Humedix "Biopharmaceutical Finished Product Production Line Certified GMP Compliant"
"Continuously Strengthening Biopharmaceutical CMO Capabilities"
Huons Group's Humedix announced on August 3 that it has officially received final certification of compliance with Good Manufacturing Practice (GMP) standards for the contract manufacturing (CMO) of biopharmaceuticals from the Ministry of Food and Drug Safety.
This GMP certification is for facilities producing finished-goods biopharmaceuticals based on recombinant genetic technology. Building on this approval, Humedix plans to handle finished production of the biopharmaceutical "human-derived hyaluronidase," which is being developed by its affiliate Huons Lab. The company is targeting product approval for human-derived hyaluronidase in the second half of this year.
The biopharmaceutical production facility that has obtained certification is equipped with large-scale production capacity (CAPA) enabling 100-liter batch manufacturing. The company expects that upon commencement of full-scale commercial production, it will expand its position in the biopharmaceutical CMO market.
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Kang Minjong, CEO of Humedix, stated, "Obtaining this biopharmaceutical GMP certification recognizes that Humedix's injection formulation manufacturing technology and quality control capabilities are at the highest level even in the biopharmaceutical field." He added, "We will continue to reinforce our biopharmaceutical CMO business capabilities to secure future growth drivers."
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