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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 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 39315 | RALTEGRAVIR POTASSIUM USP | 2023-12-30 | Active | II | Complete | 2024-02-14 | 2023-12-22 |
28/03/2025 | Emcure Pharmaceuticals |
India |
EMCURE PHARMACEUTICALS LTD | 26935 | RALTEGRAVIR POTASSIUM | 2013-03-28 | Inactive | II | N/A |