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List of Drug Master Files (DMF) of Polysorbate API Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
26/09/2024 Hubei Gedian Humanwell Pharmaceutical
China
HUBEI GEDIAN HUMANWELL PHARMACEUTICAL EXCIPIENTS CO LTD 33606 POLYSORBATE 80 (FOR INJECTION) 2020-01-07 Active IV N/A
26/09/2024 Croda Inc.
U.S.A
CRODA INC 17071 TWEEN 80 HP-LQ-(MH) 2003-12-02 Inactive IV N/A