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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 30721 SCOPOLAMINE HYDROBROMIDE USP 2016-07-06 Active II N/A
28/03/2025 Phytex Australia
Australia
PHYTEX AUSTRALIA PVT LTD 7415 SCOPOLAMINE HYDROBROMIDE 1988-03-30 Active II N/A