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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 25/04/2025 | Newgen Biotech USA |
U.S.A |
NEWGEN BIOTECH (NINGBO) | 30889 | LACTASE USP | 2016-08-22 | Active | II | N/A | ||
| 25/04/2025 | Specialty Enzymes & Probiotics |
U.S.A |
SPECIALTY ENZYMES AND BIOCHEMICALS CO | 22034 | LACTASE USP | 2008-09-18 | Active | II | N/A |
