Suppliers and packagers for generic pharmaceutical drug: cefotaxime sodium

cefotaxime sodium

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	CEFOTAXIME	cefotaxime sodium	INJECTABLE;INJECTION	065072	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9930-10	10 VIAL in 1 PACKAGE (0143-9930-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9930-01)	2002-11-20
Hikma	CEFOTAXIME	cefotaxime sodium	INJECTABLE;INJECTION	065072	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9931-25	25 VIAL in 1 PACKAGE (0143-9931-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9931-01)	2002-11-20
Hikma	CEFOTAXIME	cefotaxime sodium	INJECTABLE;INJECTION	065072	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9933-25	25 VIAL in 1 PACKAGE (0143-9933-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9933-01)	2002-11-20

CEFOXATIME SODIUM Suppliers: Global Manufacturers, APIs, and Key Sourcing Channels

Last updated: May 24, 2026

Executive summary:
The supplier set for cefotaxime sodium splits into (1) active pharmaceutical ingredient (API) manufacturers that produce cefotaxime sodium (or cefotaxime base then formulate to the sodium salt), (2) finished-dosage manufacturers that sell vials/sterile powders (typically for IV/IM use), and (3) distributors and contract sourcing intermediaries. Cefotaxime sodium remains widely supplied globally, but regulatory access (FDA/Europe filings), cGMP status, and sterile manufacturing capacity determine whether a buyer can qualify products for tenders, hospital formularies, and importation.

What companies supply cefotaxime sodium API and finished vials?

Cefotaxime sodium is commonly sourced from tier-1 global sterile injectables plants and tier-1 or tier-2 API producers in Asia and Europe, with many additional suppliers operating as regional distributors.

API supply (cef​otaxime sodium / cefotaxime intermediates)

Typical API supply chain for cefotaxime sodium:

• Cephalosporin core fermentation and beta-lactam handling (high operational controls).
• Conversion to cefotaxime and salt formation to sodium.
• Drying, milling, packaging, and batch release testing for identity, assay, impurities, and residual solvents.

Common API sourcing pattern in the market:

• API producers sell cefotaxime sodium API to formulators under supply agreements.
• Finished-dose sterile manufacturers either (a) buy API and manufacture/sterilize drug product, or (b) buy sterile bulk and finish packaging.

Finished dosage supply (sterile cefotaxime sodium vials)

Finished cefotaxime sodium is typically supplied as:

• Powder for injection in vials for IV or IM administration.
• Under multiple strengths (commonly 500 mg and 1 g, depending on market).

Finished-dose supplier qualifications usually hinge on:

• Sterile manufacturing lines
• Validation for beta-lactam contamination control
• Regulatory listing status in target countries (e.g., FDA, EMA member states via national approvals or mutual recognition pathways)

Who are the major cefotaxime sodium injectable manufacturers by region?

Cefotaxime sodium is broadly available, with different supplier concentrations by region due to approvals, tender patterns, and procurement rules.

North America sourcing profile

• Finished-dose availability is typically through brand holders and generic injectables suppliers with hospital distribution networks.
• API sourcing often comes from qualified international cGMP suppliers, but hospital buyers generally contract for finished sterile product rather than API.

Europe sourcing profile

• Europe procurement relies on manufacturers with active approvals across EU member states and marketing authorizations.
• Some suppliers focus on centralized batch release and centralized logistics for cross-border tenders.

Asia and Middle East sourcing profile

• Asia supplies both API and finished product for global export.
• Middle East procurement often includes direct importers and distributors that specialize in hospital tenders.

What is the Orange Book status of cefotaxime sodium in the US?

Cefotaxime sodium is an older, widely available antibiotic. In many cases, such products do not have enforceable US patents listed in the FDA Orange Book or are no longer under active exclusivity. For sourcing decisions, the more actionable view is:

• Whether ANDA or 505(b)(2) entries exist for specific strengths and dosage forms
• Whether there are active drug product listings for the sterile vial strengths hospitals use

Because supplier eligibility depends on US listing status per strength and NDA/ANDA holder, buyers typically qualify suppliers against:

• Product listing for the exact strength and dosage form (e.g., vial size)
• Current manufacturing location(s) and batch release practices

Which suppliers can provide cefotaxime sodium under hospital tender specifications?

Tender qualification usually requires:

• Release documentation (CoA per batch)
• GMP compliance evidence for the manufacturing site
• Sterility assurance and particulate monitoring (for sterile injectables)
• Supply continuity and lead-time reliability for the exact strength

In practice, tender-winning suppliers tend to offer:

• Local import/warehousing
• Regulatory dossier access
• Contracted packaging that matches tender labeling and vial presentations

How many suppliers are available for cefotaxime sodium and where are the bottlenecks?

Market structure for cefotaxime sodium:

• High number of distributors and multiple finished-dose manufacturers.
• Fewer qualified sterile injectables plants with consistent export capacity.
• Bottlenecks typically occur during:
  • API supply disruptions (beta-lactam production constraints)
  • Sterile manufacturing batch scheduling
  • Regulatory changes requiring updated testing or labeling formats

For procurement risk, the most sensitive points are:

• Whether a supplier has approved manufacturing sites
• Whether they can maintain supply during demand spikes
• Whether they can provide batch traceability and consistent impurity profiles

What patents protect cefotaxime sodium, and does the estate affect supplier entry?

Cefotaxime sodium is an established antibiotic. Generic entry is typically driven by:

• Drug product regulatory approval status
• Manufacturing readiness for sterile production
• Patent enforceability at the drug product level, if any

In sourcing terms:

• If there are no enforceable patents for the specific dosage form/strength in a jurisdiction, supplier entry is usually not blocked by IP.
• If patents existed historically, their practical impact today is usually limited to specific reformulations, device integrations, or novel processes, not the underlying cefotaxime sodium substance itself.

What generic entry risks exist for cefotaxime sodium in key markets?

Generic entry risk is usually low for a mature antibiotic where approvals are already common, but procurement still faces practical entry constraints:

• Regulatory bottlenecks for new sites
• Limited sterile capacity in periods of surge demand
• Supply chain concentration of cefotaxime intermediates or API purification capacity

Procurement exposure is highest where:

• Buyers rely on a small subset of suppliers with active tenders
• Manufacturers have single-source sterile packaging or a single qualified release site

How does cefotaxime sodium supply compare with ceftriaxone sodium?

Both are cephalosporin antibiotics and can compete in procurement, but supply dynamics differ:

• Ceftriaxone has different residue and formulation sensitivities that can shift procurement preference in specific guidelines.
• Cefotaxime sodium often has broader historical availability in injectable formats, but allocation risk can still occur when beta-lactam API capacity tightens.

In buying decisions:

• Compare not only price but also delivery reliability, vial strength availability, and documented sterility assurance across suppliers.

What documentation do buyers require from cefotaxime sodium suppliers?

Standard procurement qualification package for sterile injectables includes:

• Certificate of Analysis (per batch)
• GMP certificate or inspection outcome for the manufacturing site
• Sterility and endotoxin release testing documentation
• Stability data summary for the shelf life period
• Traceability for lot numbers and packaging configuration

For API-driven sourcing:

• API CoA and batch traceability
• Impurity profile comparability documentation
• Residual solvent report where applicable

What manufacturing and IP barriers can restrict cefotaxime sodium supply?

Key barriers are operational:

• Beta-lactam manufacturing requires strict contamination controls.
• Sterile filling capacity limits can restrict supply during peaks.
• Quality systems and validated cleaning cycles determine whether a plant can add volume without risk.

IP barriers for cefotaxime sodium are typically not the main obstacle compared with regulatory compliance and manufacturing capacity.

Key takeaways

• Cefotaxime sodium is a mature injectable antibiotic with a broad supplier base, but tender qualification favors suppliers with validated sterile manufacturing and reliable logistics.
• Sourcing splits into API producers and finished-dose sterile manufacturers; buyers usually contract finished sterile vials for hospital use.
• The highest procurement risk is supply continuity and sterile capacity, not IP lockout, for this mature product.
• Supplier qualification should be strength-specific and dossier-specific (exact vial strength, manufacturing site, and batch release capability).

FAQs

1) What strength and vial presentations of cefotaxime sodium are commonly stocked by hospital suppliers?
Answer: Commonly stocked presentations include powder for injection in 500 mg and 1 g vial formats, depending on country and tender specifications.

2) Can cefotaxime sodium be sourced as API for contract manufacturing?
Answer: Yes in principle, but buyers generally qualify API under cGMP and then qualify finished sterile manufacturing separately.

3) What are the main quality tests buyers should require for cefotaxime sodium vials?
Answer: CoA-based release tests typically cover identity, assay, related substances/impurities, and sterile and endotoxin testing for sterile drug product.

4) Are there known shortages of cefotaxime sodium due to beta-lactam manufacturing constraints?
Answer: Shortages can occur when beta-lactam API or sterile filling capacity is constrained, particularly during demand spikes.

5) How do distributors differ from manufacturers for cefotaxime sodium supply?
Answer: Distributors provide logistics and inventory, while manufacturers provide batch manufacturing, release testing, and regulatory dossier responsibility for the finished sterile product.

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References (APA)

No sources were provided in the prompt.