Suppliers and packagers for uptravi

uptravi

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actelion	UPTRAVI	selexipag	POWDER;INTRAVENOUS	214275	NDA	Actelion Pharmaceuticals US, Inc.	66215-718-01	1 VIAL, SINGLE-DOSE in 1 CARTON (66215-718-01) / 10 mL in 1 VIAL, SINGLE-DOSE	2021-07-29
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947	NDA	Actelion Pharmaceuticals US, Inc.	66215-602-06	1 BOTTLE in 1 CARTON (66215-602-06) / 60 TABLET, COATED in 1 BOTTLE	2015-12-21
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947	NDA	Actelion Pharmaceuticals US, Inc.	66215-602-14	1 BOTTLE in 1 CARTON (66215-602-14) / 140 TABLET, COATED in 1 BOTTLE	2015-12-21

Suppliers and packagers for uptravi

Last updated: May 28, 2026

Uptravi (selexipag) Suppliers: API, Contract Manufacturers, and Key Supply-Chain Players

Uptravi’s supply chain is anchored by the drug’s originator, Janssen Biotech (Janssen/J&J), with commercial distribution in the US and global markets supported by third-party logistics and manufacturing networks. The sourcing model for Uptravi (selexipag) is best understood as (1) originator-controlled governance of the product, (2) outsourced manufacture of one or more dosage-form components under contract, and (3) secondary manufacturing and packaging steps handled by CDMOs. Public disclosures typically identify the brand owner and dosage-form status in FDA records, while operational supplier names for the drug’s active ingredient and finished dosage form are often limited in open sources.

Who manufactures Uptravi (selexipag) in the US?

Brand owner / FDA application holder: Janssen Biotech, Inc. is listed as the NDA holder and primary contact entity for Uptravi in FDA product records.
Finished dosage form: Uptravi is marketed as oral tablets (strengths vary by titration regimen).

What does the Orange Book show for Uptravi manufacturers?

The Orange Book record for a listed drug generally ties:

• Application holder (NDA holder) to the product listing
• Dosage form and strength
• Patent and exclusivity information (not supplier-level manufacturing identities)

Open Orange Book listings do not routinely publish the names of all contract manufacturing sites or API suppliers. For Uptravi, the public-facing FDA identifiers typically surface the NDA holder rather than every upstream supplier.

What US supply-chain roles exist besides the NDA holder?

For a branded oral solid like Uptravi, the supply chain usually includes:

• API production (active ingredient selexipag)
• Drug substance purification, crystallization, and stabilization
• Tablet manufacturing (blending, granulation, compression)
• Film coating and packaging
• Labeling and distribution through wholesalers and logistics partners

Public documents more commonly name NDA holders and commercial distributors than every manufacturing site.

What companies supply the Uptravi active pharmaceutical ingredient (selexipag)?

Open-source supplier lists for selexipag API are not consistently published in a way that allows a reliable, complete mapping to named companies for every stage of production.

Which entities are typically visible for selexipag upstream supply?

For orphaned-to-highly controlled specialty brands, public visibility usually comes from:

• FDA inspections and establishment listings (site-level names may appear, but not always as “API supplier”)
• Procurement disclosures in corporate filings (often not present)
• Patent documents and regulatory submissions that name applicants, assignees, and manufacturing processes

What patent assignees indicate upstream manufacturing and process development control?

Patent estates for selexipag typically cluster around the originator’s assignees, aligning with originator control over process. This correlates with a model where API is produced either by the originator’s own network or qualified contract producers under quality agreements.

Which contract manufacturers (CDMOs) make Uptravi tablets?

Public sources rarely provide a single, complete “CDMO list” for Uptravi tablets. When contract manufacturers are involved, their identities are more likely to be visible in:

• FDA establishment databases tied to manufacturing/packaging operations
• Site-specific regulatory documentation
• Corporate manufacturing footprints

What manufacturing steps are most likely outsourced for Uptravi?

For oral solids, outsourcing is common in:

• Tableting and coating (finished dosage form)
• Packaging (bottles, cartons, labeling)
• Specialized blending/granulation steps

API and critical steps can also be outsourced, but supplier identifications are often not published in marketing-facing material.

How does Uptravi distribution work: who are the logistics and wholesale suppliers?

Brand distribution in the US typically uses:

• Wholesaler-distributors (pharmacy channel)
• Specialty distribution partners (if required by payer channel)
• Third-party logistics for fulfillment and cold-chain is generally not required for Uptravi tablets, but temperature-controlled storage may still apply.

Public commercial distribution partners are usually not branded as “suppliers” in FDA records; they are channel participants.

What FDA manufacturing site data is available for Uptravi establishments?

FDA establishment registration data can identify manufacturing and packaging site names tied to a product’s operations. That data is more precise than general “supplier” claims, but public web extracts vary and do not always map cleanly to:

• API vs drug product
• multiple tablet strengths
• secondary packaging versus primary packaging

For a defensible supplier map, the proper approach is to use FDA establishment records for Uptravi to enumerate listed facilities by operation type.

What companies are associated with Uptravi quality system and regulatory oversight?

Regulatory oversight is anchored by:

• NDA holder governance: Janssen Biotech, Inc.
• GMP quality oversight: Janssen quality systems and contract partner quality agreements
• Regulatory submissions: Janssen’s submission and labeling teams

Quality system ownership generally remains with the NDA holder even when manufacturing is contracted.

Are there multiple suppliers for Uptravi to ensure continuity of supply?

For a titration-driven oral specialty product, continuity typically requires:

• Qualified secondary manufacturing sites for drug product
• Back-up packaging and labeling vendors
• Multiple API supply sources where feasible

Public evidence for specific “supplier diversification” usually exists through establishment listings and inspection histories rather than marketing statements.

Key Takeaways

• Uptravi’s NDA holder and primary US regulatory owner is Janssen Biotech, Inc.
• Public-facing “supplier” identification for selexipag API and tablet manufacturing is limited; open sources more reliably name the NDA holder than every contract manufacturer.
• FDA establishment data is the most defensible way to enumerate manufacturing and packaging sites linked to Uptravi, but those are operational facilities rather than packaged “supplier lists.”

FAQs

1) Who is the NDA holder for Uptravi (selexipag) in the US?
Janssen Biotech, Inc.

2) Does the Orange Book list Uptravi contract manufacturers?
Orange Book listings focus on the application holder and regulatory patent/exclusivity data, not a complete list of CDMOs or API suppliers.

3) Where can you find facility-level manufacturing/packaging identities for Uptravi?
FDA establishment registration databases tied to the product’s manufacturing and packaging operations.

4) Are there backup manufacturing sites for Uptravi tablets?
Most branded oral solids use qualified secondary sites, but facility identities must be verified via FDA establishment records.

5) How can patents help identify Uptravi manufacturing and control entities?
Patent assignees and disclosed process control concepts align with originator control, but patents rarely provide a complete, operational “supplier” roster.

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References (APA)

1. Janssen Biotech, Inc. Uptravi (selexipag) NDA holder information in FDA product labeling and regulatory records. US Food and Drug Administration.
2. U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Uptravi entry for selexipag).
3. U.S. FDA Drug Establishment Registration and Listing database. (Facility registration records for Uptravi manufacturing and packaging operations).