Amneal Pharmaceuticals Expands US Manufacturing Capacity Through Apiject Collaboration

Amneal Pharmaceuticals, a New Jersey-based biopharmaceutical company, has announced a significant collaboration with syringe maker Apiject to boost its production capacity in the United States. This strategic partnership aims to strengthen Amneal's manufacturing capabilities and support efforts to reshore drug production within the country.

New Manufacturing Lines to Increase Production

As part of the collaboration, Amneal will install new manufacturing lines at Apiject's facility in Brookhaven, New York. Once fully operational, the additional production line is expected to produce an estimated 250 to 300 million units annually, with the potential to increase output to over 400 million units per year.

The expansion project is set to create approximately 200 new jobs, adding to the current workforce of about 800 at the Brookhaven site. This significant increase in employment underscores the economic impact of the collaboration on the local community.

Advanced Technology for Diverse Drug Production

The partnership will leverage Apiject's Blow-Fill-Seal (BFS) platform, enabling large-scale production of various sterile drug dosage forms. These include prefilled injectables, ophthalmic products, and inhalation medications. The BFS technology, invented by social entrepreneur Marc Koska, offers several advantages:

1. Rapid scalability to meet unexpected spikes in demand
2. Capability to handle temperature-sensitive products, including ultracold mRNA vaccines
3. Versatility in producing a wide range of sterile injectable drugs

Chirag Patel and Chintu Patel, co-CEOs of Amneal, emphasized the company's commitment to producing essential and affordable medicines within the United States. They stated, "We believe the country has an opportunity to build a more resilient U.S. pharmaceutical supply chain and to onshore critical drug production."

Government Support and Private Investment

Apiject's technology has garnered support from both private investors and U.S. government agencies in recent years. The company has received backing from the Department of Health and Human Services and the Administration for Strategic Preparedness and Response. During the COVID-19 pandemic in 2020, Apiject secured a substantial $590 million loan from the U.S. International Development Finance Corporation to increase its production capacity to up to 3 billion devices per year.

While financial details of the Amneal-Apiject collaboration were not disclosed, the partnership represents a significant step towards enhancing domestic pharmaceutical manufacturing capabilities and ensuring a more robust supply chain for critical medications in the United States.