SEOUL, South Korea--(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..

韩国首尔——（商业新闻短讯）——“HemoHim”是Kolmar BNH（KRX:200130）推出的一种增强免疫力的健康补充剂，其质量已获得美国食品和药物管理局（FDA）和澳大利亚治疗用品管理局（TGA）的国际认可，增强了其在全球市场上的可信度。。

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..

Kolmar BNH宣布，其Sejong工厂在9月接受美国FDA检查后获得了无行动指示（NAI）分类。这一分类证实了该设施完全符合美国现行质量控制良好生产规范（cGMP）标准，进一步增强了科尔马BNH作为健康补充剂行业领先的全球原始开发制造商（ODM）的竞争力。。

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.

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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是一种低酸性液体膳食补充剂，经过了广泛的测试，包括对原材料质量管理，pH值水平和稳定性的评估，以在所有这些标准上取得完美的分数。。

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.

HemoHim的质量此前已在澳大利亚得到认可，世宗工厂于2021年获得了TGA的良好生产规范（GMP）认证。TGA负责管理澳大利亚的药品和保健产品（保健补充剂），根据对产品功效，安全性和生产过程适用性的广泛评估发布GMP认证。

Furthermore, under the Mutual Recognition Arrangement (MRA) between Australia and Europe, products certified by the TGA benefit from streamlined export procedures within Europe..

此外，根据澳大利亚和欧洲之间的相互承认安排（MRA），经TGA认证的产品受益于欧洲境内简化的出口程序。。

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.

为了满足澳大利亚TGA的GMP标准，Kolmar BNH在Sejong工厂实施了标准操作程序（SOP），该程序符合国际药品生产和质量控制GMP指南。该公司还引入了实时生产监控系统，并进行了远远超过韩国监管标准的质量测试，确保了产品无缺陷。

Through these combined efforts, the company earned recognition for its reliable pharmaceutical quality..

通过这些共同努力，该公司因其可靠的药品质量而获得认可。。

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.

在FDA和TGA认证成功的基础上，科尔马BNH计划加快HemoHim向全球市场的扩张。HemoHim于2006年推出，是韩国第一款单独批准的免疫增强补充剂，由韩国天然成分制成，如当归、蛇床子和芍药。

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.

该产品由Kolmar BNH的主要合作伙伴之一Atomy经销，目前出口到大约20个国家，包括美国和中国。自推出以来，HemoHim在国内外累计销售额超过2万亿韩元，创下了前所未有的出口记录，超过2亿美元。

It has maintained its position as the top-selling product in the immune-boosting health supplement category in Korea for more than a decade..

十多年来，它一直保持着在韩国免疫增强健康补充剂类别中最畅销产品的地位。。

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.

Kolmar BNH的一位官员表示：“美国FDA的检查是通过彻底而有组织的过程确保产品安全性和有效性的关键基准。获得无行动指示（NAI）分类对Kolmar BNH来说是一项重大成就，因为它在全球舞台上验证了我们产品的质量。

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.”.

我们致力于通过持续的质量创新和额外的全球认证来提高我们在全球市场的竞争力，HemoHim是我们努力的最前沿。”。