Asenapine Sublingual Tablets

Form: Sublingual Tablets

Strength: 5 mg, 10 mg

Reference Brands: Saphris®(US); Sycrest® (EU)

Category: Antipsychotropic Drugs

Asenapine sublingual tablets are FDA-approved in the U.S. for treating schizophrenia and bipolar I disorder (acute manic or mixed episodes) in adults and pediatric patients. In the EU, they are approved under national procedures for similar indications. Regulatory compliance requires GMP-certified manufacturing, validated sublingual bioavailability data, and robust clinical safety profiles addressing risks such as oral numbness, extrapyramidal symptoms, and metabolic effects. U.S. regulations mandate boxed warnings for elderly patients with dementia-related psychosis. EU approval includes Risk Management Plans (RMPs) and pharmacovigilance systems. For dossier-ready Asenapine sublingual tablets, visit Pharmatradz.com — your B2B pharma sourcing expert.