Apiject to establish NC injectable manufacturing site using blow-fill-seal technology

Apiject Holdings has signed a lease for a 30,000-square-foot pharmaceutical manufacturing facility in Apex, North Carolina, that will house two blow-fill-seal (BFS) production lines and operate as an FDA-registered 503B outsourcing facility.

The company said the site will focus on manufacturing essential generic injectable medicines that appear on the U.S. Food and Drug Administration’s drug shortage list. The facility will also serve as the corporate headquarters for Vanguard Utility, Apiject’s operational subsidiary.

According to the company, the Apex site builds on recent regulatory and commercial progress, including the filing of a New Drug Application with the FDA for its first prefilled injection device produced using BFS technology. Apiject said the investment supports efforts to expand domestic pharmaceutical manufacturing capacity amid ongoing shortages and reliance on overseas suppliers.

“America’s dependence on foreign sources for essential medicines is a strategic vulnerability,” Jay Walker, chairman of Apiject, 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.”

The company cited persistent supply challenges, noting that more than 200 drugs regularly appear on the FDA shortage list and that most generic medicines consumed in the U.S. are manufactured abroad.

Apiject said its manufacturing strategy is based on advances in BFS processing, a technology historically used for products such as eye drops and inhalation therapies. With support from the Administration for Strategic Preparedness and Response, the company said it has adapted the technology for a broader range of liquid injectable medicines.

Unlike conventional glass vial filling, BFS manufacturing forms the container, fills the drug and seals the unit dose in a single automated process, reducing dependence on global glass supply chains, according to the company.

“BFS fundamentally changes the economics of generic injectable drug manufacturing,” Darren Alkins, CEO of Vanguard Utility, said in a statement. “With Apiject’s advancements, BFS can now be used for a broad range of liquid injectable medicines, produced quickly, at scale and at competitive costs in the United States.”

Operating under the FDA’s 503B framework, the Apex facility is intended to support faster deployment of domestically manufactured injectable medicines, the company said.