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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/08/2025 | Maithri Drugs |
India |
MAITHRI DRUGS PRIVATE LTD | 40159 | AVACOPAN | 2024-06-29 | Active | II | Complete | 2025-06-25 | 2025-05-20 |
28/08/2025 | Hetero Drugs |
India |
HETERO LABS LTD | 42058 | AVACOPAN | 2025-06-26 | Active | II | Complete | 2025-08-21 | 2025-06-25 |