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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 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 27960 | DABIGATRAN ETEXILATE MESYLATE | 2014-04-04 | Active | II | Complete | 2014-07-07 | 2014-04-21 |
| 28/03/2025 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 37633 | DABIGATRAN ETEXILATE MESYLATE | 2022-10-31 | Active | II | N/A |
