Pharmaceutical Industry Grapples with Manufacturing Challenges as Companies Seek Alternative Solutions

In recent months, the pharmaceutical industry has been rocked by manufacturing issues at a key facility, leading to regulatory setbacks and prompting companies to seek alternative production solutions. The ex-Catalent plant in Bloomington, Indiana, now owned by Novo Nordisk, has become the epicenter of quality control concerns, affecting multiple drug manufacturers and their product approvals.

FDA Rejections Prompt Strategic Shifts

Regeneron and Scholar Rock have faced complete response letters (CRLs) from the FDA due to quality problems at the Indiana facility. These regulatory setbacks have forced both companies to accelerate plans for securing alternative fill/finish capacity.

Scholar Rock CEO David Hallal revealed that the company has secured commercial fill/finish capacity from early 2026, following the Official Action Indicated (OAI) classification of the Novo Nordisk site in October. The biotech is now aiming to include this new site in an approval filing in 2026 for its drug candidate apitegromab in spinal muscular atrophy (SMA).

Regeneron, which has received multiple CRLs linked to the Indiana facility, is taking a more direct approach by bringing fill/finish operations in-house. The company is set to open a new facility in Rensselaer, New York, as part of a $7 billion investment announced in April. CEO Leonard Schleifer stated that the site is "ready to go" and is expected to come online during the coming year, initially with one production line and plans to expand to four lines over time.

Novo Nordisk Faces Scrutiny and Regulatory Challenges

While its clients seek alternatives, Novo Nordisk, which acquired the Indiana facility along with two other Catalent plants for $11 billion last year, is working to address the quality issues. The company has implemented a remediation plan and expects the facility to be ready for FDA reinspection by the end of the year.

However, Novo Nordisk itself has not been immune to regulatory challenges. The company recently received a CRL for a multidose version of Wegovy, although it has not explicitly linked this rejection to issues at the Indiana site. The acquisition of the Catalent facilities has also contributed to a 39% increase in Novo Nordisk's cost of goods sold in the third quarter.

Industry-Wide Implications and Future Outlook

The manufacturing issues at the ex-Catalent facility have highlighted the vulnerability of pharmaceutical companies to quality control problems at contract manufacturing sites. Regeneron CEO Leonard Schleifer suggested that "the biggest companies in the world have had the same issue" with this and other fillers, although many have kept quiet about receiving CRLs.

As companies like Regeneron and Scholar Rock move to secure alternative manufacturing capacity, the industry is likely to see increased emphasis on robust supply chain management and contingency planning. The situation underscores the critical importance of maintaining high-quality manufacturing processes in the pharmaceutical sector and the potential consequences of failing to do so.