QUALITY ASSURANCE

We have established the quality control system and the manufacturing control system based on the cGMP. We have also invested in the systems and improved SOPs to secure data integrity (DI) based on the ALCOA +principle. Our factories are approved by a recent FDA inspection. Policy

CERTIFICATIONS STATUS

In order to manufacture APIs and intermediates for pharmaceutical products, we have a lot of inspection experieces by the authority and customer audits, and we have been highly evaluated by the inspections and customer audits.

FDA Inspection	June 1991	Kinraku Plant
	May 1996	Kinraku Plant
	June 2000	Kinraku Plant
	June 2009	Kinraku Plant
	April 2013	Kinraku Plant, Senboku Plant
	March 2016	Kinraku Plant
	March 2019	Senboku Plant
	May 2023	Senboku Plant
	February 2024	Kinraku Plant
PMDA Inspection	January 2014	Kinraku Plant, Senboku Plant
	April 2018	Kinraku Plant
	August 2018	Kinraku Plant, Senboku Plant
	January 2020	Kinraku Plant
	February 2022	Senboku Plant
Pharmaceutical Affairs Division Inspection	January 2015	Senboku Plant
	March 2015	Senboku Plant
	May 2015	Kinraku Plant
	October 2015	Senboku Plant
	September 2016	Senboku Plant
	July 2017	Kinraku Plant, Senboku Plant
	June 2019	Senboku Plant
	January 2020	Kinraku Plant
	June 2020	Senboku Plant
	January 2022	Kinraku Plant
	March 2022	Senboku Plant
	July 2022	Kinraku Plant, Senboku Plant
	October 2022	Senboku Plant
	February 2023	Senboku Plant
	June 2023	Senboku Plant

FDA Inspection
June 1991	Kinraku Plant
May 1996	Kinraku Plant
June 2000	Kinraku Plant
June 2009	Kinraku Plant
April 2013	Kinraku Plant, Senboku Plant
March 2016	Kinraku Plant
March 2019	Senboku Plant
May 2023	Senboku Plant
February 2024	Kinraku Plant

PMDA Inspection
January 2014	Kinraku Plant, Senboku Plant
April 2018	Kinraku Plant
August 2018	Kinraku Plant, Senboku Plant
January 2020	Kinraku Plant
February 2022	Senboku Plant

Pharmaceutical Affairs Division Inspection
January 2015	Senboku Plant
March 2015	Senboku Plant
May 2015	Kinraku Plant
October 2015	Senboku Plant
September 2016	Senboku Plant
July 2017	Kinraku Plant, Senboku Plant
June 2019	Senboku Plant
January 2020	Kinraku Plant
June 2020	Senboku Plant
January 2022	Kinraku Plant
March 2022	Senboku Plant
July 2022	Kinraku Plant, Senboku Plant
October 2022	Senboku Plant
February 2023	Senboku Plant
June 2023	Senboku Plant

PHARMACEUTICAL
BUSINESS

We provide process development, method development and validation, and manufacturing services for intermediates and APIs (Active Pharmaceutical Ingredients), which have been developed by pharmaceutical companies, academia, and venture companies. Our clients can rely on our superior technologies and quality assurance system which have been developed over many years of experience in the industry.
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COSMETIC
BUSINESS

We offer sourcing, contract manufacturing and sales services of cosmetic chemicals to send beauty and moisture to customers around the world.
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CHEMICAL
BUSINESS

We supply high quality raw materials for chemicals from companies inside and outside of Japan leveraging our technologies and supply network.
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