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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 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 36029 | ACALABRUTINIB | 2021-06-30 | Active | II | Complete | 2021-08-30 | 2021-06-18 |
| 30/12/2025 | Cipla |
India |
CIPLA LTD | 35762 | ACALABRUTINIB | 2021-05-03 | Active | II | Complete | 2021-06-03 | 2021-04-16 |
