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Suppliers and packagers for DEXTROSE 40% IN PLASTIC CONTAINER
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DEXTROSE 40% 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 |
|---|---|---|---|---|---|---|---|---|---|
| Otsuka Icu Medcl | DEXTROSE 40% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 018562 | NDA | ICU Medical Inc. | 0990-7937-19 | 12 POUCH in 1 CASE (0990-7937-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG | 2019-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for DEXTROSE 40% IN PLASTIC CONTAINER
Who Supplies Dextrose 40% in Plastic Containers?
Dextrose 40% injection in plastic containers is typically supplied by large sterile injectables manufacturers with US FDA-compliant aseptic production. The supplier set is dominated by companies that sell generic and branded dextrose injection lines in elastomeric or plastic container systems (commonly Viaflex-type bags or equivalent plastic container formats).
The market’s supplier landscape is also shaped by FDA product listing requirements and the specifics of container type (plastic container/IV bag), concentration (40%), and sterile injection presentation (single-dose vs multi-dose where applicable).
What companies supply dextrose 40% injection in plastic containers?
Dextrose 40% injection suppliers fall into two practical tiers: (1) US-based sterile injectables producers and (2) global generic sterile injectables players that distribute under NDA/ANDA holders or wholesalers.
Common supplier archetypes in this product category
- Large sterile injectables manufacturers with broad ANDA portfolios covering IV fluids and electrolytes
- Companies producing both generic dextrose solutions and hospital IV fluid lines
- Contract manufacturers that support multiple brands through private label arrangements
Primary named US suppliers (sterile injectables)
The following companies are the most common suppliers and/or ANDA holders/distributors for dextrose injection strengths in plastic containers across the US hospital supply chain:
- Baxter (IV fluids manufacturing network, plastic container offerings across sterile solutions)
- Hospira/Pfizer legacy sterile supply lines (historical footprint in IV injectables, including dextrose solutions in plastic containers through branded/generic lines)
- Fresenius Kabi (IV fluids and sterile injectables with plastic container supply)
- B. Braun (hospital IV solutions and sterile injectables supply into the US through branded and generic equivalents)
- McKesson / Cardinal / AmerisourceBergen private label distribution channels (not manufacturers, but primary channel distributors that often distribute dextrose injection products sourced from licensed sterile manufacturers)
Because the question is specifically “suppliers for DEXTROSE 40% IN PLASTIC CONTAINER,” the practical answer is the manufacturer(s) listed as the applicant/holder in FDA listings for the exact presentation: 40% dextrose injection in plastic container.
What is the FDA-licensed manufacturer footprint for dextrose 40% plastic container products?
In the US, dextrose injection (40%) products are typically FDA-listed under:
- NDC-based product listings (with labeler name and manufacturing sites)
- ANDA holders for generic presentations
- License holders for branded presentations
The manufacturer footprint for “plastic container” is determined by the NDC labeler and the registered manufacturing establishment for that product’s dosage form and container type.
For procurement, the key is to match the exact NDC to the container class (plastic bag/rigid plastic container system), concentration (40%), sterility/administration label, and packaging count (single bag vs case packs).
Which NDC labelers commonly sell dextrose 40% in plastic containers?
Dextrose 40% in plastic containers is commonly distributed under:
- Generic sterile injectables labelers
- Hospital supply labelers (distributors)
- Branded hospital fluid lines
The procurable names typically appear in purchasing systems as:
- “Dextrose Injection, USP 40%”
- “Dextrose 40% in Plastic Container”
- “Dextrose Injection 40% (single-dose unit)”
The exact labeler names vary by distribution channel and NDC.
How do plastic container dextrose 40% suppliers differ by container type?
Container selection drives supplier qualification and logistics:
What to check on PO specs
- Plastic container format (IV bag vs rigid container system)
- Fill volume (commonly 50 mL, 100 mL, or equivalent, depending on specific NDC)
- Secondary port configuration (if specified)
- Overwrap and case pack count
- Storage and expiration dating
Manufacturers that support plastic bag formats typically have validated elastomer or multilayer plastic contact compliance and leachables controls for dextrose solutions.
When does exclusivity or patent protection affect dextrose 40% suppliers?
Dextrose injection at this strength is generally treated as a mature generic category. In most cases, commercial supply is driven by ANDA/market authorization status rather than active exclusivity.
From a supplier competition standpoint, the constraints are typically:
- sterile manufacturing capacity
- regulatory compliance history
- supply chain continuity for plastic container systems
- market share of specific NDCs tied to major distributors
What bottlenecks affect supply of dextrose 40% in plastic containers?
Procurement risk tends to cluster around:
- sterile aseptic manufacturing utilization for high-throughput IV solutions
- plastic container supply (bag film resins, connectors, overwrap)
- buffer capacity at distributors and hospital group purchasing organizations
- inspection-driven production interruptions
These bottlenecks can create temporary substitution demands (different NDC, different container size), which is why supplier identification should be NDC-specific.
What generic entry risks exist for dextrose 40% plastic container products?
For a widely used IV fluid product, “entry risk” is mostly a manufacturing and regulatory readiness issue:
- Ability to pass aseptic process validation and sterility assurance requirements
- Ability to meet container-closure integrity and leachables profile for the plastic system
- Scale-up capacity for a high-liquidity product that hospitals buy frequently
New entries usually compete for specific NDCs and packaging formats rather than changing the core molecule.
What procurement approach identifies the right supplier for your exact product?
For purchasing and replacement planning, suppliers should be identified by:
- Exact NDC for “Dextrose Injection USP 40% in plastic container”
- Labeler/manufacturer on the NDC listing
- Case pack and container volume
- Preferred distributor/contract (GPO or direct hospital account)
This is the most direct way to prevent receiving an equivalent strength with a different container system that may not fit clinical workflows.
Key Takeaways
- Dextrose 40% injection in plastic containers is supplied by large sterile injectables manufacturers, with distribution through hospital supply chains.
- Supplier identification is NDC-specific because “plastic container” and packaging formats map to specific manufacturing listings.
- The supplier set is dominated by major sterile IV-fluid producers and their generic labelers, with distribution-driven sourcing through GPO and wholesaler channels.
- Supply disruptions are usually capacity and container-system constraints rather than patent or exclusivity barriers.
FAQs
1) How do I confirm the manufacturer of dextrose 40% in a plastic container?
Match the product’s NDC to the FDA listing for that specific dosage form and container presentation.
2) Are distributors the same as manufacturers for dextrose 40% plastic container?
No. Distributors often label the product or sell under private distribution channels, while manufacturers are the FDA-registered sterile producers.
3) Can different NDCs be clinically interchangeable for dextrose 40% in plastic containers?
They are not always interchangeable because container format, volume, and labeling can differ. Validate against your clinical and procurement specifications.
4) What causes shortages for dextrose 40% plastic container products?
Aseptic manufacturing capacity constraints and plastic container supply chain issues are common drivers.
5) Do patent protections limit who can supply dextrose 40% plastic container?
Typically not in a meaningful way for this mature IV-fluid product category; supply competition is generally driven by regulatory and manufacturing readiness.
References (APA)
No sources were provided in the prompt, and no external document set was cited.
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