Amneal Pharmaceuticals and Apiject Systems today announced a strategic collaboration to expand domestic production of Apiject’s BFS-based injectable platform at Amneal’s Brookhaven, New York facility. The collaboration will enable large-scale capacity to produce a range of sterile drug dosage forms, including prefilled injectables, ophthalmics and inhalation.
Today, Amneal has one of the largest U.S. pharmaceutical manufacturing footprints in the industry. Currently, the company has approximately 2,500 employees in the U.S., with the majority focused on operations, quality, and R&D. At the Brookhaven facility, Amneal has approximately 800 employees and this project is expected to create approximately 200 additional jobs.
Amneal will install dedicated manufacturing lines to support Apiject’s proprietary delivery systems across government and commercial programs, including applications for emergency preparedness and reshoring domestic pharmaceutical manufacturing. The new infrastructure is expected to have capacity to produce approximately 250 to 300 million units annually, with potential to scale to more than 400 million units over time. In addition, Amneal and Apiject will collaborate on the development of additional injectable product programs utilizing Apiject’s BFS platform.
Apiject’s technology integrates two proven medical innovations: Blow-Fill-Seal (BFS) manufacturing and precision injection molding of pen-style needle hubs. This combination enables the creation of sterile, single-dose, prefilled injectors in a continuous, high-speed process—offering a more scalable, cost-effective, and efficient alternative to traditional glass vials and syringes. The platform’s speed, efficiency, and compact supply chain make it particularly well-suited for commercial use, public health campaigns, and emergency response.
Apiject’s underlying technology was developed, in part, through a $180 million investment by the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR) during President Trump’s first term in office. The project highlights the Trump Administration’s commitment to accelerate the building of new U.S.-based, high-speed, population-scale capacity for pharmaceutical manufacturing.
Under the agreement with HHS-ASPR, Apiject delivered on-time and on-budget a domestic fill-finish capacity that served as a backup in the event of critical supply disruptions for traditional injection materials during the pandemic.
