APIIC Receives $14M Award for Development, Production of Three APIs

The API Innovation Center, a St. Louis-based nonprofit with a mission to enable delivery of a market-competitive commercial supply of United States-made APIs, announced in a press release on Sept. 12, 2024 that it has received $14 million from the Administration for Strategic Preparedness and Response’s (ASPR) Center for Industrial Base Management and Supply Chain (IBMSC) to lead development and US production of three critical APIs (1–2).

ASPR, which is under the US Department of Health and Human Services (HHS), also announced the agreement on Sept. 12, saying it is part of an effort first previewed in November 2023 to make more essential medicines in the US, hoping to mitigate drug shortages in the interest of national defense (3).

"This funding represents both a financial commitment and a significant step towards securing America’s pharmaceutical resiliency and patient access to critical medicines,” Tony Sardella, chair and founder of APIIC, said in the APIIC press release. “By focusing on developing these high-impact molecules, we are creating a private-public blueprint for driving self-reliance that is essential for national health security and can be replicated across the country.”

The APIs, chosen in part for their role in US healthcare as well as their shortage history, are albuterol, which is used to treat asthma and other respiratory conditions; desmopressin acetate, which treats diabetes and blood coagulation issues; and lorazepam, which is used to treat anxiety (1). Partners with APIIC in this endeavor include Mallinckrodt Specialty Generics, Apertus Pharmaceuticals, MilliporeSigma, and the University of Missouri–St. Louis (UMSL).

“Partnering with the API Innovation Center on this important initiative allows us to leverage our strengths in research, workforce development, and community engagement to support a more secure and self-reliant pharmaceutical supply chain,” Chris Spilling, PhD, UMSL vice chancellor for research and economic and community development, said in the APIIC press release. “UMSL is proud to play a key role in advancing these critical efforts, which will have lasting impacts on both our region’s economy and the nation’s health security.”

According to APIIC, at least 83% of the top 100 generic medicines in the US have no domestic-based source for the small-molecule APIs common in current medications (1). Domestic facilities are operating below capacity, leaving the country at the whims of foreign manufacturers, their shortages, and geopolitical conflicts.

“The award we are announcing today enables a domestic supply chain that provides on-demand manufacturing for essential medicines,” said ASPR Assistant Secretary for Preparedness and Response Dawn O’Connell, in the HHS press release. “We are committed to using innovative and flexible domestic manufacturing to increase capacity and reduce reliance on foreign sources.”

References

1. APIIC. The API Innovation Center Receives $14 Million in Strategic Funding to Bolster US Pharmaceutical Independence. Press Release. Sept. 12, 2024.
2. APIIC. About—API Innovation Center. apicenter.org/about (accessed Sept. 13, 2024).
2. ASPR. Biden-Harris Administration Funds First Defense Production Act Title III Award to Onshore Manufacturing of Ingredients for Essential Medicines. Press Release. Sept. 12, 2024.