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