Last Updated: June 26, 2026

Suppliers and packagers for DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER


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DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM 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
Fresenius Medcl DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 020171 NDA Fresenius Medical Care de Mexico, S.A. de C.V. 46163-206-92 5 BAG in 1 CARTON (46163-206-92) / 2000 mL in 1 BAG 2024-08-29
Fresenius Medcl DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 020171 NDA Fresenius Medical Care de Mexico, S.A. de C.V. 46163-206-94 5 BAG in 1 CARTON (46163-206-94) / 2500 mL in 1 BAG 2024-08-29
Fresenius Medcl DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 020171 NDA Fresenius Medical Care de Mexico, S.A. de C.V. 46163-206-95 4 BAG in 1 CARTON (46163-206-95) / 3000 mL in 1 BAG 2024-08-29
Fresenius Medcl DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 020171 NDA Fresenius Medical Care de Mexico, S.A. de C.V. 46163-209-92 5 BAG in 1 CARTON (46163-209-92) / 2000 mL in 1 BAG 2024-08-29
Fresenius Medcl DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 020171 NDA Fresenius Medical Care de Mexico, S.A. de C.V. 46163-209-94 5 BAG in 1 CARTON (46163-209-94) / 2500 mL in 1 BAG 2024-08-29
Fresenius Medcl DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 020171 NDA Fresenius Medical Care de Mexico, S.A. de C.V. 46163-209-95 4 BAG in 1 CARTON (46163-209-95) / 3000 mL in 1 BAG 2024-08-29
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Last updated: June 22, 2026

ecutive summary
No complete, accurate supplier map can be produced from the provided drug description alone. “DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER” is a dialysis solution product family, and the exact supplier depends on the market (country), pack configuration, manufacturer listed on the specific label, and the product’s marketing authorization holder. Without those identifying fields, a defensible supplier list would be incomplete.

# Who supplies DELFLEX with dextrose 2.5% low magnesium low calcium in plastic container?

Which companies manufacture DELFLEX dextrose 2.5% low magnesium low calcium solutions?

Answer: Not determinable from the product description provided.

What does the DELFLEX naming usually map to?

DELFLEX is typically used for peritoneal dialysis solutions sold in multi-chamber or bag formats. In practice, “supplier” can refer to:

  • Marketing authorization holder (MAH) on the label
  • Packager/marketer (branding entity)
  • Manufacturing site (contract manufacturer)
  • Distributor to wholesalers and hospitals

Those roles vary by geography and by tender.

What are the key label identifiers to confirm the true supplier?

Answer: Not determinable from the product description provided.

Identifiers that change the supplier attribution

  • Country-specific product name and local brand labeling
  • Bottle/bag size and container material
  • Sterile barrier system and packaging format (single bag vs multi-chamber)
  • Strength presentation (dextrose 2.5%) plus electrolyte constraints (low Mg, low Ca)
  • Batch/lot label “manufactured by” line and address
  • Marketing authorization holder listed on the carton

What is the Orange Book status of DELFLEX (dextrose 2.5% low Mg low Ca)?

Answer: Not determined from the provided information.

Why Orange Book is often not the right reference for this product class

Peritoneal dialysis solutions are generally authorized as medical products, not small-molecule drug “NDA” products tracked in the US Orange Book in the same way as prescriptions for drugs. Supplier and exclusivity tracking, if any, is typically handled through FDA product listings and device/drug product databases rather than Orange Book patent listings.

How many suppliers are in the market for DELFLEX dextrose 2.5% low Mg low Ca bags?

Answer: Not determinable from the product description provided.

Market structure that drives supplier counts

  • Single MAH with multiple contract manufacturing sites
  • Multiple regional MAHs (same product, different branding)
  • Tender-based supply where distributors switch suppliers

Which distributors supply DELFLEX to hospitals and dialysis centers?

Answer: Not determinable from the product description provided.

Distributor selection is country-specific

Hospital supply channels depend on:

  • National tender procurement
  • Contracting with wholesalers
  • Local licensing and importation
  • Shelf-life logistics and approved storage constraints

What generic or alternate products compete with DELFLEX 2.5% low Mg low Ca?

Answer: Not determinable from the product description provided.

Comparator set typically includes

  • Other peritoneal dialysis solutions with matching dextrose concentration and electrolyte profiles
  • Commercial equivalents with different low Mg/low Ca specifications
  • Exchange-system compatible alternatives

What manufacturing/IP barriers affect supplier entry for DELFLEX?

Answer: Not determinable from the product description provided.

Typical barriers for sterile dialysis solutions

  • Sterile manufacturing validation and batch release controls
  • Regulatory quality systems and change control
  • Container and formulation change constraints (plastic container compatibility)
  • Packaging and stability requirements

What is the FDA regulatory pathway for DELFLEX dialysis solutions?

Answer: Not determinable from the product description provided.

Regulatory references used in practice

Depending on jurisdiction and product classification, authorities may list the product under:

  • FDA drug or biologics-related databases for infusion solutions
  • EU medicinal product authorization databases
  • Local ministries for import and marketing

Key Takeaways

  • A supplier list for “DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER” cannot be built accurately from the description alone.
  • Supplier attribution for dialysis solutions is label- and country-specific, relying on MAH and “manufactured by” lines on the specific packaging.

FAQs

  1. Who is listed as the manufacturer on the carton for DELFLEX 2.5% low magnesium low calcium plastic container?
  2. How do marketing authorization holders and distributors differ for peritoneal dialysis solutions like DELFLEX?
  3. What alternative peritoneal dialysis solutions match dextrose 2.5% low magnesium low calcium specifications?
  4. How can packaging size and plastic container type change the labeled supplier for DELFLEX?
  5. Where do you verify the correct product listing and holder for DELFLEX in a specific country?

References

No sources cited because no authoritative supplier identification data is available from the prompt.

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