Grand Island, USA

The plant currently ships approximately 200 million vials annually. Currently, the main markets are the US, Canada and the European market. The vials shipped range in size from as small as 2 mL to as large as 100 mL and include mostly critical care and anesthetic and analgesic products, utilizing either aseptic processing technology or terminal sterilization. Heparin Sodium, in various strengths and formats, is the highest-volume product produced in Grand Island and is used to prevent and treat blood clots and clotting disorders in patients.

Today, the plant consists of two production facilities for manufacturing IV drugs and one recently added facility dedicated to monobactam products filled in vials. The 193,725 square foot/17,998 square meter production facility that focuses on IV drugs features four open restricted-access barrier filling lines, one of which has lyophilization capability and two terminal sterilization lines. The other 94,500 square foot/8,779 square meter production facility focuses on IV drugs and features three isolator technology lines including lyophilization capability. Further, the fully automated monobactam facility contains 19,000 square feet /1,765 square meters of manufacturing space with the option to offer contract manufacturing services for antibiotics.

We are committed to sustainable production, which is evident in all three US plants obtaining ISO 14001:2015 (Environmental Management) certification, ISO 50001:2018 (Energy Management) certification, and ISO 45001:2018 (Safety) certification. As part of Fresenius Kabi’s responsible energy and environmental initiative, the Grand Island site implemented a strategy for waste reduction in processes and worked with internal and external experts to reduce power consumption, boost recycling, and invest in the wastewater treatment facility.

With a cross-functional team of more than 800 employees across five shifts, the plant is constantly improving and advancing. Examples include the addition of larger tanks to increase formulation batch size, automatic cleaning processes for equipment, in-line depyrogenation tunnels, automated visual inspection recipes, and packaging serialization. The site has also assembled a team to implement electronic batch records to aid in the batch release process at the highest compliance levels.

The Grand Island site looks forward to partnering with you for your contract manufacturing needs. We embrace the opportunity to learn and grow our technical capabilities together. Our team is eager to make a difference in the lives of our customers and their patients.