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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 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 29488 AZILSARTAN MEDOXOMIL MONOPOTASSIUM 2015-06-30 Active II Complete 2015-09-10 2015-06-26
28/03/2025 Alkem Laboratories
India
ALKEM LABORATORIES LTD 38047 AZILSARTAN KAMEDOXOMIL 2023-09-12 Active II N/A