Full Press Release Details
New Brookhaven, NY facility will expand domestic manufacturing of sterile injectable medicines for hospitals and health systems, help address market supply needs, and strengthen the U.S. pharmaceutical supply chain
BRIDGEWATER, N.J., July 1, 2026 – Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) today announced it has been selected by the U.S. Food and Drug Administration (FDA) to participate in the FDA PreCheck Pilot Program for the company's planned sterile manufacturing facility in Brookhaven, New York. The new facility reflects Amneal's continued investment in domestic manufacturing capabilities and will expand the company's capacity to produce sterile injectable medicines that help address market supply needs, including providing surge capacity to help address shortages, helping build a more resilient U.S. pharmaceutical supply chain for American patients.
The approximately 75,000-square-foot facility will manufacture sterile finished dosage forms using advanced aseptic processing, automation, and integrated systems that ensure quality is embedded from the ground up and support resilient domestic production. The facility’s advanced manufacturing capabilities will improve manufacturing efficiency while advancing product quality, sterility, and supply reliability. The project also will create new highly skilled manufacturing jobs.
"We are proud to have our Brookhaven sterile manufacturing project selected for the FDA's PreCheck Pilot Program," said Chintu Patel, Co-Founder and Chief Executive Officer of Amneal. "This achievement reflects our continued investment in domestic manufacturing capabilities and our relentless commitment to ensuring quality is embedded in everything we do. Once operational, this facility will further strengthen Amneal's position as a leading U.S.-based biopharmaceutical company with significant domestic sterile manufacturing capabilities at scale. By working collaboratively with the FDA through the PreCheck program, we're helping build a more resilient U.S. pharmaceutical supply chain while helping address market supply needs and expanding patient access to critical medicines."
Through its PreCheck Pilot Program, the FDA collaborates with participating companies early in the design and development of new manufacturing facilities to help accelerate readiness while maintaining rigorous quality and regulatory standards. The initiative is intended to strengthen domestic pharmaceutical manufacturing and improve the resilience of the U.S. drug supply chain.
"Advanced manufacturing is essential to ensuring hospitals and healthcare providers have ongoing access to critical medicines," said Chirag Patel, Co-Founder and Co-Chief Executive Officer of Amneal. "This facility builds on decades of investment in U.S. manufacturing and reflects our commitment to strengthening domestic pharmaceutical production through innovation, operational excellence, and collaboration.”
The Brookhaven project builds on Amneal's growing leadership in domestic production capability, with more than 160 products made in America across more than 1 million square feet of combined manufacturing space. Once operational, the facility will complement existing New York, New Jersey and Kentucky-based capabilities focused on expanding access to medicines while supporting a stronger and more resilient U.S. pharmaceutical supply chain.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) is a global biopharmaceutical company committed to improving access to high-quality medicines through the development, manufacturing and distribution of a diverse portfolio of generic, specialty and biosimilar medicines. With a growing U.S. manufacturing footprint, Amneal is helping strengthen domestic pharmaceutical production while serving patients, providers and healthcare systems around the world. For more information, visit www.amneal.com and follow us on LinkedIn.