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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 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 31664 | MACITENTAN | 2017-04-28 | Active | II | Complete | 2017-07-05 | 2017-04-17 |
28/10/2024 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 31749 | MACITENTAN | 2017-05-15 | Active | II | Complete | 2017-06-01 | 2017-05-12 |
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