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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 Lupin Manufacturing Solutions
India
LUPIN MANUFACTURING SOLUTIONS LTD 31498 DARUNAVIR ETHANOLATE (PROCESS-B) 2017-04-15 Active II Complete 2017-11-28 2017-10-10
30/12/2025 Arene Lifesciences
India
ARENE LIFE SCIENCES PRIVATE LTD 37916 DARUNAVIR ETHANOLATE 2023-03-10 Active II N/A