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FDA Approves Daytona Beach Pharmaceutical Manufacturing Site

B. Braun Medical, a leader in infusion therapy and pain management, announced that the company has received final approval by the U.S. Food & Drug Administration for its new pharmaceutical manufacturing plant in Daytona Beach, Florida.

B. Braun Medical hosted a grand opening event at the new, state-of-the-art pharmaceutical manufacturing plant on August 17th.

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 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, California, 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.

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