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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
29/01/2026 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 42858 IVACAFTOR 2025-11-01 Active II N/A
29/01/2026 Lupin Manufacturing Solutions
India
LUPIN MANUFACTURING SOLUTIONS LTD 32610 IVACAFTOR 2019-03-29 Active II Complete 2020-08-20 2020-07-02