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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 Breathgreen Pharmaceuticals
China
BREATHGREEN PHARMACEUTICAL CO LTD 39764 INDACATEROL ACETATE(MICRONIZED AND NON-MICRONIZED) 2024-03-25 Active II N/A
29/11/2025 Cipla
India
CIPLA LTD 37098 INDACATEROL ACETATE 2022-05-13 Active II N/A