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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 |