Companies affected by quality issues at a Novo Nordisk facility in Bloomington, Indiana, are seeking alternative solutions to secure their drug supply chains. The U.S. Food and Drug Administration (FDA) reinspected the site after previously identifying problems that led to regulatory setbacks for several biopharmaceutical companies.
Novo Nordisk acquired the Indiana plant, along with two other former Catalent facilities, for $11 billion last year to boost its manufacturing capacity for GLP-1 drugs. Previously operated by Catalent as a contract development and manufacturing organization (CDMO), the site provided fill/finish services for various biopharma firms.
Regeneron Pharmaceuticals received multiple complete response letters (CRLs) from the FDA starting in 2023 due to deficiencies found at the Indiana plant. Scholar Rock also received a CRL related to the facility in September. According to Regeneron CEO Leonard Schleifer, “the biggest companies in the world have had the same issue” at this and other filling sites but have not publicly discussed their regulatory challenges.
After an Official Action Indicated (OAI) classification was issued for the Indiana plant in October—signaling serious compliance concerns—both Regeneron and Scholar Rock accelerated efforts to reduce dependence on the facility.
Scholar Rock CEO David Hallal said his company “accelerated our timelines for an additional vialer” following these developments. He noted that while plans were already underway to add another U.S.-based fill/finish provider after Novo’s acquisition of Catalent’s operations, they were expedited because of recent regulatory actions impacting Scholar Rock’s spinal muscular atrophy drug candidate apitegromab.
Hallal reported that Scholar Rock has now secured commercial fill/finish capacity beginning in early 2026 with a new provider that recently passed site inspections. Technology transfer is ongoing, and inclusion of this site is planned for an approval filing next year. Analysts from BMO Capital Markets increased their estimated probability of success for apitegromab’s approval in light of these updates.
The analysts stated: “As we have seen throughout 2025, the more biotech manufacturers can plan for unforeseen CMC issues, the less likely they are to face challenges with FDA approvals. Scholar Rock’s expedited transfer for this second fill finish acknowledges this reality and could provide comfort for investors who still are wary of another Catalent site reinspection.”
Despite progress toward a possible FDA reinspection of Novo’s Bloomington facility, Hallal confirmed that Novo representatives participated in discussions with Scholar Rock and regulators about remediation efforts at the plant. However, on December 2nd, Scholar Rock disclosed that Bloomington had received an FDA warning letter.
Regeneron is also working toward greater independence by building its own fill/finish plant in Rensselaer, New York—a project included within its previously announced $7 billion investment plan. Schleifer said during an earnings call that construction is complete and operations are expected to begin within a year. At a Morgan Stanley event earlier this year, he indicated that initial operations will start with one production line but may expand up to four lines over time.
Schleifer addressed questions about past vulnerabilities stemming from reliance on third-party CDMOs: “We’ve been working on backups for quite a long time now,” he explained. He described regulatory requirements around manufacturing changes as resource-intensive due to stability testing and quality assurance demands.
Regeneron CFO Christopher Fenimore suggested last month that if no compliant filler could be listed on certain applications—specifically referencing Catalent—they would expect further CRLs from regulators. However, just days later Regeneron announced FDA approval of Eylea HD vials across additional indications despite unresolved issues at some partner sites.
A Regeneron spokesperson declined further comment regarding what changed between those statements except referring back to public press releases which did not address production specifics but noted continued work with ex-Catalent facilities.
BMO Capital Markets analysts called Eylea HD's approval "a welcome surprise as regulatory issues are starting to show signs of improvement." The company intends soon to seek approval again for its prefilled syringe product using a newly validated third-party manufacturer.
Novo Nordisk remains closely tied to its three recently acquired plants—including Bloomington—after investing heavily last year; costs related partly contributed to higher cost-of-goods-sold figures reported by Novo in Q3 financial results.
In November Novo revealed it had received an FDA CRL regarding a multidose version of Wegovy but did not confirm whether problems at Bloomington were responsible. Company officials referenced only general recommendations from regulators concerning coexistence between multi-dose and single-dose pens currently marketed rather than specific manufacturing deficiencies.
Novo stated it continues engaging with authorities over outstanding application feedback as remediation work proceeds at affected facilities.
