Regeneron and Scholar Rock Seek New Manufacturing Sites After FDA Issues at Catalent’s Indiana Facility

Regeneron Pharmaceuticals and Scholar Rock have sought alternative manufacturing facilities to address regulatory challenges stemming from quality issues at a former Catalent facility in Indiana. The U.S. Food and Drug Administration (FDA) previously rejected applications tied to the site, prompting the two biotech companies to secure new fill-and-finish capacity elsewhere. Novo Nordisk, another company linked to the facility, has not disclosed whether its FDA submissions have been similarly impacted.

The Indiana facility, now under scrutiny for quality control concerns, has created bottlenecks for companies relying on it for production. Regeneron and Scholar Rock’s decision to shift operations highlights efforts within the biotech industry to navigate regulatory hurdles and maintain progress on their respective projects. Novo Nordisk has remained silent regarding any potential effects on its own FDA applications related to the site.

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Date: December 2, 2025

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