Last updated: August 10, 2025
Introduction
The pharmaceutical industry increasingly seeks specialized parenteral nutrition products to cater to diverse medical needs. CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER exemplifies such innovation, designed for patients requiring customized nutritional therapies. Identifying reliable suppliers for this product is essential for healthcare providers, distributors, and pharmaceutical companies aiming to ensure consistent quality, availability, and regulatory compliance.
Product Overview
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER is a ready-to-use, sulfite-free, parenteral nutrition solution. It combines dextrose at a 35% concentration, packaged in a plastic container conducive to sterile handling and stability. Its sulfite-free formulation minimizes allergic reactions and sensitivities in vulnerable patient populations, aligning with current trends toward personalized and safer nutritional therapies.
Key Attributes and Specifications
- Formulation: Dextrose 35%, sulfite-free
- Container: Plastic, sterile, designed for parenteral use
- Usage: Parenteral nutrition for hospitalized or at-home patients
- Regulatory Compliance: Approved by relevant health authorities (e.g., FDA, EMA)
- Storage & Handling: Needs aseptic conditions, proper storage at controlled temperatures
Leading Suppliers and Manufacturers
1. Fresenius Kabi
Overview:
Fresenius Kabi is a global leader in infusion therapies and clinical nutrition, providing a comprehensive portfolio of sterile and bulk parenteral nutrition solutions. The company emphasizes innovation in sulfite-free formulations, aligning with the demand for reduced allergenic components.
Product Line & Capabilities:
Fresenius offers customized PN solutions, including dextrose-rich products in various containers, including plastics with advanced barrier properties for stability and safety. Their manufacturing facilities adhere to strict cGMP standards, and they are approved by major regulatory agencies worldwide.
Supply Chain & Distribution:
Fresenius Kabi’s extensive distribution network ensures reliable supply chains worldwide, particularly in North America, Europe, and Asia-Pacific markets.
2. Baxter International Inc.
Overview:
Baxter is renowned for its clinical nutrition products, including parenteral nutrition formulations that cater to diverse patient needs. Their portfolio includes sulfite-free PN solutions designed for sensitive patients.
Product Line & Capabilities:
Baxter supplies sterile, plastic-packaged PN solutions like Dextrose 35%, produced under stringent quality controls, with options for customizable formulations and container configurations.
Supply Chain & Distribution:
Baxter’s global manufacturing footprint and logistics infrastructure enable consistent product availability and rapid distribution.
3. Partum (Partum International)
Overview:
Partum specializes in sterile compounded PN solutions globally, offering customized formulations based on clinical requirements. They focus heavily on sulfite-free and allergen-minimized options.
Product Line & Capabilities:
While primarily engaged in compounded products, Partum also partners with manufacturers to provide ready-to-use solutions, including Dextrose 35% in plastic containers, with a focus on proprietary formulations ensuring sulfite-free compositions.
Supply Chain & Distribution:
Operating in multiple regions with robust compliance with international standards, Partum ensures a reliable supply chain for specialized products.
4. Cytivus (formerly Vifor Pharma)
Overview:
Cytivus manufactures specialized nutritional solutions with a focus on safety and innovation, often incorporating sulfite-free formulations tailored for sensitive populations.
Product Line & Capabilities:
Their portfolio includes sterile, ready-to-use PN products in plastic containers, emphasizing stability, sterility, and ease of administration.
Supply Chain & Distribution:
Cytivus maintains strategic partnerships to ensure product availability across major markets, with accreditation from key health authorities.
5. NUTRITIONAL SPECIALISTS and Regional Manufacturers
Numerous regional suppliers catering to local markets deliver customized sulfite-free dextrose solutions. These include companies such as Fresenius’, Braun Melsungen, and others that hold certifications aligned with the US FDA, EMA, PIC/S, and other regulatory bodies.
Criteria for Selecting Suppliers
When evaluating suppliers for CLINIMIX 5/35 sulfite-free in dextrose 35% in plastic containers, consider:
- Regulatory approvals: Ensure the manufacturer’s compliance with local and international authorities (FDA, EMA, PMDA).
- Manufacturing standards: cGMP compliance, sterile filling processes, and quality assurance.
- Product availability: Capacity to meet demand and supply continuity.
- Customization options: Ability to produce tailored formulations or packaging modifications.
- Safety and stability: Container material compatibility, stability data, and sulfite-free formulations.
- Cost and logistics: Competitive pricing, shipping capabilities, and lead times.
- Reputation and reliability: Track record of consistent quality and on-time delivery.
Regulatory and Market Considerations
Suppliers must demonstrate compliance with stringent regulatory frameworks governing sterile parenteral products. The global market demands adherence to quality certifications, such as ISO 13485, and obtaining approvals/registrations from relevant health authorities. Additionally, transparency in sourcing ingredients and manufacturing processes underscores supplier reliability.
Emerging Trends and Future Opportunities
The demand for sulfite-free and hypoallergenic PN solutions is rising, driven by increased recognition of adverse allergic reactions associated with sulfites in IV formulations. Suppliers investing in advanced manufacturing technology, such as closed system filling and real-time quality monitoring, will position themselves favorably in this niche. Moreover, strategic partnerships with biotech firms could enable the development of innovative formulations with enhanced stability and safety profiles.
Conclusion
The supply landscape for CLINIMIX 5/35 sulfite-free dextrose in plastic containers comprises established global players like Fresenius Kabi and Baxter, regional specialists, and emerging niche manufacturers. Selecting a reliable supplier hinges on rigorous evaluation of regulatory compliance, manufacturing standards, product consistency, and logistical capabilities. As the market evolves toward safer, personalized nutrition solutions, partnership with reputable suppliers will be essential for healthcare providers and distributors seeking quality assurance and supply stability.
Key Takeaways
- Multiple global and regional suppliers provide sulfite-free dextrose 35% solutions in plastic containers, with a focus on quality, regulatory compliance, and supply reliability.
- Leading companies such as Fresenius Kabi and Baxter command significant market presence, backed by extensive manufacturing capabilities.
- Supplier selection should prioritize regulatory approvals, manufacturing standards, product stability, and logistical capacity.
- The trend toward sulfite-free and allergen-minimized parenteral nutrition solutions presents growth opportunities for innovative manufacturers.
- Ensuring supply chain resilience and compliance is critical amid increasing demand for specialized nutritional therapies.
Frequently Asked Questions
1. What are the advantages of sulfite-free parenteral nutrition solutions?
Sulfite-free formulations reduce the risk of allergic reactions and sensitivities, making them suitable for vulnerable patient populations, including those with sulfite sensitivities or allergies.
2. Are CLINIMIX 5/35 solutions commercially available globally?
Availability varies by region; major suppliers like Fresenius Kabi and Baxter distribute these products worldwide, but regional regulatory approvals and supply chain logistics influence accessibility.
3. How can healthcare providers ensure the quality of sulfite-free PN solutions?
By partnering with reputable suppliers that hold stringent certifications (e.g., cGMP, ISO standards), and verifying regulatory approvals, providers can ensure product safety and efficacy.
4. What packaging considerations are important for dextrose 35% in plastic containers?
Containers must be compatible with high osmolarity solutions, stable under storage conditions, and designed to prevent contamination, such as sterile, sealable plastics with barrier properties.
5. How does the formulation of CLINIMIX 5/35 differ from other PN solutions?
CLINIMIX 5/35 is characterized by its sulfite-free composition and 35% dextrose concentration, tailored for high caloric intake with minimized allergenic potential, compared to broader PN formulations that may contain sulfites or different nutrient concentrations.
Sources:
[1] Fresenius Kabi product catalogs and regulatory filings
[2] Baxter International product information and regulatory submissions
[3] International Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) guidelines on sulfite-free formulations
[4] Market analysis reports on parenteral nutrition products
