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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 | ACS DOBFAR SPA |
Italy |
ACS DOBFAR SPA | 21594 | CILASTATIN SODIUM (STERILE BULK) | 2008-05-05 | Active | II | Complete | 2013-11-20 | 2013-11-04 |
| 28/03/2025 | Auronext Pharma Private Limited |
India |
AURONEXT PHARMA PRIVATE LTD | 28929 | CILASTATIN SODIUM USP (STERILE) | 2015-01-02 | Inactive | II | N/A |
