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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 | Aspen API |
Netherlands |
ASPEN OSS BV | 13971 | GANIRELIX | 1999-02-04 | Active | II | Complete | 2024-03-07 | 2024-03-05 |
28/03/2025 | Apicore |
India |
APICORE LLC | 36902 | GANIRELIX ACETATE | 2022-04-28 | Active | II | N/A |