Daebong LS Secures Global GMP Support to Accelerate U.S. Entry

Daebong LS, a platform company in cosmetics, pharmaceuticals, and bio materials led by CEO Park Jin-oh, announced on the 10th that it has been selected as an implementing agency for the "2026 Global GMP Certification and Regulatory Support Project" overseen by the Korea Health Industry Development Institute.

This initiative is poised to enhance Daebong LS’s capabilities in global GMP production and quality management centered around high-value pharmaceutical materials, including amino acids. It aims to establish compliance not just with the U.S. FDA but also with European regulations, thereby facilitating a more aggressive entry into these lucrative markets.

The significance of this project goes beyond mere government funding. It lays the groundwork for a comprehensive global GMP production infrastructure, transitioning from initial compliance assistance to building capabilities for global OEM supply. Daebong LS expects to secure approximately 400 million KRW in support by November 2026, which will aid in elevating its regulatory responsiveness and meeting the quality standards demanded by international clients.

Central to this growth strategy is Daebong LS’s successful export experience of SCMC (Carbocysteine) to Japan, along with its operation in the production of its key pharmaceutical ingredient N-Acetyl L-Cysteine (NAC). This expertise will be expanded into its pharmaceutical amino acids business. The company is collaborating with a consultant, a former U.S. FDA inspector, to fortify its global regulatory response capabilities across documentation management, CAPA, change control, and Quality Management System (QMS), ultimately preparing for rigorous FDA inspections and audits from overseas clients.

Flowing from this strategic plan, Daebong LS's initiatives for expanding into the U.S. market are becoming more tangible. In May, Park Jin-oh attended a meeting hosted by the U.S. Embassy in Korea, where leaders from the U.S. government and relevant organizations engaged in conversations about the prospects of Korean pharmaceutical amino acids entering the American market and the avenues for supply chain collaboration.

The cornerstone of this global strategy is the ongoing pharmaceutical amino acid project in partnership with CJ CheilJedang. Focused on commercializing four highly purified essential amino acids used in stabilizing biopharmaceutical formulations, the partnership is advancing process optimization, quality management system establishment, and securing comprehensive regulatory documentation in anticipation of FDA certification and Drug Master File (DMF) registration planned for 2028.

Leveraging the production and quality prowess gained from the global GMP support project, Daebong LS is set to intensify its essential amino acid initiatives. Post-FDA approval, the company aims to expand its OEM supply and generate international sales in collaboration with CJ CheilJedang, thereby establishing a robust growth foundation that enhances its competitive edge in both U.S. and European markets.

A representative of Daebong LS stated, "The global GMP support project is not merely a one-time assistance program but a foundational endeavor to securing our global competitiveness in the pharmaceutical amino acid sector. We will leverage our experiential knowledge from SCMC exports to Japan alongside the GMP capabilities achieved through NAC production, driving the FDA and DMF project in collaboration with CJ CheilJedang, and ultimately facilitating expansive supply to global pharmaceutical companies through OEM commercialization. We are committed to continuously enhancing our export competitiveness within the U.S. and European markets."