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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
27/02/2026 Metrochem API Private Limited
India
METROCHEM API PRIVATE LTD 41091 VORTIOXETINE HYDROBROMIDE 2024-12-31 Active II N/A
27/02/2026 Lundbeck CDM
Denmark
H LUNDBECK AS 21224 LU AA21004 HYDROBROMIDE 2008-01-17 Active II N/A