Suppliers and packagers for DEXTROSE 70% IN PLASTIC CONTAINER

DEXTROSE 70% 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
B Braun	DEXTROSE 70% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	019626	NDA	B. Braun Medical Inc.	0264-7387-50	4 CONTAINER in 1 CASE (0264-7387-50) / 2000 mL in 1 CONTAINER	2015-02-19
B Braun	DEXTROSE 70% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	019626	NDA	B. Braun Medical Inc.	0264-7510-00	12 CONTAINER in 1 CASE (0264-7510-00) / 1000 mL in 1 CONTAINER	1988-02-02
B Braun	DEXTROSE 70% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	019626	NDA	B. Braun Medical Inc.	0264-7510-10	24 CONTAINER in 1 CASE (0264-7510-10) / 500 mL in 1 CONTAINER	1988-02-02

Suppliers for the Pharmaceutical Drug: Dextrose 70% in Plastic Containers

Last updated: August 5, 2025

Introduction

Dextrose 70% in plastic containers is a widely utilized intravenous (IV) infusion solution primarily employed in clinical settings for hydration, energy replenishment, and metabolic support. As an essential pharmaceutical, the supply chain for Dextrose 70% demands rigorous compliance with regulatory standards, high manufacturing quality, and reliable distribution networks. This article provides a comprehensive overview of key suppliers globally recognized for manufacturing and supplying Dextrose 70% in plastic containers, offering insights vital for healthcare providers, procurement professionals, and pharmaceutical industry stakeholders.

Regulatory Standards and Quality Assurance

Before exploring suppliers, it is crucial to acknowledge the stringent regulatory landscape governing intravenous solutions. Suppliers must adhere to Good Manufacturing Practice (GMP) standards, overseen by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and equivalent authorities worldwide. Purity, sterility, stability, and correct formulation are non-negotiable quality parameters. Certification and rigorous quality testing underpin supplier credibility.

Major Global Suppliers of Dextrose 70% in Plastic Containers

1. Hospira, a Pfizer Company

Overview:
Hospira stands as a leading global manufacturer of sterile injectable drugs and infusion solutions, including Dextrose 70%. The company’s extensive manufacturing facilities in the United States and abroad enable widespread distribution.

Product Attributes:

• Sterile, ready-to-use solutions in plastic containers (polyethylene, polypropylene).
• Multiple volumes, often 100 mL, 250 mL, and 500 mL.
• Compliant with USP and EP standards; high-purity dextrose content.

Regulatory Credentials:

• FDA-approved facilities specializing in sterile injections.
• Transparent quality documentation and stability data.

2. Baxter International Inc.

Overview:
Baxter is a prominent player in the global infusion market, offering a comprehensive portfolio of IV solutions, including Dextrose 70%. Their manufacturing aligns strictly with international regulatory standards.

Product Attributes:

• Dextrose 70% in 100 mL to 1000 mL plastic containers.
• Compatibility with infusion pumps and medical devices.
• Stringent sterility maintenance and preservative-free formulations.

Regulatory Credentials:

• CE marking for European markets; FDA approval in the US.
• ISO certifications and continuous quality audits.

3. Fresenius Kabi

Overview:
Fresenius Kabi specializes in clinical nutrition and infusion therapies, including high-concentration dextrose solutions. Their products are recognized for quality and reliability, with extensive global distribution.

Product Attributes:

• Dextrose 70% supplied in various plastic container formats.
• Focus on batch-to-batch consistency and stability.
• Includes sterile, pyrogen-free formulations.

Regulatory Credentials:

• Approved by multiple international regulatory bodies such as the FDA, EMA, and other national agencies.
• Compliance with pharmacopoeial standards.

4. B. Braun Melsungen AG

Overview:
B. Braun manufactures a wide range of infusion solutions, with Dextrose 70% being central for clinical nutrition and hydration therapies.

Product Attributes:

• Plastic container formats ranging from 250 mL to 500 mL.
• Manufactured under strict GMP conditions, ensuring sterility and purity.
• Clear labeling and compliance with pharmacological standards.

Regulatory Credentials:

• CE mark, FDA approval, and other national certifications.
• Emphasis on environmental sustainability in manufacturing.

5. Envoy Medical (India and Asia Focus)

Overview:
Though primarily a regional player, Envoy Medical supplies high-quality Dextrose solutions across Asia and beyond, often catering to emerging markets.

Product Attributes:

• Dextrose 70% solutions in plastic formats in various sizes.
• Focused on affordability without compromising standards.
• Robust distribution network in India, Southeast Asia, and Africa.

Regulatory Credentials:

• ISI, WHO GMP certifications, and adherence to local regulatory standards.

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Emerging and Specialty Suppliers

6. Pfizer Essential Health (formerly Hospira)

Though now part of Pfizer, this division continues supplying sterile IV solutions, including Dextrose 70%, with enhanced focus on quality and innovation.

7. Local Pharmaceutical Manufacturers

Many established regional manufacturers in Latin America, Africa, and Southeast Asia produce Dextrose 70% under local regulatory oversight, often at competitive prices—key for hospitals in emerging markets.

Supply Chain Considerations

• Regulatory Compliance: Ensuring suppliers hold appropriate certifications (FDA, ISO, CE, WHO GMP) is non-negotiable.
• Quality Certifications: Validation of sterility, stability, and formulation consistency supports patient safety.
• Delivery Reliability: Global logistics capabilities, inventory management, and contingency planning influence procurement strategies.
• Pricing and Contract Terms: Negotiating favorable terms with bulk purchase discounts, payment clarification, and supply agreements.

Conclusion

Securing a reliable supplier for Dextrose 70% in plastic containers requires assessing product quality, regulatory compliance, and supply chain robustness. Leading multinational suppliers—Hospira (Pfizer), Baxter, Fresenius Kabi, and B. Braun—dominate the global market through stringent adherence to international standards, ensuring safety and efficacy. Emerging regional manufacturers expand the landscape, providing cost-effective alternatives tailored to local needs. Strategic partnerships with reputable suppliers underpin supply security and patient safety.

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Key Takeaways

• Major global suppliers include Hospira (Pfizer), Baxter, Fresenius Kabi, and B. Braun, offering high-quality Dextrose 70% solutions in plastic containers.
• Compliance with international regulatory standards (FDA, EMA, ISO) is fundamental for supplier credibility.
• Supply chain resilience depends on certifications, quality assurance, and logistical capacity.
• Regional manufacturers complement global suppliers, enabling diversified sourcing, especially in emerging markets.
• Due diligence in supplier selection optimizes safety, efficacy, and cost-efficiency.

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Frequently Asked Questions (FAQs)

1. What are the primary considerations when selecting a supplier for Dextrose 70% in plastic containers?
Quality assurance, regulatory compliance (FDA, EMA, ISO), product stability, sterility, supply reliability, and cost are paramount considerations. Verifying certifications and conducting audits enhance confidence in the supplier.

2. Are all Dextrose 70% solutions in plastic containers sterile and suitable for IV administration?
Yes, reputable suppliers manufacture Dextrose 70% solutions following GMP standards, ensuring sterility, stability, and suitability for intravenous use.

3. Can regional or local manufacturers effectively supply Dextrose 70% solutions?
Regional manufacturers can supply cost-effective options, provided they meet regulatory requirements and quality standards. Due diligence and certification validation are necessary.

4. How do regulatory differences affect the procurement of Dextrose 70% globally?
Different jurisdictions have specific registration, labeling, and safety standards. Suppliers must be certified for each market to ensure compliance and uninterrupted supply.

5. What role does supply chain management play in the availability of Dextrose 70%?
Effective supply chain management ensures timely delivery, inventory management, and contingency planning, reducing the risk of shortages in clinical settings.

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References

1. U.S. Food and Drug Administration (FDA). Good Manufacturing Practice (GMP) regulations.
2. European Medicines Agency (EMA). Guidelines on Quality of Intravenous Solutions.
3. World Health Organization (WHO). Guidelines on pharmaceutical manufacturing standards.
4. Hospira (Pfizer). Product datasheets and regulatory filings.
5. Baxter International Inc. Product documentation and regulatory approvals.
6. Fresenius Kabi. Quality assurance and product specifications.
7. B. Braun Melsungen AG. Corporate standards and global certifications.