キャタレント・ジャパン List of Products and Services

The nine locations in the United States, Europe, and the Asia-Pacific region are clinical trial drug packaging sites compliant with cGMP, and the more than 50 depots across six continents are audited clinical trial drug supply facilities. Leveraging this high-level global network and extensive expertise in global supply chains and clinical trial drug supply management, we provide flexible and integrated services that cater to Phase I through Phase IV clinical trials. As clinical trials become increasingly complex and individually designed, there is a pressing need to bring newly developed pharmaceuticals to market more quickly. However, the new drug development process frequently encounters new challenges, necessitating prompt and accurate responses each time. To address this, Catalent offers tailored solutions required for clinical trials. By flexibly responding to various challenges at every step of the clinical trial process—such as direct procurement of comparator drugs, comprehensive clinical trial drug packaging, labeling, storage in appropriate environments, global distribution, and innovative supply models—we accelerate the speed of bringing new pharmaceuticals to market. With these diverse services and capabilities, along with proven track records in various countries, we support domestic, international, and global clinical trials as a comprehensive clinical trial drug supply partner.

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Comprehensive solutions for advanced medical care: ■ Plasmids ■ iPS cells ■ Virus vectors ■ Cell therapy (autologous, allogeneic) ■ mRNA ■ Process development and analytical services ■ Clinical and commercial manufacturing ■ Clinical supply services

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The speed at which it dissolves in just 3 seconds is up to 10 times faster compared to typical orally disintegrating tablets. This is top-class technology in over-the-counter pharmaceuticals. The easy-to-take and swallowable dosage form is ideal for patients with swallowing difficulties, as well as for children and the elderly. Additionally, it serves as an ideal platform for active ingredients that need to be rapidly absorbed after administration, such as pain relievers, allergy medications, and motion sickness preventatives. Currently, Zydus's technology is utilized in over 20 products across 60 countries. In the process, we have pursued new dosage forms that are easier to take, contributing to the expansion of our customers' product portfolios. The improved pharmacokinetics before gastrointestinal absorption, the ease of use that aids patient adherence to dosage, and the dosage form that makes it easy to highlight product features. Catalent is an innovative partner that enhances the cost-effectiveness of development investments and contributes to our customers' branding.

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As an innovator in soft capsule technology, we have pursued various formulations to enhance product value over many years, resulting in the birth of OptiGel Micro (seamless capsule). This is truly the crystallization of drug delivery system (DDS) technology that clears the challenges of formulation development, such as complex formulations, the formulation of poorly soluble compounds, and the pursuit of better bioavailability. OptiGel Micro (seamless capsule) forms spherical capsules using a manufacturing process that utilizes droplets from the laminar flow of coating liquid and fill liquid, unlike the rotary die method used for soft capsule formation. The capsule size ranges from 1 to 7 mm, allowing for the production of smaller capsules than traditional soft capsules. The excipients are made from the same materials as other gelatin capsule coatings and can accommodate a wide range of contents, just like other products.

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Catalent invented the rotary die encapsulation machine widely used in soft capsule manufacturing. Since then, it has continued to lead the industry with cutting-edge drug delivery system (DDS) technology. The "OptiShell," developed in this process, is an award-winning technology that enables complex formulations of difficult-to-develop compounds, evolving drug delivery in soft capsules. OptiShell is ideal for encapsulating high-melting-point contents due to its patented coating derived from plant-based polysaccharides. Soft capsules filled with semi-solid matrices allow for the controlled release of poorly soluble or low membrane-permeable compounds, making Catalent the only company to successfully obtain FDA approval with this formulation. Additionally, in the development of immediate-release formulations, it expands the options for contents and excipients available for lipid-based capsules, addressing challenges in drug delivery. By combining the strengths of plant-based soft capsule OptiShell with other capsule technologies, the range of lipid-based capsule formulations is broadened.

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The gelatin capsules from Catalent, an innovator in soft capsules, have been loved in the over-the-counter pharmaceutical market for more than 85 years. Based on the accumulated experience and expertise in soft capsule formulation development, drug delivery systems (DDS), and supply, they have also been utilized in the food industry. Currently, they deliver over 5,000 items, including over-the-counter pharmaceuticals, health foods, and beauty capsules, to more than 70 countries, serving 21 of the top 25 healthcare companies.

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