KB News Desk
HLB Pep said Monday that it has registered its vasopressin active pharmaceutical ingredient with the US Food and Drug Administration’s Drug Master File system, advancing its push into global peptide drug markets.
Vasopressin is used to treat septic shock and severe hypotension. A DMF is a confidential submission detailing an ingredient’s manufacturing process, quality controls and stability, which drugmakers can reference in regulatory applications.
The US registration follows HLB Pep’s registration in December of Korea’s first vasopressin API DMF with the Ministry of Food and Drug Safety. The latest filing will support potential supplies to pharmaceutical companies targeting the US and other global markets.
HLB Pep said the milestone demonstrates its peptide synthesis and good manufacturing practice-based quality-management capabilities.
The company’s peptide API portfolio also includes leuprolide and ganirelix. It plans to develop additional high-value ingredients, including GLP-1-related APIs, as it expands its contract development and manufacturing business.
“Following Korea’s first MFDS DMF registration for vasopressin, the FDA filing marks another important step in our global expansion,” CEO Shim Kyoung-jae said.
“We will continue strengthening our peptide API portfolio and pursuing partnerships with global pharmaceutical companies to enhance our CDMO competitiveness.”
