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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
29/11/2025 Hybio Pharmaceutical
China
HYBIO PHARMACEUTICAL CO LTD 39223 ABALOPARATIDE, NON-STERILE BULK DRUG SUBSTANCE 2023-11-30 Active II Complete 2024-01-08 2023-12-08
29/11/2025 MSN Laboratories
India
MSN LIFE SCIENCES PRIVATE LTD 34697 ABALOPARATIDE 2020-05-30 Active II Complete 2022-05-16 2022-05-06