Celltrion clears European quality hurdle with Songdo plant certification

Korean biopharmaceutical company Celltrion said Tuesday it has renewed European Good Manufacturing Practice (EU-GMP) certification for its Songdo campus production facilities, covering a combined 250,000 liters of capacity across drug substance and drug product manufacturing. The certification, issued by the European Medicines Agency, confirms that a facility meets European Union quality standards required to supply pharmaceutical products to the European market. The renewal applies to Celltrion's Plants 1, 2 and 3 at its Songdo campus in Incheon, west of Seoul. The company said it plans to expand total production volume at the campus by about 15 percent this year compared with last year, driven largely by output from Plant 3, which began commercial production in late 2024. Celltrion projects Plant 3 will produce 128 batches this year, up about 142 percent from a year earlier, as the newer facility stabilizes operations. The company is also preparing to bring a new drug product plant online, having received building-use approval from the Incheon Free Economic Zone Authority in June. The f