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Tasimelteon bulk supplier for pharma manufacturers

Tasimelteon 20 mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 20 mg

Reference Brands: Hetlioz (USA)

Category: Sleep Disorders

Tasimelteon is a Sleep Disorders product available as Capsules in strengths 20 mg. It corresponds to the reference brand Hetlioz (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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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.

Tasimelteon — third party manufacturing & bulk supply

Tasimelteon 20 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Indicative minimum order quantity

Tasimelteon is supplied as Capsules — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Tasimelteon listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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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.

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