News | January 31, 2022

B. Braun Receives FDA Approval Of Daytona Beach Pharmaceutical Manufacturing Site

B Braun

Increased availability of IV solutions to address shortages stemming from ongoing COVID-19 crisis

BETHLEHEM, Pa. — B. Braun Medical Inc. (B. Braun), a leader in infusion therapy and pain management, today announced that the company has received final approval by the U.S. Food & Drug Administration (FDA) for its new pharmaceutical manufacturing plant in Daytona Beach, FL. The site will produce 0.9% Sodium Chloride for Injection available in B. Braun's Excel® Plus IV Bags in 1,000 mL and 500 mL sizes. Consistent with B. Braun's decades-long commitment to protect patients from exposure to harmful chemicals, the Excel Plus IV bags are not made with PVC, DEHP or natural rubber latex.

The new Daytona Beach facility is part of B. Braun's commitment to invest over $1 billion dollars to alleviate IV fluid shortages by creating additional supply and manufacturing capacity in the United States. Together with B. Braun's existing IV solutions plant in Irvine, CA, the company now has strategic manufacturing locations on both coasts. "FDA approval of our state-of-the-art pharmaceutical manufacturing plant in Daytona Beach is a win for patients across the United States," said Jean-Claude Dubacher, Chairman and CEO of B. Braun of America. "By investing in domestic manufacturing, we are helping to ensure a reliable and consistent supply of vital IV fluids that healthcare providers rely on to treat patients, especially as COVID-19 continues to endanger our communities."

"IV solutions shortages can cause serious implications for patient care and put providers in the position of delaying patient treatments or using alternative techniques," said Wes Cetnarowski, Senior Vice President and Chief Medical Officer. "Increased manufacturing capacity for solutions could not come at a better time for both patients and providers."

Delivery of products from the Daytona Beach facility are expected to begin in late February.

About B. Braun

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pennsylvania and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, explore our website.

Source: B. Braun OEM Division