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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
31/10/2025 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 31849 IVACAFTOR 2017-06-30 Active II Complete 2017-07-18 2017-06-28
31/10/2025 Alivus Life Sciences
India
ALIVUS LIFE SCIENCES LTD 28867 IVACAFTOR 2015-03-10 Active II Complete 2015-05-19 2015-03-10