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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 27/09/2025 | Hybio Pharmaceutical |
China |
HYBIO PHARMACEUTICAL CO LTD | 27265 | NESIRITIDE CITRATE, NON-STERILE BULK DRUG SUBSTANCE | 2013-06-25 | Active | II | Complete | 2014-10-07 | 2014-04-10 |
| 27/09/2025 | Mallinckrodt Pharmaceuticals |
Ireland |
MALLINCKRODT CHEMICAL INC | 10543 | BRAIN NATRIURETIC PEPTIDE | 1993-10-26 | Inactive | II | N/A |
