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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
31/10/2025 Minakem (formerly Delmar Chemicals)
Canada
DELMAR CHEMICALS INC 16243 MONTELUKAST SODIUM THIOL ACID 2002-11-15 Active II N/A
31/10/2025 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 24516 MONTELUKAST SODIUM [PROCESS-2] 2010-12-31 Active II Complete 2015-02-18 2012-12-31