Kolmar BNH (KRX: 200130), the manufacturer of the immune-boosting health supplement HemoHim, has gained international recognition for its product quality from both the U.S. Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA), further boosting its credibility in global markets.
Kolmar BNH recently announced that its Sejong plant received a No Action Indicated (NAI) classification after a U.S. FDA inspection in September. This classification confirms that the facility fully complies with U.S. Current Good Manufacturing Practice (cGMP) standards for quality control, solidifying Kolmar BNH’s position as a leading global Original Development Manufacturer (ODM) in the health supplement industry.
The FDA’s inspection was conducted to assess Kolmar BNH’s quality management systems in light of the growing exports of HemoHim to the U.S. The NAI classification reflects the FDA’s evaluation of key aspects, such as manufacturing processes, hygiene protocols, quality control systems, and employee training. HemoHim, a low-acid liquid dietary supplement, underwent rigorous testing in areas like raw material quality, pH levels, and product stability, achieving top marks in all categories.
HemoHim’s quality has also been recognized in Australia, where the Sejong plant obtained Good Manufacturing Practice (GMP) certification from the TGA in 2021. The TGA, which regulates pharmaceuticals and health supplements in Australia, grants GMP certification after an extensive review of a product’s efficacy, safety, and manufacturing processes. Under the Mutual Recognition Arrangement (MRA) between Australia and Europe, products certified by the TGA also benefit from streamlined export procedures within Europe.
To meet the TGA’s strict GMP standards, Kolmar BNH implemented a Standard Operating Procedure (SOP) at its Sejong plant, aligning with international pharmaceutical production and quality control guidelines. The company introduced real-time production monitoring systems and conducted quality tests that exceeded Korean regulatory requirements, ensuring high-quality, defect-free products. These efforts earned Kolmar BNH recognition for its pharmaceutical-grade product quality.
With certifications from both the FDA and TGA, Kolmar BNH plans to accelerate HemoHim’s expansion into global markets. Launched in 2006, HemoHim is Korea’s first individually approved immune-boosting supplement, made from natural ingredients like Angelica gigas, Cnidium officinale, and Paeonia japonica. Distributed by Kolmar BNH’s partner, Atomy, HemoHim is now sold in around 20 countries, including the U.S. and China. Since its launch, HemoHim has generated over KRW 2 trillion in cumulative sales and boasts an export record of more than USD 200 million. It has maintained its position as the top-selling immune-boosting supplement in Korea for over a decade.
A Kolmar BNH official commented, “The U.S. FDA’s inspection is a critical milestone in ensuring product safety and efficacy through a rigorous, systematic process. Achieving the NAI classification is a major accomplishment for Kolmar BNH, as it affirms the quality of our products on the global stage. We remain dedicated to enhancing our competitiveness in international markets through continuous quality innovation and further global certifications, with HemoHim leading the way.
