Providing total solutions from active pharmaceutical ingredient development to commercial production.
Our company supports the realization of new business scenes through innovative formulation technologies and continuous production technologies, with a focus on the near future. We provide comprehensive support, including non-clinical trials, drug absorption evaluations, clinical trials, bioequivalence studies, and application processes, all centralized for your convenience. We offer proposal-based business support utilizing the solid formulation technologies, product quality, and formulation development know-how that we have cultivated as a CDMO. Please feel free to contact us if you have any requests. 【Features】 ■ Comprehensive support ■ Proposal-based support ■ Advanced formulation technology development *For more details, please download the PDF or feel free to contact us.
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【Service Contents】 ■Development Strategy Consultation - Comprehensive support for API supply, formulation development, and commercial production - ・CMC Consultation ■Active Pharmaceutical Ingredient (API): Manufacturing Method Consideration ・Synthetic Route Examination ・Dissolution Improvement ・Synthetic Method Development (Optimization, Scale-Up, Industrialization Consideration) ■Formulation: Formulation Design, Investigation of Improving Absorption of Poorly Soluble Drugs, Manufacturing Method Development, Specification and Testing Method Development ・Preformulation ・Formulation Design ・Manufacturing Method Development (Optimization, Scale-Up, Industrialization Consideration) ■Clinical Trial Drug Manufacturing ・API Manufacturing ・Bulk Formulation: From Early to Late Clinical Stages ・Packaging (From Primary Packaging to Final Packaging, PTP/Blister/Bottle/Card) ・Shipping Tests and Stability Tests ■Technology Transfer: Manufacturing and Testing Methods ■Regulatory Affairs Related to CMC ・CTD Preparation (CMC Part) ・Inquiry Response Support ■Commercial Services ・PQ, PV ・Visual Inspection (Japanese Quality) ・Packaging (From Primary to Final) ・Shipping Tests and Stability Tests ・GMP Inspection Response *For more details, please download the PDF or feel free to contact us.
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Since our establishment, we have accumulated experience and achievements while receiving unwavering support from many customers. We have developed solid strengths, including reliable business quality, a certain and speedy technology transfer system, and flexible mobility that can respond promptly to various needs. In contract services for formulation development and clinical trial drug manufacturing, as well as pharmaceutical manufacturing contracts, we provide services that cover almost all dosage forms, from solid preparations and injectables to ointments, creams, and liquids. We ensure a stable supply of high-quality pharmaceuticals through an efficient production system and respond accurately and flexibly to our customers' advanced requirements. Please feel free to contact us if you have any requests.