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

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$ API Ref.Price (USD/KG) : 132Xls 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 IOL Chemicals and Pharmaceuticals
India
IOL CHEMICALS AND PHARMACEUTICALS LTD 26627 LAMOTRIGINE 2012-11-15 Active II N/A
26/09/2024 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 20548 LAMOTRIGINE 2007-05-23 Active II Complete 2015-02-25 2014-06-11