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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
28/08/2025 Maithri Drugs
India
MAITHRI LABORATORIES PRIVATE LTD 33230 FESOTERODINE FUMARATE 2018-09-29 Active II Complete 2020-09-17 2020-08-12
28/08/2025 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 26241 FESOTERODINE FUMARATE 2012-09-04 Active II Complete 2013-05-06 2012-11-02