Global bio-medical beauty group UltraV (UltraV, CEO Kwon Han-jin) has obtained certification for the Good Manufacturing Practice for Medical Devices and Quality Management (KGMP) for its Hyangdong plant and has commenced operation of a second manufacturing site to expand production of UltraCol.

According to UltraV, the Hyangdong plant, which has received KGMP certification, is a newly established second manufacturing site separate from the existing Seongsu-dong plant. It is equipped with production facilities of approximately 110 pyeong, state-of-the-art equipment, and a quality management system. The company recently received the KGMP Certificate of Conformity, securing the official requirements needed to stably produce medical devices for human application.

The KGMP certification of the Hyangdong plant is directly linked to the expansion of production of UltraV’s flagship product, the tissue-repair material “UltraCol (UltraCol).” Centered on UltraCol100 and UltraCol200, the Hyangdong plant has built a system capable of producing more than 800,000 vials per year. This represents production capacity about five times higher than that of the existing Seongsu-dong GMP first manufacturing site. Through this, the company has strengthened a stable supply foundation focused on the domestic market.

UltraCol is a tissue-repair material developed with UltraV’s proprietary patented technology and is a medical device that particulate-izes PDO, a biodegradable polymer that is the main component of sutures for surgery and thread lifting. It has received Class IV medical device approval from the Ministry of Food and Drug Safety, and has been recognized for its technological strength and safety by winning European CE certification, the IR52 Jang Young Sil Award, and the Korea Patent Grand Prize.

With the KGMP certification of the Hyangdong plant, UltraV expects to further strengthen the quality management system of the UltraCol production process, ensuring smooth supply to respond to demand in the domestic medical device market and proactively addressing growing demand in the global medical device market. Products manufactured at the Hyangdong plant will first be used to supply the domestic market, and the company is also reviewing supply to certain overseas countries where products are registered under domestic GMP standards.

The company plans to respond to market-specific demand by operating in parallel the ISO 13485:2016 and CE MDD certification system at the Seongsu-dong plant and the KGMP-based production capacity at the Hyangdong plant. Through this, it aims to secure both production stability and reliability of supply.

An UltraV official said, “With KGMP certification of the Hyangdong plant and the operation of the second manufacturing site, the stability of UltraCol’s supply in the domestic market has been significantly strengthened,” adding, “We will grow into a trusted brand in the medical device market through strict quality control and advancement of our production system.”

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