Last updated: May 12, 2026
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER Suppliers: Who Manufactures and Sources the Dialysate (U.S.)?
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER (a peritoneal dialysis solution) is supplied in the U.S. by Baxter Healthcare Corporation. The product’s supply chain is typically tied to Baxter manufacturing sites producing peritoneal dialysis (PD) dialysate solutions and related packaging components (plastic containers, ports, and overwraps), under Baxter’s quality system and regulatory submissions.
Who are the manufacturers and NDA/label holders for DIANEAL low calcium with dextrose 1.5%?
Featured snippet answer: The label holder/manufacturer for DIANEAL Low Calcium with Dextrose 1.5% in plastic container is Baxter Healthcare Corporation (Baxter).
NDA and label ownership
DIANEAL is marketed under Baxter’s regulatory submissions as a peritoneal dialysis solution. In practice, this means Baxter is the entity responsible for:
- Labeling and product specifications
- FDA regulatory ownership (application and listings)
- Supplier qualification for components integral to the dialysate container system
Typical contract manufacturing model for PD solutions
Peritoneal dialysis solutions are generally manufactured by the originator/holder or on its account at qualified manufacturing sites. While component suppliers can exist (plastic container material, connectors, ports, and films), the commercially available “supplier” designation for the finished drug is typically the NDA holder/marketing authorization holder rather than a named downstream component vendor.
Which companies supply the plastic containers and ports for DIANEAL dialysate solutions?
No complete, product-specific component supplier roster is presented in the supplied prompt.
What FDA listing and Orange Book status applies to DIANEAL 1.5% dextrose low calcium?
DIANEAL is a prescription solution used for peritoneal dialysis. For this category, the relevant FDA reference point for exclusivity and patent listings is usually the Orange Book only when patents are listed for eligible product types. The exact Orange Book listing status, patent numbers, and expiration dates cannot be stated from the provided prompt.
Are there generic or authorized equivalents of DIANEAL Low Calcium 1.5% dextrose in plastic containers?
No generic or interchangeable equivalent supplier landscape can be stated from the provided prompt.
What supply risks exist if container/port component suppliers face shortages?
PD solution continuity can be affected by:
- Container film and port connector supply constraints
- Sterile filling line capacity at qualified sites
- Regulatory lot release timing
These supply risks are operational rather than patent-driven, but the specific DIANEAL component supplier names are not provided in the prompt.
How does Baxter source ingredients like dextrose and electrolytes for DIANEAL dialysate?
For PD solutions, Baxter sources:
- Dextrose and salts used to set dialysate osmolarity and electrolyte composition
- Water-for-injection or pharmaceutical-grade water systems
- Sterile filtration and sterilization inputs consistent with the approved process
Named ingredient suppliers (at a company level) are not provided in the prompt.
Which distributors typically supply DIANEAL to hospitals and wholesalers?
The practical procurement channels for DIANEAL usually run through:
- National wholesalers (contracted distribution)
- Hospital group purchasing organizations (GPOs)
- Direct distribution by the label holder or its logistics partners
A specific distributor list for this exact SKU cannot be provided from the prompt alone.
Key Takeaways
- Label holder/manufacturer (finished product): Baxter Healthcare Corporation supplies DIANEAL Low Calcium with Dextrose 1.5% in plastic container in the U.S.
- The prompt does not contain component-level supplier names (plastic container, ports, films, connectors) or distributor listings for the exact SKU.
- Patent/exclusivity and Orange Book status also cannot be populated from the prompt.
FAQs
- Who owns the DIANEAL label in the U.S.?
- Is DIANEAL manufactured by Baxter or contract partners?
- Do PD solutions rely on specific plastic container/port suppliers?
- What are common procurement channels for PD solutions in hospitals?
- How do container supply constraints affect PD dialysate availability?
References
No source documents were provided in the prompt.
