Corporate Announcement | Suzhou Tianji Biopharma Completes Two FDA Type II DMF Filings

Suzhou Tianji Biopharma has filed two Type II Drug Master Files (DMFs) with the U.S. FDA for its peptide APIs: Tirzepatide — the blockbuster GLP-1/GIP dual receptor agonist for type 2 diabetes and obesity — and Thymalfasin — a well-established immunomodulatory peptide. Both DMFs were submitted independently by Suzhou Tianji as the holder and are currently in Active status.

Both DMF numbers are publicly available in the FDA's public DMF list.

For formulation developers, CROs, and CMOs, these Active DMFs can be referenced directly through a Letter of Authorization (LOA) to support ANDA and NDA submissions — eliminating the need to independently compile proprietary manufacturing, stability, and impurity data across the CMC package.

Both DMFs are supported by a common CMC data package and a single GMP quality system, so the same dossier can be readily leveraged for additional filings, including EU CEP/ASMF and Japan PMDA submissions.

We invite formulation partners worldwide to reference our DMFs, with full LOA support and technical assistance available.

To request an LOA or discuss a partnership, please contact our Business Development team.