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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 | CKD Bio Corporation |
South Korea |
CKD BIO CORP | 26159 | RIFAMYCIN O, NON-STERILE API | 2012-06-15 | Active | II | N/A | ||
28/03/2025 | Gujarat Themis Biosyn |
India |
GUJARAT THEMIS BIOSYN LTD | 38988 | RIFAMYCIN-O | 2023-10-26 | Active | II | N/A |