Breaking News: Guizhou Utide Biotechnology’s Tirzepatide and Retatrutide Successfully Pass U.S. Drug Master File (DMF) Filing for Peptide Active Pharmaceutical Ingredients!

Recently, the U.S. Food and Drug Administration (FDA) announced on its official website that Guizhou Utide Biotechnology Co., Ltd. has successfully completed U.S. FDA Drug Master File (DMF) filings for its peptide active pharmaceutical ingredients Tirzepatide and Retatrutide (DMF No. 042984; No. 043330). The corresponding Type II DMFs have been received and are maintained in active status.

Tirzepatide is a synthetic peptide that acts as a dual agonist of the GIP and GLP-1 receptors, while Retatrutide is a multi-receptor agonist targeting GLP-1, GIP, and glucagon receptors. Both compounds involve complex peptide structures and require stringent control in synthesis, impurity profiles, and quality consistency.

In the development and manufacturing of peptide APIs, the company has made technological innovation its central focus, strengthening its capabilities across R&D, production, and quality control, and gradually building an integrated peptide industry chain.

The successful DMF filings provide a regulatory foundation for downstream partners to reference these peptide APIs in drug development and registration for regulated markets, supporting the company’s expansion into international markets and enhancing its global competitiveness.

Looking ahead, the company will continue to advance its peptide API strategy and provide high-quality, reliable peptide solutions to customers worldwide.