Last Updated: June 25, 2026

Suppliers and packagers for DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER


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DIANEAL 137 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 137 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 137 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 137 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 137 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
Vantive Us Hlthcare DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 017512 NDA Vantive US Healthcare LLC 0941-0411-04 3000 mL in 1 BAG (0941-0411-04) 1978-09-27
Vantive Us Hlthcare DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 017512 NDA Vantive US Healthcare LLC 0941-0411-05 1000 mL in 1 BAG (0941-0411-05) 1978-09-27
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

Last updated: June 15, 2026

DIANEAL 137W (Dextrose 1.5%) Plastic Container: Who Supplies the Components and Who Manufactures the Product

DIANEAL 137W is a Baxter home hemodialysis/PD solution line (peritoneal dialysis) supplied through Baxter’s global manufacturing network. The commercial “supplier” list for this product in practice resolves to (1) Baxter (finished drug product manufacturer) and (2) upstream component suppliers that Baxter qualifies for solution formulation and plastic container systems (bags, tubing, and packaging).

Because “Suppliers for the pharmaceutical drug” can mean different supply-chain layers (finished product vs. container materials vs. active ingredient and excipients), a complete answer requires Orange Book/FDA labeling linkage plus manufacturing site and component-level sourcing. No such component-level supplier dataset is provided here.

What company manufactures DIANEAL 137W/ Dextrose 1.5% in plastic container?

Answer (finished drug product): Baxter is the manufacturer/seller of DIANEAL peritoneal dialysis solutions.

Where is DIANEAL 137W produced?

DIANEAL is manufactured in Baxter’s regional sterile solution facilities and distributed under Baxter’s marketing authorizations in the US and other markets, with local labeling often listing a manufacturer name and address for the specific presentation.

What is the product form and container system?

DIANEAL 137W in “plastic container” indicates a pre-made peritoneal dialysis solution bag system (single or twin-bag depending on the presentation). Baxter’s PD solutions use plastic container technologies that are typically compatible with sterile formulation and controlled leach profiles, but the exact container technology (and the named supplier at the container-material level) is not determinable from the prompt alone.

Which suppliers provide the plastic container system for DIANEAL 137W?

Answer (container): Baxter-qualified container and packaging suppliers provide the plastic bag, sealing film, and associated components used for sterile PD solution systems, but specific third-party supplier identities are not specified in the prompt and are not reliably derivable without access to Baxter’s device/container supplier disclosures or labeling component statements for this exact SKU (DIANEAL 137 W with 1.5% dextrose, plastic container).

What parts make up the “plastic container” for PD solutions?

  • Multi-layer bag film (polymer blend selected for dialysis solution compatibility)
  • Seals and weld materials (heat/ultrasound-weldable polymer interfaces)
  • Port connectors and tubing (if present for the transfer system)
  • Sterile packaging outer wrap and labeling systems

Who supplies dextrose and excipients used in DIANEAL 137W?

Answer: Dextrose and electrolyte excipients are supplied by Baxter-qualified commodity and specialty suppliers to Baxter’s specifications. The prompt does not identify the specific ingredient brands or named suppliers for dextrose (USP-grade) and other formulation components (e.g., sodium salts, buffers, or other constituents depending on the DIANEAL variant code 137W).

Why ingredient supplier names usually do not appear publicly

In the US, finished drug labels generally identify the manufacturer of the drug product, not the upstream excipient or container-material suppliers. Supplier qualification is typically handled under private quality agreements.

How do you identify DIANEAL 137W suppliers from FDA labeling and distributor information?

Answer (practical mapping): The only public “supplier” you can tie to DIANEAL 137W with high confidence from the information given is the finished product manufacturer (Baxter) through US labeling and distribution records. Third-party supplier names require sourcing from:

  • Container and packaging supplier qualification disclosures (not generally public)
  • NDA/DMF references tied to specific container components (rarely published in a way that names the container company)
  • Procurement documentation internal to Baxter or its contract manufacturers

What does “137W” mean for sourcing and regulatory identifiers?

Answer: The “137W” code is a Baxter product/strength identifier tied to the formulation and presentation for peritoneal dialysis solutions. It does not, by itself, identify a unique upstream supplier network that is publicly listed.

What changes could alter suppliers for the same strength?

  • Market and packaging format (single bag vs. twin bag)
  • Container material generation or supplier changes over time
  • Contract manufacturing site swaps
  • Packaging system refresh cycles

What generic or parallel-supply risk exists for identifying suppliers?

Answer: Low risk for “product supplier” identification because DIANEAL is a Baxter-branded PD solution. However, supplier identification at the upstream component level is still not reliably available through public regulatory listings.

Commercial and operational implications if you need component-level suppliers

If the goal is procurement, quality agreement drafting, or continuity planning for a PD workflow, the relevant sourcing artifacts are:

  • Baxter supplier qualification lists (internal)
  • Certificates of analysis and leachables/extractables documentation for bag materials
  • Container system biocompatibility and sterile barrier documentation None of these supplier lists are provided in the prompt.

Key Takeaways

  • DIANEAL 137W with dextrose 1.5% in plastic container is supplied by Baxter as the finished drug product manufacturer.
  • Specific third-party suppliers for the plastic container system and for dextrose/excipient sourcing are not determinable from the prompt and are generally not publicly disclosed at the ingredient/container component level.
  • For component-level supplier identification, public sources typically identify the drug product manufacturer rather than upstream supplier names.

FAQs

  1. Does DIANEAL 137W dextrose 1.5% come only from Baxter manufacturing sites?
    The branded product is associated with Baxter; specific contract manufacturer or alternate site usage depends on distribution market and time.

  2. Are the plastic bag suppliers the same across all DIANEAL presentations?
    They can differ by container system generation, bag format, and manufacturing lot requirements.

  3. Can I identify dextrose/excipient suppliers for DIANEAL from the label?
    Usually not; labels identify the finished product manufacturer and do not typically list upstream commodity suppliers.

  4. Do container-material suppliers change over product life?
    Yes, supplier changes occur over time due to capacity, quality, and regulatory updates, but the identities are not usually public.

  5. What documentation supports supplier change control for PD solution bags?
    Container system qualification dossiers, sterile barrier validation, leachables/extractables assessments, and batch COAs are used in regulated supply chains.

References

No sources were provided in the prompt.

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