Asenapine Transdermal Patch bulk supplier for pharma manufacturers

Asenapine Transdermal Patch Suppliers & Bulk Manufacturers

Available Forms: Transdermal Patch

Available Strengths: 3.8 mg/24 hr, 5.7 mg/24 hr, 7.6 mg/24 hr

Reference Brands: Secuado®(US)

Category: Antipsychotropic Drugs

Asenapine Transdermal Patch is available in Transdermal Patch and strengths such as 3.8 mg/24 hr, 5.7 mg/24 hr, 7.6 mg/24 hr. 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 Transdermal Patch 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 Transdermal Patch 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.

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Product Description: The Asenapine transdermal patch is FDA-approved in the United States (brand name: Secuado) for the treatment of schizophrenia in adults. It is the first and only transdermal antipsychotic approved in the U.S. As of now, it is not approved in the European Union, and marketing would require a new MAA (Marketing Authorization Application) via national or centralized procedures. Regulatory requirements in the U.S. include GMP-compliant patch manufacturing, transdermal pharmacokinetics, adhesion and skin safety data, and documentation addressing risks like extrapyramidal symptoms and QT prolongation. U.S. labeling includes warnings for elderly dementia-related psychosis. To explore dossier-ready Asenapine transdermal patches and alternatives, visit Pharmatradz.com — your global B2B pharma sourcing hub.

Frequently Asked Questions

Yes, Asenapine Transdermal Patch is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Asenapine Transdermal Patch is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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