Suppliers and packagers for DEXTROSE 50%

DEXTROSE 50%

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	DEXTROSE 50%	dextrose	INJECTABLE;INJECTION	019445	NDA	Henry Schein, Inc.	0404-9844-10	1 SYRINGE in 1 BAG (0404-9844-10) / 10 mL in 1 SYRINGE	2022-01-10
Hospira	DEXTROSE 50%	dextrose	INJECTABLE;INJECTION	019445	NDA	Henry Schein, Inc.	0404-9845-50	1 SYRINGE in 1 BAG (0404-9845-50) / 50 mL in 1 SYRINGE	2022-01-10
Hospira	DEXTROSE 50%	dextrose	INJECTABLE;INJECTION	019445	NDA	Henry Schein, Inc.	0404-9847-50	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9847-50) / 50 mL in 1 VIAL, SINGLE-DOSE	2022-01-10
Hospira	DEXTROSE 50%	dextrose	INJECTABLE;INJECTION	019445	NDA	Hospira, Inc.	0409-1775-10	10 CARTON in 1 PACKAGE (0409-1775-10) / 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC (0409-1775-40)	2006-02-22
Hospira	DEXTROSE 50%	dextrose	INJECTABLE;INJECTION	019445	NDA	Hospira, Inc.	0409-6648-02	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6648-02) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-6648-16)	2005-03-31
Hospira	DEXTROSE 50%	dextrose	INJECTABLE;INJECTION	019445	NDA	Hospira, Inc.	0409-7517-16	10 CARTON in 1 CONTAINER (0409-7517-16) / 1 SYRINGE, PLASTIC in 1 CARTON / 50 mL in 1 SYRINGE, PLASTIC (0409-7517-66)	2005-12-02

Suppliers for the Pharmaceutical Drug: Dextrose 50%

Last updated: February 20, 2026

Dextrose 50%, a 50% glucose solution used in medical treatments, has a broad supplier base primarily consisting of companies specializing in bulk pharmaceutical and intravenous (IV) solutions manufacturing.

Major Suppliers and Market Overview

Supplier	Location	Certification	Production Capacity	Notes
B. Braun Melsungen AG	Germany	GMP, ISO 13485	~20 million liters/year	Supplies medical-grade dextrose solutions globally.
Baxter International Inc.	USA	FDA approved, ISO 9001	Large-scale production	Offers IV solutions including Dextrose 50%.
Fresenius Kabi	Germany	GMP, ISO 13485	Extensive global capacity	Provides sterile dextrose solutions for IV use.
Hikma Pharmaceuticals	UK	MHRA approved	Regional capacities	Supplies sterile dextrose solutions in Europe and Middle East.
Guizhou Kailin Pharmaceutical	China	GMP	Growing capacity	Supplies to Asian markets, expanding globally.
Anhui Biochem Company	China	GMP	Significant production	Produces sterile IV glucose solutions.

Market Trends and Sourcing Considerations

• Regional Manufacturing: European and North American suppliers emphasize GMP, ISO, and FDA certifications, ensuring high-quality standards. Chinese manufacturers are increasing capacity and export volume, often at lower costs, but may vary in certification rigor.
• Regulatory Approvals: Ensure supplier compliance with country-specific regulations, including CE marking in Europe or FDA approval in the US.
• Quality Standards: Preferred suppliers maintain sterility, endotoxin limits, and consistent concentration, crucial for IV solutions-administered products.
• Supply Risks: Dependence on regional suppliers can lead to supply chain disruptions caused by geopolitical issues, trade policies, or manufacturing delays.
• Pricing: Chinese manufacturers often offer lower pricing but may lack some certifications or quality control measures of Western counterparts.

Procurement Notes

• Validation: Procurement should validate supplier GMP compliance, batch consistency, and sterility procedures.
• Contract Terms: Negotiate for long-term supply agreements with capacity commitments to mitigate shortages.
• Inspection & Audits: On-site audits provide verification of manufacturing standards and quality controls.
• Sources of Bulk Dextrose: Some suppliers produce dextrose monohydrate and convert it into sterile solutions; verify the purity and endotoxin levels.

Regulatory and Quality Compliance

• United States: Monitored by the FDA, requiring compliance with 21 CFR Part 211 for sterile drug manufacturing.
• European Union: Regulated by EMA and compliant with European Pharmacopoeia standards.
• China: Governed by NMPA (formerly CFDA), with increasing strictness in quality standards.

Supply Chain Considerations

• Lead Time: Typically 4-12 weeks depending on supplier and order size.
• MOQ: Many manufacturers require minimum order quantities due to sterilization batch requirements.
• Storage & Transportation: Must be stored at controlled temperatures; transportation mandates sterile conditions.

Key Takeaways

• Leading global suppliers for Dextrose 50% include B. Braun, Baxter, and Fresenius Kabi.
• Chinese manufacturers are expanding but may vary in quality and certification.
• Ensure supply chain resilience by diversifying suppliers and verifying compliance.
• Regulatory and quality standards are critical, especially for IV solutions.
• Procurement strategies should include validation, audits, and long-term contracting.

FAQs

1. What certifications should suppliers of Dextrose 50% hold?

   • They should have GMP, ISO 13485, and, where applicable, FDA approval or CE marking for sterile IV solutions.

2. Which regions dominate the Dextrose 50% supply chain?

   • Europe, North America, and China are primary manufacturing regions.

3. How does pricing vary among suppliers?

   • Chinese manufacturers tend to offer lower prices but may lack some certifications; Western suppliers typically charge higher prices with stricter quality standards.

4. What are key factors to consider in supplier selection?

   • Certification, manufacturing capacity, compliance with regulations, supply reliability, and quality control track record.

5. Are there supply risks associated with Chinese manufacturers?

   • Yes, including potential quality variability, regulatory differences, and geopolitical factors affecting logistics.

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References:

[1] U.S. Food and Drug Administration. (2022). Current Good Manufacturing Practice (CGMP) Regulations: Human Drugs. https://www.fda.gov/drugs/pharmaceutical-quality-resources/cgmp

[2] European Medicines Agency. (2022). Guidelines on sterile medicinal products. https://www.ema.europa.eu/en/human-regulatory/research-development/advanced-therapy-products/sterile-medicinal-products

[3] National Medical Products Administration (NMPA). (2022). Regulation for Pharmaceutical Manufacturing. https://www.nmpa.gov.cn/