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November 14, 2018

TOKYO, JAPAN - November 14, 2018 - Terumo Corporation (TSE: 4543) today announced that its Kofu Pharmaceutical Plant in Japan has been conferred Good Manufacturing Practice (GMP) certification on October 18, by the U.S.A. Food and Drug Administration (FDA) for the manufacturing and filling of premixed intravenous solutions.

GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. This system is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through the testing of the final product. The regulatory authorities in each country inspect and certify individual manufacturing facilities to determine whether they have manufacturing management methods that meet GMP standards, and whether systems are in place to ensure the necessary quality.

A major pharmaceutical company has developed a drug and they plan to sell it in the U.S.A. and Canada. The developed product is a premixed solution filled in soft plastic bags. The certification by the FDA allows Terumo to manufacture and fill this product. It is the first time that any premixed product manufactured by Terumo will be available on the market in the Americas.

Terumo will continue expanding its alliance business with global pharmaceutical companies, utilizing its unique technology.

About Terumo

Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.

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 or 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.

 

Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice.