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Suppliers and packagers for CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
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CEFEPIME AND DEXTROSE IN DUPLEX 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 |
|---|---|---|---|---|---|---|---|---|---|
| B Braun | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | cefepime hydrochloride | INJECTABLE;INJECTION | 050821 | NDA | B. Braun Medical Inc. | 0264-3193-11 | 24 CONTAINER in 1 CASE (0264-3193-11) / 50 mL in 1 CONTAINER | 2010-05-06 |
| B Braun | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | cefepime hydrochloride | INJECTABLE;INJECTION | 050821 | NDA | B. Braun Medical Inc. | 0264-3195-11 | 24 CONTAINER in 1 CASE (0264-3195-11) / 50 mL in 1 CONTAINER | 2010-05-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Cefepime and Dextrose in Duplex Container: Who Manufactures the Dual-Container System and Who Fills Cefepime
CEFEPIME AND DEXTROSE in duplex container is supplied through a limited set of US-labeled manufacturers and packaging/combination supply chains. Key supplier roles break into (1) cefepime API and drug-product manufacturing, (2) duplex container system supply and sterile assembly, and (3) contract repackaging/labeling for US distributors.
H1: Suppliers for Cefepime and Dextrose in Duplex Container (Dual Chamber IV Container) in the US
Which companies supply cefepime and dextrose in duplex containers for IV infusion?
Answer: The supplier set depends on the marketed NDC and whether the product is distributed as a finished sterile drug product or assembled as a combination package. Duplex-container products are typically supplied as finished drug products by the labeled drug holder/manufacturer of record, with container system sourcing handled by packaging suppliers or the same manufacturer’s packaging line.
Cefepime + dextrose duplex-container supply chain roles
- Drug-product manufacturer (sterile fill-finish): produces cefepime sterile drug product (lyophilized or solution form depending on specific presentation) and ensures sterile packaging compatibility.
- Container system/duplex assembly supplier: supplies the dual-chamber container hardware and the sterile assembly process (seals, gas transfer, mixing mechanism depending on design).
- Distributor/labeler: markets under its own NDC and sells through wholesalers and institutions.
What packaging suppliers make the duplex container used for cefepime and dextrose IV?
Answer: Duplex container systems are commonly sourced from specialized IV packaging OEMs used across multiple antibiotic and reconstitution products. For cefepime + dextrose specifically, the duplex-container manufacturer is not always visible in public labeling; it is typically embedded within the drug-product manufacturer’s packaging supply chain.
Duplex-container design variants that affect supplier selection
- Single-use sterile dual-chamber plastic container with separation between cefepime and diluent.
- Mixing mechanism that allows controlled transfer from diluent chamber to powder/lyophilized chamber or vice versa.
- Barrier and compatibility constraints tied to cefepime and dextrose chemical and physical stability.
Are cefepime and dextrose duplex containers interchangeable across NDCs?
Answer: No. Interchangeability depends on NDC-specific presentation, container volume capacity, closure system, and mixing functionality. Even when the active ingredients match (cefepime and dextrose), container geometry and sterile assembly differences can change substitution feasibility for hospitals and group purchasing organizations.
What drives non-interchangeability
- Chamber sizes and final reconstituted volume
- Closure type and port geometry
- Shelf-life and stability specifications tied to container-material system
What is the FDA status of cefepime + dextrose duplex-container products (Orange Book listings)?
Answer: Cefepime combination products are generally listed in the FDA’s Orange Book if they have Orange Book-listed patents. Duplex-container presentations may have separate listings by NDC.
How to interpret Orange Book listings for supplier mapping
- Listed drug (RLD): ties to the manufacturer and labeler
- Dosage form and strength: may map to a specific container configuration
- Patent family coverage: may correspond to specific formulations or packaging technologies tied to drug-product applicants
Which supplier is the RLD for cefepime and dextrose duplex containers?
Answer: The RLD depends on the specific NDC/presentation of “cefepime and dextrose in duplex container.” The identity of the RLD manufacturer is determined by the Orange Book’s “RLD/Applicant” entry for that exact listing.
Practical procurement implication
Group purchasing and contracting typically reference the NDC not the therapeutic label alone. Supplier mapping should therefore be done at NDC level.
How many supplier groups cover cefepime + dextrose duplex containers?
Answer: In the US, coverage usually clusters into a small number of finished drug product manufacturers and a smaller number of packaging/sterile assembly partners. The number of active suppliers varies with market demand and outages, but the OEM packaging universe is broader than the finished drug-product universe.
Typical supplier count pattern in mature sterile antibiotics
- Finished drug-product suppliers: limited
- Duplex-container OEM/assembly capability: concentrated among packaging specialists
- Relabeling/distribution: usually more varied than manufacturing
What generic entry risks exist for cefepime and dextrose duplex-container products?
Answer: Entry risks hinge on:
- sterile manufacturing capacity constraints,
- stability and container compatibility,
- and the regulatory pathway’s ability to demonstrate equivalence at the specific NDC level.
Risk factors that block or delay generic substitution
- Container compatibility (material and mixing performance)
- Sterility assurance and aseptic process validation
- Patent coverage tied to presentation, formulation, or packaging technology
How do patent expiration and exclusivity timelines affect supplier competition?
Answer: Supplier competition increases after expiration of:
- drug-product and formulation patents tied to the specific presentation
- any data exclusivity periods tied to the RLD
- and any settlement terms that restrict generic filings or launches for duplex-container presentations.
What to check to time supplier transitions
- Patent expiration dates for the exact Orange Book listing
- Any regulatory exclusivities impacting ANDA timing
- Litigation outcomes that can delay or constrain launches
Which patent litigation affects cefepime + dextrose duplex-container suppliers?
Answer: Litigation typically attaches to specific ANDA filings and Orange Book-listed patents for the listed drug and its presentations. Cefepime antibiotic products can face Paragraph IV challenges that affect launch timing and supplier entry.
How litigation outcomes map to procurement risk
- Settlement agreements can delay generic availability even after certain expirations.
- Consent decrees can restrict specific manufacturing methods or product presentations.
Commercial landscape: what suppliers compete on price and availability?
Answer: For hospital procurement, the competitive set is driven by:
- NDC-level availability,
- contracting status with major GPOs,
- and sterile supply continuity during shortages.
What drives pricing differences between suppliers
- Whether the product is a true RLD or an authorized generic
- Supply chain scale for duplex-container sterile assembly
- Contracting status and distribution agreements
Manufacturing/IP barriers for duplex-container antibiotic presentations
Answer: The largest practical barriers are sterile fill-finish validation and container compatibility validation for the specific duplex system.
Barriers that make switching suppliers hard
- Demonstrating stability in the chosen dual-chamber configuration
- Matching mixing completeness and reconstituted solution properties
- Aseptic process controls and sterility assurance testing tailored to the container design
Key Takeaways
- Cefepime and dextrose duplex-container products are supplied through a small finished-drug manufacturing universe, with duplex-container hardware handled by specialized packaging and sterile assembly supply chains.
- Supplier identification must be done at NDC/presentation level, since duplex container designs and submissions differ across listings.
- Competitive entry and procurement stability depend on sterile manufacturing validation, container compatibility, and any Orange Book-listed patent or litigation outcomes tied to that exact presentation.
FAQs
- How can procurement teams identify the manufacturer for a cefepime and dextrose duplex container product by NDC?
- What documentation shows container compatibility for cefepime and dextrose duplex-container generics?
- Do authorized generics for cefepime and dextrose duplex containers come from the same sterile assembly partners as the RLD?
- How do shortages typically affect supply of cefepime duplex-container presentations at the NDC level?
- Which regulatory filings usually govern the equivalence of cefepime and dextrose duplex-container presentations (ANDA vs other pathways)?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
- FDA. Drug Applications and Databases (including NDC and labeling resources).
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