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

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$ API Ref.Price (USD/KG) : 3,406Xls 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 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 28262 NILUTAMIDE 2014-06-23 Active II Complete 2015-03-12 2014-12-24
26/09/2024 Kekule Pharma
India
KEKULE PHARMA LTD 25465 NILUTAMIDE 2011-09-29 Active II Complete 2014-11-18 2014-06-17