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List of Drug Master Files (DMF) of Imatinib Mesilate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 959Xls download

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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
26/09/2024 Acebright India Pharma Private Limited
India
ACEBRIGHT INDIA PHARMA PRIVATE LTD 26322 IMATINIB MESYLATE [DRUG SUBSTANCE(NON-STERILE)] 2012-08-17 Active II N/A
26/09/2024 Cipla
India
CIPLA LTD 26170 IMATINIB MESYLATE (A-FORM) 2013-01-23 Active II Complete 2017-02-01 2016-09-28