastructure before, during, and post crisis response. This meeting, and subsequent engagements with stakeholders, will further identify vulnerabilities in the upstream pharmaceutical supply chain, deliver insights that can guide risk mitigation strategies and investments, and help inform policy changes that advance supply chain resilience.

For more information about the USP Medicine Supply Map visit https://qualitymatters.usp.org/increasing-visibility-in-the-medicines-supply-chain

Media Contact:
Anne Bell
Email: adb@usp.org
Office: 301-998-6785
Mobile: 240-701-3242

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