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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
24/02/2025 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 30088 NILOTINIB HYDROCHLORIDE 2015-12-31 Active II Complete 2016-03-16 2016-02-04
24/02/2025 Granules India Limited
India
GRANULES INDIA LTD (UNIT-V) 37531 NILOTINIB HYDROCHLORIDE MONOHYDRATE 2022-09-30 Active II N/A