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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/03/2025 | Hybio Pharmaceutical |
China |
HYBIO PHARMACEUTICAL CO LTD | 39223 | ABALOPARATIDE, NON-STERILE BULK DRUG SUBSTANCE | 2023-11-30 | Active | II | Complete | 2024-01-08 | 2023-12-08 |
| 28/03/2025 | MSN Laboratories |
India |
MSN LIFE SCIENCES PRIVATE LTD | 34697 | ABALOPARATIDE | 2020-05-30 | Active | II | Complete | 2022-05-16 | 2022-05-06 |
