Contract services for research and development and manufacturing of synthetic pharmaceuticals.
As an agent for multiple CDMOs in South Korea and Taiwan, we provide intermediary services for contract research and development and manufacturing of synthetic pharmaceutical intermediates, active pharmaceutical ingredients, and formulations.
Regarding active pharmaceutical ingredient manufacturing, we support outsourcing at various stages of new drug development and generic pharmaceuticals, from establishing synthetic methods to small-scale trial production for clinical testing (from grams to kilograms), GMP production, and commercial production. We are also capable of GMP production and regulatory registration for highly contained substances such as anticancer drugs, steroids, and highly pharmacologically active materials. In formulation manufacturing, we mediate contract services for formulation development, manufacturing method formulation research, setting quality standards, developing testing methods, and CMC-related tasks. The CDMO we represent complies with GMP regulations in various countries as well as ICH and PIC/S guidelines. Even at the development stage, we conduct process improvements and data management aimed at market launch, supporting smooth regulatory submissions.
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basic information
1. Production Technology - Production in compliance with PIC/S GMP certified by Sterility Assurance Levels (SAL) - Adoption of single-use technology to prevent cross-contamination 2. Active Pharmaceutical Ingredient Manufacturing - Production of low molecular weight peptides and peptide-drug conjugates (PDC) 3. Formulation Manufacturing - Production of oral solid dosage forms - Production of sterile final formulations such as powder formulations, liquids, and freeze-dried powders - Aseptic filling and packaging of vials, pre-filled syringes, and cartridges 4. Formulation Platform Technology - Osmotic release control system - Pellet-coated extended-release OD tablets - Sustained absorption oral extended-release system - Ultra-fine crystal long-acting injectable formulations 5. Therapeutic Areas for Generic Pharmaceuticals Cardiovascular, metabolic products, central nervous system (CNS) products, antiepileptics, sedatives and hypnotics, dementia & Parkinson's syndrome, other CNS drugs, gastrointestinal, kidney diseases, urology, respiratory, orthopedics, infectious diseases, etc.
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Applications/Examples of results
1. Active Pharmaceutical Ingredient Manufacturing - Production of low molecular weight peptides and peptide-drug conjugates (PDCs) 2. Formulation Manufacturing - Production of oral solid dosage forms - Production of sterile final formulations such as powder formulations, liquid formulations, and freeze-dried powders - Aseptic filling and packaging of vials, pre-filled syringes, and cartridges 3. Generic Pharmaceutical Therapeutic Areas - Cardiovascular, metabolic products, central nervous system (CNS) products, antiepileptic drugs, sedatives and hypnotics, dementia & Parkinson's syndrome, other CNS drugs, gastrointestinal, kidney diseases, urology, respiratory, orthopedics, infectious diseases, etc.
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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.