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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 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
28/03/2025 Phytex Australia
Australia
PHYTEX AUSTRALIA PARTY LTD 7408 SCOPOLAMINE BASE 1988-03-30 Active II Complete 2016-05-06 2015-06-30