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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
24/02/2025 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 30814 CLOMIPRAMINE HYDROCHLORIDE 2016-08-20 Active II Complete 2016-10-21 2016-08-22
24/02/2025 H. Lundbeck AS
Denmark
LUNDBECK PHARMACEUTICALS ITALY SPA 8864 CLOMIPRAMINE HYDROCHLORIDE 1990-11-19 Active II Complete 2015-02-25 2015-01-26