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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 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 31358 DARUNAVIR PROPYLENE GLYCOLATE 2017-01-25 Active II Complete 2017-05-23 2017-01-25
31/10/2025 Cipla
India
CIPLA LTD 40826 DARUNAVIR HYDRATE (PROCESS II) 2025-01-10 Active II Complete 2025-05-12 2025-04-08