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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 | 35438 | TEDUGLUTIDE | 2020-12-08 | Active | II | N/A | ||
28/03/2025 | AmbioPharm |
U.S.A |
AMBIOPHARM INC | 30583 | TEDUGLUTIDE NON-STERILE | 2016-08-12 | Active | II | Complete | 2016-11-04 | 2016-08-01 |