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

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$ API Ref.Price (USD/KG) : 17,475Xls 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 ALP Pharm
China
ALP PHARM BEIJING CO LTD 32611 BESIFLOXACIN HYDROCHLORIDE 2018-03-08 Active II N/A
26/09/2024 HEC Pharm
China
RUYUAN HEC PHARM CO LTD 32160 BESIFLOXACIN HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE 2017-11-01 Inactive II N/A