SEOUL, South Korea, April 28, 2025 /PRNewswire/ — SmallLab Inc, a microneedle platform company, has received final approval from the U.S. Food and Drug Administration (FDA) for its over-the-counter (OTC) drug manufacturing facility.
Image povided by Smalllab Inc.
The approval follows a Good Manufacturing Practice (GMP) inspection conducted in October.
SmallLab received a VAI rating, indicating that only one minor observation was noted, which was fully resolved by December. This rating also reflects the FDA’s recognition and trust in the company’s quality management practices.
Since 2022, SmallLab has operated a smart factory for OTC-grade pharmaceutical production, exporting its products to the U.S., Europe, and beyond. With this FDA approval, the facility is now officially recognized as GMP-compliant for OTC drug manufacturing.
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.
CEO James Lee stated, “We put human health and beauty first. With our microneedle technology, we aim to lead the global market and maximize customer satisfaction.”
Previously selected as a Daejeon Star Company and a Promising SME, SmallLab has been recognized for its technological excellence. As an ODM company, it supplies OTC acne patches, serums, and sunscreens. This FDA approval further solidifies its position as a small but powerful player on the global stage.
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