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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
28/03/2025 ALP Pharm
China
ALP PHARM BEIJING CO LTD 32611 BESIFLOXACIN HYDROCHLORIDE 2018-03-08 Active II N/A
28/03/2025 HEC Pharm
China
RUYUAN HEC PHARM CO LTD 32160 BESIFLOXACIN HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE 2017-11-01 Inactive II N/A