Kaneka officially starts continuous manufacturing under GMP

Commercial production utilizing flow chemistrybeganJune 2018 at Kaneka Singapore

TOKYO,Aug. 14,2018 --Kaneka Corporation (Headquarters: Minato-ku,Tokyo; President: Mamoru Kadokura) have installed continuous manufacturing equipment to be applied to pharmaceutical products at Kaneka Singapore Co. (Pte.) Ltd,(Headquarters: Singapore; President: Kazuhiko Yamada) with commercial production under cGMP already underway as of June 2018.

Kaneka officially starts continuous manufacturing under GMP

In the field of small molecule pharmaceutical products,the recent demands have begun to trend toward an increased number of more diversified and smaller volume targets. With these changes,more efficient production technology is needed to address the broad range of targets now required. Continuous manufacturing,or Flow Chemistry,is a manufacturing technology that allows the introduction of raw materials with little to no operator exposure and presents an easy,safe and convenient approach to manufacturing,including reactions that may require tough or dangerous conditions under typical batch reaction conditions. Our equipment is a unique,Kaneka designed reactor that allows diversity of application through the ability to select the relevant parameters of the reaction tubing based on laboratory and scale-up research providing the highest performance of reactions. Kaneka Singapore has been qualified as a manufacturer from the US FDA *1 in 2017,and we expect to apply this continuous manufacturing infrastructure to various Regulatory Starting Material (RSM),Intermediate,and API projects,including targets requiring GMP *2 production.

Kaneka has capability from process development to commercial production with excellent quality assurance,and we now aim to expand our solution services in the Health Care business field utilizing this new technology.

*1 Abbreviated name of Food and Drug Administration. It is an agency within the Department of Health and Human Services in US and has responsibility for regulating the manufacturing,marketing,and distribution of pharmaceutical products.

*2 Abbreviated name of Good Manufacturing Practice,the recommended guidelines and minimum requirements to ensure that products are consistently high in quality.

< Kaneka Singapore Co. (Pte.) Ltd. >

Representative: CEO,Kazuhiko Yamada

Paid-in Capital: 16 million Singapore dollars

Headquarter: Singapore

Establishment: 1979

Business field: Sales and manufacturing of pharmaceutical products.

Contact:

Alan Walker

VP Pharma,Kaneka Americas Holding

(212) 705-4392

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