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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | Bachem AG |
Switzerland |
BACHEM AMERICAS INC | 8509 | PARATHYROID HORMONE (1-34) HUMAN | 1990-04-04 | Active | II | N/A | ||
28/10/2024 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 38923 | TERIPARATIDE | 2023-09-29 | Active | II | Complete | 2023-11-13 | 2023-09-29 |
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