Terumo Announces GMP Certification Has Been Awarded for the Manufacturing and Filling of Premixed Intravenous Solutions from the FDA (U.S.A.)

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.