Suppliers and packagers for CEFTAROLINE FOSAMIL

CEFTAROLINE FOSAMIL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	CEFTAROLINE FOSAMIL	ceftaroline fosamil	POWDER;INTRAVENOUS	208075	ANDA	Apotex Corp.	60505-6124-1	10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6124-1) / 20 mL in 1 VIAL, SINGLE-DOSE (60505-6124-0)	2026-02-12
Apotex	CEFTAROLINE FOSAMIL	ceftaroline fosamil	POWDER;INTRAVENOUS	208075	ANDA	Apotex Corp.	60505-6125-1	10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6125-1) / 20 mL in 1 VIAL, SINGLE-DOSE (60505-6125-0)	2026-02-12

Suppliers and packagers for CEFTAROLINE FOSAMIL

Last updated: May 24, 2026

Ceftaroline Fosamil Suppliers, Contract Manufacturers, and API/Intermediate Supply Base (US and Global)

Ceftaroline fosamil supply chains typically split into: (1) active pharmaceutical ingredient (API) and key intermediates for ceftaroline fosamil, (2) finished-dose production for ceftaroline fosamil drug product (DFP), and (3) packaging and distribution under Finished Product labeling for US launch. For actionable procurement, the critical sourcing question is not “who makes ceftaroline fosamil,” but “who holds validated manufacturing for US commercial supply and what raw-material route and intermediates they use.”

Who supplies ceftaroline fosamil API and key intermediates?

Ceftaroline fosamil is a prodrug of ceftaroline and requires a specialized synthetic route that depends on β-lactam handling, controlled phosphorylation/esterification steps, and strict impurity controls typical of parenteral cephalosporin-class antibiotics. In practice, supplier visibility is fragmented across:

• API manufacturers and API intermediate suppliers (phosphorylated intermediates)
• Specialized contract development and manufacturing organizations (CDMOs) with validated β-lactam processes
• Finished-dose sterile manufacturing sites for lyophilized or solution presentations (depending on labeled formulation)

Direct, supplier-level identification requires linkage to FDA drug product/labeling, regulatory filings, and commercial procurement records. Without that, naming specific companies risks misattribution because multiple tiers can participate (API, intermediate, sterile fill-finish, or repackaging) without being visible in public regulatory databases.

Which companies manufacture ceftaroline fosamil finished drug product for the US market?

For US commercial supply, ceftaroline fosamil product distribution is anchored to the FDA-labeled drug product and its current holder for the New Drug Application (NDA). The drug product manufacturer may differ from the API supplier, and the sterile manufacturing site may be different from packaging sites.

Operationally, buyers should source against:

• The FDA label’s “Manufactured for” or “Distributed by” section (drug product responsibility and lot traceability)
• Current good manufacturing practice (cGMP) status of the sterile manufacturing facility
• Whether the company supplies via direct contract supply, third-party distribution, or repackaging

Because supplier names and site assignments are not contained in the prompt, a complete, accurate “which companies” list cannot be produced here.

What is the Orange Book status for ceftaroline fosamil and how does it affect supplier competition?

Ceftaroline fosamil is a branded antibiotic with likely patent and exclusivity protection that constrains direct generic supply. Orange Book listings determine whether there are approved ANDAs with Paragraph IV challenges and whether multiple finished-dose suppliers exist.

Supply impact of Orange Book status

• If there are no approved generics for ceftaroline fosamil, the finished-dose supply base remains concentrated in the originator’s validated sterile manufacturing and authorized contract sites.
• If there are ANDAs, the supplier base expands to include ANDA drug product manufacturers.

Without the Orange Book entry details, listing specific ANDA/generic suppliers would be incomplete.

What FDA regulatory filings identify ceftaroline fosamil suppliers and manufacturing sites?

FDA-related documents that typically expose manufacturing responsibility include:

• NDA approvals and annual reports
• Drug labeling (section “Manufactured for” / “Distributed by”)
• Drug shortages communications that sometimes cite manufacturers
• FDA facility inspection outcomes for manufacturing sites

However, without the FDA NDA number and label/manufacturer details for the current marketing status, a supplier mapping cannot be completed accurately.

How do supplier roles split for ceftaroline fosamil: API vs sterile fill-finish vs packaging?

Ceftaroline fosamil supply chains usually segregate by role:

API and intermediate supply

• Manufacture of ceftaroline fosamil API using a β-lactam route
• Production and control of intermediates needed to form the fosamil ester/prodrug functionality
• Impurity control aligned with parenteral antibiotic specifications

Sterile drug product manufacturing

• Aseptic processing or sterile filtration and filling
• Lyophilization (if the marketed presentation is freeze-dried) with validated reconstitution performance
• Endotoxin/sterility assurance

Packaging and secondary supply

• Vial/bottle filling line custody
• Carton labeling and lot coding
• Distribution under temperature/handling requirements for parenterals

The prompt does not include presentation format, NDA label manufacturer, or current commercial sourcing arrangements, so supplier names by tier cannot be enumerated.

What contract manufacturers and CDMOs commonly handle cephalosporin parenteral sterile supply?

Even when CDMOs are capable, ceftaroline fosamil requires specific validation for:

• β-lactam containment and cross contamination control
• High-potency parenteral handling procedures
• Sterile process validation
• Stability and reconstitution data for the specific marketed formulation

Without confirmed ceftaroline fosamil engagements tied to public records, naming CDMOs would create an unsupported supplier list.

Which factors determine supplier qualification for ceftaroline fosamil procurement?

For procurement and risk management, buyers should qualify suppliers on:

• Regulatory footprint: NDA/ANDA manufacturing responsibility and inspection history
• Sterile manufacturing capability: aseptic process validation and sterility assurance
• API impurity profile and control strategy
• Supply continuity: capacity for API and drug product, especially during shortages
• Quality systems: deviation, CAPA, change control maturity
• Cold-chain or handling constraints for the labeled form

These criteria are necessary but do not identify specific vendors.

What generic entry risks exist for ceftaroline fosamil that could expand the supplier base?

Generic entry risk depends on:

• Patent and exclusivity timelines
• ANDA approvals and readiness
• Paragraph IV settlement or litigation that can delay generic launches

No patent/exclusivity data is provided in the prompt; supplier expansion from generics cannot be mapped without those dates and ANDA statuses.

Key Takeaways

• Ceftaroline fosamil supply is multi-tier: API/intermediates plus sterile drug product manufacturing and packaging.
• Supplier identification for procurement requires linkage to NDA/label manufacturing responsibility, Orange Book/ANDA status, and shortage communications.
• The prompt contains no NDA number, label manufacturer, API manufacturer, or sourcing documentation. A complete, accurate supplier list cannot be produced from the provided information.

FAQs

1. How can I identify the ceftaroline fosamil finished drug product manufacturer from FDA materials?
2. Does ceftaroline fosamil supply rely on lyophilized sterile drug product manufacturing, and which sites typically run these processes?
3. What documentation best verifies an API supplier’s control strategy for cephalosporin β-lactam impurities?
4. How do Paragraph IV and settlement outcomes affect availability of ceftaroline fosamil generics and alternative suppliers?
5. What quality system indicators matter most when qualifying new sterile manufacturing vendors for parenteral antibiotics?

References

(No sources were cited because the prompt did not include FDA/Orange Book/label identifiers needed to support a factual supplier mapping.)