Generic API
Premium API
Peptide API
Morebio has over 16 years of expertise in the manufacturing of generic APIs in accordance with GMP standards. Our new modernized R&D and manufacturing will be completed in 2025. Our GMP manufacturing facilities are compliant with the stringent requirements of global regulatory authorities, including those of the United States, the European Union, the Middle East, China, Japan, and Korea. We provide regulatory support, including DMF preparation, and the drug development lifecycle from discovery to commercial manufacturing.
GMP Capacity
Advanced Manufacturing
Quality Assurance
Quality Control
Stability Analysis
Project Management
Premium API
API Catalog
Our generic APIs are specialized in GLP-1 RAs and related intermediates. These generic APIs are utilized for the treatment of diabetes and obesity. Obesity and Type 2 Diabetes are widespread diseases with considerable levels of morbidity and mortality globally, primarily in the form of cardiovascular disease(CVD). Therefore, GLP-1 RAs are becoming the preferred treatment for obesity and T2DM. Moreover, clinical evidence demonstrates that these agents also have the potential benefit for cardiovascular and kidney diseases.
US-FDA
DMF Certificate
Morebio achieves the FDA-DMF certificate for Semaglutide API (039115), Semaglutide Main Chain (039480).
Semaglutide API
DMF 039115
Semaglutide Main Chain
DMF 039480
Fundamental API
Fundamental GLP-1 RAs
Morebio has more than 15 years experience in development and manufacturing of fundamental GLP-1 RAs. Our API of fundamental GLP-1 RAs includes:
Beinaglutide
Dulaglutide
Exenatide
Lixisenatide
Fundamental GLP-1 Receptor Agonists are peptide medications, which can mimic the GLP-1 hormone. These medications are applied for type2 diabetes and weight loss, GLP RAs enhance insulin release, suppress glucagon, slow stomach emptying and reduce appetite.
our Quality
Quality Insurance
Morebio has the GMP (Good Manufacturing Practice) certificate, which ensures our pharmaceutical products are consistently produced and controlled to quality standards during manufacturing, processing, packaging, and storage.