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…
Korean biopharmaceutical firm Celltrion has secured renewed European Good Manufacturing Practice (EU-GMP) certification for its Songdo campus production facilities. This certification, granted by the European Medicines Agency, verifies that the plant meets EU quality standards necessary for supplying pharmaceutical products to the European market. Celltrion's Plants 1, 2, and 3 at the Songdo campus in Incheon, located west of Seoul, have been certified.
The company anticipates a 15 percent increase in total production volume at the campus this year compared to last year, primarily due to Plant 3. This facility, which began commercial production in late 2024, is projected to produce 128 batches this year, marking a significant 142 percent increase from the previous year as the newer facility stabilizes its operations.
In addition to the certification, Celltrion is preparing to launch a new drug product plant, having received building-use approval from the Incheon Free Economic Zone Authority in June.
Written by urgent.news from The Korea Times's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
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