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List of Drug Master Files (DMF) of 04102_SIAL Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 9Xls 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 Rotem Industries
Israel
ROTEM-AMFERT-NEGEV LTD 13149 EXCIPIENT, WHITE PHOSPHORIC ACID 1998-08-25 Active IV N/A
26/09/2024 EPROVA AG 5097 PHOSPHORIC ACID (76541-72-5) DESIGNATED AS SR-202 1983-08-22 Inactive II N/A