Raphas microneedle passes US FDA's cGMP inspection

South Korea's microneedle maker Raphas Co. announced on Wednesday that it has passed the Current Good Manufacturing Practice (cGMP) inspection by the US Food and Drug Administration (FDA) for its microneedle patch used in acne treatment medications.

With this recent FDA cGMP approval, Raphas has not only obtained the ability for mass production based on its droplet extension (DEN) technology but also gained recognition for the quality of its pharmaceutical products. 

Earlier in January, Raphas registered its acne treatment microneedle patch called "Killa ES" with the FDA using the original design manufacturer (ODM) approach and launched the product in the North American market through the US company Heyday in April.

Following the cGMP inspection approval and the successful launch of Killa ES, Raphas plans to release its brand-new acne treatment microneedle patch called RapMed-2303 in the North American market by the fourth quarter of this year. The company is also preparing to obtain approval for general pharmaceuticals as improved drugs in the South Korean market.

"With the successful inspection, the foundation for exporting microneedle patch medications to the North American market has been established," a Raphas source said. "We expect substantial sales increase in both the United States and Korea based on this achievement."

Write to Ye-Na Kim at yena@hankyung.com