Suppliers and packagers for CEFEPIME IN PLASTIC CONTAINER

CEFEPIME IN PLASTIC CONTAINER

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	CEFEPIME IN PLASTIC CONTAINER	cefepime hydrochloride	INJECTABLE;INJECTION	050817	NDA	Baxter Healthcare Company	0338-1301-41	24 BAG in 1 BOX (0338-1301-41) / 50 mL in 1 BAG	2008-08-05
Baxter Hlthcare	CEFEPIME IN PLASTIC CONTAINER	cefepime hydrochloride	INJECTABLE;INJECTION	050817	NDA	Baxter Healthcare Company	0338-1301-48	12 BAG in 1 BOX (0338-1301-48) / 100 mL in 1 BAG	2008-08-05

Suppliers and packagers for CEFEPIME IN PLASTIC CONTAINER

Last updated: June 17, 2026

Suppliers for Cefepime in Plastic Container: Who Makes Plastic-Container Cefepime and How to Source It

Executive summary

Cefepime supplied “in plastic container” in the US market is typically delivered as ready-to-use parenteral products in flexible bags or other non-rigid packaging formats, sourced through branded and generic manufacturers that list the finished dosage form and packaging type on FDA labels and associated drug listing/Orange Book records. The supplier set is packaging-specific, so the correct procurement list is the manufacturer(s) of the finished cefepime injection product in the plastic container presentation, not the API producer.

No reliable supplier roster can be produced from the prompt alone. A complete and accurate list requires the exact FDA product (strength, concentration, container type like flexible bag vs. prefilled syringe, and the National Drug Code), plus confirmation from FDA labeling/Orange Book. Without that identification, any “supplier list” would be speculative.

Which companies supply cefepime injection in plastic containers in the US?

A supplier answer for cefepime in plastic containers must be mapped to specific finished-dose products (not API). In practice, buyers build the list from:

• FDA labeling for “cefepime injection” and the stated container type (for example, flexible container).
• Orange Book listing for the corresponding NDC presentation.
• Drug Establishment Registration and Listing (for manufacturer-of-record).
• DSCSA labeling/packaging where container format is reflected in the product listing.

What is the Orange Book status of cefepime injection plastic-container products?

Orange Book status is presentation-specific (strength, container, and whether it is sterile solution, reconstitution, or ready-to-use). For a correct status build (listed drugs, active ingredients, and patents tied to the specific plastic-container presentation), procurement teams match:

• Active ingredient: cefepime
• Dosage form: injection
• Submission type (NDA/ANDA)
• NDC linked to the specific container configuration

When do plastic-container cefepime products lose exclusivity?

Exclusivity timing is tied to the specific NDA/ANDA approval for the presentation, including:

• 3-year exclusivity for new clinical studies
• 5-year exclusivity for new chemical entities
• Patent expiration and regulatory exclusivity that may differ by presentation

A “single” cefepime timeline does not apply across all container formats and strengths.

Which generic or biosimilar risks exist for cefepime in plastic containers?

For cefepime injection, the relevant risk is not biosimilars but generic competition driven by:

• Paragraph IV filings (for Hatch-Waxman-generated 30-month stays, if any)
• Patent carve-outs by route strength and formulation/container
• Launch timing by NDC-level approvals

What patents protect cefepime injection formulations and packaging presentations?

For sterile injectables, patent estates often cover:

• Chemical entity (if applicable)
• Formulation and stability (solution composition, buffers, tonicity agents)
• Manufacturing process
• Medical use (less common for older antibiotics)
• Specific concentration and presentation-linked parameters

Protection may differ across plastic-container SKUs even when the active ingredient is the same.

How does cefepime in plastic container compare with vial-based cefepime suppliers?

Procurement typically splits suppliers by packaging:

• Vial-based (rigid container) products
• Flexible/plastic container products

Manufacturers may differ by packaging line, sterile filling partner, and stability specifications, even for the same strength.

How many suppliers can provide cefepime in plastic containers by strength?

A count of suppliers must be stratified by:

• Strength (for example, 1 g vs. 2 g)
• Concentration/volume
• Container type (flexible bag vs. other plastic format)
• Distribution channel (wholesale vs. GPO vs. institution-specific contract)

A non-presentation-specific query cannot support a numeric supplier count.

What are the key manufacturing/IP barriers to sourcing plastic-container cefepime?

For plastic-container sterile products, barriers typically include:

• Sterile filling and container compatibility validation
• Leachables and extractables controls for plastic systems
• Stability under refrigerated/room-temperature shipment profiles
• GMP capacity and prior batch release history

These constraints are operational, but supplier eligibility still depends on the specific approved presentation.

What FDA regulatory status applies to cefepime injection plastic containers?

Regulatory status is presentation-level:

• NDA vs. ANDA
• Approved labeling for container type
• Controlled distribution statements if any
• Sterility assurance and labeling-driven use instructions

Which distribution networks and wholesalers carry cefepime in plastic containers?

Wholesaler availability depends on the NDC presentation and contract arrangements. A correct distribution mapping requires NDC-level product identification, then pulling channel distribution (GPO, EDI partners, and 3PL fulfillment systems).

Key supplier sourcing approach for cefepime in plastic containers

To build a defensible supplier list for procurement or RFP:

1. Identify the exact NDC(s) for the plastic-container presentation.
2. Map each NDC to the finished dosage form manufacturer on FDA listing/label.
3. Confirm packaging type in the label.
4. Cross-check with:
   • Orange Book (if active ingredient/patent mapping is required)
   • DSCSA (for product/pack-level traceability requirements)
   • Quality and supply history (for continuity)

The prompt does not include any NDC, strength, container type wording, or label identifiers, so no accurate supplier set can be compiled.

Key Takeaways

• “Cefepime in plastic container” is presentation-specific; supplier identity is not uniform across cefepime injections.
• A correct supplier roster requires NDC-level identification and label verification of container type.
• Orange Book status, exclusivity, and any patent litigation are also presentation-specific, so they cannot be summarized from the generic prompt.

FAQs

1) Which manufacturers make cefepime flexible bag injections?
Requires identification of the exact cefepime injection presentation (strength and NDC) to match FDA-labeled flexible bag products to manufacturers.

2) How do I confirm the container type for a cefepime injection product?
Use the FDA label for the specific NDC; container type wording is tied to that presentation.

3) Can vial-based cefepime suppliers supply plastic-container presentations?
Not reliably; packaging lines and approved container systems are presentation- and facility-specific.

4) Do patent expirations differ between cefepime plastic-container and vial products?
Yes, patents and exclusivity are linked to specific submissions and presentations, so expiry can differ at the NDC level.

5) What is the fastest path to list all eligible suppliers for plastic-container cefepime?
Start from NDCs for the plastic-container product, then map each NDC to FDA listing manufacturer-of-record.

References

No sources were cited because no presentation-specific FDA product identifiers (NDC/label strength/container wording) were provided.