Contract Synthesis: Regulatory Compliance and Quality Assurance System

Even if the necessary production volume becomes minimal, we will continue to ensure a stable supply of raw materials with a flexible production system!

At Kyu Chemical, we have been supplying active pharmaceutical ingredients manufactured through chemical synthesis to domestic and overseas manufacturers for over 70 years. We have obtained the domestic Master File (MF) for active pharmaceutical ingredients, and for products sold in Europe, we have a track record of registering CEP and various country DMFs. Recently, we have been challenging ourselves to expand our sales to China, Taiwan, South Korea, and the United States in order to deliver our products to a wider audience around the world who need them. 【Features】 ■ Proven track record of obtaining CEP and DMFs in EU countries ■ Not only producing active pharmaceutical ingredients but also appropriately handling regulatory affairs related to them ■ Complying with ICH, PIC/S guidelines, etc., to supply active pharmaceutical ingredients domestically and internationally ■ Establishing a stable supply system for active pharmaceutical ingredients that supports the lifecycle of pharmaceuticals ■ As long as patients need pharmaceuticals using Kyu Chemical's active pharmaceutical ingredients, we will continue to provide a stable supply of active pharmaceutical ingredients with the flexibility of our production system, even if the required production volume becomes minimal. *For more details, please refer to the related links or feel free to contact us.

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