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Tasimelteon bulk supplier for pharma manufacturers

Tasimelteon Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 20 mg

Reference Brands: Hetlioz (USA)

Category: Neurology

Tasimelteon is available in Capsules and strengths such as 20 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, Tasimelteon 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)

Tasimelteon 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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📘 Sourcing Guide

Product Description:

Tasimelteon is a selective melatonin receptor agonist marketed under the brand name Hetlioz. It is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of circadian rhythm sleep disorders. Tasimelteon is primarily indicated for adults with non-24-hour sleep–wake disorder (Non-24), a condition most commonly affecting totally blind individuals whose internal circadian rhythms are not aligned with the 24-hour day.

In addition, tasimelteon is indicated for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in adults and adolescents aged 16 years and older. An oral suspension formulation is also available for children aged 3 to 15 years with SMS. Tasimelteon works by selectively targeting melatonin receptors MT1 and MT2 in the brain, helping regulate the sleep-wake cycle, restore circadian rhythm, and improve sleep quality.

Tasimelteon is available as oral capsules and oral suspension under strict medical supervision. Its targeted mechanism of action and approval in multiple regions make it a valuable therapeutic option for patients with circadian rhythm-related sleep disorders, particularly those with total blindness or genetic conditions affecting sleep regulation.

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Frequently Asked Questions

Tasimelteon is used to treat non-24-hour sleep-wake disorder (Non-24) in totally blind individuals and other circadian rhythm sleep disorders.

Tasimelteon is made from the active pharmaceutical ingredient tasimelteon, a synthetic melatonin receptor agonist.

The trade name of Tasimelteon is Hetlioz.

Hetlioz is manufactured and marketed by Vanda Pharmaceuticals.

The generic name is tasimelteon.

The brand name is Hetlioz.

Tasimelteon is manufactured in GMP-approved facilities, primarily in the USA, for regulated use in circadian rhythm sleep disorders.

Yes, Tasimelteon 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, Tasimelteon 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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