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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
27/02/2026 Breathgreen Pharmaceuticals
China
BREATHGREEN PHARMACEUTICAL CO LTD 41421 ENSIFENTRINE 2025-03-17 Active II N/A
27/02/2026 Cipla
India
CIPLA LTD 42916 ENSIFENTRINE (C) 2025-11-26 Active II N/A