Good news! | Retatrutide API has officially received its FDA DMF number.

            Recently, Hangzhou Thinheal Pharma -Tech Co., Ltd. successfully obtained Drug Master File (DMF) registration from the U.S. Food and Drug Administration (FDA) for its retatrutide active pharmaceutical ingredient (API) (DMF NUMBER ASSIGNED: 42912). This marks a new stage in the registration and application process for this product in the United States and represents another important milestone in the company's global expansion.

             addition, several of the company's previously registered key products maintain active DMF status, including:

                 In the global field of metabolic disease treatment, retatrutide, as a representative of a new generation of multi-target peptide molecules, has demonstrated outstanding performance in diabetes treatment and weight management, thanks to its unique triple-receptor synergistic mechanism.  Furthermore, it shows significant clinical potential in the systemic intervention of metabolic syndrome.  Its industrialization not only demands higher precision control in peptide synthesis processes but also poses systemic challenges to the stability of large-scale production, the reproducibility of process scaling, and the quality control system throughout the entire chain from research and development to manufacturing. This reflects the comprehensive technological hurdles involved in bringing peptide drugs from molecular innovation to industrial application.

                 The successful FDA DMF filing for the retatrutide active pharmaceutical ingredient (API) marks a significant milestone for the company, demonstrating the completion of systematic API process development, quality control system establishment, and large-scale production capabilities for this molecule. This lays a crucial foundation for future international regulatory submissions and global collaborations for the finished drug product.  This achievement is not only a milestone for a single product but also reflects the company's years of continuous dedication to the peptide drug field, the ongoing refinement of its technology platform and industrial system. It showcases our comprehensive capabilities in the engineering, large-scale production, and international quality standards of complex peptide molecules, further strengthening our industrial foundation and strategic positioning in the field of innovative metabolic drugs.