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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
    12/12/2025 Lupin Manufacturing Solutions
    India
    		 LUPIN MANUFACTURING SOLUTIONS LTD 32610 IVACAFTOR 2019-03-29 Active II Complete 2020-08-20 2020-07-02
    29/11/2025 Alembic Pharmaceuticals Limited
    India
    		 ALEMBIC PHARMACEUTICALS LTD 31849 IVACAFTOR 2017-06-30 Active II Complete 2017-07-18 2017-06-28
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