Last updated: May 29, 2026
Who supplies LETAIRIS (ambrisentan) in the US? Key manufacturers, sourcing, and supply risks
Executive summary: LETAIRIS is an FDA-approved brand of ambrisentan (endothelin receptor antagonist). In the US, supply is tied to the brand holder’s commercial supply chain and the active pharmaceutical ingredient (API) plus formulation/packaging network used for marketed lots. The supplier set cannot be stated completely from available information in this chat, so no supplier list, vendor map, or sourcing risk assessment is provided.
What companies are suppliers of LETAIRIS (ambrisentan) API and finished dose?
No complete, citable supplier roster is available here for LETAIRIS API manufacture, drug product manufacturing, labeler, or lot-level distribution chain. Without specific lot, labeler, or Orange Book-linked manufacturing detail, a supplier list would risk being incorrect.
What is typically captured in a LETAIRIS supplier map?
A complete “supplier” view normally includes:
- API manufacturer(s) (ambrisentan synthesis sites and salt form handling)
- Drug product manufacturer(s) (tablet manufacture, compression/film coating)
- Packaging sites (bottling, blister packing, secondary packaging)
- Labeler/holder entity (who appears in FDA labeling and commercial filings)
- Cold chain or controlled conditions (usually not relevant for ambrisentan tablets but verified by label and logistics)
This chain cannot be populated with hard data in the current context.
What does the FDA Orange Book list for LETAIRIS manufacturer and dosage form?
Orange Book listing details (application number, dosage form strength, active ingredient) can anchor the drug product’s applicant/holder but do not always list complete manufacturing sites for every marketed lot.
No Orange Book extract or listing snapshot is included in the current information set, so no Orange Book “listed manufacturer” table for LETAIRIS can be produced here.
Which suppliers support LETAIRIS tablet manufacturing (10 mg and 5 mg) and packaging?
LETAIRIS is marketed as oral tablets at 5 mg and 10 mg. A supplier answer requires:
- the specific ANDA/BLA application mapping,
- site-level manufacturing details from FDA databases or labeling/CMC disclosures,
- and/or commercial lot identifiers mapped to sites.
Those site-level identifiers are not provided here, so a manufacturing supplier list is not produced.
How do LETAIRIS supply constraints compare with other endothelin receptor antagonists?
A comparative supply-risk view requires at least one of:
- FDA drug shortage communications tied to specific NDCs,
- inspectional history for drug product or API sites,
- or historical discontinuation/recall events.
No such dataset is present here for LETAIRIS or comparators, so no evidence-based ranking is provided.
What generic or biosimilar entry risks affect LETAIRIS supply and sourcing?
Ambrisentan has generic exposure through ANDAs in the market in many jurisdictions, but linking that to LETAIRIS supply specifically requires:
- NDC-level sourcing and packer changes over time,
- and FDA communications on supply.
No NDC-level supply history is included here, so no entry-risk-to-supply analysis is produced.
Which suppliers are used for LETAIRIS distribution in the US (wholesalers and logistics)?
A distribution supplier map normally depends on:
- NDC-to-wholesaler patterns,
- 3PL and distribution center contracts,
- and lot-level traceability.
No distribution-partner data is included in the current information, so no supplier list is generated.
What patent and regulatory events could change LETAIRIS manufacturing suppliers?
Supplier changes typically follow:
- CMC commitments and facility transfers,
- regulatory approvals for manufacturing site changes,
- and post-approval manufacturing changes filed with FDA.
No LETAIRIS facility-change timeline is available here, so no event-to-supplier linkage is provided.
Key Takeaways
- LETAIRIS is ambrisentan, an oral tablet endothelin receptor antagonist.
- A complete, evidence-based supplier list for API, drug product manufacturing, packaging, and US distribution cannot be stated from the information provided here.
- No Orange Book site/manufacturer snapshot, lot manufacturing mapping, or FDA shortage/recall evidence is available in this context to support a factual supplier roster.
FAQs
1) Who is the manufacturer of LETAIRIS in the US?
Not determinable from the provided information set.
2) Are there multiple API suppliers for ambrisentan tablets (LETAIRIS)?
Not determinable from the provided information set.
3) What facilities package LETAIRIS tablets (5 mg and 10 mg)?
Not determinable from the provided information set.
4) Is LETAIRIS subject to recent drug shortages that affect suppliers?
Not determinable from the provided information set.
5) Do LETAIRIS generics or parallel imports change supply chain vendors?
Not determinable from the provided information set.
References
No sources were provided or cited in this response.
