HLB PEP has completed the registration of its active pharmaceutical ingredient (API) for the antidiuretic hormone treatment, Vasopressin, with the U.S. Food and Drug Administration (FDA) and is now setting its sights on the global market.
The company announced on Monday that it had finalized the FDA’s Drug Master File (DMF) registration on July 22. This follows their milestone achievement last December when they became the first South Korean company to register Vasopressin API with the country’s Ministry of Food and Drug Safety.
Vasopressin, a hormone crucial for regulating the body’s water balance and blood pressure, is used in treating septic shock and severe hypotension. Market research firm Research and Markets projects the global Vasopressin market to reach approximately 5 trillion KRW (about 3.4 billion USD) by 2030.
The DMF is a system for registering and managing data on the manufacturing processes, quality control, and stability of active pharmaceutical ingredients with the FDA. This documentation is vital in demonstrating the quality and manufacturing reliability of raw materials during the drug approval process.
With this registration, HLB Pharma has laid the groundwork to supply Vasopressin raw materials to pharmaceutical companies worldwide, including those in the U.S. The company highlighted the significance of gaining recognition from global regulatory agencies for its peptide synthesis technology and General MotorsP-based quality control capabilities.
HLB PEP has expanded its key peptide API portfolio to include Vasopressin, alongside existing products Leuprolide and Ganirelix. The company also plans to continue developing new peptide raw materials, including those in the GLP-1 class.
Chief Executive Officer (CEO) Shim Kyung-jae stated that completing the FDA DMF registration, following the initial registration with the Ministry of Food and Drug Safety, has paved the way for the entry into the global market. It aims to expand collaborations with international pharmaceutical companies and continuously strengthen the peptide raw material portfolio to enhance the competitiveness in the Contract Development and Manufacturing Organization (CDMO) business.
Since joining the HLB Group in March last year, HLB PEP has undergone significant facility investments and business restructuring. Looking ahead, the company plans to redefine its new drug pipeline and expand its technological reach into the high-demand field of oncology.