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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 | American Pacific Corporation |
U.S.A |
AMPAC FINE CHEMICALS LLC | 35234 | OSELTAMIVIR PHOSPHATE DRUG SUBSTANCE | 2021-08-06 | Active | II | Complete | 2022-06-23 | 2022-06-13 |
| 28/03/2025 | Azico Biophore India Pvt. Ltd |
India |
AZICO BIOPHORE INDIA PRIVATE LTD | 36183 | OSELTAMIVIR PHOSPHATE | 2021-08-28 | Active | II | N/A |
