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

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$ API Ref.Price (USD/KG) : 105Xls 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 Alkem Laboratories
India
ALKEM LABORATORIES LTD 35610 AMLODIPINE BENZOATE 2021-03-31 Active II N/A
26/09/2024 Cadila Pharmaceuticals
India
CADILA PHARMACEUTICALS LTD 27726 PHTHALOYL AMLODIPINE 2014-01-31 Active II N/A