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List of Drug Master Files (DMF) of Prestwick3_000351 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 173Xls 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 Amoli Organics
India
AMOLI ORGANICS PRIVATE LTD 30551 CHLORTHALIDONE USP 2016-05-24 Active II Complete 2017-03-22 2016-08-19
26/09/2024 Chromo Laboratories
India
CHROMO LABORATORIES INDIA PRIVATE LTD 33071 CHLORTHALIDONE USP 2018-08-30 Active II Complete 2024-05-20 2024-05-07