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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
24/02/2025 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 16112 LEFLUNOMIDE USP 2002-08-29 Active II N/A
24/02/2025 Cipla
India
CIPLA LTD 16109 LEFLUNOMIDE USP 2002-08-23 Active II Complete 2016-02-18 2015-08-21