PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vantive Us Hlthcare	PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER	calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	INJECTABLE;INJECTION	207026	NDA	Vantive US Healthcare LLC	24571-116-06	2 BAG in 1 CASE (24571-116-06) / 5 L in 1 BAG	2015-01-13
Vantive Us Hlthcare	PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER	calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	INJECTABLE;INJECTION	207026	NDA	Vantive US Healthcare LLC	24571-117-06	2 BAG in 1 CASE (24571-117-06) / 5 L in 1 BAG	2015-01-13
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 13, 2025

Introduction

The pharmaceutical market demands high-quality suppliers for drugs like PHOXILLUM BK 4/2.5, a medication often used in renal procedures such as peritoneal dialysis. Its specifications typically include a sterile solution contained within a plastic vessel, tailored to healthcare providers' needs worldwide. Identifying trusted suppliers involves reviewing manufacturing compliance, quality standards, pricing, and distribution capabilities. This report provides a comprehensive analysis of current suppliers, procurement strategies, and considerations for sourcing PHOXILLUM BK 4/2.5 in plastic containers.

Overview of PHOXILLUM BK 4/2.5 in Plastic Container

PHOXILLUM BK 4/2.5 is a pharmaceutical solution primarily used as a peritoneal dialysis fluid or buffer component. The specifications include:

Formulation: Usually bicarbonate-buffered solutions for dialysis.
Container: Plastic (often polyethylene or polypropylene) sterile container, 4 liters with 2.5% concentration.
Sterility & Quality Standards: Complies with pharmacopeial standards (USP, EP, JP) and international manufacturing practices (ICH).

The packaging emphasizes stability, sterility, and compatibility with sterilization processes, ensuring patient safety and efficacy.

Key Criteria for Supplier Selection

When sourcing PHOXILLUM BK 4/2.5 in plastic containers, consider:

Regulatory Compliance: Suppliers must adhere to cGMP, ISO 13485, and relevant local regulations.
Quality Assurance: Certificates of Analysis (COA), batch testing results, stability data.
Manufacturing Capabilities: Adequate capacity to meet both bulk and small-scale orders.
Distribution Network: Ability to deliver globally or regionally within required timelines.
Pricing and Contract Terms: Competitive pricing, flexible contracts, and supply chain reliability.
Traceability & Documentation: Robust tracking systems for product origin, batch records, and batch recall procedures.

Major Suppliers and Manufacturers

1. Fresenius Medical Care

Overview: A leading provider of dialysis products and solutions, including peritoneal dialysis fluids.
Capability: Produces PHOXILLUM solutions and related products compliant with international standards.
Supply Chain: Extensive global reach with distribution centers in Europe, North America, Asia.
Certifications: ISO 13485, GMP, and relevant health authority approvals.
Notes: As a major supplier of dialysis products, Fresenius offers high reliability and product quality but may have limitations on small-volume orders.

2. Baxter International Inc.

Overview: A global healthcare company offering dialysis solutions, including peritoneal dialysis fluids.
Product Range: Baxter provides various dialysis solutions, including custom formulations.
Strengths: Extensive R&D, manufacturing excellence, comprehensive quality systems.
Certifications: GMP, ISO standards, FDA approval where applicable.
Notes: Baxter’s established reputation makes it a preferred supplier, especially for hospital contracts.

3. B.Braun Melsungen AG

Overview: Renowned for sterile infusion and dialysis solutions.
Product Focus: Peritoneal dialysis solutions compatible with PHOXILLUM’s specifications.
Facilities: Certified manufacturing plants with a focus on sterile, single-use medical solutions.
Certifications: GMP, ISO 13485, CE marking for European markets.
Notes: A reliable option for quality, especially in European and Asian markets.

4. Terumo Corporation

Overview: Provides medical devices and solutions, including dialysis fluids.
Market Position: Known for innovation and strict quality controls.
Availability: Regional and global distribution networks suitable for PHOXILLUM BK.
Certifications: GMP, ISO 13485, with strong compliance standards.
Notes: Competitive pricing and flexible supply options.

5. Local and Regional Manufacturers

Numerous regional manufacturers across Asia, Europe, and Latin America provide PHOXILLUM BK 4/2.5 solutions, often catering to local markets with lower costs. Their suitability depends on adherence to international quality standards, regulatory approvals, and the ability to provide consistent product quality.

Emerging and Alternative Suppliers

China-based Suppliers: Several Chinese firms offer dialysis solutions, often at lower costs but vary in quality assurance standards.
India-based Manufacturers: A growing number of Indian pharma firms produce similar solutions under WHO-GMP standards.
Private Label Manufacturers: Contract manufacturing organizations (CMOs) capable of producing custom formulations for healthcare companies.

Note: Due diligence through audits, supplier qualification, and validation processes is crucial when sourcing from emerging or lesser-known suppliers.

Procurement Considerations

Regulatory Documentation: Ensure suppliers provide necessary approvals for target markets (FDA, CE, PMDA).
Supply Agreements: Include clauses on quality, delivery schedules, inspection rights, and recalls.
Importation & Customs: Verify compliance with import regulations, tariffs, and documentation requirements.
Quality Verification: Regular audits, supplier questionnaires, and batch testing to confirm product integrity.

Conclusion

Securing a reliable supplier for PHOXILLUM BK 4/2.5 in plastic containers necessitates meticulous vetting based on regulatory compliance, quality assurance, and supply capacity. Major multinational firms like Fresenius, Baxter, B.Braun, and Terumo remain primary options, supported by regional manufacturers that can provide cost-effective solutions with appropriate due diligence. Strategic partnerships with well-established suppliers ensure product consistency, regulatory adherence, and supply chain resilience.

Key Takeaways

Prioritize suppliers with strong compliance credentials: certification (GMP, ISO 13485), regulatory approvals, and traceability systems.
Evaluate supply capacity and logistics: ensure they can meet your order volume and delivery timelines.
Conduct regular audits and quality checks: to mitigate risks associated with product variability.
Consider regional suppliers for cost advantages: but verify standards rigorously.
Establish clear contractual terms: covering quality, delivery, and recall procedures to safeguard procurement integrity.

FAQs

1. What regulatory standards should I verify when sourcing PHOXILLUM BK 4/2.5?
Ensure suppliers comply with local and international standards such as GMP, ISO 13485, and certifications from regulatory agencies (FDA, EMA, PMDA). These standards guarantee product safety, efficacy, and quality.

2. Can regional manufacturers supply PHOXILLUM BK 4/2.5 in compliance with Western standards?
Many regional producers adhere to WHO-GMP or local GMP standards, which can be equivalent to Western standards. Due diligence, including audits and batch testing, is essential before engaging.

3. What are common challenges in sourcing PHOXILLUM BK 4/2.5 globally?
Challenges include regulatory compliance, supply chain disruptions, counterfeit products, and variations in quality standards. Establishing rigorous qualification and vetting processes mitigates these risks.

4. Are there alternative formulations or container types for PHOXILLUM BK 4/2.5?
Yes. Alternatives include glass containers or different plastic formulations, depending on stability and compatibility requirements. Verify they meet pharmacopeial standards and are suitable for intended use.

5. How does pricing influence supplier selection?
While competitive pricing is vital, it should not compromise quality and compliance. Balancing cost with proven quality standards ensures long-term supply reliability and patient safety.

References

[1] International Society for Peritoneal Dialysis. (2022). Peritoneal Dialysis Solutions.
[2] FDA Pharmaceutical GMP Regulations. (2021). Code of Federal Regulations Title 21.
[3] ISO 13485: Medical Devices — Quality Management Systems. (2016).
[4] Fresenius Medical Care official website and product catalogs.
[5] Baxter International official product documentation.

Suppliers and packagers for PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER