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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 | CSPC CENWAY TIANJIN PHARMACEUTICALS CO LTD |
China |
CSPC CENWAY TIANJIN PHARMACEUTICALS CO LTD | 20146 | GCLE (NON-STERILE, BULK FORM) | 2007-01-04 | Active | II | N/A | ||
| 28/03/2025 | Otsuka Chemical Co Ltd |
Japan |
OTSUKA CHEMICAL CO LTD | 20451 | P-METHOXYBENZYL(6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1-AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE, GCLE | 2007-04-10 | Inactive | II | N/A |
