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    Darolutamide

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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 Alembic Pharmaceuticals Limited
    India
    		 ALEMBIC PHARMACEUTICALS LTD 37912 DAROLUTAMIDE 2023-03-30 Active II Complete 2023-04-20 2023-03-30
    30/12/2025 Changzhou Pharmaceutical Factory
    China
    		 CHANGZHOU PHARMACEUTICAL FACTORY 42127 DAROLUTAMIDE 2025-06-30 Active II N/A
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