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🇰🇷 South Korea /Health & Science

Korea United Pharmaceutical renews Ukraine GMP certification, steps up Eastern Europe push

From Dong-A Ilbo · () Korean

Translated from Korean and summarized by DistantNews. Read the original for the full story.

At a glance

Press release Official statement Approved/passed
  • Korea United Pharmaceutical’s Sejong Plant 1 has renewed its Ukrainian Good Manufacturing Practice certification after passing an on-site regulatory inspection.
  • The plant first received Ukrainian GMP approval in 2023 and retained its status after a reinspection three years later.
  • The company said the renewal supports stable product supplies to Eastern European markets and confirms confidence in its production and quality systems.

Korea United Pharmaceutical’s Sejong Plant 1 has cleared a strict Ukrainian on-site inspection and renewed its Good Manufacturing Practice certification, giving the company a stronger platform in Eastern Europe.

The plant, located in Jeondong-myeon in Sejong City, passed a final review by Ukrainian medicines regulators, who follow European Union guidelines. The renewal allows the facility to retain its GMP status after first receiving approval in 2023.

Ukraine tightened its medicines safety oversight and shifted from document-based reviews to in-person inspections in 2022. Before that change, the company continued approvals using a GMP certificate issued under the Pharmaceutical Inspection Co-operation Scheme, or PIC/S.

Korea United Pharmaceutical signed a technology export agreement with global pharmaceutical company Teva in 2013 for Clanza CR tablets, an improved anti-inflammatory pain medicine. It obtained Ukrainian product approval in 2016.

The company said the successful inspection demonstrates that its manufacturing and quality-control systems meet demanding international standards. It added that the renewed certification will help stabilize supplies to key Eastern European markets and that it will continue detailed quality management in line with major overseas regulators.

The researchers are not meant to break their ties with their American university.

· Pieter BallonVUB’s vice-rector for research explained that the program is intended to connect, rather than replace, the researchers’ US affiliations.
About this summary

Originally published by Dong-A Ilbo in Korean. Translated, summarized, and contextualized automatically by DistantNews, with a note on how the source frames the story. Not individually reviewed before publishing. How this works.

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