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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
29/01/2026 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 36600 BINIMETINIB 2021-12-30 Active II Complete 2022-05-13 2022-04-19
29/01/2026 MSN Laboratories
India
MSN LABORATORIES PRIVATE LTD 36434 BINIMETINIB 2021-12-09 Active II Complete 2022-02-15 2022-01-06