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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 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 31848 | AFATINIB DIMALEATE | 2017-06-30 | Active | II | Complete | 2017-07-18 | 2017-06-27 |
| 28/03/2025 | Fresenius Kabi Oncology Limited |
India |
FRESENIUS KABI ONCOLOGY LTD | 30927 | AFATINIB DIMALEATE | 2016-12-31 | Inactive | II | N/A |
