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

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$ API Ref.Price (USD/KG) : 14Xls 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 Amoli Organics
India
AMOLI ORGANICS PRIVATE LTD 23028 DICLOFENAC POTASSIUM USP 2009-08-12 Active II Complete 2017-10-27 2017-10-16
26/09/2024 Cheng Fong Chemical Co., Ltd
China
CHENG FONG CHEMICAL CO LTD 11990 DICLOFENAC POTASSIUM 1996-06-06 Inactive II N/A