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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 27484 | ISOTRETINOIN | 2013-09-27 | Active | II | Complete | 2014-05-13 | 2013-09-25 |
| 29/11/2025 | Siegfried AG |
Switzerland |
SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH | 4676 | 13-CIS-RETINOIC ACID (ISOTRETINOIN) | 1982-09-27 | Active | II | Complete | 2014-06-23 | 2013-08-09 |
