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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 Metrochem API Private Limited
India
METROCHEM API PRIVATE LTD 41091 VORTIOXETINE HYDROBROMIDE 2024-12-31 Active II N/A
28/03/2025 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 31281 VORTIOXETINE HYDROBROMIDE 2016-12-30 Active II Complete 2017-02-01 2016-12-27