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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
28/11/2024 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 37094 CYSTEAMINE BITARTRATE 2022-06-01 Active II N/A
28/11/2024 ACIC Fine Chemicals
U.S.A
ACIC PHARMACEUTICALS INC 26816 CYSTEAMINE BITARTRATE 2013-09-05 Active II Complete 2015-05-26 2013-09-06