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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 12/01/2026 | Apex Healthcare Limited |
India |
APEX HEALTHCARE LTD | 42324 | BUPIVACAINE HYDROCHLORIDE USP | 2025-08-21 | Active | II | N/A | ||
| 30/12/2025 | Moehs Iberica |
Spain |
MOEHS IBERICA SL | 22228 | BUPIVACAINE HYDROCHLORIDE | 2008-11-24 | Active | II | Complete | 2013-01-29 | 2013-01-07 |
