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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 | Polpharma |
Poland |
ZAKLADY FARMACEUTYCZNE POLPHARMA SA | 39559 | PALBOCICLIB | 2024-04-04 | Active | II | N/A | ||
| 31/10/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 32646 | PALBOCICLIB | 2018-03-28 | Active | II | Complete | 2018-07-16 | 2018-06-15 |
