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U.S. Pharmacopeia Supply Map Releases Global API Mfg. Findings

First findings from Supply Chain Insights Series show the significance of large Indian facilities in pharmaceutical supply chain vulnerability.

By: Kristin Brooks

Managing Editor, Contract Pharma

U.S. Pharmacopeia (USP), an independent scientific organization, released the first findings from its Medicine Supply Vulnerability Insights Series sourced from USP’s global Medicine Supply Map. 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 U.S. 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).

 
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. These insights can help direct 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,” said Vimala Raghavendran, who heads USP’s Pharmaceutical Supply Chain Center.

The Insight 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. 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.”
 
The aim is 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. 

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