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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
28/03/2025 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 30833 D-PENICILLAMINE 2016-09-28 Active II Complete 2017-01-13 2016-09-28
28/03/2025 Granules India Limited
India
GRANULES INDIA LTD 31922 PENICILLAMINE, USP 2017-11-03 Active II Complete 2017-12-06 2017-11-09