Class II · OngoingAug 7, 2025
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · OngoingAug 7, 2025
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · OngoingAug 7, 2025
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · OngoingAug 6, 2025
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II · OngoingAug 6, 2025
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II · OngoingMar 13, 2025
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations
Class II · OngoingFeb 28, 2025
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · OngoingFeb 28, 2025
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · OngoingFeb 28, 2025
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · OngoingFeb 28, 2025
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · OngoingJan 22, 2025
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class II · OngoingJan 22, 2025
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.