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

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$ API Ref.Price (USD/KG) : 231Xls 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 Moehs Iberica
Spain
MOEHS IBERICA SL 36834 DULOXETINE HYDROCHLORIDE 2022-03-16 Active II Complete 2022-04-15 2022-03-08
26/09/2024 SCI Pharmtech
Taiwan
SCI PHARMTECH INC 24939 DULOXETINE HYDROCHLORIDE 2011-05-06 Active II Complete 2013-07-23 2013-03-06