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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 | Biocon |
India |
BIOCON SA | 27093 | INSULIN GLARGINE (RDNA ORIGIN) | 2013-05-24 | Active | II | N/A | ||
28/03/2025 | Tonghua Dongbao Pharma |
China |
TONGHUADONGBAO PHARMACEUTICAL CO LTD | 36695 | INSULIN GLARGINE | 2022-02-16 | Active | II | N/A |