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

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$ API Ref.Price (USD/KG) : 1,142Xls download

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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 Alkem Laboratories
India
ALKEM LABORATORIES LTD 33372 ELUXADOLINE 2019-01-02 Active II Complete 2019-03-01 2018-12-21
26/09/2024 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 33590 ELUXADOLINE 2019-02-16 Active II Complete 2019-03-13 2019-02-15