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List of Drug Master Files (DMF) of Glycerol Phenylbutyrate 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 Nuray Chemicals Private Limited
India
NURAY CHEMICALS PRIVATE LTD 27125 GLYCEROL PHENYLBUTYRATE 2013-07-03 Active II Complete 2013-09-16 2013-07-02
26/09/2024 Hetero Drugs
India
HETERO DRUGS LTD 34468 GLYCEROL PHENYLBUTYRATE 2020-04-21 Active II Complete 2020-05-13 2020-02-26