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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actelion	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279	NDA	Actelion Pharmaceuticals US, Inc.	66215-232-56	4 BLISTER PACK in 1 CARTON (66215-232-56) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66215-232-14)	2021-07-29
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290	NDA	Actelion Pharmaceuticals US, Inc.	66215-101-03	10 BLISTER PACK in 1 CARTON (66215-101-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK	2001-11-20
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290	NDA	Actelion Pharmaceuticals US, Inc.	66215-101-06	1 BOTTLE, PLASTIC in 1 CARTON (66215-101-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2001-11-20
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290	NDA	Actelion Pharmaceuticals US, Inc.	66215-102-03	10 BLISTER PACK in 1 CARTON (66215-102-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK	2001-11-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 27, 2026

Tracleer is supplied through multiple manufacturing and distribution channels, with the brand’s marketed supply tied to the specific licensed site(s) used for each market’s regulatory authorization and to the wholesaler/distributor network supporting import and commercial logistics. The “supplier” set for Tracleer is therefore a mix of (1) marketing authorization holders and (2) contract manufacturers listed in regulatory filings and (3) national wholesaling/distribution partners.

What companies supply Tracleer (bosentan) in the US?
Featured snippet answer: Tracleer in the US is supplied through authorized FDA-registered drug manufacturing and distribution channels tied to the approved label and associated FDA drug listing. The relevant “supplier” entities are those named on the FDA label and in FDA drug registration listings for the specific dosage forms (film-coated tablets and strengths).

US supply chain structure: who qualifies as a “supplier”

Tracleer’s US “supplier” universe typically splits into three buckets:

Marketing and label responsibility: the company responsible for the approved brand labeling and FDA registrations for the marketed product.
Manufacturing sites: contract or internal manufacturing plants that produce the drug product for US release under the approved marketing authorization.
Distribution/wholesaling: entities that deliver to US wholesalers and pharmacies under normal pharmaceutical distribution agreements (not always named on the public label, but shown through distribution records and wholesaler networks).

How to map Tracleer “supplier” entities for US commercial use

For any supplier assessment (licensing, diligence, sourcing, or dispute risk), the executable approach is to anchor on:

FDA label “Manufactured for / Manufactured by” language for each strength and dosage form.
FDA registration and listing entries for drug product manufacturing and for distributor/labeler roles.
Authorized trading partners in the national supply chain (often visible in procurement data and commercial filings rather than in the label).

What companies manufacture bosentan for Tracleer tablets (originator supply)?

Tracleer tablets are manufactured as finished drug product by one or more registered manufacturing sites. These sites appear in public label text and regulatory product documentation. For supplier diligence, the critical question is whether the same site makes all strengths (or multiple sites support 62.5 mg and 125 mg), and whether the manufacturing is internal or outsourced.

Dosage forms covered by Tracleer supply

Tracleer 62.5 mg tablets
Tracleer 125 mg tablets

Contract manufacturing vs internal manufacturing

Tracleer’s brand supply has historically relied on manufacturing networks that include:

Licensed drug product manufacturers (tableting/film coating and packaging)
Active ingredient supply chain (bosentan API is sourced and controlled through validated suppliers, typically not listed on the consumer-facing label but traceable in manufacturing registration records)

Which suppliers provide bosentan API and excipients for Tracleer?

API and excipient supply does not map cleanly to “supplier” names on the consumer label. The API and key excipient supplier universe is normally captured in:

CMC disclosures and manufacturing agreements
Drug master files or cross-referenced DMFs (when used)
Quality agreements tied to the approved commercial manufacturing sites

What’s usually discoverable from public documentation

Even when API suppliers are not named on the label, supplier due diligence can still identify:

API manufacturing site(s) registered under FDA or other regulators
Drug product manufacturing site(s) that certify finished product release

What is the Orange Book status of Tracleer and what does it imply for suppliers?

Tracleer is a brand-name small molecule indicated for pulmonary arterial hypertension (PAH) and is generally followed by generic competition over time. Orange Book status drives generic availability, which in turn changes the supplier landscape for the market as multiple manufacturers distribute lower-cost equivalents.

How Orange Book status affects supply risk

Brand continuation: when exclusivity and patent protection remain, supply may be concentrated in fewer channels.
Generic entry: when generics launch, procurement suppliers broaden (multiple ANDA manufacturers and labelers).
Supply continuity: manufacturing changes and scale adjustments are common around launches, affecting lead times and cost.

Which generics compete with Tracleer and how does that change “supplier” options?

Once generics are approved, the market shifts from single-brand supply to multiple ANDA labelers and manufacturing sites. For a purchaser, supplier options expand while supply reliability depends on:

Which ANDA manufacturers are actively commercial
Whether any are under supply constraints
Which strengths/dosage forms are produced at which sites

Comparative landscape: brand vs generic sourcing

Tracleer: higher price, originator-managed supply chain and fixed manufacturing footprint.
Generics: more bidders for API and contract manufacturing capacity, often with multiple sites and labelers.

When does Tracleer lose exclusivity, and what generic entry risks exist for manufacturers?

Exclusivity and patent timelines determine when Paragraph IV filings and authorized generic strategies can affect market supply. Supplier planning should track:

Patent expiration for formulation and method-of-use claims
Any settlements that accelerate or delay generic launches
Whether additional pediatric exclusivity or data exclusivity impacts launch timing

Launch-timing impacts on supplier strategy

Pre-expiration: supplier contracts for API and packaging are typically stable.
Post-patent: procurement shifts toward competing labelers and lower-cost bids, increasing price volatility and supply swapping.

What patent or litigation events affect Tracleer supply and sourcing?

Patent litigation can change supplier risk in two ways:

Generic launch delay: fewer competitors remain in-market.
Market share shifts: after settlements, specific generic entrants may launch, changing the effective supplier pool.

Practical effect for suppliers and purchasers

If fewer competitors launch, the brand’s available supply may face tighter distribution capacity.
If multiple generics launch together, distributors may split volume across multiple ANDA labelers, reducing concentration risk for some suppliers.

How do global market authorizations change Tracleer supplier coverage?

Tracleer’s supplier list varies by jurisdiction due to:

Different marketing authorization holders
Different registered manufacturing sites per country
National import and distribution networks

What global “supplier mapping” typically includes

Country-by-country label language listing manufacturing site(s)
Local marketing authorization holder responsibilities
Distribution agreements with major wholesalers and pharmacy chains

What are the main procurement suppliers for Tracleer tablets in commercial distribution?

In the US, procurement suppliers are usually wholesalers and specialty pharmaceutical distributors plus authorized purchasing channels. The practical way to identify them for a buyer is through:

Contract pharmacy and hospital group purchasing organizations
Wholesaler catalog availability (strength and pack size)
Specialty distributor fulfillment routes

Procurement unit considerations

Tablet strength (62.5 mg vs 125 mg)
Bottle size and packaging configuration
Cold chain is not typical for tablets, so lead time is dominated by manufacturing and release capacity rather than temperature requirements

Key data table: Tracleer “supplier” categories to use for diligence

Supplier category	What it controls	Where it is verified for Tracleer	Why it matters
Marketing authorization holder / labeler	US/EU submissions, label ownership, regulatory responsibility	FDA label, registration listings	Determines who is accountable for supply and recall actions
Drug product manufacturing site	Finished tablet production, coating, packaging	FDA label “Manufactured for/by,” FDA registrations	Determines batch release capacity and change control risk
API / key material manufacturers	API supply continuity and quality	Regulatory registrations and CMC-linked sources	Determines upstream risk and cost drivers
Wholesalers and distributors	Retail and hospital fulfillment routes	Procurement networks and authorized distribution records	Controls delivery reliability and substitution practices
Generic ANDA manufacturers (post-launch)	Competing supply into distribution	Orange Book, ANDA approvals, labeler listings	Expands supplier options and reduces concentration

Key Takeaways

Tracleer “suppliers” should be treated as a regulatory supply-chain problem, not a single-company list: marketing responsibility, manufacturing sites, and distribution channels each create different supplier identifiers.
The most reliable supplier mapping for due diligence is built from FDA label/manufacturing language plus FDA drug registration listings by strength (62.5 mg and 125 mg).
Patent and exclusivity status affect how quickly generics enter, which materially changes the supplier pool (and supply reliability dynamics) for purchasers.

FAQs

How can I identify Tracleer tablet manufacturing sites for each strength (62.5 mg vs 125 mg)?
Do Tracleer generics use the same manufacturing sites as the brand?
Which regulatory listings show the labeler and manufacturing responsibilities for Tracleer in the US?
How do wholesaler substitutions work for Tracleer when generics are available?
What procurement risks increase during Tracleer transitions between brand supply and generic competition?

References

FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA.
FDA Drug Registration and Listing System (DRLS) and public labeling records for Tracleer (bosentan). US FDA.
DailyMed, Tracleer (bosentan) prescribing information and label manufacturing text. US National Library of Medicine.

Suppliers and packagers for tracleer

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Tracleer (bosentan) Drug Suppliers: What Companies Manufacture, Supply, and Distribute the Brand Across Markets