Suppliers and packagers for avycaz

avycaz

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494	NDA	Allergan, Inc.	0456-2700-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0456-2700-10) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0456-2700-01)	2014-12-26

Suppliers and packagers for avycaz

Last updated: May 25, 2026

AVYCAZ suppliers: Who manufactures and supplies ceftazidime-avibactam in the US and globally?

Avycaz (ceftazidime and avibactam) is supplied through a defined manufacturer supply chain centered on the branded product owner and sterile injectable manufacturing. In the US, Avycaz supply is tied to FDA-licensed manufacturing sites listed for the approved product and to authorized distributors that carry the NDA/Orange Book-labeled product inventory. Supplier mapping, including “who makes the drug” versus “who distributes it,” depends on the specific dosage strength (2.5 g powder for injection) and the labeled NDC holder listed on the FDA label and Orange Book.

Who supplies AVYCAZ (ceftazidime-avibactam) in the US?

Answer (US): The supply chain for Avycaz in the US is anchored by the NDA holder and the FDA-listed manufacturing sites for the finished drug product (sterile powder for injection), then routed through authorized wholesale distributors and hospital/IDN contracting channels.

What does “supplier” mean for AVYCAZ?

• Drug substance suppliers: Companies that produce ceftazidime and avibactam active ingredients and intermediates (typically via contract manufacturers under commercial NDA-level confidentiality).
• Drug product manufacturers: Firms that aseptically process and package the finished sterile lyophilized powder-in-vial presentation for the labeled strengths.
• Commercial distributors: Wholesalers and authorized distributors that distribute Avycaz to hospitals, wholesalers, GPOs, and specialty channels.

How to identify the finished-drug manufacturer (best proxy)

For practical licensing, procurement, and supply-risk diligence, the most probative sources are:

• FDA label “Manufactured for” / “Distributed by” sections
• FDA Orange Book listing for the NDA (finished dosage form manufacturing site linkages can be derived from label and application data)
• FDA SPL product label package for the specific NDC

Which companies manufacture ceftazidime-avibactam (AVYCAZ) finished product?

Answer: Finished product manufacturers are those listed on the Avycaz FDA label and connected to the approved NDA for the sterile injectable powder. Without the exact NDC-level label text and Orange Book entry for the specific presentation, a definitive company list cannot be produced.

Dosage form and pack structure that governs manufacturing

• Avycaz is supplied as powder for injection (commonly presented as 2.5 g equivalent of ceftazidime with avibactam).
• Finished product manufacturing and packaging vary by:
  • vial configuration
  • kit assembly (if any)
  • NDC presentation and labeler

What are the AVYCAZ Orange Book and FDA label manufacturing sites?

Answer: The Orange Book and FDA label identify the NDA and the approved listed finished dosage form presentations. Label-associated manufacturing site identification is the operational starting point for supplier mapping in procurement and contracting.

Why Orange Book helps with supplier mapping

• Orange Book ties the NDA to the approved product and lists relevant patent and exclusivity items.
• The label provides the “manufactured for” and/or “distributed by” elements.
• Together, they identify which manufacturer is responsible for the finished injectable product.

Which distributors supply AVYCAZ to hospitals and wholesalers?

Answer: In the US, distributors supplying Avycaz are typically large national wholesalers and specialty channels that carry NDA products under GPO and IDN contracts. Specific distributor identity is NDC- and contract-dependent.

Distribution pattern

• National wholesalers carry Avycaz inventory through distribution centers and contract pharmacy/hospital fulfillment models.
• Hospital systems often source via:
  • GPO-negotiated contracts
  • prime vendor arrangements
  • direct purchase agreements via specialty distributors

How do global suppliers differ for AVYCAZ?

Answer: Outside the US, Avycaz supply depends on each country’s marketing authorization holder and local release and distribution partners, often with:

• local packaging/labeling
• different finished product release sites
• parallel importer pathways in some markets

Global “supplier” categories

• Marketing authorization holder (MAH)
• Local marketing/distribution partner
• Local batch release and customs importer
• Finished product manufacturer (may stay the same globally)

What contract manufacturing constraints affect AVYCAZ supply?

Answer: Avycaz supply is sensitive to:

• sterile manufacturing slot availability
• lyophilization capacity
• vial and closure supply
• stability and cold-chain constraints for intermediates (where applicable)
• API release lead times for ceftazidime and avibactam

Key supply risk points in ceftazidime-avibactam production

• API lot disposition timing
• sterile lyophilization cycles
• batch release testing turnaround
• packaging line changeovers for NDC-specific presentations

AVYCAZ supplier risks: How do you assess shortages and lead times?

Answer: Supplier risk assessment uses:

• manufacturing site capacity history
• FDA drug shortage database signals (if applicable)
• allocation patterns during prior disruption periods
• lead times tied to specific NDCs

Operational metrics used in procurement

• confirmed-to-ship dates by NDC
• fill rate and backorder duration
• substitution approvals at the hospital formulary level
• alternate supplier availability for future allocation

What generic or biosimilar supply threatens AVYCAZ suppliers?

Answer: Avycaz is a small-molecule antibacterial (not a biologic). Competitive supply threats come from authorized generics or Paragraph IV-driven generic entry, which would shift sourcing from branded manufacturer to multiple generic labelers and manufacturing sites. The magnitude depends on patent and exclusivity status in the relevant jurisdictions.

Key Takeaways

• “Supplier” for Avycaz can mean finished drug manufacturer, API producer, or distributor; the operationally decisive identifier is the finished-drug manufacturing site on the FDA label for the specific NDC.
• US procurement and supply-risk mapping should be built from FDA label + Orange Book NDA linkage, then translated into distributor contracts via GPO/IDN channels.
• Global sourcing varies by market authorization holder and local release/distribution arrangements, even when the finished drug manufacturing site is stable.

FAQs

1. How do I determine the finished-drug manufacturer for Avycaz for a specific NDC?
2. Which wholesaler-distributor channels typically carry Avycaz in the US?
3. What manufacturing bottlenecks most often impact sterile lyophilized injectable antibiotic supply?
4. How does generic entry change the Avycaz supplier landscape in the US?
5. Where can I verify Avycaz label “manufactured for” and “distributed by” information for compliance?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (ceftazidime and avibactam/Avycaz NDA listings).
2. U.S. FDA. Avycaz (ceftazidime and avibactam) prescribing information and FDA label (NDC-specific label “Manufactured for/Distributed by” sections).