Humedix, an aesthetics and pharmaceutical company under the Huons Group, said it has received final certification from the Ministry of Food and Drug Safety confirming its manufacturing facility meets Good Manufacturing Practice (GMP) standards for biopharmaceutical contract manufacturing, or CMO — production carried out on behalf of other drugmakers.

The certification covers a facility for producing finished recombinant biologic drugs. Humedix said the approval extends its established quality and manufacturing system — previously built around chemical drugs and aesthetic products — into the biopharmaceutical sector.

With the certification, Humedix said it plans to handle finished-product manufacturing for "human-derived hyaluronidase," a biopharmaceutical currently in development by its affiliate, Huons Lab.

The company said the certification positions it to begin commercial production as soon as Huons Lab receives regulatory approval for the drug, which the affiliate is targeting for the second half of this year.

Humedix said the newly certified facility has large-scale production capacity, capable of handling batches of up to 100 liters.

The company said that once commercial-scale production begins following drug approval, it expects the facility's stable supply capacity to significantly expand its position in the global biopharmaceutical CMO market.

"This biopharmaceutical GMP certification confirms that Humedix's injectable manufacturing technology and quality control capabilities are at the highest level, now extending into the biologics field as well," Humedix CEO Kang Min-jong said in a statement.

"We will continue strengthening our biopharmaceutical CMO capabilities to secure future growth drivers."

Humedix said it operates advanced manufacturing equipment and process expertise covering a range of injectable drug formats, including vials, prefilled syringes, freeze-dried medicines and ampoules, along with sterile production systems designed to meet increasingly stringent global quality standards.

The company said it already carries out contract manufacturing for a number of pharmaceutical and biotech firms in Korea and abroad.

This article was published with the assistance of generative AI and edited by The Korea Times.