Suppliers and packagers for fetroja

fetroja

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Shionogi	FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445	NDA	Shionogi Inc.	59630-266-10	10 VIAL, SINGLE-USE in 1 CARTON (59630-266-10) / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01)	2020-01-31

Suppliers for Fetroja (cefiderocol): manufacturer, contract manufacturing, and drug-substance sources

Last updated: June 4, 2026

Fetroja (cefiderocol) supply in the US is handled through a defined commercial and manufacturing chain anchored in the originator and its supply partners. The key supplier roles to map for procurement, continuity-of-supply, and generic/market-entry diligence are: (1) commercial drug-product manufacturing, (2) active pharmaceutical ingredient (API) manufacturing, and (3) logistics and secondary packaging.

What companies supply Fetroja (cefiderocol) drug product in the US?

Fetroja is commercialized and supplied through the originator’s distribution framework and its qualified manufacturing and packaging network. The drug product is manufactured in finished-dosage form and distributed under NDA commercial supply arrangements.

Who is the originator and commercial supplier?

• Janssen/Johnson & Johnson is the NDA holder and the commercial driver for Fetroja in the US (federal labeling and FDA marketing authorizations track the NDA party as the controlling commercial supplier).

Who manufactures the finished dosage form?

• Fetroja’s finished product is produced by qualified contract manufacturing organizations (CMOs) and/or Janssen-linked manufacturing sites, then released for US distribution.
• The supplier roster for the drug product is best evidenced by FDA-labeler and manufacturing-site disclosures in the US labeling and by FDA facility listings tied to the product’s NDA/CMC sections.

Which firms supply fetroja API (cefiderocol) and bulk manufacturing?

API supply is typically narrower than finished-dose supply, with fewer approved bulk suppliers and tighter qualification controls. API manufacturing is performed at a small number of chemical plants under approved process and quality systems.

Bulk cefiderocol manufacture: key supplier categories

• Cefiderocol API manufacturer(s): companies operating the approved API production route and release testing.
• Salt/form or intermediate suppliers: if cefiderocol is produced via specific intermediates, certain upstream suppliers can be part of the validated supply chain even if they do not appear as direct labeler entities.

What to check for upstream suppliers

• Drug Master File (DMF) holders for API (if used) and supplier names tied to CMC.
• FDA establishment registrations mapped to the API manufacturing role.

What is the Orange Book status of Fetroja and why it matters for supplier access?

Fetroja is a brand-only, protected antibiotic with limited or no direct generic substitutes in the US, so supply risk is mostly about brand manufacturing continuity rather than generic competition. The Orange Book status also informs whether there are parallel API sources linked to approved generic labeling.

How Orange Book listing guides supplier diligence

• If Fetroja has no therapeutically equivalent generic ANDAs with compatible labeling, procurement options are constrained to brand supply and possible authorized distributors.
• Patent/protection status shapes whether CMOs can be retooled to alternative suppliers without IP risk.

Who are the authorized distributors and logistics suppliers for Fetroja?

Distribution is handled by the originator’s distribution partner network plus wholesalers, specialty distributors, and hospital logistics channels. For procurement planning, the actionable mapping is:

• NDA-holder distribution entities
• GPO-facing wholesalers
• Hospital and specialty pharmacy distribution partners

Typical distribution structure for specialty antibiotics

• Wholesalers are the primary route to hospitals.
• Specialty distribution supports cold-chain or time-critical handling, if applicable to packaging requirements (Fetroja is typically handled as a sterile injectable drug under standard controlled conditions).

What packaging and labeling suppliers support Fetroja supply?

Finished-dose supply depends on:

• Secondary packaging providers (bottling/kit packaging, cartonization)
• Labeling contractors (unit-of-use labels, lot/expiry integration)
• Kit assembly providers if the commercial configuration uses kit formats

Why packaging suppliers matter

• When manufacturing capacity is strained, packaging capacity becomes a bottleneck even if drug substance and sterile filling are available.
• Lot release timelines are tied to packaging and labeling completion plus QA release testing.

How can you map Fetroja suppliers by establishment roles (procurement-grade framework)?

Use a role-based supplier map that aligns with FDA manufacturing and quality expectations:

Role 1: NDA drug-product manufacturer (sterile filling and finishing)

• Site category: finished sterile injectable production
• Deliverables: vials/solution preparation, sterile filling, stoppering, crimping, labeling, QA release support

Role 2: API manufacturer (cefiderocol bulk)

• Site category: chemical synthesis of cefiderocol and bulk QA release
• Deliverables: API bulk production, impurity profile control, stability support

Role 3: QA testing and batch release support

• Could be internal QA or a contracted release testing lab under the NDA controls
• Often includes microbiology/sterility testing contractors in some networks

Role 4: Distribution and wholesale partners

• Wholesalers and specialty distributors that hold inventory and deliver to healthcare systems

What supplier risks exist for Fetroja (cefiderocol) continuity?

For procurement and supply-chain risk management, the main risk drivers are:

• Batch release timing and QA workload: sterile injectables often face release bottlenecks.
• Sterile fill capacity: if the fill-finish line is constrained, new lots lag even if API is available.
• Packaging and labeling capacity: lot-specific labeling changes can delay readiness.
• Raw-material lead times: cefiderocol synthesis can require niche chemical inputs with constrained supply.

Which alternative supply routes exist if a primary manufacturer is constrained?

In protected brand antibiotics, alternative supply options usually come from:

• Secondary fill-finish sites pre-qualified by the NDA-holder
• Transfer of manufacturing tech packs to backup CMOs (requires CMC updates and approval/qualification under FDA controls)
• In-house backup production if the originator maintains redundant sterile fill capacity

Key takeaways

• Fetroja supply is anchored in Janssen/Johnson & Johnson’s commercial NDA framework and a small network of approved manufacturers.
• The actionable supplier mapping for due diligence is drug-product sites, API sites, and packaging/labeling roles, then the wholesale and specialty distribution partners.
• Supplier risk for Fetroja is dominated by sterile manufacturing capacity, QA lot release, packaging throughput, and upstream raw-material availability.

FAQs

1) What is the most reliable way to identify Fetroja’s manufacturing sites?
Use the FDA-labeled manufacturing establishment information tied to the NDA and facility registrations for drug-product and API roles.

2) Are there multiple API suppliers for cefiderocol under Fetroja?
API supply networks for protected antibiotics often include more than one qualified bulk source, but the only procurement-grade confirmation is mapping approved API establishments tied to the NDA’s CMC.

3) Do authorized wholesalers control Fetroja availability to hospitals?
In practice, inventory is primarily routed through US wholesalers and specialty distributors that service hospital procurement channels.

4) How does patent protection affect supplier substitution for Fetroja?
Patent protection restricts generic entry, so substitution usually comes from brand-manufactured lots, not independent generic API or finished-dose products.

5) What are the biggest bottlenecks in Fetroja supply?
Sterile fill-finish capacity, batch release testing, and secondary packaging/labeling completion tied to lot readiness.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. U.S. Food and Drug Administration. Drug Approval Package for Fetroja (cefiderocol). FDA.
3. U.S. Food and Drug Administration. Drugs@FDA. FDA.
4. U.S. Food and Drug Administration. Labeling and FDA establishment facility registration databases. FDA.