La Paz Obtains US FDA cGMP Approval for 'Microneedle'

Lapass announced on the 26th that it has passed the current Good Manufacturing Practice (cGMP) inspection by the U.S. Food and Drug Administration (FDA) for its acne treatment microneedle patch pharmaceutical product.

After registering Killa ES (Extra Strength) ODM monograph final track with the FDA in January 2023, Lapass launched the product in the North American market in April through its partner Heyday. By improving drug absorption through microneedle technology that addresses the shortcomings of conventional topical acne treatments, and providing protection to acne-affected areas in the form of a patch-type pharmaceutical product, it received a positive response in the North American market and secured additional orders.

This FDA cGMP certification recognizes Lapass’s DEN manufacturing technology as the world’s first not only for its mass production capability but also for its pharmaceutical quality.

Following the successful cGMP inspection and the initial launch of Killa ES, Lapass is preparing to release its own brand RapMed-2303 (microneedle patch for acne treatment) in the North American market within the fourth quarter of this year. Additionally, it is preparing to obtain approval for an improved new drug as an over-the-counter medicine targeting the Korean market.

A Lapass representative stated, “cGMP is a standard for excellent pharmaceutical manufacturing and quality management recognized by the FDA. Passing this inspection has established a foundation for exporting microneedle patch pharmaceuticals to the North American market, and based on this, we expect to realize and expand sales in both the U.S. and Korea.”

This content was produced with the assistance of AI translation services.