Secured EAEU GMP certification through Russia's Ministry of Industry and Trade Foundation laid for entry into the markets of five countries beyond Russia's single standard Expecting accelerated global business expansion
Korea United Pharm Inc. announced on the 16th that its Sejong Plant 1 has received Good Manufacturing Practice (GMP) approval from the Eurasian Economic Union (EAEU). This achievement demonstrates the company's possession of a manufacturing and quality management system that meets global standards, laying the foundation for future global market expansion.
This approval process was conducted under the supervision of the Russian Ministry of Industry and Trade, allowing Sejong Plant 1 to be recognized for GMP compliance not only in Russia but also in all five EAEU countries, including Belarus, Kazakhstan, Kyrgyzstan, and Armenia. The EAEU GMP is a more stringent regional standard than the single-country standard of Russia, and holding this certification enables activities across the entire pharmaceutical market within the union.
The certification document specifies that Korea United Pharm Inc.'s manufacturing and quality management system aligns with the European Union (EU) GMP guidelines and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards. Through this, the company has once again publicly confirmed its international-level management capabilities.
Korea United Pharm Inc. has already accumulated experience in collaboration with global pharmaceutical companies. In 2013, it signed a technology export contract for the improved drug 'Clanza CR Tablet' with multinational pharmaceutical company TEVA, and in 2019, it obtained Russian GMP approval, proving its competitiveness in overseas markets.
A representative from Korea United Pharm Inc. emphasized, "This EAEU GMP approval is an achievement that shows Korea United Pharm Inc. meets the quality standards required by the international pharmaceutical industry. Based on this, we will actively enter the Eurasian market and accelerate the expansion of our global business."
Kim Sang-jun
AI-translated with ChatGPT. Provided as is; original Korean text prevails.
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