Korea United Pharm Inc. (CEO Kang Duck-young) announced that its Sejong Plant 1 has passed the rigorous on-site inspection conducted by Ukraine’s pharmaceutical authorities, which follow European Union (EU) guidelines, thereby demonstrating world-class capabilities in pharmaceutical manufacturing and quality control.

Located in Jeondong-myeon, Sejong Special Self-Governing City, Korea United Pharm’s Sejong Plant 1 recently received renewed approval for Good Manufacturing Practice (GMP) for pharmaceuticals from Ukrainian regulatory authorities. Following its initial acquisition of Ukrainian GMP status in 2023, Sejong Plant 1 has maintained its certification by once again being deemed compliant in this year’s re-inspection.

Korea United Pharm signed a technology export agreement in 2013 with global pharmaceutical company Teva (TEVA) for the improved anti-inflammatory and analgesic drug “Klanza CR Tab.” and obtained local marketing authorization in Ukraine in 2016. Initially, approvals were maintained through a paper-based inspection process grounded in a Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP certificate. However, as Ukrainian health authorities significantly reinforced their pharmaceutical safety management standards, the system was converted in 2022 to an in-person, on-site inspection format involving direct visits.

Having successfully completed this on-site inspection, Korea United Pharm has not only cleared the stringent quality verification procedures of overseas regulatory bodies but also further enhanced the stability of product supply to its key hub market in Eastern Europe.

A Korea United Pharm representative stated that passing the strict on-site verification by Ukrainian authorities reconfirmed international confidence in the company’s production and quality management systems, adding that the company will continue to pursue precise quality control that meets the standards of major overseas regulatory agencies.

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