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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 | Agno Pharma |
U.S.A |
AGNO PHARMA | 38746 | STERILE MANNITOL USP/EP/BP | 2024-06-26 | Active | IV | N/A | ||
| 31/10/2025 | Ingredion Pharma Solutions |
U.S.A |
CORN PRODUCTS BRASIL INGREDIENTS INDUSTRIAIS LTDA | 7246 | MANNITOL | 1987-12-07 | Inactive | II | N/A |
