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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 Alivus Life Sciences
India
GLENMARK LIFE SCIENCES LTD 32644 PROGUANIL HYDROCHLORIDE USP 2018-03-30 Active II N/A
28/03/2025 Divis Laboratories
India
DIVIS LABORATORIES LTD 18065 PROGUANIL HYDROCHLORIDE 2005-02-06 Active II Complete 2014-12-16 2014-12-08