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

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$ API Ref.Price (USD/KG) : 430Xls 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 Metrochem API Private Limited
India
METROCHEM API PRIVATE LTD 34732 DEXKETOPROFEN TROMETAMOL 2020-03-21 Active II N/A
26/09/2024 Huangshi Shixing Pharmaceutical
China
HUBEI HUANGSHI SHIXING PHARMACEUTICAL CO LTD 23201 DEXKETOPROFEN TROMETAMOL 2009-09-18 Inactive II N/A