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List of Drug Master Files (DMF) of Prestwick3_000358 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 63Xls 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 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 17604 CEPHALEXIN USP 2004-07-31 Active II N/A
26/09/2024 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 32930 CEPHALEXIN USP (ENZYMATIC ROUTE) 2019-03-29 Active II Complete 2019-05-07 2019-03-29