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

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$ API Ref.Price (USD/KG) : 128Xls 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 Alchem International Private Ltd
India
ALCHEM INTERNATIONAL PRIVATE LTD 38319 NICOTINE USP (4691A) 2023-05-18 Active II N/A
26/09/2024 Porton Pharma Solutions
China
PORTON FINE CHEMICALS LTD 26541 NICOTINE USP 2012-10-03 Active II N/A