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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 | Ami Lifesciences Private Limited |
India |
AMI LIFESCIENCES PRIVATE LTD | 38201 | EDOXABAN TOSYLATE MONOHYDRATE | 2023-03-24 | Active | II | N/A | ||
| 31/10/2025 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 37896 | EDOXABAN TOSYLATE MONOHYDRATE | 2022-12-23 | Active | II | N/A |
