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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
25/04/2025 | Asymchem Laboratories |
China |
ASYMCHEM LIFE SCIENCE TIANJIN CO LTD | 28838 | REPAGLINIDE | 2014-11-17 | Inactive | II | N/A | ||
25/04/2025 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 23068 | REPAGLINIDE USP (NON-STERILE DRUG SUBSTANCE) | 2009-08-24 | Active | II | N/A |