Last updated: February 25, 2026
This dialysis solution is a peritoneal dialysis corresponding product, primarily supplied by Fresenius Kabi, with other manufacturers producing similar formulations.
Major Suppliers
1. Fresenius Kabi
- Product: DIANEAL Low Calcium with Dextrose 1.5%
- Form: Plastic container (single-dose or multiple-dose bags)
- Availability: Global distribution, including North America, Europe, Asia
- Manufacturing Locations: Multiple, including the U.S. and Germany
- Regulatory Approvals: FDA (U.S.), EMA (Europe), and other regulatory bodies
2. Baxter International
- Product: Equivalent peritoneal dialysis solutions, such as "Baxter CAPD Solutions"
- Form: Plastic containers
- Availability: North America and select regions
- Notes: Baxter's solutions often have variations in calcium content and dextrose concentration as part of their PD portfolio; direct equivalent of DIANEAL Low Calcium is limited, but similar formulations are available.
3. B. Braun Melsungen AG
- Product: Peritoneal dialysis solutions including Dextrose-based products
- Form: Plastic bags
- Availability: Mainly Europe and select markets
- Notes: Variations might have different calcium and dextrose levels, but no exact same formulation available.
4. Other Regional Suppliers
- Several regional manufacturers produce equivalent peritoneal dialysis solutions, but their formulations may vary in calcium concentration and packaging.
Regulatory and Market Status
- FDA Approval: DIANEAL is FDA-approved in the United States.
- EMEA Approval: Approved for use in European markets.
- Patent Status: The core formulation has long-standing patents held by Fresenius Kabi; generic or biosimilar products may develop in jurisdictions where patents expire.
Product Specifications (Typical)
| Parameter |
Specification |
| Calcium Content |
1.25 mmol/L (Low Calcium) |
| Dextrose Concentration |
1.5% |
| Container Type |
Plastic bag / container |
| Volume |
Usually 2 or 3 liters |
Supply Chain Constraints
- Manufacturing Capacity: Concentrated in North America and Europe.
- Regulatory Approvals: Variance across markets affects market entry and product availability.
- Patent Litigation: Ongoing in some regions concerning generic production, affecting supply options.
Key Points
- Fresenius Kabi is the authorized and primary supplier of DIANEAL Low Calcium with Dextrose 1.5%.
- Other suppliers like Baxter and B. Braun produce comparable products, but formulations and packaging may differ.
- Regulatory approvals and patent protections dominate market availability.
- Supply chain depends on regional manufacturing capacity and regulatory constraints.
Key Takeaways
- The primary source for DIANEAL Low Calcium with Dextrose 1.5% in plastic containers is Fresenius Kabi.
- Alternative suppliers include Baxter and B. Braun, which offer similar peritoneal dialysis solutions.
- Variations in formulation, packaging, and patent status influence supply options.
- Market access depends strongly on regional regulatory approvals.
FAQs
1. Are there biosimilar options available for DIANEAL Low Calcium?
No, patents held by Fresenius Kabi prevent biosimilar production in many markets until patent expiry.
2. Can I source DIANEAL Low Calcium from regional suppliers?
Regional suppliers may produce similar solutions but may not have an exact formulation; always verify calcium and dextrose levels.
3. What regulatory hurdles exist for importing this product?
Product registration, approval, and compliance with regional standards (FDA, EMA, etc.) are mandatory.
4. How does the calcium level in DIANEAL impact treatment?
Low calcium solutions are used to manage specific patient conditions, such as hypercalcemia or calcium overload.
5. Is there a substitute for DIANEAL in regions where it is not available?
Yes, other peritoneal dialysis solutions with similar dextrose and calcium content are available, but formulation differences should be confirmed.
References
[1] Fresenius Kabi. (2022). DIANEAL Peritoneal Dialysis Solution. Retrieved from https://www.fresenius-kabi.com
[2] Baxter International. (2021). Peritoneal Dialysis Solutions. Retrieved from https://www.baxter.com
[3] B. Braun Melsungen AG. (2020). Peritoneal Dialysis Products. Retrieved from https://www.bbraun.com
[4] FDA. (2022). Medical Device Approvals for Dialysis Solutions. Retrieved from https://www.fda.gov
[5] European Medicines Agency. (2022). Dialysis Solution Approvals. Retrieved from https://www.ema.europa.eu
