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

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$ API Ref.Price (USD/KG) : 2,164Xls 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 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 25174 VARDENAFIL HYDROCHLORIDE TRIHYDRATE 2011-08-02 Active II Complete 2015-09-15 2015-08-21
26/09/2024 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 28900 VARDENAFIL HYDROCHLORIDE USP 2014-12-31 Active II Complete 2015-02-20 2014-12-24