HemoHim Manufacturer Kolmar BNH Receives NAI Classification from the US FDA

<!DOCTYPE html> <html lang="en" xmlns:wb="//open.weibo.com/wb"> <head> <meta charset="utf-8"> <title>HemoHim Manufacturer Kolmar BNH Receives NAI Classification from the US FDA - Business Wire China</title> <meta name="viewport" content="width=device-width, initial-scale=1.0"> <meta name="description" content="SEOUL, South Korea--(BUSINESS WIRE)--&lsquo;HemoHim,&rsquo; an immune-boosting health supplement from Kolmar BNH (KRX: 200130), has earned inte"> <meta name="keywrods" content=""> <meta name="author" content="Business Wire China"> <link href="/css/bootstrap.css" rel="stylesheet"> <link href="/css/main.css?ver=20220804" rel="stylesheet"> <link href="/css/bootstrap-responsive.css" rel="stylesheet"> <script type="text/javascript" src="/js/jquery.min.js"></script> <script type="text/javascript" src="/js/bootstrap.js"></script> <script type="text/javascript" src="/js/main.js"></script>  <script src="//tjs.sjs.sinajs.cn/open/api/js/wb.js" type="text/javascript" charset="utf-8"></script> </head> <body>  <div class="header"> <div class="wrap"> <div class="container"> <div class="full_980 relative">  <div class="top_panel visible-desktop"> <a href="/zh">简体中文</a> | <a href="/hk">繁體中文</a> | <a href="/en">English</a> <div class="globalsite"><select id="globalsite" class="languages"><option value="0">Business Wire Global sites</option> <option value="1">Business Wire Global</option><option value="3">UK/Ireland</option><option value="4">Deutschland</option><option value="5">France</option><option value="6">Italy</option><option value="7">Japan</option> </select> </div> </div> <div class="logo"><a href="/en"><img src="/images/bwlogo_webmain_china.png" alt="Business Wire China" width="360" height="80"/></a></div> <div class="clear"></div> <div class="navigation"> <ul class="sf-menu"> <li class="current"><a href="/en">Home</a> </li> <li><a href="/en/news/index.html">News</a> </li> <li><a href="/en/events/index.html">Events</a> </li> <li><a href="/en/medias/index.html">Media Services</a> </li> <li><a href="/en/about/index.html">About Us</a> <ul> <li><a href="/en/about/contact.html">Contact Us</a></li> </ul> </li> </ul> <div class="clear"></div>  <div class="search_form visible-desktop"> <form action="/en/news/search" method="get"> <input class="inp_search" name="s" type="text" value="Search..." title="Search..." /> <input type="submit" class="search_btn" value=" " /> </form> </div>  </div>  </div> </div> </div> </div>   <div class="page_wrapper"> <div class="wrap"> <div class="container"> <div id="content"> <script src="http://tjs.sjs.sinajs.cn/open/api/js/wb.js?appkey=3616646312" type="text/javascript" charset="utf-8"></script> <script type="text/javascript" src="/js/swfobject.js"></script> <div class="full_980 main_wrap"> <div class="row"> <div class="span9 main_block story"> <p><a href="https://kolmarbnh.co.kr/en/" target="_blank"><img src="/files/logos/L/logo_Kolmar_BNH.jpg" alt="KOLMAR BNH"></a></p> <h2 class="storytitle">HemoHim Manufacturer Kolmar BNH Receives NAI Classification from the US FDA</h2> <div class="storytimelang"> <span class="time">2024-10-22 17:42</span> <span class="lang"> <ul> <li><a href="/zh/news/58055.html"><img src="/images/zh_cn.png" alt="zh_cn"></a></li> <li><a href="/hk/news/58055.html"><img src="/images/zh_hant.png" alt="zh_hant"></a></li> <li><a href="/en/news/58055.html"><img src="/images/en.png" alt="en"></a></li> </ul> </span> <div class="clear"></div> </div> <ul class="industry-list"> <li><a href="/en/industry/manufacturing.html" class="btn">Manufacturing</a></li> <li><a href="/en/industry/health-pharmaceutical.html" class="btn">Health and Pharmaceutical</a></li> </ul> <div class="storycontent"> <div itemprop="articleBody"> <p> SEOUL, South Korea--(<span itemid="https://www.businesswire.com" itemprop="provider publisher copyrightHolder" itemscope="itemscope" itemtype="https://schema.org/Organization"><span itemprop="name"><a href="https://www.businesswire.com/" itemprop="url" referrerpolicy="unsafe-url" rel="nofollow">BUSINESS WIRE</a></span></span>)--‘HemoHim,’ an immune-boosting health supplement from <a href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fkolmarbnh.co.kr%2Fen%2F&esheet=54138541&newsitemid=20241021625609&lan=en-US&anchor=Kolmar+BNH&index=1&md5=9b155d49752d5f05f5c309c911f60720" referrerpolicy="unsafe-url" rel="nofollow" shape="rect" target="_blank">Kolmar BNH</a> (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.</p> <p> 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.</p> <p> 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.</p> <p> 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.</p> <p> 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.</p> <p> 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.</p> <p> 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.”</p> </div> <div> <h2> Contacts</h2> <p> Kolmar Holdings<br /> Jang Woo Lee<br /> <a href="mailto:jay.lee@kolmar.co.kr" referrerpolicy="unsafe-url" rel="nofollow" shape="rect" target="_blank">jay.lee@kolmar.co.kr</a></p> </div> <div class="story-image"> <img src="/files/news/54138541-1729591179-1.jpg" alt="HemoHIM G, manufactured by Kolmar BNH and distributed by Atomy (Image: Kolmar BNH)"/> <p class="caption">HemoHIM G, manufactured by Kolmar BNH and distributed by Atomy (Image: Kolmar BNH)</p> </div> </div> <div class="subjects"> <ul class="subject-list"> <li><a href="/en/subject/products-services.html">Products & Services News</a></li> </ul> </div> <div class="clear"></div> <div class="commentbox"> <wb:comments url="auto" border="y" width="auto" skin="blue" appkey="3616646312" ></wb:comments> </div> </div> <div class="span3 sidebar"> <div class="widget"> <h3>Business Wire Weibo</h3> <wb:follow-button uid="2676312451" type="red_2" width="136" height="24" ></wb:follow-button> </div> <div class="widget"> <h3>Industries</h3> <ul class="industry"> <li><a href="/en/industry/corporate-social-responsibility">Corporate Social Responsibility</a></li> <li><a href="/en/industry/manufacturing">Manufacturing</a></li> <li><a href="/en/industry/chemical">Chemical</a></li> <li><a href="/en/industry/health-pharmaceutical">Health and Pharmaceutical</a></li> <li><a href="/en/industry/property">Property</a></li> <li><a href="/en/industry/travel">Travel</a></li> <li><a href="/en/industry/automotive">Automotive</a></li> <li><a href="/en/industry/life-entertainment">Life and Entertainment</a></li> <li><a href="/en/industry/energy-environmental">Energy and Environmental</a></li> <li><a href="/en/industry/retail">Retail</a></li> <li><a href="/en/industry/transportation">Transportation</a></li> <li><a href="/en/industry/business-ecommerce">Business and E-commerce</a></li> <li><a href="/en/industry/communications-media">Communications and Media</a></li> <li><a href="/en/industry/metals-mining">Metals and Mining</a></li> <li><a href="/en/industry/finance">Finance</a></li> <li><a href="/en/industry/technology">Technology</a></li> <li><a href="/en/industry/sports">Sports</a></li> <li><a href="/en/industry/education">Education</a></li> <li><a href="/en/industry/art-culture">Art and Culture</a></li> <li><a href="/en/industry/legal">Legal</a></li> </ul> </div> <div class="widget"> <h3>Latest Releases</h3> <ul class="story"> <li><span class="time">2025-02-18 16:29</span><br/><a href="/en/news/58961.html">Venture Global Announces Commencement of Commercial Operations at Calcasieu Pass</a></li> <li><span class="time">2025-02-18 16:25</span><br/><a href="/en/news/58960.html">NIQ Navigates Clients Forward with Strategic Analytics & Insights Solutions</a></li> <li><span class="time">2025-02-18 16:21</span><br/><a href="/en/news/58959.html">Azizi Developments Announces Sales Launch for Burj Azizi, the World’s Second-Tallest Tower at 725m</a></li> <li><span class="time">2025-02-18 16:05</span><br/><a href="/en/news/58958.html">Galderma’s Nemluvio® (Nemolizumab) Granted Marketing Authorization in the United Kingdom and Switzerland for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis</a></li> <li><span class="time">2025-02-18 10:47</span><br/><a href="/en/news/58957.html">Ruler of Ras Al Khaimah, UAE, Says ‘Science is the Bedrock Upon Which We Build a Sustainable Future’ During Opening Address at 16th International Workshop on Advanced Materials</a></li> </ul> </div> </div> </div> </div> </div> </div> </div> </div>   <div id="footer" class="hidden-phone"> <div class="wrap"> <div class="container"> <div class="full_980 relative">  <a href="#" id="totop_btn" class="visible-desktop visible-tablet"></a>   <div class="footer_top"> <div class="col940"> <div class="row"> <div class="span6"> <h4>Shanghai Office</h4> <p class="foot_home">Rm 1502 Xincheng Mansion, No. 167 Jiangning Rd, Shanghai, China</p> <p class="foot_phone">+86 21 5239 8905</p> <p class="foot_email"><a href="mailto:sh@businesswirechina.com">sh@businesswirechina.com</a></p> </div> <div class="span6"> <h4>Business Wire Hong Kong</h4> <p class="foot_home">51/F Hopewell Centre, 183 Queen's Road East<br/>Wan Chai, Hong Kong</p> <p class="foot_phone">+852 3602 3091</p> <p class="foot_email"><a href="mailto:hk@businesswire.com">hk@businesswire.com</a></p> </div> </div> </div> </div>   <div class="footer_bottom"> <div class="fleft"> <div class="copyright">© 2008-2016 Interfax Business Wire Service, all rights reserved.</div> </div> <div class="clear"></div> </div>  </div> </div> </div> </div> <script type="text/javascript"> var _gaq = _gaq || []; _gaq.push(['_setAccount', 'UA-669196-13']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); </script> <script language="javascript"> $(document).ready(function() { $("#globalsite").bind("change",function(){ var links = ['','http://www.businesswire.com','http://www.businesswire.ca/','http://www.businesswire.co.uk/','http://www.businesswire.de/','http://www.businesswire.fr/','http://www.businesswire.it/','http://www.businesswire.jp/']; var val = $(this).val(); var link = links[val]; if(link.length>0) { window.open(link); } }); }); </script> </body> </html>

CINXE.COM

HemoHim Manufacturer Kolmar BNH Receives NAI Classification from the US FDA - Business Wire China