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

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$ API Ref.Price (USD/KG) : 213Xls 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 Century Pharmaceuticals
India
CENTURY PHARMACEUTICALS LTD 34800 CLARITHROMYCIN USP 2020-07-22 Active II N/A
26/09/2024 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 20023 CLARITHROMYCIN USP 2006-11-21 Active II Complete 2017-03-15 2016-09-22