Imipramine HCl ER capsules

Form: Capsules (Extended-Release)

Strength: 75 mg, 100 mg, 125 mg, 150 mg

Reference Brands: Tofranil-PM® (US)

Category: Antipsychotropic Drugs

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.