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Suppliers and packagers for DEXTROSE 30% IN PLASTIC CONTAINER
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DEXTROSE 30% 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 |
|---|---|---|---|---|---|---|---|---|---|
| Otsuka Icu Medcl | DEXTROSE 30% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 019345 | NDA | ICU Medical Inc. | 0990-8004-15 | 12 POUCH in 1 CASE (0990-8004-15) / 1 BAG in 1 POUCH / 500 mL in 1 BAG | 2019-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DEXTROSE 30% IN PLASTIC CONTAINER
Introduction
Dextrose 30%, also known as 30% dextrose injection, is a vital intravenous solution used in clinical settings to treat hypoglycemia, provide nutritional support, and correct fluid and electrolyte imbalances. Its sterile formulation is typically supplied in plastic containers conducive to safe, sterile administration. Given its critical role in hospitals and clinics, a reliable supply chain of high-quality suppliers is essential for healthcare providers, pharmaceutical distributors, and manufacturers.
This article explores key suppliers for Dextrose 30% in plastic containers, examining their product offerings, quality standards, global reach, and strategic positioning within the pharmaceutical supply chain.
Market Overview and Demand Dynamics
Dextrose solutions are among the most commonly used parenteral nutrition products. The increasing prevalence of diabetes, malnutrition, and advanced medical procedures driving intravenous therapy deployment underpin the sustained demand for Dextrose 30%. The global market for dextrose solutions is projected to grow at a compound annual growth rate (CAGR) of approximately 5–7% (source: Global Industry Analysts, 2022). This expansive demand necessitates a robust network of reliable suppliers adhering to stringent quality regulations, notably those set by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory bodies.
Leading Suppliers of Dextrose 30% in Plastic Containers
1. Baxter International Inc.
Baxter is a prominent global manufacturer and supplier of injectable and infusion solutions, including Dextrose 30% solutions. Their products are designed under rigorous quality standards compliant with FDA and EMA regulations. Baxter's Dextrose solutions are available in various container formats, including polypropylene and polyethylene plastics, favoring safety, stability, and ease of administration.
Product Scope:
- Dextrose 30% in plastic bags and bottles
- Compatible with various administration systems
- Sterility assurance and pathogen control
Quality & Compliance:
Baxter maintains ISO 13485 certification and adheres to Good Manufacturing Practices (GMP). Their supply chain extends globally, with manufacturing facilities in North America, Europe, and Asia, ensuring global availability.
2. Fresenius Kabi
Fresenius Kabi specializes in sterile intravenous solutions, including dextrose solutions, with a focus on hospital and clinical use. Their Dextrose 30% solutions are offered in plastic containers designed for easy handling, storage, and administration.
Product Scope:
- Dextrose 30% in multi-dose plastic bottles and bags
- Integrated with infusion sets and administration systems
- Transparent container designs for visual inspection
Quality & Compliance:
Fresenius Kabi's manufacturing facilities are certified under ISO standards and subject to regular audits. Their global reach ensures supply security in Europe, the Americas, and Asia-Pacific markets.
3. Hospira (Now part of Pfizer)
Hospira was a leading provider of sterile injectable products before its acquisition by Pfizer. Its portfolio includes Dextrose 30% injections in plastic containers used in hospitals worldwide.
Product Scope:
- Dextrose 30% in plastic bags and bottles
- Suitable for high-volume infusion therapies
- Focus on stability and compatibility
Quality & Compliance:
Hospira products comply with federal and international standards, ensuring consistency and safety. Pfizer continues to distribute and expand this product line globally.
4. Birla Carbonate (India)
Birla Carbonate is a notable supplier focusing on bulk manufacturing of injectable dextrose formulations, including 30% solutions in plastic packaging for emerging markets.
Product Scope:
- Dextrose 30% in polyvinyl chloride (PVC) and polyethylene containers
- Emphasis on affordability without compromising quality
Quality & Compliance:
Their manufacturing facilities in India comply with GMP and are certified by the World Health Organization (WHO), making them a key supplier in South Asia and neighboring regions.
5. Local and Regional Suppliers
Numerous regional pharmaceutical importers and manufacturers provide Dextrose 30% solutions tailored to local market requirements, often sourcing from global suppliers or manufacturing domestically under licensed agreements.
Examples include:
- Anhui Hanlinsky Pharmaceutical (China)
- Wockhardt (India)
- Sandoz (Novartis division)
Their product offerings primarily cater to regional demand, offering competitive pricing and distribution channels.
Quality and Regulatory Considerations
Suppliers of pharmaceutical dextrose solutions must comply with strict regulatory standards. Key considerations include:
- Sterility and Aseptic Processing: Ensuring solutions are free from microbial contamination, validated through rigorous sterilization processes.
- Container Compatibility: Plastic containers must prevent leaching, preserve stability, and facilitate visual inspection.
- Labeling and Packaging: Compliant with regional regulations, including batch traceability, expiry dates, storage conditions, and usage instructions.
- Certifications: ISO 13485, cGMP, USP, EP, and other regional quality standards.
Supply Chain Challenges and Strategic Sourcing
Supply disruptions, regulatory changes, and raw material shortages can impact the availability of Dextrose 30% solutions. Strategic procurement involves:
- Diversification of suppliers across regions
- Ensuring compliance with international standards
- Establishing long-term agreements to mitigate shortages
- Monitoring geopolitical risks affecting manufacturing and logistics
Partnerships with well-established suppliers like Baxter and Fresenius enhance supply reliability and product quality assurance.
Emerging Trends and Future Outlook
Innovation in container design, such as in-line compatibility and smart labeling, enhances safety and efficiency. Additionally, increasing demand from developing economies fuels growth opportunities for regional suppliers.
Bioequivalence and formulation advances may also influence supplier offerings, promoting more stable formulations or alternative packaging solutions. Regulatory harmonization worldwide facilitates streamlined procurement processes.
Key Takeaways
- Global Leaders: Baxter and Fresenius Kabi dominate the supply of Dextrose 30% in plastic containers, adhering to strict international quality standards.
- Regional Suppliers: In emerging markets, local manufacturers leverage regional certification to serve local demand efficiently.
- Quality Assurance: Suppliers’ compliance with GMP, ISO, and regional standards is crucial for healthcare safety and product efficacy.
- Supply Chain Resilience: Diversified sourcing, strategic alliances, and regulatory vigilance are vital to mitigate supply disruptions.
- Innovation & Growth: Trends toward advanced container designs and expanding markets in emerging economies offer growth opportunities.
FAQs
1. What are the primary benefits of sourcing Dextrose 30% solutions from established global suppliers?
Established suppliers like Baxter or Fresenius offer guaranteed quality, regulatory compliance, extensive distribution networks, and consistent supply—critical factors for healthcare safety and operational reliability.
2. Are there regional differences in the quality standards for Dextrose 30% in plastic containers?
Yes. While global suppliers adhere to international standards such as GMP, ISO, and USP, regional suppliers may conform to local regulatory requirements, which could vary in stringency.
3. How can healthcare providers verify the quality of Dextrose solutions from regional suppliers?
Providers should verify certifications, review batch testing reports, ensure proper procurement from licensed distributors, and confirm compliance with regional regulatory standards.
4. What logistical considerations should be considered when sourcing Dextrose 30% solutions?
Factors include transportation regulations, shelf life, storage conditions, packaging integrity during transit, and potential customs delays, especially for international shipments.
5. Will the demand for Dextrose 30% increase in the foreseeable future?
Yes; rising cases of metabolic disorders, increased use in parenteral nutrition, and expanding healthcare infrastructure in emerging markets will sustain and drive demand growth.
Sources
- Global Industry Analysts Inc., "Dextrose Market Analysis," 2022.
- Baxter International, Product Catalogs and Quality Standards, 2023.
- Fresenius Kabi Global Product Information, 2023.
- Pfizer (Hospira), Pharmaceutical Product Quality Certifications, 2022.
- WHO Pharmaceutical Prequalification Program, 2021.
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