Editor’s (re)View: Novo Nordisk knew what it was getting in purchase of troubled Indiana site

Buyer’s remorse is a horrible feeling for consumers who purchase a house or a car that’s a real lemon. In cases of faulty products or fraud, who can blame buyers for being blindsided? But it’s quite a different story when it comes to Novo Nordisk’s purchase last year of a troubled Catalent contract manufacturing plant in Bloomington, Indiana.   

It was with great fanfare that Novo Nordisk bought the Indiana facility, along with two other Catalent sites in Belgium and Italy, in a $11 billion deal completed in December 2024 with parent company Novo Holdings. These three facilities were the crown jewels in a separate, but related acquisition to Novo Holdings’ $16.5 billion buyout of contract manufacturer Catalent.  

However, Novo Nordisk knew what it was getting when the Danish drugmaker purchased Catalent’s troubled Indiana site from Novo Holdings. While the plant has recently been hit with the FDA’s most severe post-inspection classification, Official Action Indicated (OAI), it is a facility that has been plagued with problems for several years.

In early 2024, Reuters obtained an FDA report in a Freedom of Information Act request, revealing that the Indiana plant recorded around 194 deviations between Oct. 31, 2021, and Oct 31, 2023, “meaning some aspects of certain batches had failed to meet quality control standards” with Catalent failing to “identify the root cause of 171 of those incidents.”

Regulators in November 2023 found “quality control lapses” at the Indiana factory including discovery of a “pest” on the manufacturing line — though what sort of creature was found and precisely where was not explained in the FDA’s redacted report — according to Reuters.

If this sounds familiar, it should. In August, STAT obtained a copy of an FDA inspection report which found “cat hair, pests, bacteria, and equipment failures” were among the concerns cited by the agency at the Indiana site.       

No company feels as bad about the problems at Novo Nordisk’s Bloomington plant than Regeneron and Scholar Rock, as both have products manufactured at the facility. Last month, Scholar Rock announced that the FDA issued a Complete Response Letter (CRL) for a Biologics License Application (BLA) for its treatment of patients with spinal muscular atrophy.

“We continue to work closely with Novo Nordisk, and we have requested a Type A meeting with FDA to discuss next steps for resubmitting our BLA,” Scholar Rock said in a statement this week. “We plan to share more information during our third quarter 2025 business update call in November.”

In August, the FDA pushed back its target decision date for two of Regeneron’s supplemental BLAs for a high-dose formulation of Eylea, following the agency’s site inspection at the Novo Nordisk site in Indiana. This week, Regeneron said it plans to submit an application to include an additional manufacturing filler within the next three months.

For its part, Novo Nordisk said it is “in active dialogue with the FDA” and the company’s contract development and manufacturing organization customers “about this matter.” However, BMO Capital Markets analysts in a note to investors this week said Novo Nordisk’s actions are likely not quick enough for “companies with delayed approvals and CRLs.”

With the recent OAI classification and “no clear timelines” on observation resolution, the analysts wrote they are “less inclined to believe that the issues cited in the observations are under control.”