HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% 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
Hospira	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019339	NDA	Hospira, Inc.	0409-4520-30	30 POUCH in 1 CASE (0409-4520-30) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-4520-02)	2022-12-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction
Heparin sodium, a widely used anticoagulant, plays a crucial role in preventing and treating thromboembolic disorders. The specific formulation of Heparin Sodium 10,000 Units in Dextrose 5% in a plastic container is essential in clinical settings such as intensive care units and surgical procedures. Securing a reliable supply chain for this formulation is vital for healthcare providers, pharmaceutical distributors, and regulatory authorities. This article provides a comprehensive overview of key suppliers globally capable of manufacturing and distributing this specific heparin formulation, emphasizing quality, regulatory compliance, and supply stability.

Global Market for Heparin Sodium
The global heparin market is dominated by a handful of pharmaceutical giants with established manufacturing capabilities and extensive distribution networks. The primary suppliers are mostly based in the United States, Europe, and Asia, notably China and India, which host many contract manufacturing organizations (CMOs) specializing in parenteral anticoagulants. The complexity in manufacturing, including sourcing of raw materials (porcine intestinal mucosa, bovine sources are less common), strict regulatory adherence, and high standards for sterility, limits the number of feasible suppliers.

Key Suppliers of Heparin Sodium 10,000 Units in Dextrose 5% in Plastic Containers

1. Baxter International Inc.

Overview:
Baxter is a leading manufacturer of injectable drugs, including heparin products. Their portfolio includes various formulations of heparin, made under rigorous quality controls aligned with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) standards.

Product Specifications:
Baxter offers heparin sodium injections in multiple strengths and volumetric configurations, including pre-filled plastic containers with Dextrose 5%. Baxter’s Heparin Sodium Injection 10,000 Units/10 mL (or equivalent container size) is marketed globally, with a robust supply chain in North America, Europe, and Asia.

Regulatory Compliance:
Baxter's products are manufactured within cGMP standards, with extensive documentation supporting regulatory approval for markets like the US (FDA), EU (EMA), and Japan (PMDA).

2. B. Braun Melsungen AG

Overview:
B. Braun provides heparin solutions primarily for critical care and surgical applications. The company's focus on sterile, high-quality injectables makes it a preferred supplier in many hospital networks worldwide.

Product Specifications:
Their Heparin Sodium Injection in Dextrose is available in various container types, including plastic bags and vials, with potency levels corresponding to 10,000 units in a 5% Dextrose solution.

Regulatory Compliance:
B. Braun products meet international standards, with approval across many jurisdictions. They operate under their rigorous quality management systems ensuring product safety and consistency.

3. Fresenius Kabi

Overview:
Fresenius Kabi's portfolio encompasses a wide range of sterile, parenteral drugs, including heparin formulations. The company is reputed for manufacturing high-quality, affordable pharmaceutical solutions.

Product Specifications:
Fresenius produces Heparin Sodium in Dextrose 5% in sterile, disposable plastic containers, supporting global distribution, especially in European and Asian markets.

Regulatory Compliance:
Their manufacturing facilities adhere to cGMP, with approval from key regulatory bodies including the FDA and EMA.

4. APP Pharmaceuticals (a division of Fresenius Kabi)

Overview:
Specializing in injectable pharmaceuticals, APP Pharmaceuticals supplies heparin formulations with proven regulatory and quality standards.

Product Specifications:
They offer 10,000-unit heparin sodium in Dextrose 5% in plastic containers, suitable for outpatient and inpatient settings.

Regulatory Compliance:
Their products are approved and compliant with international pharmacopeias, including USP and EP standards.

5. Zhejiang Verygene Bio-pharm Co., Ltd. (China)

Overview:
As a prominent Chinese manufacturer, Zhejiang Verygene specializes in heparin biosimilars and complex injectables. Their products are increasingly exported due to competitive pricing and comparable quality.

Product Specifications:
They manufacture heparin sodium 10,000 Units/10 mL in Dextrose 5%, sterilized and packed in plastic containers.

Regulatory Compliance:
The company possesses approvals from Chinese regulatory authorities (NMPA) and has initiated registrations in other jurisdictions, including some EU countries.

6. Other Notable Suppliers

Nantong Edihe Pharmaceuticals (China)
Livzon Pharmaceutical Group (China)
Yunnan Baiyao Group Co., Ltd. (China)
Their offerings typically focus on regional markets but are increasingly expanding their international footprint.

Considerations in Supplier Selection
When sourcing Heparin Sodium 10,000 Units in Dextrose 5%, several factors are critical:

Regulatory Status: Suppliers with approved products in target markets ensure compliance and quality assurance.
Manufacturing Standards: cGMP adherence guarantees safety, consistency, and sterility.
Supply Chain Stability: Proven track records of consistent supply are vital, especially in high-demand periods.
Pricing and Contract Terms: Competitive pricing, coupled with favorable contractual commitments, influences procurement decisions.
Traceability and Quality Documentation: Robust batch traceability and quality certificates (COAs, stability reports) are mandatory.

Regulatory Landscape and Certification
Manufacturers and suppliers must align with international regulations covering sterile injectables, such as the USP, European Pharmacopeia, and local authorities like the FDA and NMPA. For global distribution, suppliers often seek WHO prequalification or equivalent certifications, which reflect adherence to Good Manufacturing Practices (GMP) and quality standards.

Emerging Trends and Challenges

Biosimilar Competition: The rise of biosimilar heparins from Chinese manufacturers impacts market dynamics, driving price competition but demanding rigorous regulatory approval.
Supply Chain Disruptions: Raw material shortages, particularly porcine mucosa, can impact production capacity.
Regulatory Hurdles: Variations in global regulatory requirements necessitate comprehensive dossiers and local approvals.

Conclusion
Securing a reliable supplier for Heparin Sodium 10,000 Units in Dextrose 5% in plastic containers involves evaluating manufacturers across regulatory compliance, quality control, and supply capacity. Established global leaders like Baxter, B. Braun, and Fresenius Kabi remain the most trusted sources due to their extensive cGMP-compliant manufacturing infrastructure. Chinese manufacturers are increasingly significant, offering competitive options for regional and emerging markets.

Key Takeaways

Prioritize suppliers with global regulatory approvals and robust GMP compliance for high-stakes clinical use.
Evaluate supply chain stability to mitigate shortages, especially amid raw material volatility.
Consider leveraging regional Chinese suppliers for competitive pricing, but ensure they meet international quality standards.
Maintain rigorous qualification and audit protocols for supplier due diligence.
Stay attuned to evolving regulatory landscapes, which influence product registration and market access.

FAQs

What are the primary considerations when selecting a supplier for Heparin Sodium 10,000 Units in Dextrose 5%?
Regulatory compliance, manufacturing quality, supply reliability, pricing, and documentation are critical.
Are Chinese manufacturers reliable sources for high-quality heparin formulations?
Yes, many Chinese manufacturers have achieved international certifications (e.g., NMPA, WHO prequalification) and meet global quality standards, though due diligence is essential.
How does regulatory approval impact the procurement of heparin products?
Approved suppliers in target markets ensure product safety, efficacy, and legal compliance, facilitating smooth distribution and reimbursement.
What are the risks associated with supply chain disruptions for heparin?
Raw material shortages, geopolitical factors, and manufacturing delays can lead to shortages, affecting patient care and procurement costs.
What certifications should I verify before purchasing heparin sodium from a supplier?
Look for GMP compliance, USP/EP/JP pharmacopeial certifications, regulatory approvals, and traceability documentation.

References

[1] MarketsandMarkets. “Heparin Market by Source, Type, Application, and Region — Global Forecast to 2030.”
[2] Baxter International. Product catalog and quality certifications.
[3] B. Braun Melsungen AG. Regulatory filings and product details.
[4] Fresenius Kabi. International quality standards documentation.
[5] WHO Prequalification Program. List of approved heparin products and manufacturers.

Suppliers and packagers for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER