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List of Drug Master Files (DMF) of 2-[[(2R)-2-sulfanylpropanoyl]amino]acetic acid 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 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 35512 TIOPRONIN 2020-12-31 Active II Complete 2021-09-07 2021-08-18
26/09/2024 Porton Pharma Solutions
China
PORTON PHARMA SOLUTIONS LTD 29447 TIOPRONIN NON-STERILE BULK DRUG 2015-06-01 Active II N/A