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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/01/2026 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 43304 | NIRAPARIB TOSYLATE | 2025-12-31 | Active | II | N/A | ||
| 04/02/2026 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 41455 | NIRAPARIB TOSYLATE MONOHYDRATE | 2025-03-27 | Active | II | N/A |
