Apiject announced today that it signed a lease on a 30,000-square-foot pharmaceutical manufacturing facility in Apex, North Carolina.
The injection delivery system developer plans for the new facility to house two advanced blow-fill-seal (BFS) production lines and serve as an outsourcing facility focused on producing essential generic injectable medicines currently on the FDA’s drug shortage list. Apiject also plans for the site to house the corporate headquarters for its Vanguard Utility subsidiary.
According to a news release, the new facility builds on momentum across its efforts to “restore U.S. control over essential medicines.” It recently filed an FDA new drug application (NDA) for its first BFS-based pre-filled injection device as well.
Apiject said it hopes to help reshore critical U.S. manufacturing capacity and strengthen national resilience in key industries.
The company built its manufacturing strategy on BFS technology, hoping to expand it to most liquid injectable medicines. Unlike traditional glass vial packaging, BFS forms the drug container, fills the medicine and seals the dose in one continuous, automated process.
Apiject said its Apex facility will prioritize the production of generic, shortage-listed injectable medicines. It hopes to allow for aster deployment of essential drugs manufactured domestically.
“This facility represents the next step in Apiject’s ongoing work to translate advanced American manufacturing technology into real domestic capacity,” said Apiject chair Jay Walker.
