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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
25/04/2025 Alchem International Private Ltd
India
ALCHEM INTERNATIONAL PRIVATE LTD 31278 ATROPINE SULFATE USP 2016-12-20 Active II N/A
25/04/2025 Nuray Chemicals Private Limited
India
SS PHARMA LLC 33781 ATROPINE SULFATE MONOHYDRATE USP 2019-08-08 Active II Complete 2019-09-25 2019-06-25