Suppliers and packagers for HETLIOZ

HETLIOZ

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677	NDA	Vanda Pharmaceuticals Inc.	43068-220-01	30 CAPSULE in 1 BOTTLE (43068-220-01)	2014-04-04

Suppliers and packagers for HETLIOZ

Last updated: May 25, 2026

Suppliers for Hetlioz (tasimelteon): API, finished-dose manufacturers, and supply-chain risk

Executive summary: Hetlioz (tasimelteon) is supplied as an FDA-approved capsule (20 mg). The practical “supplier” stack relevant to buyers and competitors breaks into: (1) licensed U.S. marketing/label ownership, (2) the contract manufacturer(s) that produce finished capsules for commercial supply, (3) API sourcing, and (4) distribution-channel capacity. No sourcing details for Hetlioz API or finished-dose manufacturers are provided in the prompt, and an accurate supplier list requires Orange Book and FDA drug-label supply-chain identifiers plus confirmed filings and/or current distributor records. Per the constraints, this response cannot be completed without those verified facts.

Who supplies Hetlioz capsules in the US and who is the label owner?

Hetlioz is an FDA-approved medicinal product with a defined U.S. label holder and commercial distribution structure. To identify the actual supplier set, the required fields are:

• FDA label/Drug Listing name (U.S. applicant/holder)
• Orange Book listing (product-specific NDA and listed drug information)
• Manufacturer/Distributor section from the current prescribing information
• Lot-level supply chain (where available) from FDA/market data or company sourcing disclosures

Result: The prompt does not include label-holder name, NDA number, or any cited listing showing manufacturer/distributor or applicant. A correct “supplier” answer depends on those exact identifiers.

What does the Hetlioz prescribing information list for manufacturing and distribution?

The prescribing information typically lists:

• Manufacturer for drug product (finished capsules)
• Manufacturer for drug substance (API), if disclosed
• Distributor/marketing organization

Result: No prescribing information text or manufacturer/distributor data is included, so a supplier list cannot be stated accurately.

How to confirm Hetlioz supplier identity from the Orange Book?

An Orange Book entry for the NDA and strength provides:

• NDA holder
• Applicant/manufacturer for the listed drug
• Patent-linked product details
• Sometimes multiple listed products for the same dosage form

Result: No Orange Book entry details are provided.

What is the Hetlioz API (tasimelteon) supplier landscape?

For API sourcing, buyers typically look for:

• API manufacturer names tied to the NDA (drug substance section)
• DMF/ASMF-linked suppliers (where disclosed)
• Contract manufacturing networks for tasimelteon synthesis and final crystallization/polymorph control

Result: No NDA/DMF/ASMF identifiers or verified supplier names are included in the prompt, so an API supplier list cannot be produced without risking incorrect attribution.

Which contract manufacturers can make tasimelteon for US supply?

A defensible answer requires confirmed:

• API manufacturer(s) for commercial production
• Evidence from filings, label references, or procurement confirmations

Result: No evidence is provided.

Which finished-dose manufacturers produce Hetlioz capsules (20 mg) for commercial supply?

“Finished-dose supplier” can mean:

• The contract manufacturer producing the capsule dosage form
• The site(s) releasing finished product for the U.S. market
• The marketing/distribution entity in the U.S.

Result: No current drug product manufacturing sites or contract manufacturers are provided.

What manufacturing sites are used for Hetlioz capsules?

This requires:

• Current GMP site references in the label
• FDA inspection or establishment lists tied to the NDA product

Result: No site data is included.

How does Hetlioz supply reliability depend on its supplier chain?

Supply risk is driven by:

• Single vs multi-site drug product manufacturing
• API source concentration (tasimelteon synthetic steps and specialized intermediates)
• Regulatory constraints (cGMP compliance, validated processes, change-management history)

Result: With no supplier identities or site count provided, supply reliability cannot be quantified.

Are there alternative suppliers for Hetlioz beyond the original manufacturer?

Alternative suppliers can include:

• Contract manufacturers producing under tolling or license for the original holder
• Parallel distributors
• Authorized generics or re-labelers (if any)

Result: The prompt provides no information about authorized generics, distribution contracts, or alternative manufacturing authorizations.

What generic or competitor products create supplier displacement risk for Hetlioz?

Competitive products can affect supplier bargaining power if:

• API producers reallocate capacity
• Finished-dose CDMOs prioritize other NDA loads
• Waivers or shortages trigger re-sourcing

Result: No competitor list, launch timing, or supply incidents are provided.

Key Takeaways

• A complete, accurate answer on suppliers for Hetlioz (tasimelteon) requires confirmed U.S. label-holder and manufacturer/distributor identifiers, plus API sourcing facts.
• The prompt contains no such verified identifiers, so providing names would risk incorrect information.

FAQs

1. What is the NDA number for Hetlioz that maps to Orange Book supplier listings?
2. Does Hetlioz disclose its drug product and drug substance manufacturers on the label?
3. Which DMF/ASMF filings correspond to tasimelteon API suppliers used for commercial supply?
4. Do Hetlioz supply disruptions occur at the API step or the capsule manufacturing step?
5. Are there licensed alternative manufacturers for Hetlioz capsules in the U.S.?

References

1. [No cited sources in the prompt were provided.]