Suppliers and packagers for AZACTAM

AZACTAM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol Myers Squibb	AZACTAM	aztreonam	INJECTABLE;INJECTION	050580	NDA	E.R. Squibb & Sons, L.L.C.	0003-2560-16	10 VIAL, SINGLE-DOSE in 1 CARTON (0003-2560-16) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2010-04-01
Bristol Myers Squibb	AZACTAM	aztreonam	INJECTABLE;INJECTION	050580	NDA	E.R. Squibb & Sons, L.L.C.	0003-2570-16	10 VIAL, SINGLE-DOSE in 1 CARTON (0003-2570-16) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2010-04-01
Bristol Myers Squibb	AZACTAM	aztreonam	INJECTABLE;INJECTION	050580	NDA	A-S Medication Solutions	50090-7494-0	10 VIAL, SINGLE-DOSE in 1 CARTON (50090-7494-0) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2010-04-01

Suppliers and packagers for AZACTAM

Last updated: June 2, 2026

AZACTAM (aztreonam) Suppliers: Who Manufactures and Supplies Aztreonam Products in the US and Globally

Executive summary: AZACTAM is the brand for the injectable monobactam antibiotic aztreonam (typically supplied as aztreonam for injection, powder for reconstitution). The supplier landscape is dominated by the original-brand manufacturer and its supply partners, plus authorized generics and generic manufacturers that supply aztreonam via FDA-approved labels (including Orange Book–listed products) and through global sterile injectables supply chains.

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Who are the suppliers and manufacturers for AZACTAM (aztreonam) products?

Short answer (supplier map): AZACTAM supply is split across (1) the brand/label holder chain and (2) manufacturers of approved aztreonam injectable equivalents under NDA/ANDA supply agreements.

Brand product supply chain (AZACTAM)

• Brand: AZACTAM
• Active ingredient: aztreonam
• Dosage form: sterile injectable (powder for reconstitution)

Supplier responsibility typically sits with:

• The US NDA holder/brand owner for commercial distribution.
• Sterile manufacturing sites contracted to produce aztreonam powder and package vials/bottles.
• Labeler/distributors that hold the commercial distribution rights in specific markets.

Generic and authorized generic suppliers (US)

For US penetration, the dominant “supplier set” is defined by FDA-approved manufacturers listed for:

• aztreonam for injection products (same or equivalent dosage strengths and presentation)
• authorized generics where applicable
• multiple ANDA labels with different manufacturing sites

What determines “who supplies” in practice

• Whether the product is NDA-origin (brand) or ANDA-origin (generic)
• GMP site qualification and sterile filling and finishing capacity
• Supply allocation driven by shortages and batch yields
• Contract packaging and distribution agreements by region

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Which companies supply generic aztreonam for injection instead of brand AZACTAM?

Short answer: Any supplier that has an FDA-approved aztreonam for injection label (ANDA, with Orange Book listing) can supply US. Market reality often clusters around a few sterile injectables specialists with sustained supply.

How to identify true suppliers (not just labelers)

When assessing supplier risk, focus on:

• The ANDA holder (legal marketing authorization)
• The listed manufacturing sites (sterile drug substance/drug product)
• The repackager/labeler chain (some “supplier” entities are downstream distributors)

Common supplier categories

• Sterile injectables manufacturers producing β-lactam/monobactam–class antibiotics
• Contract manufacturing organizations (CMOs) providing sterile filling and lyophilization/reconstitution-ready packaging
• Multiple-strength portfolios (to diversify batch demand and reduce single-product capacity risk)

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What does the FDA Orange Book show about AZACTAM suppliers and approved aztreonam equivalents?

Short answer: Orange Book provides the authoritative list of FDA-approved products and the patent/exclusivity status that determines which suppliers can legally market competing versions.

Orange Book fields that map to suppliers

• Application number (NDA/ANDA)
• Holder/Applicant
• Dosage form
• Strength
• Patent numbers linked to the product and any exclusivity period
• Market entry constraints (where applicable)

Commercial implication

• Suppliers with Orange Book–listed ANDAs that are not blocked by exclusivity or unexpired patents can generally market their products.
• If AZACTAM has expired exclusivities for specific presentations, the supplier set typically broadens quickly through ANDA entrants.

(Note: this analysis requires the specific AZACTAM NDA/Orange Book entry and the current supplier list by strength and presentation.)

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What supplier risks matter for AZACTAM (aztreonam) procurement?

Short answer: The supplier risks for aztreonam injectable are mostly sterile manufacturing and regulatory continuity risks.

Key procurement risk drivers

• Sterile facility constraints (β-lactam-class contamination control and batch throughput)
• Raw material availability (aztreonam drug substance sourcing)
• Reconstitution system compatibility (vial type, stopper, and fill-finish specifications)
• Regulatory deviations that can force batch holds or label variations
• Shortage dynamics across the aztreonam class, since limited sterile capacity can trigger allocation

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How do AZACTAM suppliers differ by country and regulatory market?

Short answer: The supplier set differs because sterile injectable approvals are product- and market-specific, with regional marketing authorizations and manufacturing approvals.

Market-based supplier patterns

• US: FDA approval and Orange Book govern marketing authorization for generic entrants
• EU/UK: EMA national variation, local marketing authorizations, and QP release requirements
• Other markets: national registrations and local distributor agreements dominate

Practical due diligence for global procurement

• Confirm marketing authorization number per country
• Match manufacturing site to the approved dossier
• Verify traceability through batch documentation and GMP certificates

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What formulations and strengths are most relevant to suppliers (and substitution)?

Short answer: Substitution and supply depend on matching strengths, vial size, and reconstitution-ready presentation.

Supplier substitution constraints

• If a supplier’s product differs by:
  • strength
  • vial size
  • reconstitution vehicle
  • labeling indications or dosing instructions then substitution may require clinical and pharmacy review, even if pharmacologically equivalent.

Pharmacy and procurement screening inputs

• National product listing in the hospital formulary or payer’s formulary rules
• NDC/packaging match for US procurement
• Storage and handling requirements in the label

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Key Takeaways

• AZACTAM supply is structured around the brand’s legal marketing authorization chain and approved aztreonam injectable manufacturers for generic equivalents.
• In the US, the definitive supplier list is determined by FDA-approved labels (NDA/ANDA) and their Orange Book listings for specific strengths and presentations.
• Procurement risk is dominated by sterile injectables manufacturing capacity, batch yields, regulatory continuity, and drug substance availability.
• Global supplier sets vary by market authorization and approved manufacturing sites, so procurement should be dossier- and batch-documentation-driven.

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FAQs

1) What’s the difference between the AZACTAM brand supplier and generic aztreonam suppliers?

The brand supplier chain is tied to the AZACTAM label holder and its manufacturing/packaging partners; generic suppliers market FDA-approved equivalents under ANDA applications with their own manufacturing sites.

2) Who can legally supply aztreonam for injection in the US?

Any entity whose product is FDA-approved for aztreonam for injection (NDA or ANDA) and compliant with exclusivity/patent constraints for the relevant presentation.

3) How do shortages affect AZACTAM availability?

Shortages typically reflect constrained sterile injectable manufacturing capacity, drug substance supply interruptions, or regulatory holds, which can shift allocations toward manufacturers with available batch inventory.

4) Are AZACTAM and generic aztreonam interchangeable?

They are usually substitutable as therapeutically equivalent injectable antibiotics, but procurement substitution should match strength, presentation, and labeling to avoid dosing or handling mismatches.

5) What should a buyer verify to qualify a new aztreonam supplier?

Verify FDA approval status, listed manufacturing site(s), GMP certificate coverage, batch release documentation, and packaging/presentation match to the buyer’s spec and formulary.

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. Drug Shortages. https://www.accessdata.fda.gov/scripts/drugshortages/