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.
About Terumo Corporation
Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers, with over $5 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices, including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician-office use. Terumo contributes to society by providing valued products and services to the healthcare market, and by responding to the needs of healthcare providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.