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List of Drug Master Files (DMF) of Prestwick3_000485 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 249Xls 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 ACS DOBFAR SPA
Italy
ACS DOBFAR SPA 13780 CEFACLOR MONOHYDRATE 1998-09-01 Active II N/A
26/09/2024 Bristol Myers Squibb
U.S.A
BRISTOL MYERS SQUIBB CO 13218 CEFACLOR 1998-04-30 Inactive II N/A