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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
27/02/2026 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 35809 BESIFLOXACIN HYDROCHLORIDE 2021-03-29 Active II N/A
27/02/2026 ALP Pharm
China
ALP PHARM BEIJING CO LTD 32611 BESIFLOXACIN HYDROCHLORIDE 2018-03-08 Active II N/A