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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 | ALP Pharm |
China |
ALP PHARM BEIJING CO LTD | 38773 | TIRZEPATIDE | 2023-08-30 | Active | II | N/A | ||
28/03/2025 | Apicore |
India |
APICORE US LLC | 40123 | TIRZEPATIDE | 2024-07-27 | Active | II | N/A |