Amneal collaborates with Apiject to establish sterile and blow-fill-seal (BFS) capabilities in Brookhaven, NY

Bridgewater, NJ - Today we announced an exciting strategic collaboration with Apiject to support U.S.-based production of the medical technology company's advanced blow-fill-seal (BFS) injectable platform.

The collaboration marks Amneal's expansion of our U.S. manufacturing footprint with advanced sterile and BFS capabilities. It also aligns well with our strategic efforts to build class-leading injectables capability for our growing portfolio of products.

As part of this collaboration, Amneal will install dedicated manufacturing lines with capacity to produce ~250-300 million units annually (potential to scale to 400+ million over time) in our Brookhaven, NY facility.

Apiject's proprietary delivery systems will support a host of government and commercial programs, including applications for emergency preparedness and reshoring domestic pharmaceutical manufacturing, as well as Amneal's growing injectable portfolio. It will also enable large-scale capacity to produce a range of sterile drug dosage forms, including prefilled injectables, ophthalmics and inhalation.

Apiject's technology integrates two proven medical innovations: (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 well-suited for commercial use, public health campaigns, and emergency response. Apiject's underlying technology was developed, in part, through an investment by the U.S. Department of Health and Human Services (HHS) and Administration for Strategic Preparedness and Response (ASPR).

We'd like to thank all those who made this collaboration possible, particularly our Corporate Development and Legal teams. We hope you share our excitement over these new capabilities and the enhanced innovations they will make possible for patients.