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

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$ API Ref.Price (USD/KG) : 550Xls 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 Olpha
Latvia
OLAINFARM JSC 20543 MEMANTINE HYDROCHLORIDE 2007-05-09 Active II Complete 2013-02-07 2012-11-27
26/09/2024 Cohance Lifesciences
India
COHANCE LIFESCIENCES LTD 29180 MEMANTINE HYDROCHLORIDE USP 2015-03-16 Active II Complete 2019-04-22 2019-02-11