{"id":21942,"date":"2025-04-28T22:26:16","date_gmt":"2025-04-28T15:26:16","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=21942"},"modified":"2025-04-28T22:26:16","modified_gmt":"2025-04-28T15:26:16","slug":"small-lab-co-ltd-obtains-fda-otc-approval-leading-the-k-beauty-wave","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=21942","title":{"rendered":"Small Lab Co., Ltd., obtains FDA OTC approval. Leading the K-Beauty wave"},"content":{"rendered":"<p><span class=\"legendSpanClass\"><span class=\"xn-location\">SEOUL, South Korea<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">April 28, 2025<\/span><\/span> \/PRNewswire\/ &#8212; <span><a href=\"https:\/\/smalllab.co.kr\/\" target=\"_blank\" rel=\"nofollow\">SmallLab Inc<\/a>, a<\/span>\u00a0microneedle platform company, has received final approval from the U.S. Food and Drug Administration (FDA) for its over-the-counter (OTC) drug manufacturing facility.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\">\n<p> <a href=\"https:\/\/mma.prnasia.com\/media2\/2674514\/1.html\" target=\"_blank\" rel=\"nofollow\"> <img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2674514\/1.jpg?p=medium600\" title=\"Image povided by Smalllab Inc.\" alt=\"Image povided by Smalllab Inc.\" \/> <\/a> <br \/><span>Image povided by Smalllab Inc.<\/span><\/p>\n<\/div>\n<p><span>The approval follows a Good Manufacturing Practice (GMP) inspection conducted in October.<\/span><\/p>\n<p>SmallLab received a VAI rating, indicating that only one minor observation was noted, which was fully resolved by December. This rating also reflects the <span>FDA&#8217;s<\/span> recognition and trust in the <span>company&#8217;s<\/span> quality management practices.<\/p>\n<p>Since 2022, SmallLab has operated a smart factory for OTC-grade pharmaceutical production, exporting its products to the U.S., <span class=\"xn-location\">Europe<\/span>, and beyond. With this FDA approval, the facility is now officially recognized as GMP-compliant for OTC drug manufacturing.<\/p>\n<p>Leveraging its proprietary large-area (LSCR) microneedle technology, SmallLab is developing microneedle patch pharmaceuticals formulated with a variety of active ingredients. The company aims to become a global leader in OTC contract manufacturing.<\/p>\n<p>CEO <span class=\"xn-person\">James Lee<\/span> stated, &#8220;We put human health and beauty first. With our microneedle technology, we aim to lead the global market and maximize customer satisfaction.&#8221;<\/p>\n<p>Previously selected as a Daejeon Star Company and a Promising SME, SmallLab has been recognized for its technological excellence. <span>As an ODM company, it supplies OTC acne patches, serums, and sunscreens. <\/span>This FDA approval further\u00a0<span>solidifies<\/span> its position as a small but\u00a0<span>powerful<\/span> player on the global stage.<\/p>","protected":false},"excerpt":{"rendered":"<p><!-- wp:html --><\/p>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">SEOUL, South Korea<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">April 28, 2025<\/span><\/span> \/PRNewswire\/ &#8212; <span><a href=\"https:\/\/smalllab.co.kr\/\" target=\"_blank\" rel=\"nofollow\">SmallLab Inc<\/a>, a<\/span>\u00a0microneedle platform company, has received final approval from the U.S. Food and Drug Administration (FDA) for its over-the-counter (OTC) drug manufacturing facility.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\">\n<p> <a href=\"https:\/\/mma.prnasia.com\/media2\/2674514\/1.html\" target=\"_blank\" rel=\"nofollow\"> <img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2674514\/1.jpg?p=medium600\" title=\"Image povided by Smalllab Inc.\" alt=\"Image povided by Smalllab Inc.\" \/> <\/a> <br \/><span>Image povided by Smalllab Inc.<\/span><\/p>\n<\/div>\n<p><span>The approval follows a Good Manufacturing Practice (GMP) inspection conducted in October.<\/span><\/p>\n<p>SmallLab received a VAI rating, indicating that only one minor observation was noted, which was fully resolved by December. This rating also reflects the <span>FDA&#8217;s<\/span> recognition and trust in the <span>company&#8217;s<\/span> quality management practices.<\/p>\n<p>Since 2022, SmallLab has operated a smart factory for OTC-grade pharmaceutical production, exporting its products to the U.S., <span class=\"xn-location\">Europe<\/span>, and beyond. With this FDA approval, the facility is now officially recognized as GMP-compliant for OTC drug manufacturing.<\/p>\n<p>Leveraging its proprietary large-area (LSCR) microneedle technology, SmallLab is developing microneedle patch pharmaceuticals formulated with a variety of active ingredients. The company aims to become a global leader in OTC contract manufacturing.<\/p>\n<p>CEO <span class=\"xn-person\">James Lee<\/span> stated, &#8220;We put human health and beauty first. With our microneedle technology, we aim to lead the global market and maximize customer satisfaction.&#8221;<\/p>\n<p>Previously selected as a Daejeon Star Company and a Promising SME, SmallLab has been recognized for its technological excellence. <span>As an ODM company, it supplies OTC acne patches, serums, and sunscreens. <\/span>This FDA approval further\u00a0<span>solidifies<\/span> its position as a small but\u00a0<span>powerful<\/span> player on the global stage.<\/p>\n<p><!-- \/wp:html --><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-21942","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/21942","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21942"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/21942\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21942"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21942"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21942"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}