Kolmar BNH’s HemoHim earns top FDA and TGA certifications

A South Korean health supplement, HemoHim, produced by Kolmar BNH, has earned prestigious recognition from both the U.S. Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA). These certifications are expected to boost the product’s credibility in international markets, solidifying Kolmar BNH’s position as a leader in the global health supplement industry.

Kolmar BNH, listed on the Korean Stock Exchange (KRX: 200130), recently announced that its Sejong plant received a No Action Indicated (NAI) classification following an inspection by the FDA. This classification confirms that the plant meets the stringent requirements of U.S. Current Good Manufacturing Practice (cGMP) standards, highlighting its high-quality production processes and reinforcing Kolmar BNH’s reputation as a key Original Development Manufacturer (ODM) in the health supplement sector.

The FDA’s inspection evaluated the company’s ability to maintain rigorous quality control in response to the growing demand for HemoHim in the U.S. The NAI classification signifies that Kolmar BNH passed the inspection with flying colours, after thorough reviews of its manufacturing processes, hygiene standards, and employee training. Specific tests of the product, including assessments of its raw materials, pH levels, and overall stability, resulted in perfect scores across all categories.

In addition to the FDA’s recognition, HemoHim had already achieved Good Manufacturing Practice (GMP) certification from the TGA in Australia in 2021. The TGA is responsible for regulating pharmaceuticals and health supplements in Australia, and its certification further validates the quality and safety of Kolmar BNH’s production processes. The GMP certification from the TGA is particularly valuable as it simplifies export procedures to European markets under the Mutual Recognition Arrangement (MRA) between Australia and the European Union.

To meet the TGA’s stringent standards, Kolmar BNH introduced advanced procedures at its Sejong plant, aligning with international GMP guidelines for pharmaceutical production. These include a real-time production monitoring system and quality control measures that exceed local Korean regulations. As a result, Kolmar BNH’s products have earned a reputation for being reliable and free from defects.

HemoHim, launched in 2006, is the first individually approved immune-boosting supplement in South Korea. Made from natural Korean ingredients such as Angelica gigas, Cnidium officinale, and Paeonia japonica, the product has been a major success both domestically and internationally. Distributed by Atomy, one of Kolmar BNH’s key partners, HemoHim is exported to around 20 countries, including the United States and China. To date, the product has achieved over KRW 2 trillion in cumulative sales, with exports exceeding USD 200 million.

Kolmar BNH sees the recent FDA and TGA certifications as crucial milestones that will help expand HemoHim’s reach in global markets. An official from the company stated, “The FDA’s NAI classification is a major endorsement of the safety and quality of our products. We will continue to prioritise innovation and seek additional global certifications to enhance our competitiveness in the health supplement industry.”

With HemoHim leading the charge, Kolmar BNH plans to push forward with its global expansion strategy, aiming to maintain its position as a leader in the immune-boosting health supplement category.