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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 | EUROAPI | France | EUROAPI HUNGARY LTD | 19690 | IRBESARTAN DRUG SUBSTANCE | 2006-08-15 | Active | II | N/A | ||
| 31/10/2025 | Sanofi | France | SANOFI CHIMIE | 10310 | IRBESARTAN DRUG SUBSTANCE | 1993-06-30 | Active | II | N/A | 
