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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 | Alchem International Private Ltd |
India |
ALCHEM INTERNATIONAL PRIVATE LTD | 30687 | HYOSCINE EP (SCOPOLAMINE) | 2016-07-06 | Active | II | Complete | 2017-09-14 | 2017-06-02 |
| 31/10/2025 | Phytex Australia |
Australia |
PHYTEX AUSTRALIA PARTY LTD | 7408 | SCOPOLAMINE BASE | 1988-03-30 | Active | II | Complete | 2016-05-06 | 2015-06-30 |
