B. Braun gets FDA nod for new IV manufacturing site in Florida amid continued IV fluid shortages

B. Braun Medical, a German infusion therapy company, has received the FDA’s approval to begin operations at its new IV saline solution manufacturing facility in Daytona Beach, Florida.

The facility, which is part of the company’s pledge to spend $1 billion on its U.S. manufacturing and supply chain to address shortages of IV fluids, will produce 0.9% sodium chloride for injection. The 1,000-milliliter and 500-milliliter bags won’t be made with PVC, DEHP or natural rubber latex, which can contain harmful chemicals to humans, the company said.

B. Braun expects to begin delivering products from the facility later this month.

“IV solutions shortages can cause serious implications for patient care and put providers in the position of delaying patient treatments or using alternative techniques,” Wes Cetnarowski, M.D., B. Braun senior vice president and chief medical officer, said in a statement.

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Shortages of IV fluids, which the FDA continues to list as being in short supply, reach back to 2015 and were exacerbated by a bad flu season in 2017. The advent of the COVID-19 pandemic has further stressed supplies.

To help alleviate the situation, B. Braun made its $1 billion pledge in 2019, which also included expanding operations at its Irvine, California, and Allentown, Pennsylvania, manufacturing sites.

The shortfalls in IV fluids in the U.S. triggered a Senate hearing in the fall of 2015, which called on the Federal Trade Commission to investigate shortages of saline.