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New report released by USP offers a look into API supply-chain vulnerabilities.
US Pharmacopeia (USP), an independent scientific organization, announced on March 16, 2022 that its USP Medicine Supply Vulnerability Insights Series reveals vulnerabilities in global API supply.
The first conclusion released from the Series discusses the significance of large Indian facilities in the manufacturing of API. There are currently 114 facilities in India with more than 30 active US-approved API products, which is significantly higher than any other region of the world.
The 40 external datasets and 250 million data points provided by the Medicine Supply Map show a comprehensive view of the upstream pharmaceutical supply chain. This information can aid in directing regulatory actions to protect against over-concentrated sources of API and build supply resilience.
“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,” commented Ronald T. Piervincenzi, USP CEO. “Without visibility into the medicine supply chain, preparing for the next crisis is not possible.”
“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,” added Dave Levin, MD, chief medical and information officer of Phlow Corp., a US-based pharmaceutical company.