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Newsroom 2018

July 18, 2018

U.S. FDA Approves Terumo BCT's Sodium Citrate 4% w/v Anticoagulant Solution Amid Shortage

LAKEWOOD, Colo. USA – July 18, 2018 – The U.S. Food and Drug Administration (FDA) recently approved Terumo BCT's Sodium Citrate 4% w/v Anticoagulant Solution USP, indicated for anticoagulating whole blood during automated apheresis procedures. On an official FDA shortage list for over a year, sodium citrate anticoagulant solution is commonly used during apheresis procedures that collect plasma that is later used to treat serious medical conditions.

Terumo BCT is a global leader in blood component, therapeutic apheresis and cellular technologies with nearly 7,000 employees and manufacturing facilities in Belgium, India, Japan, the U.K., the U.S. and Vietnam. The company has 30 years of experience making pharmaceutical solutions. The newly approved sodium citrate will be available in the U.S. later this summer.

"We heard from numerous customers that the shortage of sodium citrate was starting to have an impact on patients," said Tim Costello, a vice president of Terumo BCT. "This FDA approval will help alleviate the U.S. shortage and improve patient lives."

Terumo BCT's manufacturing facility in Larne, U.K., specializes in liquid solutions including Sodium Citrate 4% w/v Anticoagulant Solution USP. The company has supplied parts of Europe, Asia and Australia with this same sodium citrate product for more than 10 years.

Sodium citrate is used by blood centers and plasma collection organizations. The solution is also used in plasma fractionation, a process that enables the derivatives to be used in pharmaceuticals.

About Terumo BCT

Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing and pathogen reduction technologies. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

(Notice) Among the information that Terumo discloses, the forward-looking statements including financial projections are based upon our assumptions using information available to us at the time and are not intended to be guarantees of future events or performance. Accordingly, it should be noted that actual results may differ from those forecasts on projections due to various factors. Factors affecting to actual results include, but are not limited to, changes in economic conditions surrounding Terumo, fluctuations of foreign exchange rates, and state of competition. The market share information in this press release is partly derived from our own independent research.

 

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