Humedix Obtains GMP Certification for Biopharmaceutical Product Manufacturing Line

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[NA Eun-kyung, Edaily Reporter] Humedix is accelerating its expansion into the global biopharmaceutical contract manufacturing organization (CMO) market by strengthening its biopharmaceutical manufacturing capabilities.

Humedix (CEO Kang Min-jong), a subsidiary of Huons Group, announced on August 3 that it has received Good Manufacturing Practice (GMP) certification from South Korea's Ministry of Food and Drug Safety (MFDS) for biopharmaceutical contract manufacturing operations.

The GMP certification covers the company's drug product manufacturing facility for recombinant biopharmaceuticals. With this certification, Humedix has further demonstrated its advanced manufacturing and quality management capabilities, extending beyond its established expertise in chemical pharmaceuticals and aesthetic products to include biopharmaceutical manufacturing.

Leveraging this GMP certification, Humedix plans to undertake drug product manufacturing for Huonslab's human-derived hyaluronidase, a biopharmaceutical candidate currently under development by its affiliate.

Through the newly obtained biopharmaceutical GMP certification, Humedix has completed preparations to initiate commercial-scale manufacturing immediately following regulatory approval of Huonslab's product. Huonslab is currently targeting marketing authorization for its human-derived hyaluronidase product in the second half of this year.

According to Humedix, the newly certified biopharmaceutical manufacturing facility is equipped with a 100-liter production capacity, enabling large-scale manufacturing. The company expects that once regulatory approval is obtained and commercial production begins, its stable manufacturing infrastructure will significantly strengthen its position in the biopharmaceutical CMO market.

"This GMP certification for our biopharmaceutical manufacturing proves that Humedix's expertise in injectable manufacturing technologies and quality management has been recognized as being of the highest standard in the biopharmaceutical sector," said Kang Min-jong, Chief Executive Officer of Humedix. "We will continue to strengthen our biopharmaceutical CMO capabilities to secure future growth drivers."

Humedix operates advanced manufacturing facilities capable of producing a broad range of injectable dosage forms, including vials, pre-filled syringes (PFS), lyophilized products, and ampoule injections, supported by proprietary manufacturing process expertise. The company also operates state-of-the-art aseptic manufacturing systems that comply with increasingly stringent global quality standards. Leveraging its high-quality manufacturing capabilities, Humedix is actively expanding its CMO business with numerous pharmaceutical and biotechnology companies in both domestic and international markets.