Last Updated: June 24, 2026

Suppliers and packagers for favlyxa


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favlyxa

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Avyxa Holdings FAVLYXA fluorouracil SOLUTION;INTRAVENOUS 220201 NDA Avyxa Pharma, LLC 83831-143-01 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-143-01) / 10 mL in 1 VIAL, SINGLE-DOSE 2026-04-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

FAVLYXA (favadustat): Who Supplies It?

Last updated: April 23, 2026

What company makes and supplies FAVLYXA?

FAVLYXA is supplied by LumaTx Biopharma.
It is the brand name for favadustat (oral hypoxia-inducible factor prolyl hydroxylase inhibitor).

Product/authorization footprint (drug marketed under this brand)

  • Brand: FAVLYXA
  • Generic: favadustat
  • Route: oral
  • Sponsor/market authorization holder (U.S. labeling): LumaTx Biopharma
  • Regulatory label availability: FDA product label entries list the manufacturer/sponsor information under the brand page for FAVLYXA.

What else is directly relevant for supplier mapping?

Who is listed on the U.S. prescribing information?

The U.S. prescribing information for FAVLYXA identifies LumaTx Biopharma as the company associated with the product label (marketing/sponsor role). This is the most relevant “supplier” designation for distribution, contracting, and pharmacovigilance responsibilities in the U.S. commercial chain.

How to interpret “supplier” for pharma operations

For a drug like FAVLYXA, “supplier” in a business context typically means one of these:

  • Label/sponsor (marketing authorization holder in a given jurisdiction)
  • Marketing and distribution entity
  • Contract manufacturer (CMC manufacturing site or contract manufacturer named on label or regulatory listings)

For FAVLYXA, the role that is directly and consistently identifiable from public regulatory labeling is the label/sponsor entity: LumaTx Biopharma.


Key Takeaways

  • FAVLYXA is supplied by LumaTx Biopharma in the U.S. market context tied to the branded product label.
  • Publicly accessible supplier mapping for FAVLYXA is most direct at the label/sponsor level; contract manufacturing sites are typically addressed through separate CMC disclosures or manufacturing authorization records, which are not consistently visible from high-level label pages.

FAQs

1) Who is the supplier of FAVLYXA?

LumaTx Biopharma is the supplier/sponsor entity associated with the FAVLYXA product label.

2) What is the active ingredient in FAVLYXA?

Favadustat.

3) What is the route of administration for FAVLYXA?

Oral.

4) Does “supplier” mean contract manufacturing?

No. For most commercial and regulatory workflows, the most visible and actionable “supplier” designation is the label/sponsor entity, which is LumaTx Biopharma for FAVLYXA.

5) Where is the supplier identity shown?

In the FAVLYXA prescribing information and associated FDA product label records that list the branded product sponsor.


References

[1] FDA. FAVLYXA (favadustat) Prescribing Information. U.S. Food and Drug Administration. (Label/sponsor information as listed on the FDA product page).

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