Celltrion has completed the renewal of the European Medicines Agency (EMA) Good Manufacturing Practice (EU-GMP) certification for its production facilities at the Songdo campus in Incheon. The company plans to increase overall production at the Songdo campus by approximately 15% this year compared to the previous year.
On September 22, Celltrion announced that it has finalized the EU-GMP renewal for its active pharmaceutical ingredient (DS) and finished pharmaceutical product (DP) production facilities.
The renewal covers a total of 250,000 liters of DS production facilities across Songdo's Plants 1 to 3, as well as other DP production facilities. Celltrion stated that this renewal allows it to meet the quality standards set by European regulatory authorities and maintain a stable production and quality base for supplying products to global markets.
Based on the stabilization of production at Plant 3, Celltrion plans to enhance production efficiency by expanding the overall production at the Songdo campus by about 15% compared to last year.
The company is also preparing to launch a new finished pharmaceutical product plant within the Songdo campus. Currently, it is undergoing installation qualification and operational qualification assessments, with plans to commence commercial production after completing the relevant procedures. Efforts to improve production yield and diversify the supply chain are also underway.
Meanwhile, Celltrion aims to expand its portfolio of commercialized biosimilars and has adopted a sales strategy focused on high-profit products. The company has set a revenue target of 5.3 trillion won and an operating profit target of 1.8 trillion won for this year.
* This article has been translated by AI.
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