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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 30/12/2025 | Ami Lifesciences Private Limited |
India |
AMI LIFESCIENCES PRIVATE LTD | 40643 | TEGOPRAZAN (CRYSTALLINE) | 2024-10-07 | Active | II | N/A | ||
| 30/12/2025 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 38991 | TEGOPRAZAN | 2023-12-30 | Active | II | N/A |
