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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 | Newgen Biotech USA |
U.S.A |
NEWGEN BIOTECH | 31154 | ALPHA GALACTOSIDASE | 2016-11-10 | Active | II | N/A |
