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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/06/2025 | Bachem AG |
Switzerland |
BACHEM AG | 31458 | BIVALIRUDIN | 2017-03-31 | Active | II | N/A | ||
| 28/06/2025 | TAPI Technology & API Services |
Israel |
TAPI NL BV | 20863 | BIVALIRUDIN | 2007-09-18 | Active | II | Complete | 2012-11-23 | 2012-11-13 |
