Celltrion secures approval for new drug product plant in Songdo
Celltrion announced on Friday that it has received construction approval to build a new drug product (DP) manufacturing plant in Songdo, Incheon.
The new facility, permitted by the Incheon Free Economic Zone Authority, will be located near the company's existing Plant 1 and have an annual production capacity of around 8 million liquid vials.
Celltrion plans to complete construction in the first half of 2026 to begin full-scale commercial production in 2027. The plant will manufacture existing biosimilar products such as Truxima and Vegzelma, along with newly approved liquid vial treatments like Idencelt, Stekyma and Aptozuma.
Pharmaceutical products are generally categorized into drug substances (DS), produced through processes such as cell culture and purification, and drug products, the finished form of the drug formulated for patient administration.
With the expansion of its DP manufacturing capacity, the company anticipates a 30 percent reduction in production costs per product compared to current contract manufacturing organization expenses, strengthening its competitiveness in international bidding markets.
The new DP plant will feature isolators to prevent exposure to hazardous substances, reducing contamination risks while enhancing operational efficiency through advanced manufacturing equipment and process automation.
By integrating the new facility with the existing DP production line at Plant 2, the company aims to shorten product shipment timelines, improve workforce efficiency and enhance overall production capabilities.
The increased in-house DP manufacturing capacity will also allow greater flexibility in global supply strategies. With expanded options for DS and DP supply, Celltrion can better adapt to country-specific market conditions and export requirements.
Meanwhile, the company plans to adopt a flexible production strategy in the US by leveraging local CMO partnerships to mitigate potential tariff risks. This two-track approach is expected to enhance market responsiveness in line with global economic conditions.
To meet the growing global demand for pharmaceuticals and expand its product portfolio, Celltrion has been strengthening its production capabilities.
The company has secured a total DS production capacity of 250,000 liters, consisting of its 100,000-liter Plant 1, 90,000-liter Plant 2 and the recently operational 60,000-liter Plant 3.
For DP production, the company currently manufactures 4 million liquid vials annually at Plant 2. With the additional 8 million vials from the new facility, Celltrion's total annual DP production capacity will increase to 12 million vials.
"With the DP plant expansion, we can proactively respond to rising global demand and new product launches, ensuring a stable supply of high-quality pharmaceuticals," a Celltrion official said. "By strengthening our production capacity and cost competitiveness, we aim to accelerate global market expansion and drive company growth."
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Korea Herald
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- Korea Herald
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FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipate" the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Humira is a registered trademark of AbbVie. YUFLYMA ® is a registered trademark of Celltrion, Inc., used under license.
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