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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
29/07/2025 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 38206 LUMATEPERONE TOSYLATE 2023-03-31 Active II Complete 2023-09-21 2023-08-17
06/08/2025 Maithri Drugs
India
MAITHRI LABORATORIES PRIVATE LTD 38730 LUMATEPERONE TOSYLATE 2023-09-20 Active II Complete 2023-10-26 2023-09-22