Last Updated: June 24, 2026

Suppliers and packagers for TYVASO DPI


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TYVASO DPI

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
United Therap TYVASO DPI treprostinil POWDER;INHALATION 214324 NDA United Therapeutics Corporation 66302-610-02 1 KIT in 1 PACKAGE (66302-610-02) * 4 INHALANT in 1 BLISTER PACK * 4 INHALANT in 1 BLISTER PACK * 4 INHALANT in 1 BLISTER PACK 2022-05-23
United Therap TYVASO DPI treprostinil POWDER;INHALATION 214324 NDA United Therapeutics Corporation 66302-616-03 4 BLISTER PACK in 1 KIT (66302-616-03) / 7 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK 2022-05-23
United Therap TYVASO DPI treprostinil POWDER;INHALATION 214324 NDA United Therapeutics Corporation 66302-620-03 1 KIT in 1 PACKAGE (66302-620-03) * 4 INHALANT in 1 BLISTER PACK * 4 INHALANT in 1 BLISTER PACK 2022-05-23
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for TYVASO DPI

Last updated: April 25, 2026

Who Supplies TYVASO DPI? (Manufacturer and Key Upstream Sources)

TYVASO DPI is the dry-powder formulation of treprostinil inhalation, marketed in the US as Tyvaso DPI (treprostinil inhalation powder). The product is manufactured for market by United Therapeutics Corporation (brand owner) and produced through its commercial supply chain, with core development and formulation anchored to United Therapeutics’ treprostinil inhalation platform.

What is the brand’s manufacturer (market authorization holder/manufacturing responsibility)?

  • United Therapeutics Corporation is the company responsible for Tyvaso DPI commercialization and the associated US product filing/labeling ownership.

Who supplies TYVASO DPI to patients in the US?

  • United Therapeutics Corporation is the direct supplier through its marketed product program for the US.

What does the product contain that affects supplier scope?

TYVASO DPI is a treprostinil inhalation powder delivered using a DPI device system. Supply chain scope typically separates into:

  • Drug substance and finished drug product (treprostinil and powder formulation)
  • Inhalation device components (the DPI device system used by patients)
  • Packaging and distribution (bottles/blistering, cartons, labeling, distribution under GMP)

What upstream supplier categories exist for a DPI inhalation product?

For TYVASO DPI, upstream suppliers are typically organized into the same categories used across inhalation dry powder products:

  • API (treprostinil) supply
  • Formulation and particle engineering (powder blending)
  • Device supply (DPI actuator and relevant components)
  • Fill-finish and packaging under GMP

What publicly attributable supplier names are tied to TYVASO DPI?

No additional upstream vendor names are consistently and publicly disclosed in the accessible product-facing sources for TYVASO DPI beyond the brand owner and product responsibility.

Actionable business implication: if your goal is vendor qualification, commercial procurement, or competitive intelligence on CMOs/DMOs and component suppliers, the correct target is to trace current Tyvaso DPI manufacturing sites and component sourcing via regulatory manufacturing disclosure (labeling and product registration data) and device procurement records, then map those sites to known CMO/ODM capabilities. For TYVASO DPI specifically, the only reliably identified supplier in public product-facing materials is the brand owner and manufacturing responsibility: United Therapeutics Corporation.


Key Takeaways

  • United Therapeutics Corporation is the identified supplier/manufacturer responsible for Tyvaso DPI (treprostinil inhalation powder) in the US.
  • TYVASO DPI’s supply chain splits into treprostinil API/final powder manufacture, DPI device components, and GMP packaging/distribution, but publicly disclosed upstream vendor names are not clearly established from product-facing materials beyond the brand owner.
  • Vendor identification for CMO/DMO and device component supply requires mapping manufacturing and device disclosure tied to Tyvaso DPI’s regulatory product information.

FAQs

  1. Who is the manufacturer/supplier for TYVASO DPI in the US?
    United Therapeutics Corporation is the product manufacturer/supplier responsible for Tyvaso DPI commercialization and US product ownership.

  2. Is TYVASO DPI the same treprostinil as other Tyvaso forms?
    Yes. Tyvaso DPI uses treprostinil; the difference is the dry-powder inhalation formulation and DPI delivery system versus other inhalation formats.

  3. Does TYVASO DPI require a specialized inhalation device supplier?
    Yes. As a DPI, Tyvaso DPI includes a device system. Device component sourcing typically comes from separate device/ODM supply channels.

  4. Are API suppliers for treprostinil disclosed publicly for TYVASO DPI?
    Not reliably in standard public product-facing sources for Tyvaso DPI; disclosures typically require regulatory manufacturing details and traceability to sites and contracts.

  5. What supplier categories should procurement teams map for TYVASO DPI?
    Map API, powder formulation/fill-finish, device components, and GMP packaging/distribution.


References

[1] United Therapeutics Corporation. TYVASO DPI (treprostinil) US prescribing information/product materials.

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