July 31, 2018
TOKYO, JAPAN and LEUVEN, BELGIUM - July 31, 2018 - Terumo Corporation (TSE: 4543) today announced that the Terumo Hospital Company Alliance Division plant of Terumo Yamaguchi D&D Corporation for fill and finish, a wholly-owned subsidiary of Terumo, has been conferred Good Manufacturing Practice (GMP) certification on July 2, by the European Medicines Agency (EMA) for the manufacturing and filling of PLAJEX™ pre-fillable syringes with i-coating™ stoppers.
GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing 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.
The certification by the EMA allows Terumo Hospital Company Alliance Division to manufacture and fill PLAJEX™ pre-fillable syringes with biologics for customers that wish to market their product in Europe. Outside of Japan, the Terumo Hospital Company Alliance Division operates as Terumo Pharmaceutical Solutions.
In May 2017, the EMA received an application from Fujifilm Kyowa Kirin Biologics Co., Ltd., seeking approval to market Hulio™ (Humira® biosimilar, product code: FKB327, generic name: adalimumab). On July 27, 2018 the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a marketing authorization for Hulio™. The decision of the European Commission on the approval is expected in October 2018. Through the agreement between Fujifilm Kyowa Kirin Biologics Co., Ltd and Terumo Corporation, the Terumo Yamaguchi D&D Corporation will formulate, fill, and finish Hulio™ in the PLAJEX™ pre-fillable syringe system.
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 health care market, and by responding to the needs of health care 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.
The PLAJEX™ pre-fillable syringe system offers drug delivery solutions and technologies for injection and infusion. Available in staked-needle and integrated luer lock formats, this modern-day primary container system protects sensitive biotherapeutics and small molecules.
(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.