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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
30/12/2025 Honour Lab Limited
India
HONOUR LAB LTD 31895 AZILSARTAN KAMEDOXOMIL 2017-11-28 Active II Complete 2018-01-04 2017-08-08
30/12/2025 Lupin Manufacturing Solutions
India
LUPIN MANUFACTURING SOLUTIONS LTD 33732 AZILSARTAN KAMEDOXOMIL 2019-04-17 Active II Complete 2019-07-12 2019-06-05