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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 32336 METYROSINE USP 2017-12-22 Active II Complete 2018-03-13 2017-12-22
28/03/2025 Apicore
India
APICORE LLC 37364 METYROSINE, USP 2022-09-06 Active II N/A