Amneal, Apiject Expand BFS to Boost U.S. Sterile Drug Production

Amneal Pharmaceuticals and Apiject Systems have announced a strategic partnership to boost domestic pharmaceutical production in the United States. 

The collaboration will expand the use of Apiject’s Blow-Fill-Seal (BFS) injectable platform at Amneal’s facility in Brookhaven, New York.

This initiative will increase the capacity to manufacture various sterile drug forms such as prefilled injectables, ophthalmic solutions, and inhalation products. It also supports efforts to improve emergency preparedness and reinforce the U.S. drug supply chain by relocating production to domestic sites.

Amneal, which already holds a major manufacturing footprint in the country, employs approximately 2,500 people in the U.S., including 800 at the Brookhaven site. The project is expected to generate around 200 new jobs at the facility.

As part of the agreement, Amneal will install dedicated production lines to support both government and commercial applications using Apiject’s BFS system. The new infrastructure aims to produce up to 300 million units annually, with the ability to scale beyond 400 million units in the future. The companies will also work together to develop new injectable drug programmes using this technology.

Apiject’s platform merges BFS manufacturing with injection-moulded needle hubs to produce sterile, single-dose, prefilled devices. This integrated process offers a cost-effective and scalable alternative to traditional glass vials and syringes, with advantages in speed, supply chain efficiency, and sustainability.

The underlying BFS technology was initially supported by a $180 million investment from the U.S. Department of Health and Human Services during the Trump administration, aimed at enhancing domestic pharmaceutical production during public health emergencies. 

Apiject fulfilled its role by establishing a reliable fill-finish capacity that could be used in case of supply chain disruptions during the COVID-19 pandemic.

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