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…
Biopharmaceutical firm Celltrion has secured European Good Manufacturing Practice (EU-GMP) certification for its Songdo facility, the Korean company announced on Tuesday. This certification, granted by the European Medicines Agency, verifies that the Songdo campus manufacturing plants comply with EU quality standards necessary for supplying pharmaceutical products to European markets.
The renewal certification covers Plant 1, 2, and 3 at Celltrion's Songdo campus in Incheon, west of Seoul. The 250,000 liters of combined capacity across drug substance and drug product manufacturing ensures the facility meets stringent European Union quality requirements.
Celltrion intends to boost total production volume at the Songdo campus by approximately 15 percent this year compared to last year. This growth is primarily attributed to Plant 3, which commenced commercial production late 2024. The company anticipates Plant 3 will manufacture 128 batches in 2024, marking a significant increase of about 142 percent over the previous year as the facility stabilizes its operations.
Additionally, Celltrion is preparing to launch a new drug product plant. The company received building-use approval from the Incheon Free Economic Zone Authority in June, paving the way for the facility's operation.
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.
