{
  "id": 9072119,
  "title": "Celltrion clears European quality hurdle with Songdo plant certification",
  "url": "https://urgent.news/2026/09/22/celltrion-clears-european-quality-hurdle-with-songdo-plant",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-09-22T03:27:03.000Z",
  "source": {
    "name": "The Korea Times",
    "slug": "the-korea-times-koreatimes",
    "url": "https://www.koreatimes.co.kr/business/companies/20260922/celltrion-clears-european-quality-hurdle-with-songdo-plant-certification"
  },
  "original_language": "en",
  "account": "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.\n\nThe 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.\n\nCelltrion 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.\n\nAdditionally, 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.",
  "summary": "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…",
  "key_points": [
    "Celltrion secures EU-GMP certification for Songdo facility.",
    "Certification covers Plants 1, 2, and 3 with 250,000 liters capacity.",
    "Plant 3 to increase production by 142% in 2024."
  ],
  "editors_take": "Celltrion's EU-GMP certification for its Songdo facility solidifies its foothold in European markets, enabling the company to supply pharmaceutical products that meet stringent EU quality standards.",
  "illustration": null,
  "coverage": {
    "outlets": 2,
    "also_reported_by": [
      {
        "outlet": "The Korea Times",
        "title": "Celltrion clears European quality hurdle with Songdo plant certification",
        "url": "https://urgent.news/2026/09/22/celltrion-clears-european-quality-hurdle-with-songdo-plant-9077015",
        "published": "2026-09-22T04:02:03.000Z"
      }
    ]
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}