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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 40216 SUVOREXANT 2024-08-02 Active II N/A
28/03/2025 Dasami Lab
India
DASAMI LAB PRIVATE LTD 38929 SUVOREXANT (FORM-II) 2023-10-25 Active II Complete 2023-11-27 2023-10-26