US-based biopharmaceutical company Amneal Pharmaceuticals and medical technology firm Apiject Systems have announced a partnership aimed at enhancing domestic production capabilities.
This collaboration will focus on expanding Apiject’s blow-fill-seal (BFS) injectable platform at Amneal’s Brookhaven facility in New York.
It aims to bolster the capacity for producing a variety of sterile drug dosage forms, including prefilled injectables, ophthalmics, and inhalation products.
Amneal co-CEOs Chirag Patel and Chintu Patel said: “This collaboration marks a significant step in expanding our US manufacturing footprint with advanced sterile pharmaceutical capabilities.
“We continue to invest in advanced pharmaceutical manufacturing in the United States, which reflects our commitment to producing essential and affordable medicines in America for Americans.
“We believe the country has an opportunity to build a more resilient US pharmaceutical supply chain and to onshore critical drug production, and we are eager to lead the charge.”
The partnership is expected to generate approximately 200 jobs at Amneal’s Brookhaven site. The company currently employs around 800 staff members at the location as part of its broader US workforce of approximately 2,500.
The collaboration involves the installation of dedicated manufacturing lines to support Apiject’s delivery systems for both government and commercial applications. This expansion will cater to emergency preparedness efforts and the reshoring of pharmaceutical manufacturing while enhancing Amneal’s injectable product lineup.
The new infrastructure aims to produce around 250 to 300 million units annually, with potential scalability to over 400 million units.
Apiject’s BFS technology combines blow-fill-seal manufacturing with precision injection molding for pen-style needle hubs. This integration facilitates the rapid production of sterile, single-dose injectors as an economical and efficient alternative to conventional glass vials and syringes.
The platform’s streamlined process is advantageous for commercial distribution, public health initiatives, and emergency response scenarios.
Apiject co-founder, executive chairman, and CEO Jay Walker said: “Our collaboration with Amneal is win, win, win. It provides America with an increased domestic-based capacity to manufacture a new category of prefilled drug delivery devices with supply chain, speed, scalability, and sustainability advantages over traditional offerings.
“It provides Amneal increased manufacturing options to serve its current and future commercial customers. And it provides Apiject a trusted company to bring a wide range of critical injectable drugs to the US and global market.”
The development of Apiject’s technology received backing from a $180m investment by the US Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response during the first Trump administration.
Under an agreement with HHS-ASPR, Apiject is said to have successfully delivered on-time and on-budget domestic fill-finish capacity, providing a contingency solution during potential disruptions in traditional injection material supplies throughout the pandemic.
