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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 37322 MANGANESE SULFATE MONOHYDRATE 2022-07-19 Active II Complete 2022-10-11 2022-09-23
28/03/2025 Metrochem API Private Limited
India
METROCHEM API PRIVATE LTD 36960 MANGANESE SULFATE MONOHYDRATE USP 2022-06-10 Active II Complete 2022-07-11 2022-07-05