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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 | Abiochem Biotechnology |
China |
YIKELAI (TAIZHOU) PHARMACEUTICAL CO LTD | 38496 | (3R)-N-(TERT-BUTOXYCARBONYL)-3-AMINO-4-(2,4,5-TRIFLUOROPHENYL)BUTANOIC ACID (PROCESS II) | 2023-06-28 | Active | II | N/A | ||
| 28/03/2025 | Chiral Quest |
China |
CHIRAL QUEST (SUZHOU) CO LTD | 27115 | (R)-3-(TERT-BUTOXYCARBONYLAMINO)-4-(2,4,5-TRIFLUOROPHENYL) BUTANOIC ACID | 2013-04-22 | Active | II | N/A |
