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.
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.
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.