HLB PEP Registers Vasopressin API for Antidiuretic Hormone with US FDA

HLB Peptide has completed the registration of its Active Pharmaceutical Ingredient (API) for the antidiuretic hormone therapy drug vasopressin in the Drug Master File (DMF) of the U.S. Food and Drug Administration (FDA).

According to HLB Peptide on July 27, the FDA DMF registration has enabled the company to establish a foundation for supplying vasopressin API to pharmaceutical companies in the United States and globally. The DMF system is used to register and manage data on the manufacturing process, quality control, and stability of APIs with the FDA. This data serves as core documentation to prove the quality and manufacturing reliability of the API when a finished pharmaceutical drug manufacturer applies for approval.

This FDA DMF registration is significant as it reflects that HLB Peptide’s peptide synthesis technology and GMP-based quality control capabilities have been recognized by global regulatory agencies. With this, the company has expanded its major peptide API portfolio from existing leuprolide and ganirelix to include vasopressin, further strengthening its competitiveness in the global CDMO (Contract Development and Manufacturing Organization) business. In addition, HLB Peptide plans to accelerate the development of new peptide APIs such as those in the GLP-1 class, and to further expand its portfolio of high value-added peptide APIs.

Shim Kyungjae, CEO of HLB Peptide, stated, "Following our status as the first in Korea to register vasopressin in the MFDS DMF, we have now also completed FDA DMF registration in the United States, laying an important foundation for entering the global market. Going forward, we plan to expand collaboration opportunities with global pharmaceutical companies and continuously strengthen our peptide API portfolio to enhance our competitiveness in the global CDMO business."

This content was produced with the assistance of AI translation services.