ST Humanwell Secures German BfArM Marketing Authorization for Fentanyl Citrate Injection
November 4, 2026
Source: drugdu
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News summary: On November 3, ST Humanwell reported that its 80%-owned subsidiary Yichang Humanwell had obtained German BfArM authorization for fentanyl citrate injection. Approved uses include adjunctive analgesia during anaesthesia, combination with neuroleptics, premedication and intensive-care pain management.
Filed through the DCP in July 2023, the application involved approximately RMB 4 million in German registration expenditure. Authorization is valid for five years. IQVIA and Cortellis put combined 2025 sales in France, Germany, Italy, Spain and the UK at approximately USD 16 million; major manufacturers include Pfizer and Hikma. Humanwell expects the approval to support its international expansion.
Source: URL: https://finance.eastmoney.com/a/202611033919644738.html
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