Advanced pharmaceutical manufacturing
Search documents
Amneal and Apiject to Expand Sterile and Blow-Fill-Seal (BFS) Capabilities for Advanced Pharmaceutical Manufacturing in the U.S.
GlobeNewswire News Roomยท 2025-05-08 11:00
Core Viewpoint - Amneal Pharmaceuticals and Apiject Systems have announced a strategic collaboration to enhance domestic production of sterile drug dosage forms, particularly prefilled injectables, at Amneal's Brookhaven, NY facility, aiming to strengthen the U.S. drug supply chain [1][2][3] Group 1: Collaboration Details - The collaboration will enable large-scale production capacity for sterile drug dosage forms, including injectables, ophthalmics, and inhalation [1] - Amneal's Brookhaven facility will create approximately 200 high-quality jobs as part of this project [2] - The new manufacturing lines are expected to produce approximately 250 to 300 million units annually, with potential scalability to over 400 million units [3] Group 2: Strategic Importance - This partnership reflects Amneal's commitment to onshore critical drug production and build a more resilient U.S. pharmaceutical supply chain [3] - The collaboration is seen as a win for increasing domestic manufacturing capacity and providing Amneal with enhanced options to serve commercial customers [4] - Apiject's technology, which combines Blow-Fill-Seal (BFS) manufacturing and precision injection molding, offers a scalable and efficient alternative to traditional drug delivery methods [4][9] Group 3: Background and Investment - Apiject's technology development was supported by a $180 million investment from the U.S. Department of Health and Human Services, highlighting governmental support for U.S.-based pharmaceutical manufacturing [5] - The collaboration aims to address supply chain disruptions experienced during the pandemic by establishing a domestic fill-finish capacity [6]