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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
    28/10/2024 Alembic Pharmaceuticals Limited
    India
    		 ALEMBIC PHARMACEUTICALS LTD 31848 AFATINIB DIMALEATE 2017-06-30 Active II Complete 2017-07-18 2017-06-27
    28/10/2024 Fresenius Kabi Oncology Limited
    India
    		 FRESENIUS KABI ONCOLOGY LTD 30927 AFATINIB DIMALEATE 2016-12-31 Inactive II N/A