Korea United Pharm announced on Tuesday that its Sejong Plant 1 has obtained Good Manufacturing Practice (GMP) certification from the Eurasian Economic Union (EAEU). This certification signifies that its manufacturing and quality management systems meet standards equivalent to those of the European Union (EU) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

PIC/S refers to the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme.

Located in Jeondong-myeon, Sejong Special Self-Governing City, Korea United Pharm's Sejong Plant 1 received the EAEU GMP certification through Russia’s Ministry of Industry and Trade.

Korea United Pharm demonstrated its global-level manufacturing and quality management capabilities by securing Russian GMP approval in 2019, following its 2013 technology export agreement with multinational pharmaceutical company Teva for the improved new drug Clanza CR Tablets.

This EAEU GMP certification is valid across the entire EAEU market, encompassing Russia, Belarus, Kazakhstan, Kyrgyzstan, and Armenia.

Notably, the EAEU GMP compliance certificate explicitly states that this certification corresponds to the standards of the EU GMP guidelines and PIC/S principles, reaffirming the international recognition of Korea United Pharm's manufacturing and quality management systems.

“This EAEU GMP approval reaffirms the excellence of Korea United Pharm's manufacturing and quality management at a global level,” a company official said. “Based on this, we will accelerate our entry into the Eurasian market and further expand our overseas presence.”