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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 | 29805 | METHSCOPOLAMINE BROMIDE USP | 2015-09-24 | Active | II | Complete | 2015-11-20 | 2015-09-28 |
| 31/10/2025 | Phytex Australia |
Australia |
PHYTEX AUSTRALIA PVT LTD | 7410 | METHSCOPOLAMINE BROMIDE | 1988-03-30 | Active | II | Complete | 2022-02-17 | 2021-09-16 |
