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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
04/06/2025 Honour Lab
India
HONOUR LAB LTD 31895 AZILSARTAN KAMEDOXOMIL 2017-11-28 Active II Complete 2018-01-04 2017-08-08
04/06/2025 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 29488 AZILSARTAN MEDOXOMIL MONOPOTASSIUM 2015-06-30 Active II Complete 2015-09-10 2015-06-26