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  • US approval of Celltrion Yuflyma was delayed
  • by | translator Kim, Jung-Ju | Feb 24, 2023 05:53am
Completed in May
Issues raised during due diligence of overseas DP manufacturing plants
Receive a suitability grade and solve the pointed out issues by the manufacturer
Celltrion continues consultation with the FDA
Celltrion has confirmed that the U.S. Food and Drug Administration (FDA) will complete the Yuflyma final approval review by May of this year. Celltrion announced on the 23rd that it had confirmed that the final approval review of Yuflyma would be completed by May of this year while continuing discussions with the FDA. Earlier, the U.S. approval process for Yuflyma was somewhat delayed as foreign finished drug manufacturers in charge of finished product production received criticism from the FDA. Celltrion emphasized that the delay in FDA approval of Yuflyma was due to the situation of overseas finished manufacturing plants that had nothing to do with Celltrion's own technology. Overseas finished drug manufacturing pla
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