Product/Composition:- | Imipramine HCl ER capsules |
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Strength:- | 75 mg, 100 mg, 125 mg, 150 mg |
Form:- | Capsules (Extended-Release) |
Reference Brands:- | Tofranil-PM® (US) |
MOQ | As per the manufacturer batch size |
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Imipramine is a tricyclic antidepressant (TCA) that works by inhibiting the reuptake of norepinephrine and serotonin, increasing their availability in the synaptic cleft and enhancing mood regulation. It also has mild anticholinergic and sedative properties. The extended-release (ER) formulation provides sustained therapeutic levels over time. Imipramine ER capsules are used to treat major depressive disorder and nocturnal enuresis (bedwetting) in children aged 6 and older, especially when other treatments are ineffective.
Imipramine HCl ER capsules are FDA-approved in the United States for the treatment of depression and childhood enuresis (bedwetting). As a tricyclic antidepressant (TCA), it requires CNS safety labeling, including warnings for suicidal thoughts in young adults and children. ER formulations must meet strict modified-release manufacturing and bioequivalence standards for generics. In the European Union, imipramine is approved under national authorizations for similar psychiatric and urological indications. EU regulatory requirements include GMP-compliant production, Risk Management Plans (RMPs), and pharmacovigilance obligations. For dossier-ready supply and global sourcing of Imipramine HCl ER capsules, visit Pharmatradz.com.
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