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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
29/11/2025 Enaltec Labs
India
ENALTEC LABS PRIVATE LTD 28230 TROSPIUM CHLORIDE USP 2014-09-11 Active II Complete 2014-12-22 2014-09-04
29/11/2025 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 41847 TROSPIUM CHLORIDE USP 2025-04-30 Active II N/A