B. Braun receives FDA approval for Florida pharmaceutical manufacturing plant

B. Braun Medical announced today that it received final approval from the FDA for its new pharmaceutical manufacturing plant.

Bethlehem, Pennsylvania-based B. Braun’s Daytona Beach, Florida-based plant 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 news release, the B. Braun Excel Plus IV bags are not made with PVC, DEHP or natural rubber latex in an effort to protect patients from exposure to harmful chemicals.

The company said its new Daytona Beach facility represents part of its commitment to invest more than $1 billion to alleviate IV fluid shortages through the addition of supply and manufacturing capacity in the U.S. Adding a Florida manufacturing plant complements the company’s existing IV solutions facility in Irvine, California, giving B. Braun strategic locations on both coasts.

B. Braun expects the delivery of products from the Daytona Beach facility to begin in late February.

“FDA approval of our state-of-the-art pharmaceutical manufacturing plant in Daytona Beach is a win for patients across the United States,” B. Braun of America Chairman and CEO Jean-Claude Dubacher said in the release. “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.”