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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | BioSpectra |
U.S.A |
BIOSPECTRA | 31669 | UREA A PHARMACEUTICAL INGREDIENT | 2017-04-24 | Active | II | N/A | ||
| 29/11/2025 | Cambridge Isotope Laboratories |
U.S.A |
CAMBRIDGE ISOTOPE LABORATORIES INC | 11378 | 13C UREA | 1995-03-16 | Active | II | N/A |
