Finished Pharmaceutical Product Using Leuprolide API Gains Mexican Approval Following Domestic Green Light
Clears Approval Process Without Local Inspection; US FDA DMF Registration Also Underway
Peptide active pharmaceutical ingredients (APIs) supplied by HLB Pep (196300) have achieved their first major milestone in entering overseas pharmaceutical markets. With a domestic drugmaker's finished pharmaceutical product utilizing leuprolide raw materials receiving product approval in Mexico, the company has opened up avenues for international expansion in its API business, which has traditionally focused on the domestic market.
HLB Pep announced on the 10th that the finished drug manufactured using its leuprolide acetate raw material has secured product approval from Mexico's health regulatory agency, COFEPRIS.
The pharmaceutical product first obtained domestic approval last year. HLB Pep has supplied the raw material since the domestic approval stage, marking the first time a finished drug utilizing the company's API has received approval from an overseas regulatory authority.
Streamlined Review Utilizing Korean Approval Reduces Local Inspection Burden
Changes to Mexico's pharmaceutical review system played a significant role in this approval. This year, Mexico's COFEPRIS recognized the Korean Ministry of Food and Drug Safety (MFDS) as a Reference Regulatory Authority. Consequently, pharmaceuticals approved in Korea can now utilize a streamlined review pathway that leverages the MFDS's review results.
HLB Pep's leuprolide raw material was also approved without requiring a separate local inspection in Mexico, backed by its domestic Good Manufacturing Practice (GMP) compliance certification and Drug Master File (DMF) registration.
In the overseas pharmaceutical approval process, review procedures and manufacturing facility inspections are critical factors influencing market entry. This case is significant as domestic approval and quality control histories were directly leveraged in the Mexican approval process.
Expanding Overseas Registrations to Other Peptide APIs Following Leuprolide
Leuprolide is a peptide-based ingredient used to treat conditions such as prostate cancer and precocious puberty. HLB Pep has accumulated extensive manufacturing experience by supplying the raw material to domestic drugmakers since its predecessor days as Anygen.
Since being incorporated into the HLB Group last year, the company has upgraded its GMP production facilities to cGMP standards—the manufacturing and quality control benchmarks for major markets like the United States—while expanding its synthesis and purification equipment.
Building on the Mexican approval, the company plans to scale up direct overseas supplies of leuprolide APIs. It is also pursuing international registrations for other peptide raw materials, including desmopressin, ganirelix, and vasopressin.
Preparations for entering the U.S. market are proceeding in parallel. HLB Pep is sequentially executing the Drug Master File (DMF) registration process with the U.S. Food and Drug Administration (FDA). However, DMF registration is a separate procedure from the marketing authorization of finished pharmaceutical products.
"This approval signifies that the quality and regulatory compliance capabilities of our APIs have been validated by overseas regulators," said Shim Kyung-jae, CEO of HLB Pep. "Along with providing stable raw material supplies to support domestic pharmaceutical companies in their global ventures, we will actively expand the direct overseas supply of our leuprolide APIs."
