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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 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 41013 NAPHAZOLINE NITRATE 2024-12-31 Active II N/A
28/03/2025 ALP Pharm
China
ALP PHARM BEIJING CO LTD 23643 NAPHAZOLINE NITRATE (DRUG SUBSTANCE, NON-STERILE) 2010-03-12 Inactive II N/A