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List of Drug Master Files (DMF) of Prestwick3_000477 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 232Xls 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 Hubei Gedian Humanwell Pharmaceutical
China
HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTD 27668 PROGESTERONE 2013-11-01 Active II Complete 2018-10-25 2018-07-27
26/09/2024 Pfizer CentreOne
U.S.A
PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INC 1418 PROGESTERONE MICRONIZED AND CRYSTALS 1969-09-04 Active II Complete 2013-03-06 2013-02-14