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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
28/06/2025 Fresenius Kabi Oncology Limited
India
FRESENIUS KABI ONCOLOGY LTD 33869 ALECTINIB HYDROCHLORIDE 2019-06-12 Inactive II N/A
28/06/2025 Hetero Drugs
India
HETERO LABS LTD 39383 ALECTINIB HYDROCHLORIDE 2024-01-30 Active II N/A