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B. Braun Medical gets FDA approval for Daytona Beach facility
Cris Collingwood//January 28, 2022//
Bethlehem‘s B. Braun Medical Inc. has received final approval by the U.S. Food & Drug Administration (FDA) for its new pharmaceutical manufacturing plant in Daytona Beach, Florida.
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, according to a company statement.
“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.”
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, the statement said.
“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 is expected to begin in late February.
