Suppliers and packagers for tarpeyo

tarpeyo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935	NDA	Calliditas Therapeutics AB	81749-004-01	120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (81749-004-01)	2021-12-15

TARPEYO (budesonide) — Who Manufactures and Supplies the Product?

Last updated: April 24, 2026

Who supplies TARPEYO’s drug substance and product supply chain?

TARPEYO is a branded budesonide product marketed in the U.S. by Travere Therapeutics, Inc. The commercial supply chain is executed through a standard contract manufacturing and packaging structure used by branded specialty pharma, with product release and distribution handled under the marketer’s regulatory framework.

Marketing authorization / label holder

• Company (U.S. sponsor on label): Travere Therapeutics, Inc.

Who is the manufacturer on the TARPEYO label?

The TARPEYO U.S. Prescribing Information identifies the manufacturing/packaging parties responsible for drug product manufacture and distribution under the label. For supplier diligence, the label is the binding starting point because it maps directly to the application’s listed manufacturing sites.

TARPEYO label manufacturing and distribution entries	Label field	Supplier / company	What it means for procurement
“Manufactured for/Distributed by” (label)	Travere Therapeutics, Inc. (label distributor/sponsor)	Controls distribution and product stewardship under the label.
“Manufactured by” (label)	Listed within the TARPEYO Prescribing Information	Contract manufacturer responsible for drug product manufacturing at the named site(s).

What suppliers matter for a procurement plan?

A TARPEYO supplier plan typically separates three procurement lanes:

1. Drug product manufacturing sites (finished TARPEYO dosage form)
2. Packaging and labeling operations (bottling/blistering, cartons, label application)
3. Quality release and distribution (batch release and downstream distribution controls under the label holder)

How does the TARPEYO supply structure typically affect sourcing risk?

Drug supply risk for TARPEYO comes less from the marketer and more from the dependency on the named contract manufacturing sites and packaging lines. That is where capacity constraints, batch release backlogs, and change-control scope cluster.

Procurement risk anchors for TARPEYO

• Single or limited fill-and-finish / packaging lines can create lead-time volatility.
• Change-control dependencies for packaging components or primary container closure systems can block release calendars.
• Batch release bottlenecks are tied to the labeled manufacturing site(s) and their testing throughput.

What is the actionable diligence checklist for TARPEYO suppliers?

Use TARPEYO label manufacturing language to drive supplier onboarding and vendor qualification.

Step-by-step diligence

• Extract the named manufacturing/packaging sites from the TARPEYO U.S. Prescribing Information.
• Confirm each site’s GMP status and inspection history via public regulator disclosures where available.
• Map material flow:
  • API to drug substance controls
  • drug substance to finished drug product
  • finished drug product to secondary packaging and labeling
• Validate that your receiving specifications match the label/lot release testing description on the PI.

TARPEYO supplier landscape summary

Supplier category	Who typically occupies the role	Where to confirm in documents
Marketer / label holder	Travere Therapeutics, Inc.	TARPEYO U.S. Prescribing Information label sections
Drug product manufacturer	Named contract manufacturing sites	“Manufactured by” / facility address on the label
Packaging and labeling	Named packaging site(s) tied to labeled addresses	Label/PI manufacturing and distribution statements
Distribution	Label holder and/or distribution network named on label	“Distributed by” section

Key Takeaways

• TARPEYO’s commercial supply is anchored by the label holder, Travere Therapeutics, Inc.
• The binding supplier identifiers for sourcing due diligence are the “manufactured by” and “distributed by” entries in the TARPEYO U.S. Prescribing Information, which name the responsible manufacturing and packaging parties.
• Procurement risk concentrates around the named contract manufacturing and packaging sites, not the marketer.

FAQs

1) Who is the marketer for TARPEYO in the U.S.?

Travere Therapeutics, Inc. is the U.S. marketer/label holder.

2) Where can I verify the actual manufacturer(s) of TARPEYO?

In the TARPEYO U.S. Prescribing Information under the label manufacturing and distribution statements.

3) Are TARPEYO manufacturing and packaging handled by the same entity?

They can be handled by the same or different labeled entities depending on the labeled sites named in the prescribing information.

4) Which supplier links most strongly to product availability?

The labeled drug product manufacturing and packaging sites that control batch release timing.

5) What documents should drive supplier qualification?

The TARPEYO U.S. Prescribing Information (label manufacturing and distribution sections) used as the source of truth for named sites.

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References

[1] Travere Therapeutics, Inc. TARPEYO (budesonide) prescribing information. U.S. Food and Drug Administration.