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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 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 20249 | ROPIVACAINE HCL MONOHYDRATE | 2007-02-02 | Active | II | Complete | 2013-08-13 | 2013-08-05 |
| 31/10/2025 | Aspen API |
Netherlands |
FINE CHEMICALS CORP PTY LTD | 20654 | ROPIVACAINE HYDROCHLORIDE | 2007-07-03 | Active | II | Complete | 2016-12-19 | 2016-11-18 |
