Last updated: April 26, 2026
Who manufactures and supplies TYVASO (treprostinil) products?
TYVASO (treprostinil) is supplied by United Therapeutics Corporation (maker/brand owner in the U.S.). The active ingredient is treprostinil (manufactured under cGMP by qualified suppliers), and the finished-dose inhalation products are produced by contract and internal manufacturing sites supporting United Therapeutics’ inhalation portfolio.
Because “suppliers” can mean either (1) finished-dose manufacturing sites (drug product manufacturers) or (2) raw-material (API) suppliers, the table below separates the supply base categories.
What is the drug product supply chain structure for TYVASO?
Drug product (finished dose) manufacturing and supply
TYVASO is marketed as a unit-dose inhalation system. The relevant manufacturing parties are listed in FDA labeling and registration documents, and are the entities that supply completed drug product to distributors/pharmacies.
| Supply category |
Entity type |
What it supplies |
Where it is documented |
| Brand owner / marketer |
United Therapeutics Corporation |
Commercialization and U.S. market supply chain oversight for TYVASO |
U.S. FDA product labeling and regulatory filings |
| Drug product manufacturer |
Finished-dose manufacturer (contract and/or internal) |
TYVASO unit-dose inhalation product |
FDA drug labeling (manufactured for / distributed by) and FDA registration systems |
| Distributor |
Wholesaler/distributor network partner(s) |
Product distribution to wholesalers and pharmacies |
U.S. distribution channels referenced in product labeling and commercial supply chain |
Who supplies the API for TYVASO (treprostinil)?
Treprostinil is the active ingredient in TYVASO. API suppliers are typically disclosed through (a) Drug Master Files (DMFs) and/or (b) FDA submissions that cite controlled manufacturing information, which are not always public by named company in the label itself.
| Supply category |
Entity type |
What it supplies |
Disclosure level in public sources |
| Treprostinil API |
API manufacturer (DMF holder or named manufacturer supporting submissions) |
Treprostinil used to manufacture TYVASO |
Public label often does not name the API supplier; may be discoverable via DMF and regulatory references |
What can be stated precisely from public FDA product labeling for TYVASO?
FDA product labeling commonly identifies:
- the company marketing the product,
- who manufactures or distributes the finished dosage form (often stated as “Manufactured for” / “Distributed by”),
- the strength and presentation, and
- U.S. contact and label sponsor.
Public, label-level identification of the finished-dose manufacturer and distributor is the most reliable “supplier” mapping that can be stated without relying on confidential DMF-level details.
TYVASO label-level supplier identities
| TYVASO product |
Label sponsor / marketer |
Finished product “manufactured for/distributed by” identity |
Publicly named in FDA label |
| TYVASO (treprostinil) inhalation solution |
United Therapeutics Corporation |
Manufacturer/distributor appears on the packaged label section (commonly “Manufactured for” / “Distributed by”) |
Yes, in the label |
Which TYVASO formats change the supplier mapping?
TYVASO has existed in multiple presentations over time (dose formats and packaging changes). Supplier mapping can change with:
- transfers of manufacturing between sites,
- contract manufacturer changes for one strength or packaging configuration,
- scale-up/line additions.
For business diligence, supplier identity should be checked against the exact National Drug Code (NDC) and the current FDA label for that presentation.
Actionable supplier diligence steps for TYVASO (how to identify the exact manufacturer for your NDC)
Use NDC-linked FDA labeling to lock down the drug product manufacturer
- Pull the current FDA label associated with the specific TYVASO NDC and strength.
- Extract the “Manufactured for” / “Distributed by” lines.
- Cross-check with current FDA registration listing for the manufacturing site linked to that product.
Use UDI/NDC and FDA registration data to map the manufacturing site
- Each finished-dose configuration maps to a manufacturing registration record under FDA’s drug establishment and device/labeling linkages.
- This yields the legal drug product manufacturer name and site address.
API supplier mapping (treprostinil) via DMF-level references
- Identify the DMF or listed API manufacture reference embedded in FDA submission summaries.
- Only public DMF disclosures will produce named API suppliers; some API source detail remains non-public.
Key Takeaways
- TYVASO is supplied under United Therapeutics’ U.S. brand ownership, and finished-dose supplier identities are typically captured in FDA labeling as “manufactured for” and “distributed by.”
- API suppliers for treprostinil are often not explicitly named on the public TYVASO label; mapping treprostinil API suppliers typically requires regulatory-document or DMF-level discovery.
- Supplier identity can shift by NDC and presentation, so diligence should start at the NDC-specific FDA label and registration.
FAQs
-
Is United Therapeutics the supplier of TYVASO finished drug product?
United Therapeutics is the brand sponsor/marketer; the finished-dose manufacturer is identified in the TYVASO label under “manufactured for” / “distributed by” language.
-
Can the treprostinil API supplier be read directly from the TYVASO label?
Often the public label does not name the API supplier; API source mapping usually requires DMF or submission-linked disclosures.
-
Do TYVASO supplier names change across product strengths or presentations?
They can. Contract and site assignments can vary by NDC and packaging configuration, so supplier diligence should be NDC-specific.
-
What is the most reliable public source to identify the TYVASO finished-dose manufacturer?
The current FDA product labeling for the specific TYVASO NDC and strength.
-
What is the most reliable method to identify the API supplier for treprostinil?
DMF-level or submission-level references tied to the specific product and regulatory filing history.
References
[1] U.S. Food and Drug Administration. TYVASO (treprostinil) prescribing information and FDA labeling (accessed via FDA Drugs@FDA).
[2] U.S. Food and Drug Administration. Drugs@FDA database (product label and regulatory information).
[3] U.S. Food and Drug Administration. Drug Establishment Registration and Listing (registration records for drug product manufacturing sites).
