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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 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 32336 | METYROSINE USP | 2017-12-22 | Active | II | Complete | 2018-03-13 | 2017-12-22 |
28/10/2024 | Apicore LLC |
India |
APICORE LLC | 37364 | METYROSINE, USP | 2022-09-06 | Active | II | N/A |
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