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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
28/03/2025 Arene Lifesciences
India
ARENE LIFE SCIENCES PRIVATE LTD 34105 EMTRICITABINE 2019-10-17 Active II N/A
28/03/2025 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 20708 EMTRICITABINE (NON-STERILE) DRUG SUBSTANCE 2007-07-18 Active II Complete 2017-12-01 2017-10-11