HemoHim Manufacturer Kolmar BNH Receives NAI Classification from the US FDA

  SEOUL, South Korea - Monday, 21. October 2024 AETOSWire 

(BUSINESS WIRE)--‘HemoHim,’ an immune-boosting health supplement from Kolmar BNH (KRX: 200130), has earned international recognition for its quality from both the U.S. Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA), enhancing its credibility in the global marketplace.

Kolmar BNH announced that its Sejong plant obtained a No Action Indicated (NAI) classification following an inspection by the U.S. FDA in September. This classification, which confirms that the facility fully complies with U.S. Current Good Manufacturing Practice (cGMP) standards for quality control, has further intensified Kolmar BNH’s competitiveness as a leading global Original Development Manufacturer (ODM) in the health supplement industry.

The FDA inspection was conducted to evaluate Kolmar BNH’s quality management capabilities, particularly in response to the increasing exports of HemoHim to the U.S. The NAI classification reflects a comprehensive evaluation of key factors, including manufacturing processes, hygiene standards, quality control procedures, and employee training. HemoHim, a low-acid liquid dietary supplement, underwent extensive testing, including assessments of raw material quality management, pH levels, and stability, to achieve perfect scores across all these criteria.

HemoHim’s quality has previously been recognized in Australia, where the Sejong plant obtained Good Manufacturing Practice (GMP) certification from the TGA in 2021. The TGA, responsible for regulating pharmaceuticals and healthcare products (health supplements) in Australia, issues GMP certification based on an extensive evaluation of product efficacy, safety, and the suitability of the production processes. Furthermore, under the Mutual Recognition Arrangement (MRA) between Australia and Europe, products certified by the TGA benefit from streamlined export procedures within Europe.

To meet the Australian TGA’s GMP standards, Kolmar BNH implemented a Standard Operating Procedure (SOP) at the Sejong plant that aligns with international GMP guidelines for pharmaceutical production and quality control. The company also introduced a real-time production monitoring system and conducted quality tests that far exceeded Korean regulatory standards, ensuring defect-free products. Through these combined efforts, the company earned recognition for its reliable pharmaceutical quality.

Building on its success with FDA and TGA certifications, Kolmar BNH plans to expedite HemoHim's expansion into global markets. Launched in 2006, HemoHim is Korea’s first individually approved immune-boosting supplement, made from Korean natural ingredients such as Angelica gigas, Cnidium officinale, and Paeonia japonica. Distributed by Atomy, one of Kolmar BNH’s key partners, the product is currently exported to approximately 20 countries, including the United States and China. Since its debut, HemoHim has generated over KRW 2 trillion in cumulative sales, both at home and abroad, with an unprecedented export record of over USD 200 million. It has maintained its position as the top-selling product in the immune-boosting health supplement category in Korea for more than a decade.

An official from Kolmar BNH said, “The U.S. FDA’s inspection is a critical benchmark for ensuring product safety and efficacy through a thorough and organized process. Receiving a No Action Indicated (NAI) classification is a significant achievement for Kolmar BNH, as it validates the quality of our products on the global stage. We are committed to enhancing our competitiveness in global markets through ongoing quality innovation and additional global certifications, with HemoHim at the forefront of our efforts.”

 

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Contacts

Kolmar Holdings

Jang Woo Lee

jay.lee@kolmar.co.kr