Suppliers and packagers for generic pharmaceutical drug: cefuroxime axetil

cefuroxime axetil

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alkem Labs Ltd	CEFUROXIME AXETIL	cefuroxime axetil	TABLET;ORAL	065496	ANDA	Major Pharmaceuticals	0904-7542-10	2 BLISTER PACK in 1 CARTON (0904-7542-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2025-08-25
Alkem Labs Ltd	CEFUROXIME AXETIL	cefuroxime axetil	TABLET;ORAL	065496	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-656-14	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-656-14)	2010-12-01
Alkem Labs Ltd	CEFUROXIME AXETIL	cefuroxime axetil	TABLET;ORAL	065496	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-656-20	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-656-20)	2010-12-01
Alkem Labs Ltd	CEFUROXIME AXETIL	cefuroxime axetil	TABLET;ORAL	065496	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-657-20	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-657-20)	2010-12-01

Cefuroxime Axetil Suppliers: Who Manufactures API, Provides Contract Packaging, and Supplies Finished Dosage Forms?

Last updated: May 25, 2026

Cefuroxime axetil is a widely supplied oral antibiotic across multiple dosage strengths and formats. The supplier landscape splits into (1) API and key intermediates, (2) finished-dose manufacturers (tablets, suspensions), and (3) distribution and packaging partners. A reliable supplier map requires tying each commercial product to its labeled manufacturer (NDC), while IP strength and regulatory status require Orange Book and FDA product labeling alignment.

Which companies supply cefuroxime axetil API, intermediates, and contract manufacture?

Answer: Cefuroxime axetil is supplied through a mix of branded-generic finished-dose manufacturers and generic API/CMO players, with supply originating primarily from established global antibiotic producers in Europe and Asia. The actionable way to map “suppliers” for procurement is to list labeled finished-dose manufacturers per NDC and API/CMO suppliers tied to common manufacturing sites used across markets.

What is the typical supply chain for cefuroxime axetil?

• API production: Cefuroxime axetil synthesis from cefuroxime (or related synthetic routes) and esterification steps.
• Finished dose formulation: Tablet formulation and coating, or suspension grade formulation with solubilizers and stabilizers suited to axetil ester chemistry.
• Packaging: Unit-dose blistering for tablets; bottle packaging for oral suspension with validated shelf-life controls.

How to identify “API suppliers” in practice for cefuroxime axetil

Procurement teams usually infer API sources via:

• Corporate disclosures tied to manufacturing sites listed on drug product labeling or DMFs
• Shared manufacturing equipment and sites used by multiple product labels
• For US products, linkage through ANDA filings to DMF references and manufacturing sites (if accessible through Orange Book and regulatory documentation)

Because “API supplier” is not consistently visible at the finished product label level, the highest-confidence supplier list for operational buying is based on finished-dose labeled manufacturers and contract packaging/CMC partners named in submissions.

What finished-dose manufacturers supply cefuroxime axetil tablets and suspensions?

Answer: Finished-dose supply comes from multiple global generics companies that market cefuroxime axetil under different strengths, such as 250 mg and 500 mg tablets, and oral suspension variants (strength depends on country labeling).

Which dosage forms dominate procurement?

• Oral tablets: 250 mg and 500 mg are common internationally.
• Oral suspension: Used where pediatric dosing is required.
• Liquid reconstitution requirements: Typically reduced by standardized suspension manufacturing versus extemporaneous compounding.

How do labeled manufacturers differ from “CMO suppliers”?

• The labeled manufacturer is the firm on the NDC label responsible for marketed product release.
• The CMO/packager may operate a manufacturing facility and perform blending, compression, coating, sterile exclusion (not applicable), filling, and packaging under contract.
• Contracts often change across launches and revalidations; labeled manufacturers usually remain the most stable procurement anchor.

What contract manufacturing and packaging partners support cefuroxime axetil production?

Answer: Antibiotic oral solid dose manufacturing is supported by CMOs that handle beta-lactams and controlled formulation processes, with additional capabilities for:

• Taste-masked suspension systems (for pediatric products)
• Moisture-controlled tablet coating and humidity-sensitive release steps
• Compliance with antibiotic manufacturing segregation rules and cleaning validation

What CMC capabilities matter for cefuroxime axetil?

• Moisture and stability controls: Axetil ester is formulation-sensitive.
• Uniformity: Beta-lactams require tight dose uniformity validation.
• Film-coating performance: For tablets, coating thickness and dissolution profile must be locked.
• Microbial and endotoxin controls: For suspensions, microbial limits are critical and affect shelf-life.

What is the regulatory status in the US and how does it shape supplier selection?

Answer: In the US, cefuroxime axetil is regulated under FDA approval for each NDA/ANDA product label. Supplier selection is constrained by approved product labeling, manufacturing site use, and any associated regulatory commitments.

What does “Orange Book status” usually mean for suppliers?

• If a cefuroxime axetil product is covered by an Orange Book listing, the ANDA entrant must satisfy patent certification requirements for exclusivity and patent barriers.
• Manufacturing sites tied to approved ANDA processes must be maintained to preserve approval.

When do cefuroxime axetil exclusivity and patents affect supplier entry?

Answer: Patent and exclusivity effects shape which generic suppliers can launch, but the supplier landscape is also influenced by supply availability and ongoing manufacturing readiness rather than IP alone.

Typical entry blockers

• Patent-protected formulations and polymorphs (if applicable to the specific product)
• Method-of-use patents (less common for classic antibiotics but possible if specific dosing regimens are claimed)
• Manufacturing method claims for esterification route intermediates or process controls

Practical impact for procurement and licensing

• If the market product is “fully generic,” supplier competition increases and pricing pressure rises.
• If fewer suppliers are approved due to patent/CMC constraints, procurement risk rises due to limited sources.

How many suppliers support cefuroxime axetil globally?

Answer: Supplier count varies by region and dosage form. Oral beta-lactams usually have broad generic footprints, but suspensions often have fewer approved manufacturers due to formulation and stability constraints.

Why tablets usually have more sources than suspensions

• Tablet processes are more tolerant across manufacturing sites.
• Suspensions require higher control of taste, viscosity, particle stability, and sedimentation.

Which regions have the strongest cefuroxime axetil supply coverage?

Answer: Coverage is typically strongest across:

• Europe and UK: mature generics ecosystems for oral antibiotics
• India: broad antibiotic manufacturing base and export-oriented production
• China and other Asia-Pacific: significant active and finished-dose production capacity

Regional labeling requirements can still force a subset of firms to supply specific NDCs or local markets.

What commercial and supply risks exist for cefuroxime axetil procurement?

Answer: Procurement risk clusters around formulation transitions, manufacturing site changes, beta-lactam contamination controls, and packaging line capacity.

Common disruptions that affect supply

• Manufacturing scale-down or site maintenance in antibiotic facilities
• Packaging lead-time constraints for bottles versus blisters
• Regulatory holds tied to data integrity or batch deviation investigations

How to mitigate supplier concentration risk

• Dual-source for each dosage strength
• Align forecasting with revalidation and packaging lead times
• Maintain alternate lot release pathways where permitted

What is the strongest approach to build an actionable supplier list for cefuroxime axetil?

Answer: Build the supplier list at the level procurement decisions actually use:

1. Identify NDC/marketed SKU holders for each dosage form and strength.
2. Extract labeled manufacturing sites from product labeling.
3. Map shared CMOs where multiple labels use the same facility.

This yields a defensible “who supplies what” list for negotiations, RFQs, and vendor qualification.

Key Takeaways

• Cefuroxime axetil supply is best mapped by labeled finished-dose manufacturers per NDC/market product, then traced to packaging and CMO sites.
• Tablets usually have broader supplier depth than suspensions due to CMC complexity and stability/taste requirements.
• Patent and exclusivity barriers can reduce approved launch count in specific jurisdictions, but supply readiness and packaging capacity often dominate day-to-day procurement risk.
• For operational sourcing, prioritize vendors with validated manufacturing and release for the exact dosage form and strength you buy.

FAQs

1. How do I find cefuroxime axetil suppliers by NDC without relying on API-only databases?
2. Which cefuroxime axetil dosage forms have the fewest approved generic suppliers?
3. What CMO capabilities are most important for beta-lactam oral suspension manufacturing?
4. How do Orange Book patent certifications affect which generic firms can supply cefuroxime axetil in the US?
5. What manufacturing site changes typically trigger supply delays for cefuroxime axetil tablets or suspensions?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
3. FDA. Labeling and drug product information (accessed via Drugs@FDA and SPL data). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/spl/