Closer To Home: Rethinking API Manufacturing

The U.S. pharmaceutical supply chain has become increasingly dependent on overseas production of active pharmaceutical ingredients (APIs), exposing vulnerabilities related to geopolitical tensions, trade disruptions, quality oversight, and public health emergencies. Recent events, including pandemics and export restrictions, have highlighted the risks of relying heavily on foreign API manufacturing.

Join experts Brian Doty, VP of R&D and Programs for the API Innovation Center; Hugh Kelly, Associate VP and Site Head of Indianapolis API Manufacturing at Eli Lilly and Company; and Dennis Hall, VP of AMTs for U.S. Pharmacopeia; as they examine potential strategies for retrofitting current facilities or outfitting new facilities to bring API manufacturing in-house. These experts will explore opportunities in facility design, process updates, technological advancements, raw material sourcing, and quality control for more cost-efficient, expedient domestic API manufacturing. They will also delve into the benefits of domestic production, including improved supply chain resilience, enhanced quality control and faster response to demand surges. The analysis will address key challenges such as higher production costs, workforce and infrastructure requirements, and regulatory complexity. Finally, the panel will examine policy options and industry strategies that could enable a sustainable transition toward localized API production.