桂化学 List of Products and Services

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.

• Other contract services
• Other services
• Chemicals

Our company has a high-level active pharmaceutical ingredient containment clean room equivalent to ISO Class 8 for pharmaceutical manufacturing. Equipped with single-use isolators, we can produce small quantities of highly potent active pharmaceutical ingredients (from a few grams to several kilograms) while preventing cross-contamination. Through strict humidity control, we can produce high-quality active pharmaceutical ingredients throughout the year, and we offer custom synthesis of active pharmaceutical ingredients tailored to customer needs via a walk-in draft. 【Features】 ■ Single-use isolators ■ Highly potent active pharmaceutical ingredients ■ Single-use to prevent cross-contamination ■ Walk-in draft installed for multi-variety small-scale organic synthesis reactions *For more details, please refer to the related links or feel free to contact us.

• Other contract services
• Other services
• Chemicals

At Kyu Chemical, we also handle the manufacturing of active pharmaceutical ingredients (APIs) for clinical trial drugs and pharmaceutical products on a gram scale. We conduct process improvements and data management with the premise of commercialization from the development stage, supporting everything from process development to market launch. Production activities are carried out under a management system compliant with ICH and PIC/S guidelines, and we are also capable of synthesizing compounds for drug discovery and related substances. If you have active pharmaceutical ingredients that are too small in quantity and have been rejected by overseas manufacturers, please contact us. 【Features】 ■ Manufacturing of highly pharmacologically active pharmaceutical ingredients (HPAPI) ■ Manufacturing of APIs for clinical trial drugs ■ Manufacturing of small quantities of APIs *For more details, please refer to the related links or feel free to contact us.

• Other contract services
• Other services
• Chemicals

We would like to introduce our "Process Chemistry Development Using PAT." The quality of active pharmaceutical ingredients (APIs) is believed to depend on the depth of understanding of the manufacturing process. By using PAT, detailed data on reaction conditions and crystallization conditions can be obtained, leading to assurance of quality through the manufacturing process. If formulation does not proceed well, such as unstable dissolution test results, the cause may lie in the crystal form of the API. PAT allows for real-time monitoring of the crystallization process. 【Features】 ■ Setting of reaction conditions ■ Setting of crystallization conditions ■ Setting of manufacturing processes *For more details, please refer to the related links or feel free to contact us.

• Other contract services
• Other services

Our company offers contract manufacturing for various scales and compounds. We provide high-quality active pharmaceutical ingredients along with a high level of service, which we call Katsura Chemical Quality, and we accept contract manufacturing of high-quality active pharmaceutical ingredients from milligrams (mg) to tons (t). 【Features】 ■ The development department supports contract manufacturing for process research and development ■ Collaboration with alliance companies ■ Multi-plant compliant with GMP *For more details, please download the PDF or feel free to contact us.

• Other Testing Contract
• Other contract manufacturing
• Other purification and extraction