Asenapine Sublingual Tablets Suppliers & Bulk Manufacturers
Available Forms: Sublingual Tablets
Available Strengths: 5 mg, 10 mg
Reference Brands: Saphris®(US); Sycrest® (EU)
Category:
Antipsychotropic Drugs
Asenapine blocks dopamine D2 and serotonin 5-HT2A receptors, helping manage symptoms of schizophrenia and bipolar I disorder. Its sublingual delivery allows rapid absorption, making it effective for acute manic or mixed episodes, especially in patients needing fast symptom relief or with difficulty swallowing oral tablets.
Asenapine Sublingual Tablets is available in Sublingual Tablets
and strengths such as 5 mg, 10 mg.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Asenapine Sublingual Tablets is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Asenapine Sublingual Tablets can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
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.
Disclaimer: By continuing to browse, you agree to the terms of use of this website and the Trade Marks displayed, in compliance with the provisions of the Trademark Act, 1999, Section 30 and 30(1) under 'Fair use.'
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Back to Listing