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

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$ API Ref.Price (USD/KG) : 3,159Xls 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 Changzhou Pharmaceutical Factory
China
CHANGZHOU PHARMACEUTICAL FACTORY 38958 AGOMELATINE 2023-09-27 Active II N/A
26/09/2024 Changzhou Pharmaceutical Factory
China
CHANGZHOU PHARMACEUTICAL FACTORY 26965 AGOMELATINE 2013-03-08 Inactive II N/A