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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【Do you have any of these concerns?】 ■ Unable to find an active pharmaceutical ingredient (API) manufacturer that can comply with overseas regulations ■ Insufficient data for the API part when applying for formulation approval ■ Want to expand the sale of Japan-quality APIs overseas ■ Not well-informed about the regulatory situation for APIs intended for overseas use ■ Need to register a new DMF due to regulatory circumstances ■ Existing manufacturers have ceased production, and we need to ensure stable supply from next year onwards *For more details, please refer to the related links or feel free to contact us.
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【Achievements (Excerpt)】 ■ Active Pharmaceutical Ingredient A: EU, September 2014 - Present, CEP registration, inquiry response ■ Active Pharmaceutical Ingredient B: France, July 2007 - Present, ASMF registration, inquiry response ■ Active Pharmaceutical Ingredient B: Netherlands, July 2007 - Present, ASMF registration, inquiry response ■ Active Pharmaceutical Ingredient C: Taiwan, August 2016 - Present, ASMF registration, inquiry response ■ Active Pharmaceutical Ingredient D: China, September 2020 - Present, DMF registration *For more details, please refer to the related links or feel free to contact us.
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Since our establishment, we have been supplying pharmaceutical raw materials to various pharmaceutical companies both domestically and internationally. We mainly focus on items that require complex synthesis routes and lengthy processes, as well as niche raw materials with few suppliers, even in small quantities. Please feel free to consult us if you have any requests.
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