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List of Drug Master Files (DMF) of Lomitapide Mesylate 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 Glenmark Life Sciences
India
GLENMARK LIFE SCIENCES LTD 30272 LOMITAPIDE MESYLATE 2016-03-23 Active II Complete 2016-04-08 2016-03-23
26/09/2024 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 31454 LOMITAPIDE MESYLATE (FORM-M) 2017-02-22 Active II N/A