A wholly-owned subsidiary, Takara Biotechnology (Dalian) Co., Ltd. Acquires ISO:13485 certification

  • 2019/05/07

Kusatsu/Shiga, Japan – April 24, 2019 –  Takara Bio Inc. (Takara Bio) announced that Takara Biotechnology (Dalian) Co., Ltd. (Dalian city, China, hereafter “Takara Biotechnology (Dalian)”), a wholly-owned subsidiary of Takara Bio has acquired ISO 13485:2016 certification, an international standard for quality management system of medical devices and diagnostic pharmaceuticals.

  Takara Biotechnology (Dalian) is a core manufacturing facility for research reagents sold by Takara Bio group. It acquired ISO 9001:2015 certification, an international standard for quality management system in 2015 and subsequent ISO 13485 certification this time in order to meet the requirements for in vitro diagnostic pharmaceuticals.

  Takara Bio will provide high-quality reagents and services for the life sciences with focuses on quality management system.

【Accreditation】

StandardISO 13485:2016
Organization registeredTakara Biotechnology (Dalian) Co., Ltd.
Scope registeredContracted manufacturing for molecular biology reagents applicable to in vitro diagnostic pharmaceuticals
Date of registrationMarch 26, 2019
Accreditation no.CN19/42045
AuthoritySGS United Kingdom Ltd.

【Overview of Takara Biotechnology (Dalian)】

Company nameTakara Biotechnology (Dalian) Co., Ltd.
Location19-No.2 Dongbei Street, Dalian Economic and Technical Development Zone, Dalian city, Liaoning, 116600, China
Date established1993
Number of employee514 (As of March 31, 2019)
Business descriptionManufacture of research reagents, etc.

For more information:PR・IR Department, Takara Bio Inc.
E-mail: bio-ir@takara-bio.co.jp