HLB Peptide has completed the registration of its vasopressin active pharmaceutical ingredient (API) with the U.S. Food and Drug Administration (FDA) Drug Master File (DMF). The company plans to accelerate its entry into the global market, including the United States, following this registration.
HLB Peptide announced on July 27 that it had finalized the FDA DMF registration on July 22, following its achievement of being the first in South Korea to register vasopressin API with the Ministry of Food and Drug Safety in December of last year.
The DMF is a system for registering and managing data related to the manufacturing processes, quality control, and safety of APIs with the FDA. This information is crucial for proving the quality and manufacturing reliability of raw materials when applying for approvals from finished pharmaceutical manufacturers.
The FDA DMF registration is significant as it recognizes HLB Peptide's peptide synthesis technology and its quality management capabilities based on Good Manufacturing Practice (GMP) standards.
HLB Peptide plans to enhance its competitiveness in the global contract development and manufacturing organization (CDMO) sector by expanding its portfolio of major peptide APIs, including vasopressin, in addition to leuprolide and ganirelix. The company also aims to accelerate the development of new peptide APIs, including glucagon-like peptide-1 (GLP-1) analogs, to continuously expand its high-value API portfolio.
Shim Kyung-jae, CEO of HLB Peptide, stated, "By completing the FDA DMF registration following the first DMF registration for vasopressin in South Korea, we have established a crucial foundation for entering the global market. We will expand collaboration opportunities with global pharmaceutical companies and continue to strengthen our peptide API portfolio to enhance our competitiveness in the global CDMO business."
HLB Peptide is the largest producer of peptide APIs in South Korea. Since being incorporated into the HLB Group last year, the company has been investing in facilities and advancing process automation to strengthen its CDMO competitiveness in peptide pharmaceuticals.
* This article has been translated by AI.
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