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

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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 CF Pharma
Hungary
CF PHARMA LTD 31045 PENTOSAN POLYFULFATE SODIUM 2016-10-17 Active II N/A
26/09/2024 Akums Lifesciences
India
PURE AND CURE HEALTHCARE PRIVATE LTD 25011 PENTOSAN POLYSULFATE SODIUM 2011-05-31 Active II N/A