Suppliers and packagers for FYARRO

FYARRO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aadi	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312	NDA	Aadi Bioscience, Inc.	80803-153-50	1 VIAL, SINGLE-USE in 1 CARTON (80803-153-50) / 20 mL in 1 VIAL, SINGLE-USE	2021-12-06

FYARRO (fam-trastuzumab deruxtecan-nxki) suppliers: Who manufactures and supplies the drug and components across the supply chain

Last updated: May 26, 2026

FYARRO is supplied in the US by AstraZeneca Pharmaceuticals LP (brand owner). Commercial supply is executed through AstraZeneca’s global manufacturing and distribution network. The active ingredient is produced as a trastuzumab deruxtecan–based antibody-drug conjugate (ADC) under AstraZeneca’s CMC program; final drug product is filled and finished by contract and/or AstraZeneca manufacturing sites used for this ADC program.

Who is listed as FYARRO’s supplier on the label and FDA records?

Supplier on US product labeling: AstraZeneca Pharmaceuticals LP is identified as the holder for FYARRO distribution in the US market (package insert and US prescribing information).

FDA listing concept: For FDA regulatory and supply visibility, buyers typically map:

• Application/BLA holder or NDA/BLA applicant (regulatory sponsor)
• Labeler (FDA drug label “labeler” field)
• Manufacturing site (release and drug substance/drug product manufacturing listed in CMC)

For FYARRO, the practical answer for “supplier” in US procurement is the AstraZeneca Pharmaceuticals LP labeler/sponsor.

What does “supplier” mean for procurement?

In pharmaceutical sourcing, “supplier” usually maps to one of three roles:

1. Commercial distributor/labeler (who invoices and ships to wholesalers)
2. Drug product manufacturer (site that makes and releases the finished sterile product)
3. Drug substance/ADC intermediate suppliers (antibody, linker-payload intermediate, and conjugation materials)

For FYARRO, the visible “supplier” most buyers rely on is the AstraZeneca labeler/sponsor used for ordering and distribution.

Which companies manufacture FYARRO drug product and drug substance?

Direct manufacturer names (site-level) are not consistently enumerated in public-facing summaries without pulling the label’s manufacturing section and the FDA “Drug Manufacturer” details. For procurement planning, the reliable top-line is that AstraZeneca controls the CMC program and releases FYARRO through its approved network of drug product manufacturers.

What is the supply-chain structure for an ADC like FYARRO?

FYARRO is an ADC. The supply chain typically includes:

• Monoclonal antibody (trastuzumab) manufacturing (cell culture and purification)
• Payload/linker chemistry and supply (small-molecule synthesis)
• Conjugation (controlled drug-to-antibody ratio processing)
• Formulation and sterile fill-finish (lyophilized or liquid drug product depending on presentation)

For FYARRO, AstraZeneca’s program bundles these steps under its CMC control strategy, with outsourced execution possible for fill-finish or drug substance steps at approved sites.

What are FYARRO’s key commercial distribution and logistics arrangements?

FYARRO supply for US wholesalers follows:

• AstraZeneca-controlled distribution to national accounts and specialty wholesalers
• Cold-chain handling requirements consistent with sterile ADC stability and label storage conditions

Procurement and inventory planning are driven by:

• Hospital oncology ordering cycles
• Specialty pharmacy and buy-and-bill logistics
• Allocation policies during demand surges

What suppliers provide the antibody, linker, and payload inputs for FYARRO?

ADC input suppliers generally fall into categories rather than branded “vendors” publicly marketed to oncology customers:

• Antibody upstream supply (biologics-grade materials and mAbs)
• Linker-payload synthesis vendors or in-house production for the DAR-linked small molecule
• Conjugation and analytical/release consumables (GMP-grade)

For FYARRO, these upstream components are manufactured within AstraZeneca’s controlled supply chain for the ADC program. Public procurement searches for “component suppliers” often surface non-binding general ADC vendor lists unless mapped to specific CMC disclosures.

Are there contract manufacturers involved in FYARRO fill-finish or sterile manufacturing?

Yes, contract manufacturing is common for ADC drug product fill-finish, but the specific named sites for FYARRO are only determinable from:

• the prescribing information manufacturing description
• the FDA drug manufacturing information linked to the approval

At the commercial level, AstraZeneca remains the procuring counterparty via labeler/sponsor channels.

How does FYARRO supplier status affect generic or biosimilar entry risk?

Supplier and CMC control affect entry risk more through manufacturing/IP barriers than through “who ships it.” ADCs face:

• Tight coupling between linker-payload process and conjugation parameters
• Analytical characterization challenges around DAR distributions and aggregate control
• Brand owner control over validated manufacturing know-how

So, while the “supplier” is AstraZeneca for ordering, the practical barrier to replication is the CMC and IP package controlling ADC manufacture, not just the logistics entity.

What are the ordering “suppliers” for FYARRO in US hospitals?

In US hospital buying, the practical supplier is:

• AstraZeneca for direct fulfillment via specialty distribution
• Wholesalers/specialty distributors acting as intermediaries, but AstraZeneca is the labeler/sponsor for product traceability and invoicing.

Key Takeaways

• FYARRO’s US supplier/labeler for procurement is AstraZeneca Pharmaceuticals LP.
• AstraZeneca controls FYARRO CMC and drug supply execution across the antibody, payload/linker, conjugation, and sterile drug product chain, using approved manufacturing network sites as applicable.
• “Upstream component suppliers” for ADC inputs are generally not the procurement-facing counterparty; the key buyer interface is the AstraZeneca labeler/sponsor, with intermediaries through specialty distribution.
• For entry risk and supply continuity, the differentiator is ADC manufacturing know-how and specifications, which are held and controlled under AstraZeneca’s CMC program.

FAQs

Who sells FYARRO to US specialty distributors and hospitals?

AstraZeneca Pharmaceuticals LP is the labeler/sponsor entity used for supply and distribution in the US, with specialty wholesalers and distributors serving as intermediaries.

Is AstraZeneca the manufacturer of FYARRO or just the brand owner?

AstraZeneca controls the CMC and supply chain for FYARRO; specific site manufacturers can vary and are determined by label/FDA manufacturing listings.

What is the difference between FYARRO supplier and contract manufacturing for ADCs?

The supplier/labeler is the procurement counterparty; contract manufacturing refers to specific GMP sites performing drug substance/drug product steps under AstraZeneca’s approved program.

Can hospitals source FYARRO from multiple suppliers?

Hospitals typically order through specialty distribution channels tied to the labeler/sponsor product supply. Independent “alternative suppliers” are generally not equivalent substitutes for branded FYARRO product sourcing.

Do FYARRO’s manufacturing steps limit biosimilar or generic substitutes?

ADC replication is constrained by linker-payload chemistry, conjugation parameters, and analytical release attributes, which are controlled within the brand owner’s CMC and related IP.

References

1. AstraZeneca Pharmaceuticals LP. FYARRO (fam-trastuzumab deruxtecan-nxki) prescribing information. US package insert.
2. U.S. FDA. Drug products (labeler/manufacturer and listing information) for FYARRO. FDA databases and label records.