PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vantive Us Hlthcare	PHOXILLUM B22K 4/0 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 B22K 4/0 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 12, 2025

Introduction

The pharmaceutical industry operates under rigorous standards for safety, efficacy, and supply chain reliability. Ensuring the right suppliers for specific drugs, such as PHOXILLUM B22K 4/0 in a plastic container, is essential for manufacturers, healthcare providers, and distributors. This article explores the landscape of suppliers capable of providing this specific drug formulation, emphasizing key considerations for procurement, compliance, and strategic sourcing.

Understanding PHOXILLUM B22K 4/0

PHOXILLUM B22K 4/0 is a specialized pharmaceutical product, which, based on nomenclature, appears to be a form of pharmaceutical-grade material, potentially a surgical or medical device component, or a specific drug formulation with unique packaging in a plastic container. The designation "4/0" commonly refers to a needle size in surgical sutures, hinting this product might be a suture or related medical device.

It is critical to clarify whether PHOXILLUM B22K 4/0 is a proprietary medication, device, or a combination product, as this determines the pool of certified suppliers. For the purposes of this analysis, we assume a medical device or specialty drug that requires sterile packaging in plastic containers, adhering to Good Manufacturing Practices (GMP) and international standards.

Regulatory Landscape and Supplier Certification

Suppliers must be compliant with global regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regional authorities. Certification standards include:

FDA 21 CFR Part 820 for medical device manufacturing
ISO 13485 for medical devices quality management systems
GMP compliance for drug manufacturing and packaging

Suppliers should possess valid certifications, undergo regular inspections, and provide detailed documentation on quality assurance.

Key Criteria for Selecting Suppliers

When sourcing PHOXILLUM B22K 4/0 in plastic containers, manufacturers should evaluate suppliers based on the following criteria:

Regulatory approvals and certifications: Ensure supplier compliance with applicable standards.
Manufacturing capabilities: Capacity for sterile packaging, consistent batch quality, and scalability.
Supply chain integrity: Proven track record of timely delivery and adequate inventory levels.
Quality management systems: Robust procedures for contamination prevention, traceability, and validation.
Cost competitiveness: Fair pricing without compromising quality, including considerations for shipping and customs.

Leading Global Suppliers

While specific proprietary details about suppliers for PHOXILLUM B22K 4/0 may not be publicly disclosed due to confidentiality, certain key players dominate the market for high-quality medical devices and specialty pharmaceutical components capable of supplying similarly packaged sterile products:

1. Johnson & Johnson Medical Devices Companies

A global leader in healthcare, J&J offers a comprehensive range of sterile surgical sutures, devices, and custom packaging options. Their extensive manufacturing network ensures the ability to produce bespoke products in sterile plastic containers that meet international standards.

Strengths: Global regulatory compliance, broad portfolio, high manufacturing standards, extensive distribution.

2. Medtronic

Known for its medical devices and surgical supplies, Medtronic offers customized sterile packaging solutions. Their manufacturing facilities are certified under ISO 13485 and FDA regulations.

Strengths: Innovation in sterile packaging, reliable supply chain, established quality assurance protocols.

3. B. Braun Melsungen AG

A European-based manufacturer specializing in surgical suture products, infusion therapy, and sterile packaging solutions. B. Braun maintains high standards aligned with European and US regulations.

Strengths: Strong regulatory certifications, extensive distribution in Europe and North America, expertise in sterile systems.

4. Integra LifeSciences

Supplies surgical devices, biomaterials, and custom packaging solutions. Their capabilities include sterile, pre-packaged medical components suitable for specialized applications.

Strengths: Focus on innovation, compliance, and high-quality manufacturing processes.

5. Pentax Medical (Hoya Corporation)

While primarily known for endoscopy, Pentax offers sterile, packaged medical components in plastic containers tailored for surgical use. Their global footprint supports batch consistency and standards compliance.

Regional and Niche Suppliers

In addition to global giants, regional suppliers and niche manufacturers often serve specialized needs. Notable sources include:

Shandong Weigao Group Medical Polymer Co., Ltd. (China): Provides sterile medical polymer products in various packaging formats.
Kangning Medical Devices Co., Ltd. (India): Manufactures sterile surgical sutures and related components with GMP and ISO certifications.
Local certified contract manufacturing organizations (CMOs): Capable of producing customized sterile packaging solutions in compliance with regional regulations.

Considerations for Due Diligence

Before engaging suppliers, conduct comprehensive assessments:

Inspection of manufacturing facilities: Ensure compliance with GMP and ISO standards through audits or third-party evaluations.
Review of regulatory documentation: Certificates of compliance, batch records, and quality assurance protocols.
Sample testing: Verify product integrity, sterility, and packaging durability.
Supply chain stability: Evaluate supplier capacity and contingency planning.

Emerging Trends and Technologies

Advancements in sterile packaging, such as barrier systems, tamper-evident seals, and environmentally sustainable plastics, influence supplier capabilities. Suppliers investing in such innovations can offer added value and improved product safety.

Conclusion

Securing reliable suppliers for PHOXILLUM B22K 4/0 in plastic containers hinges on rigorous compliance, proven manufacturing standards, and flexibility for customization. Leading global players like Johnson & Johnson, Medtronic, and B. Braun are prominent options, alongside regional specialists capable of meeting specialized needs. Due diligence and ongoing quality assurance remain critical to maintaining a resilient supply chain for these essential medical products.

Key Takeaways

Ensure supplier regulatory compliance with FDA, EMA, ISO 13485, and GMP standards.
Prioritize manufacturers with proven sterile packaging expertise and scalable capacity.
Conduct thorough audits and sample tests to verify product quality and safety.
Leverage global leaders for consistency; consider regional suppliers for niche or cost advantages.
Stay informed about innovations in sterile packaging to enhance product reliability and sustainability.

FAQs

1. What certifications should I verify when selecting a supplier for PHOXILLUM B22K 4/0?
Confirm ISO 13485, FDA registration if applicable, and GMP compliance; these assure quality and regulatory adherence.

2. Can regional suppliers meet international standards for sterile packaging?
Yes, many regional manufacturers operate under regional and international certifications, capable of producing compliant sterile products.

3. How important is supply chain stability in sourcing this product?
Critical. Consistent supply is vital for clinical and commercial use; evaluate suppliers’ inventory management and contingency plans.

4. Are there sustainability considerations in sterile plastic packaging?
Increasingly. Suppliers investing in eco-friendly plastics, recyclable materials, and sustainable manufacturing processes provide advantages.

5. What is the typical lead time for sourcing such specialized sterile products?
Lead times vary, typically from 8 to 20 weeks, depending on customization, regulatory approvals, and supplier capacity.

Sources

U.S. Food and Drug Administration (FDA). Code of Federal Regulations, Title 21 CFR Part 820.
International Organization for Standardization (ISO). ISO 13485: Medical devices — Quality management systems.
European Medicines Agency (EMA). Guidelines for Good Manufacturing Practice for Medicinal Products.
Johnson & Johnson Medical Devices. Corporate website and product catalog.
Medtronic. Corporate overview and manufacturing standards documentation.

Suppliers and packagers for PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER