Suppliers and packagers for VELETRI

VELETRI

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	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260	NDA	Actelion Pharmaceuticals US, Inc.	66215-402-01	1 VIAL in 1 CARTON (66215-402-01) / 10 mL in 1 VIAL	2010-04-22
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260	NDA	Actelion Pharmaceuticals US, Inc.	66215-403-01	1 VIAL in 1 CARTON (66215-403-01) / 10 mL in 1 VIAL	2010-04-22

Suppliers and packagers for VELETRI

Last updated: June 9, 2026

Veletri (epoprostenol) suppliers: API, formulation, and finished-dose manufacturing sources

Veletri (epoprostenol for injection) is supplied to the U.S. market by Xellia Pharmaceuticals for the finished product through its U.S. operations. The active pharmaceutical ingredient (API) and other upstream components are sourced through commercial supply chains, but public, company-attributed supplier names for the API and for every excipient/packaging item are not consistently disclosed in U.S. public regulatory and patent records.

Finished-dose supplier (U.S.)

• Finished product supplier/marketing channel: Xellia Pharmaceuticals (U.S.)

Upstream supplier transparency

• API supplier names: Not reliably enumerated in public FDA labeling, Orange Book entries, or publicly indexed patent assignee data in a way that supports a complete, supplier-by-supplier mapping.
• Excipients, sterile manufacturing consumables, and packaging components: Supplier identities are typically governed by confidential qualification and supply agreements and are not consistently published in FDA reviews or Orange Book listings.

Who manufactures Veletri (epoprostenol) in the U.S.?

Answer: Xellia Pharmaceuticals supplies/manufactures the finished Veletri injection product for the U.S. market under commercial distribution.

What to check in public records

• FDA product labeling (Highlights of Prescribing Information; “Manufactured for” / “Distributed by” blocks)
• FDA Orange Book entry for Veletri (active ingredient and dosage form; some label blocks reflect manufacturer/distributor, while not always listing “site”)
• NDC directory and label imprint text (can indicate the firm named on the carton or label)

What companies supply the epoprostenol API for Veletri?

Answer: A complete public list of epoprostenol API suppliers for Veletri is not consistently disclosed in U.S. public records.

Why supplier names are hard to enumerate

• API supply is often handled via qualified commercial sources and contract manufacturing with limited disclosure.
• Orange Book listings usually tie the product to the NDA and sometimes a listed manufacturer/distributor, not a full API supplier chain.
• Patent filings can identify process inventors/assignees, but they do not systematically disclose commercial API vendors.

Which formulations and strengths are supplied, and does that change sourcing?

Answer: Supplier and manufacturing qualification can differ by presentation (e.g., vial fill size, kit configuration, diluent/transfer components) even when the active ingredient is the same. Public supply-chain maps by strength are not fully enumerated in FDA public artifacts.

Practical implications for sourcing

• Sterile aseptic processing and container closure systems can drive different qualified sites.
• The supplier named on labeling can differ from an internal manufacturing site name, depending on contract manufacturing structures.

Does Veletri rely on contract manufacturing, and how does that affect supplier visibility?

Answer: Yes, Veletri’s finished-dose supply chain is consistent with modern contract manufacturing and commercialization structures, which reduces the completeness of publicly visible supplier lists.

Contract structures that obscure “who supplies what”

• NDA holder branding with contract sterile filling and finishing
• Separate roles for:
  • API procurement
  • sterile drug product manufacturing
  • packaging and kit assembly
  • distribution

What Orange Book status does Veletri have, and does it indicate any other suppliers?

Answer: Orange Book status is useful for exclusivity and generic/505(b)(2) competition risk, but it does not reliably enumerate upstream API suppliers for the reference product.

What Orange Book listings typically show

• NDA number
• active ingredient (epoprostenol)
• dosage form
• patent numbers linked to formulation/process/method-of-use (if available)
• exclusivity periods

How do Veletri supplier choices impact generic entry risk (and who might challenge it)?

Answer: Generic entry risk is driven by patent/exclusivity status and bioequivalence/clinical comparability for epoprostenol formulations, not by publicly disclosed upstream supplier identities.

Why “supplier list” is not the key variable

• A generic can source from different API vendors and still be blocked by:
  • listed patents
  • exclusivity periods
  • formulation/process IP barriers
  • sterile manufacturing and quality system constraints

What manufacturing/IP barriers can constrain alternative suppliers?

Answer: The main barriers are typically:

• sterile aseptic manufacturing qualification and container closure system performance
• process patents or trade-secret know-how covering sterile preparation or handling
• regulatory expectations for stability, leachables, and dose delivery uniformity

Veletri is operationally complex

• Epoprostenol is chemically unstable and generally requires controlled preparation and administration practices, which increases the regulatory and manufacturing burden for any alternate supplier.

How does Veletri’s supply compare with other epoprostenol brands?

Answer: Direct supplier-to-supplier comparisons between brands are limited by disclosure gaps in public records. Competitive differentiation is often driven by:

• labeled manufacturer/distributor identity
• kit configuration and delivery method
• aseptic manufacturing site qualification

Cross-brand supplier mapping limits

• Public documents often name a firm associated with labeling/distribution, not every upstream supplier.

Key Takeaways

• Finished-dose supply for Veletri (U.S.): Xellia Pharmaceuticals is the public-facing supplier for the finished injection product.
• API supplier identification: Public records do not provide a complete, verifiable list of epoprostenol API suppliers used for Veletri.
• Upstream supplier visibility is constrained by typical contract qualification and confidentiality practices.
• Generic or biosimilar-style entry risk depends on Orange Book patents and exclusivity, not on publicly visible upstream supplier identities.
• Manufacturing barriers are primarily sterile aseptic processing qualification, stability/handling constraints, and IP tied to product/process.

FAQs

1. Where is the firm name shown on Veletri labeling and how should that be interpreted for “supplier”?
   Check the “Manufactured for” and “Distributed by” blocks on the FDA-approved label and carton/NDC imprint; this indicates the responsible labeling firm, which may differ from the internal manufacturing site.

2. Does the Orange Book list epoprostenol API suppliers for Veletri?
   No; it typically lists NDA/product information and listed patents/exclusivity, not complete upstream API vendor rosters.

3. Can Veletri’s API be sourced from multiple vendors without changing the reference product?
   Yes in practice, since qualified API suppliers can vary while maintaining the same labeled product, as long as regulatory quality standards are met.

4. Do different Veletri package configurations change which manufacturers are involved?
   They can, because sterile filling, finishing, kit assembly, and packaging qualification can be split across sites with different responsible firms.

5. What is the fastest way to confirm a current Veletri supplier for procurement?
   Use the current label/NDC listing associated with the specific package size and lot, then verify against the firm named on the label and any current FDA label revisions tied to that NDC.

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References

1. U.S. Food and Drug Administration. Veletri (epoprostenol) prescribing information and label (accessed via FDA drug labeling).
2. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Veletri, epoprostenol).
3. DailyMed. Veletri (epoprostenol) drug label (accessed via dailymed.nlm.nih.gov).
4. FDA. Drugs@FDA database for Veletri (NDA entry and label history).