Providing all-in-one services from the early research stage to IND!
In "Synthetic Pharmaceutical Development and IND Package," we will appropriately propose services that meet the client's needs from the early research stage to IND. The main contents include synthetic pharmaceutical CMO/cGMP, label body API synthesis, and IND package (including the preparation of application documents), among others. Services related to ADME, safety, and IND packages are not limited to synthetic pharmaceuticals and can also be provided for biopharmaceuticals. [Main Service Contents] - Compound synthesis - Small-scale synthesis - Process development and industrialization - Radioactive compounds, etc. For more details, please contact us or download the catalog.
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basic information
【Overview】 [Compound Synthesis] ○ Process research, novel synthesis (De novo synthesis) ○ Synthesis of radioactive compounds (non-GMP and cGMP) ○ Synthesis of stable-labeled compounds, identification and synthesis of impurities and similar compounds ○ Synthesis of reference drugs for analysis, evaluation and selection of administration routes ○ Process optimization, robustness and process limits testing ○ Process validation ○ Preparation of cGMP-compliant APIs for preclinical and clinical trials [Small Scale Synthesis] ○ Small scale synthesis capabilities → Novel synthesis De novo synthesis, chiral synthesis → Identification of analogs, metabolites, and degradation products [Process Development and Industrialization] ○ Process chemistry → Discovery and clarification of synthetic routes → Process improvement and optimization → Robustness and process limits testing [Radioactive Compounds] ○ Synthesis of labeled compounds ○ Customized synthesis of 4C, 3H, and stable isotopes ○ Radioactive detection dedicated HPLC and NMR ○ Identification of degradation products/impurities ○ Long-term storage and stability testing of radioactive labeled compounds, etc. ● For more details, please contact us or download the catalog.
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Company information
Libra Medicina Co., Ltd. aims to contribute to the improvement of health and quality of life for people around the world by being involved in the creation of innovative pharmaceuticals and medical devices through development support services and licensing activities, delivering hope to patients suffering from serious diseases.