Prefilled drug delivery device specialist Apiject has signed a lease for a new site in Apex, North Carolina, that will house two blow-fill-seal production lines.
The 30,000-square-foot facility will operate as a FDA-registered 503B outsourcing plant that will churn out generic injectable drugs on the agency’s shortage list, the company said in a Jan. 16 press release.
Financial terms related to the lease and the overall cost and completion date of the project were not disclosed.
Operating under the auspices of the 503B program, the North Carolina plant will prioritize the manufacture of generic injectable medicines facing shortages in order to speed distribution of essential drugs manufactured within the U.S., Apiject said.
The new facility represents part of the company’s effort to support the restoring of critical drug production capacity in the U.S., Apiject said.
“America's dependence on foreign sources for essential medicines is a strategic vulnerability,” Jay Walker, Apiject’s chairman, said in a statement. “This facility represents the next step in Apiject's ongoing work to translate advanced American manufacturing technology into real domestic capacity.”
In September, the company filed a new drug application with the FDA for what could become the first single-dose, single-use prefilled plastic syringe of its kind.
The device integrates blow-fill-seal liquid packaging technology and precision injection molding of pen-style needle hubs. The combo allows for prefilled drug delivery devices that are more scalable and affordable than traditional glass vials and prefilled syringes, the company said.