Finished Drug Made with HLB PEP Ingredient Receives Marketing Approval in Mexico

[Financial News] HLB PEP, a KOSDAQ-listed company specializing in peptide active pharmaceutical ingredients (APIs), announced on the 10th that a Korean finished drug using leuprorelin acetate supplied by the company had received marketing approval from Mexico’s pharmaceutical regulator, COFEPRIS.
The product received marketing approval in Korea last year. HLB PEP has supplied leuprorelin API produced at facilities meeting Good Manufacturing Practice (GMP) standards since the domestic approval process. This is the first time a finished drug made with an HLB PEP ingredient has received marketing approval from an overseas regulator.
This year, Mexico’s pharmaceutical regulator recognized Korea’s Ministry of Food and Drug Safety (MFDS) as a reference regulatory authority. As a result, medicines approved in Korea can undergo a simplified review process that draws on the MFDS’s review findings. According to HLB PEP, its leuprorelin API—which had received a domestic GMP compliance determination and completed drug master file (DMF) registration—was also accepted during the approval process without a separate local on-site inspection.
Leuprorelin is a peptide hormone drug used to treat prostate cancer and precocious puberty, among other conditions. HLB PEP is one of the few domestic peptide ingredient manufacturers that has supplied leuprorelin API to Korean pharmaceutical companies since it operated as its predecessor, Anigen. Since joining HLB Group last year, it has upgraded its production facilities to cGMP standards and expanded its synthesis and purification equipment.
A pharmaceutical industry official explained, “The fact that an ingredient supplied in Korea was used in a finished drug approved overseas can be presented as a real-world application case when discussing supply with overseas pharmaceutical companies,” adding, “Further expansion of supply will depend on how well we respond to market-specific ingredient registration requirements and the quality standards demanded by customers.”
HLB PEP plans to expand overseas registrations of the peptide ingredients in its portfolio, including leuprorelin, desmopressin, ganirelix and vasopressin, following this approval. It is also proceeding in stages with DMF registration with the U.S. Food and Drug Administration (FDA).
HLB PEP CEO Sim Gyeong-jae said, “This approval means that the quality of our ingredients and our regulatory capabilities have also been validated by overseas regulators,” adding, “Alongside a stable supply of ingredients to support Korean pharmaceutical companies’ global expansion, we will actively expand direct overseas supply of leuprorelin API.”
[email protected] Choi Doo-seon Reporter