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 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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.
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