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

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$ API Ref.Price (USD/KG) : 396Xls 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 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 20708 EMTRICITABINE (NON-STERILE) DRUG SUBSTANCE 2007-07-18 Active II Complete 2017-12-01 2017-10-11
26/09/2024 Cipla
India
CIPLA LTD 19785 EMTRICITABINE 2006-09-22 Active II Complete 2014-05-24 2014-03-19