NIPTE Announces Call to Achieve US Pharmaceutical Independence by Building On-Shore Capacity and Capabilities

A strategy to mitigate US pharmaceutical supply chain risk seeks to identify and commercialize new synthesis pathways for critical drug substances based on domestically sourced materials. 

MINNEAPOLIS, June 18, 2024 /PRNewswire/ — Today, the US depends on imports from China and other overseas sources for a majority of the active pharmaceutical ingredients (APIs) used to make drug products critical to US patients. The National Institute for Pharmaceutical Technology and Education (NIPTE) today announced a strategy for mitigating this risk to the US pharmaceutical supply chain and the US population who depend on access to these life-saving medicines.

“If a major disruption of international commerce prevented the US from importing APIs and finished pharmaceutical products, the impact could be catastrophic,” says Vadim J. Gurvich, Executive Director of NIPTE and Research Associate Professor at the University of Minnesota. “We currently lack much of the industrial capacity needed to replace API imports. We need to find consensus and begin to implement a plan.”  

A strategy, described in a publication on NIPTE’s website nipte.org, identifies several needs and structures a plan of activities to identify the 50 most critical medicines as well as new synthetic pathways for both APIs and excipients using chemical building blocks that are manufactured in the US or closely allied countries. The work would build on existing critical medicine lists and would use AI tools to optimize manufacturing routes for the portfolio of drugs.

“AI-assisted retrosynthetic analysis and reaction databases can be used to create potential routes to each regulatory starting material (RSM). Other tools will be expanded to predict impurities and identify separation procedures,” explains Gurvich. “In developing updated, advanced manufacturing processes, we can also build in efficiency and environmental and economic sustainability.”

Such efficiencies could translate to lower-cost processes for generic drugs, which could help alleviate drug shortages. 

“We are issuing a call to action to refine the identified priorities and begin to work towards implementation,” says Gurvich. “The time to act is now.”

About NIPTE

The National Institute for Pharmaceutical Technology and Education (NIPTE) is a non-profit academic organization of 17 US universities that collaborate with industry, academia, and government to improve the way medicines are designed, developed, and manufactured to meet the needs of patients.

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SOURCE National Institute for Pharmaceutical Technology and Education (NIPTE)