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List of Drug Master Files (DMF) of Glycine 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 Evonik
Germany
EVONIK REXIM (NANNING) PHARMACEUTICAL CO LTD 30393 GLYCINE 2016-03-02 Active II Complete 2017-03-31 2016-12-27
26/09/2024 Chattem Chemicals, Inc
U.S.A
CHATTEM CHEMICALS INC 1271 AMINOACETIC ACID (GLYCINE) 1968-12-13 Active II N/A