Last Updated: May 11, 2026

Suppliers and packagers for DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER


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DIANEAL LOW CALCIUM W/DEXTROSE 1.5% 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 LOW CALCIUM W/DEXTROSE 1.5% 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 LOW CALCIUM W/DEXTROSE 1.5% 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 LOW CALCIUM W/DEXTROSE 1.5% 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 LOW CALCIUM W/DEXTROSE 1.5% 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
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER: Supplier Map for Product, Packaging, and Input Materials

Last updated: May 7, 2026

Who supplies DIANEAL LOW CALCIUM W/DEXTROSE 1.5% in a plastic container?

DIANEAL (low-calcium peritoneal dialysis solution) is a branded product manufactured and supplied in the U.S. by Baxter Healthcare Corporation. The brand is marketed for peritoneal dialysis and typically supplied in multi-chamber or single-bag plastic container formats depending on the specific labeled presentation.

Primary supplier (product brand/manufacturer):

  • Baxter Healthcare Corporation (DIANEAL brand owner and manufacturer/supplier in the U.S.) [1]

Which container suppliers are implicated for the “plastic container” format?

For peritoneal dialysis solutions, the “plastic container” is part of the finished-goods system and is generally built around:

  • A multi-layer plastic bag (commonly co-extruded films designed for compatibility with dialysis solutions)
  • Seals and ports
  • Sterilization-ready packaging architecture

However, the public-facing regulatory label for DIANEAL 1.5% low-calcium does not consistently identify the specific film/bag maker by name. What is reliably stated on regulated product labeling is the manufacturer of the finished dosage form (Baxter), not the underlying polymer-film or bag-assembly supplier.

Finished-goods container supplier (named on labeling):

  • Not itemized to the bag-film or bag-assembly subcontractor in standard product labeling; the finished product manufacturer is Baxter. [1]

Who supplies the drug substance inputs (dextrose and electrolytes) used in DIANEAL?

DIANEAL is a compounded formulation of dextrose plus salts/electrolytes and buffers (typical for low-calcium peritoneal dialysis). Public regulatory labeling for DIANEAL generally specifies composition (active ingredients and/or components) but does not list named upstream raw-material suppliers for each component.

Named input suppliers:

  • Not specified at the level of named third-party raw-material manufacturers in standard DIANEAL labeling/label sections; the labeled manufacturer is Baxter. [1]

What can be treated as the actionable supplier list for procurement?

For R&D, sourcing, contracting, or competitive mapping, the procurement-relevant supplier set that can be supported from public labeling is limited to the finished product manufacturer. Upstream suppliers for bag films and raw chemicals are not disclosed on the product label.

Supplier list (label-supported)

Supply role Entity Evidence level
Finished product manufacturer / brand supplier (DIANEAL Low Calcium w/ Dextrose 1.5% in plastic container) Baxter Healthcare Corporation Explicit on product labeling [1]
Container film/bag assembly subcontractor Not named in product labeling Not label-disclosed in standard DIANEAL labeling [1]
Raw-material (dextrose, electrolytes, buffer) suppliers Not named in product labeling Not label-disclosed in standard DIANEAL labeling [1]

How to use this in vendor qualification for R&D or supply assurance

Given the label-supported supplier boundary, the practical path for vendor qualification is to contract through, or be sourced by, the finished dosage form manufacturer and then request disclosed supply-chain documentation internally (GMP traceability, supplier qualification, and change-control letters).

The business-relevant decision point is whether your requirement is:

  • Procure finished DIANEAL product for clinical or commercial use (use Baxter as the supplier anchor), or
  • Source packaging film/bag components and raw materials directly (requires supplier qualification outside what is disclosed on-label)

Key Takeaways

  • Baxter Healthcare Corporation is the label-supported supplier/manufacturer for DIANEAL (low calcium with dextrose) 1.5% in plastic container presentations in the U.S. [1]
  • The specific subcontractors that supply plastic container film/bag assembly and upstream raw chemicals are not identified by name in the standard DIANEAL labeling text that identifies Baxter as manufacturer.
  • For actionable procurement or competitive supply mapping, the only directly supportable supplier from labeling alone is Baxter.

FAQs

  1. Is Baxter the manufacturer of DIANEAL Low Calcium w/ Dextrose 1.5%?
    Yes. DIANEAL is manufactured/supplied by Baxter Healthcare Corporation based on product labeling. [1]

  2. Does the DIANEAL label name the plastic bag/film subcontractor?
    No. The label identifies the finished product manufacturer, not the upstream plastic container maker by name. [1]

  3. Are upstream suppliers for dextrose and electrolytes listed on the DIANEAL label?
    No. The label provides formulation information but does not name upstream raw-material suppliers. [1]

  4. Who should be contacted for change-control and supply-chain documentation on DIANEAL packaging?
    The finished product manufacturer, Baxter, since packaging supply-chain parties are not named in labeling. [1]

  5. Can you build a supplier list beyond Baxter from publicly available DIANEAL labeling?
    Not at the named-vendor level for the bag-film subcontractor or raw-material suppliers, based on the label text that supports Baxter as manufacturer. [1]


References

[1] Baxter Healthcare Corporation. DIANEAL (low calcium with dextrose) 1.5% in plastic container prescribing/labeling information (manufacturer/sponsor listing on product label).

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