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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
28/10/2024 Apotex Pharmachem
Canada
APOTEX PHARMACHEM INDIA PVT LTD 27201 SAXAGLIPTIN HCI WITH MANNITOL COPRECIPITATE 20% 2013-07-05 Inactive II N/A
28/10/2024 Beijing Huikang Boyuan Chemical Tech CO.
China
BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTD 29299 SAXAGLIPTIN HCL 2015-05-11 Active II N/A