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List of Drug Master Files (DMF) of AM20060780 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 63Xls 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 Granules India Limited
India
GRANULES INDIA LTD 35694 BUPROPION HYDROCHLORIDE USP 2021-03-29 Active II Complete 2021-05-27 2021-04-15
26/09/2024 Aarti Pharmalabs
India
AARTI PHARMALABS LTD 27204 BUPROPION HYDROCHLORIDE 2013-06-17 Active II Complete 2013-10-19 2013-06-25