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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 37094 | CYSTEAMINE BITARTRATE | 2022-06-01 | Active | II | N/A | ||
| 31/10/2025 | Maithri Drugs |
India |
MAITHRI LABORATORIES PRIVATE LTD | 35758 | CYSTEAMINE BITARTRATE (MONOHYDRATE) | 2021-03-29 | Active | II | N/A |
