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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 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 30868 | GEFITINIB | 2016-09-19 | Active | II | Complete | 2016-12-13 | 2016-09-08 |
| 31/10/2025 | Cdymax |
India |
CDYMAX (INDIA) PHARMA PRIVATE LTD | 40456 | GEFITINIB | 2024-09-03 | Active | II | N/A |
