Last Updated: September 24, 2026

Suppliers and packagers for DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER


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DIANEAL PD-2 W/ DEXTROSE 3.5% 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
Vantive Us Hlthcare DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 017512 NDA Vantive US Healthcare LLC 0941-0409-01 6000 mL in 1 BAG (0941-0409-01) 1978-09-27
Vantive Us Hlthcare DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 017512 NDA Vantive US Healthcare LLC 0941-0409-05 3000 mL in 1 BAG (0941-0409-05) 1978-09-27
Vantive Us Hlthcare DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 017512 NDA Vantive US Healthcare LLC 0941-0409-06 2000 mL in 1 BAG (0941-0409-06) 1978-09-27
Vantive Us Hlthcare DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 017512 NDA Vantive US Healthcare LLC 0941-0409-07 5000 mL in 1 BAG (0941-0409-07) 1978-09-27
Vantive Us Hlthcare DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 017512 NDA Vantive US Healthcare LLC 0941-0411-04 3000 mL in 1 BAG (0941-0411-04) 1978-09-27
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Suppliers and packagers for DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

Last updated: June 26, 2026

DIANEAL PD-2 W/ Dextrose 3.5% in Plastic Container: Who Supplies It, What Markets It, and What Supplier Options Exist

Di an eal PD-2 with dextrose 3.5% in a plastic container is supplied under the Baxter Healthcare product system for peritoneal dialysis solutions. The branded product is marketed in the US under Baxter’s ownership/control of the finished dosage form (sterile peritoneal dialysis solution in flexible plastic containers).

Bottom line for procurement: The practical “supplier” for DIANEAL PD-2 in the US commercial supply chain is Baxter (finished goods and distribution). For alternative sourcing, the business question typically shifts from “who supplies DIANEAL PD-2” to “which manufacturers supply therapeutically equivalent peritoneal dialysis solutions” and “which wholesalers carry those SKUs,” since DIANEAL PD-2 is a branded Baxter product.

What companies supply DIANEAL PD-2 3.5% dextrose plastic container?

Baxter Healthcare supplies the finished, marketed DIANEAL PD-2 product in plastic containers in the US distribution network. The drug label and prescribing information identify Baxter as the manufacturer/marketer for the marketed product (finished goods).

What does the product configuration imply for suppliers?

“Plastic container” in DIANEAL PD-2 refers to flexible container peritoneal dialysis solution packaging. That packaging format typically binds supply to the sponsor/manufacturer because of:

  • container-specific manufacturing lines and sterile fill processes
  • compatibility of the container material with the solution system
  • packaging configuration and NDC/strength-specific labeling

That means alternative supply is more realistically achieved via:

  • other Baxter plants or approved manufacturing sites under Baxter’s control (same branded product), or
  • different peritoneal dialysis solution manufacturers (generics or equivalents), not the same DIANEAL SKU.

What is the Orange Book status of DIANEAL PD-2 (dextrose 3.5%) and what does it imply about supplier competition?

Featured-snippet answer: DIANEAL products are typically listed in FDA drug databases as branded drugs under Baxter; competitive entry for complex sterile dialysis solutions is constrained by CMC, container, and sterility requirements, which in practice reduces straightforward “multiple generic suppliers” for the same packaged presentation.

Key business implication: If FDA Orange Book lists DIANEAL PD-2 for certain strengths/presentations, that listing framework governs ANDA entry risk and Paragraph IV opportunities. When multiple equivalent products exist, suppliers can appear as wholesalers distributing those alternatives; otherwise, DIANEAL remains primarily Baxter-controlled.


Who supplies peritoneal dialysis solutions that can substitute for DIANEAL PD-2 3.5% dextrose?

Featured-snippet answer: Substitution is usually through other peritoneal dialysis solutions with comparable concentrations and clinically equivalent indications rather than through “repackaged DIANEAL.” In the US, peritoneal dialysis solutions are a mature, regulated category with a small number of manufacturers, so supplier alternatives usually depend on the exact strength and container configuration.

Procurement reality for PD solutions: Hospitals and dialysis providers typically source through:

  • national distributors (that carry Baxter brands plus other PD solution brands)
  • group purchasing organizations (GPOs)
  • direct distribution contracts with Baxter or alternate manufacturers

Without the exact NDC in-hand for the DIANEAL PD-2 3.5% plastic container presentation, the supplier map cannot be stated precisely at NDC level. In practice, supplier choice is determined by the distribution contract and product availability for the same solution strength and packaging configuration.


Which companies are likely involved in the manufacturing supply chain for DIANEAL PD-2 plastic containers?

For an injectable sterile peritoneal dialysis solution in a flexible plastic container, the supply chain has two practical layers:

  1. Finished-goods manufacturer/holder: Baxter supplies the marketed finished product under its drug establishment and label control.
  2. Packaging and raw-material ecosystem: container film, sterilization validation, and component suppliers are typically qualified vendors to the finished-goods manufacturer. Those upstream suppliers are rarely visible as “public alternatives” because procurement at hospital level is NDC/SKU-based, not component-based.

Business-use interpretation: When buyer teams ask “who supplies,” they usually mean either:

  • the finished-goods brand holder (Baxter for DIANEAL), or
  • alternative brand manufacturers for procurement flexibility.

How can a buyer identify the correct DIANEAL PD-2 suppliers for tendering and contracting?

Featured-snippet answer: Use NDC-to-distributor mapping at the channel level and label-to-manufacturer mapping at the clinical/product level. The two-step process is:

  • Confirm the exact NDC for “DIANEAL PD-2 with dextrose 3.5% in plastic container.”
  • Map NDC to wholesalers/SKU availability for the region and contract terms.

This avoids mismatches where a similar strength exists in different containers or formats.


What generic entry risks exist for DIANEAL PD-2 (dextrose 3.5%) that would change suppliers?

Featured-snippet answer: Generic entry risk exists only where FDA has an ANDA pathway for a specific presentation and where the manufacturer can meet CMC and container constraints. For sterile PD solutions in flexible containers, the practical barrier is often CMC and container compatibility rather than the concept of dextrose concentration itself.

Supplier diversification typically happens when:

  • an additional brand is approved and stocked through distributor networks, or
  • a branded competitor (not necessarily a generic) wins formulary placement.

Supplier landscape comparison: DIANEAL PD-2 vs other peritoneal dialysis solution brands

Featured-snippet answer: DIANEAL’s supplier identity is Baxter for the branded SKU. Competitive alternatives depend on which equivalent peritoneal dialysis solution brands a provider’s formulary includes, and on channel availability.

Procurement-facing comparison frame (what matters to buyers):

  • same dextrose concentration (3.5%)
  • same PD solution type (PD-2 regimen specificity)
  • same container configuration (plastic container)
  • availability in the hospital’s contracted distribution footprint
  • lead times and cold chain needs (PD solutions are generally not cold chain dependent, but packaging supply continuity matters)

Key Takeaways

  • DIANEAL PD-2 with dextrose 3.5% in plastic containers is a Baxter-supplied branded peritoneal dialysis solution for the US market.
  • Practical supplier switching is rarely “between DIANEAL suppliers” and more often “between PD solution brands” and distributor availability.
  • Buyer tendering should be NDC-driven and container/presentation specific to avoid substitution errors.

FAQs

  1. How do I verify the manufacturer for a specific DIANEAL PD-2 plastic container NDC?
    Check the prescribing information and label for the exact NDC; the marketed label identifies Baxter as the drug manufacturer/marketer for that presentation.

  2. Can a hospital substitute DIANEAL PD-2 (3.5% dextrose) with another peritoneal dialysis solution brand?
    Substitution depends on equivalence by strength, PD regimen category, and container/presentation, and on formulary and clinical protocol acceptance.

  3. What procurement channels typically stock DIANEAL PD-2 in plastic containers?
    National wholesalers/distributors and contracted supplier networks under hospital GPOs generally determine availability, with Baxter as the branded finished-goods source.

  4. What would most likely increase the number of suppliers for DIANEAL PD-2-equivalent products?
    New approvals for equivalent peritoneal dialysis solutions in the same strength and presentation that can meet CMC and container requirements, then get stocked through distributor networks.

  5. Does container type (plastic) change who can supply PD solutions?
    It usually does, because container-specific sterile fill and compatibility constraints limit the set of qualified manufacturers for a given presentation.


References

  1. Baxter. DIANEAL PD-2 with Dextrose 3.5% prescribing information/label information (US product label).

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