Approval Granted in Korea Also ‘Valid’ in Mexico ... First Overseas Approval for an HLB Pep Ingredient

[Financial News] After Mexico recognized Korea’s Ministry of Food and Drug Safety as a reference regulatory authority, a domestically made finished drug containing an HLB Pep ingredient received marketing authorization without an on-site inspection.
HLB Pep, a company specializing in peptide active pharmaceutical ingredients (APIs), announced on the 10th that a finished drug made in Korea for which it supplied leuprorelin acetate had received marketing authorization from Mexico’s Federal Commission for the Protection against Sanitary Risks (COFEPRIS).
The finished drug received marketing authorization in Korea last year and has now also been approved overseas. HLB Pep has supplied leuprorelin API produced at its GMP facility since the domestic approval stage. This is the first time a finished drug containing an HLB Pep ingredient has been approved by an overseas regulatory authority.
This year, COFEPRIS recognized Korea’s Ministry of Food and Drug Safety as a Reference Regulatory Authority. As a result, medicines approved in Korea can now obtain approval in Mexico through a simplified review that draws on the ministry’s review results. HLB Pep’s ingredient, backed by a domestic GMP compliance certification and a Drug Master File (DMF) registration, was also recognized through this pathway without a separate inspection.
Leuprorelin is a leading peptide hormone drug used for conditions including prostate cancer and precocious puberty. HLB Pep is one of the few peptide ingredient manufacturers in Korea and has supplied leuprorelin API to Korean pharmaceutical companies since the days of its predecessor, Anigen. After joining HLB Group last year, it upgraded its GMP facilities to cGMP standards and expanded its synthesis and purification equipment.
HLB Pep plans to use this approval as a springboard to increase overseas registrations of its peptide ingredients, including leuprorelin, desmopressin, ganirelix and vasopressin. It is also proceeding with DMF registration filings with the U.S. Food and Drug Administration (FDA) in stages.
HLB Pep CEO Shim Gyeong-jae said, "This approval means that the quality of our ingredients and our ability to meet regulatory requirements have also been validated by overseas regulatory authorities," adding, "Along with ensuring a stable supply of ingredients to support Korean pharmaceutical companies’ global expansion, we will actively increase direct overseas supplies of leuprorelin ingredients as well."  [email protected] Jung Myung-jin, Reporter