Quality Control2019-01-30T19:01:39+00:00

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Ensuring Quality, Safety, Reliability
and Effectiveness For All Our Products.

Quality Assurance Policy

Denka Seiken is determined to make a positive contribution to society as a manufacturer and supplier of a broad range of vaccines and in vitro diagnostic test reagents. We provide services in accordance with the Pharmaceutical Affairs Law and International Organization for Standardization (ISO), to ensure quality, safety, reliability and effectiveness of all our products.

Denka Seiken’s Environmental Policy is “Work towards Co-existence and Co-prosperity with our Local Community”.

Principles of Environmental Management System

1. Companywide operation is in accordance with ISO 14001; Environment Management System.

2. The company abides by environmental standards for its agreements, rules and regulations.

3. Awareness of the importance of natural resources and is dedicated to reducing energy consumption and industrial waste.

4. Strives to reduce the environmental burden of company activities by examining the impact at community level.

5. Minimizes untoward environmental impact by establishing clear objectives and goals to this effect.

6. Company quality management policy is documented, practiced and maintained by all employees of Denka Seiken.

7. These principles are free for public viewing and available upon request, with the intention to continuously improve our Environment Management System.

ISO14001

In June 2000, Denka Seiken received certification from Bureau Veritas Quality International (BVQI), the most widely recognized certification body in the world, for conformity with our Environmental Management System and ISO14001. With the importance of environmental awareness growing, Denka Seiken’s corporate policy is to be environmentally responsible by conscientiously making efforts to minimize the impact of its business activities on the environment.

ABOUT

A History of Innovation and Manufacturing Excellence
Denka Seiken Co., Ltd. is a publicly traded biomedical company founded in 1950 with its head office in Tokyo and manufacturing facilities in Niigata, Japan.

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Sustained and Growing Global Demand for Denka Seiken Products.
Denka Seiken Co., Ltd. is a publicly traded biomedical company founded in 1950 with its head office in Tokyo and manufacturing facilities in Niigata, Japan.

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Total R&D Commitment to Enhance Technology Focused on Promotion of Health
Having introduced genetic modification technology, Denka Seiken became the first commercial producer in Japan of Norovirus(NV) antibodies, and developed in vitro diagnostic tests.

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Ensuring Quality, Safety, Reliability and Effectiveness For All Our Products.
Denka Seiken is determined to make a positive contribution to society as a manufacturer and supplier of a broad range of vaccines and invitro diagnostic test reagents.

Read More

ISO13485 Certification

ISO13485(181219-200630)(PDF)

Denka Seiken Co., Ltd.

Head Office:
Nihonbashi Mitsui Tower
1-1 Nihonbashi-Muromachi 2-chome,
Chuo-ku, Tokyo 103-8338, JAPAN

Established:
February 11, 1950

Paid-in Capital:
1,000 million YEN(JP)

Number of Employees:
725 (As of April 1, 2017)

Business:
Production, sales and import and export of clinical chemistry, immunochemistry, bacteriological and virological diagnostic reagents and food/environment testing reagent

Fiscal year ends:
March

Offices:
Factories:
Niigata Plant, Kagamida Plant (Gosen-shi, Niigata)

Branch Offices:
Tokyo, Osaka, Kanetsu

Sales Offices:
Sapporo, Sendai, Nagoya, Hiroshima, Fukuoka

Subsidiaries:
Denka Seiken UK Limited
Denka Seiken USA Incorporated
Denka Seiken (SHANGHAI) Co.,Ltd.