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List of Drug Master Files (DMF) of Everolimus 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 Farmhispania
Spain
FARMHISPANIA SA 34295 EVEROLIMUS (2.0% BHT) 2019-12-20 Active II Complete 2020-07-28 2019-12-23
26/09/2024 Chunghwa Chemical Synthesis & Biotech
Taiwan
CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD 26819 EVEROLIMUS PRE-MIX USP 2013-02-08 Active II Complete 2013-09-11 2013-03-14