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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 | Porton Pharma Solutions |
China |
PORTON PHARMA SOLUTIONS LTD | 40093 | ALECTINIB HYDROCHLORIDE | 2024-06-13 | Active | II | N/A | ||
| 28/03/2025 | Fresenius Kabi Oncology Limited |
India |
FRESENIUS KABI ONCOLOGY LTD | 33869 | ALECTINIB HYDROCHLORIDE | 2019-06-12 | Inactive | II | N/A |
