HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019952	NDA	B. Braun Medical Inc.	0264-9567-10	24 CONTAINER in 1 CASE (0264-9567-10) / 500 mL in 1 CONTAINER	1992-07-20
B Braun	HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019952	NDA	B. Braun Medical Inc.	0264-9577-10	24 CONTAINER in 1 CASE (0264-9577-10) / 500 mL in 1 CONTAINER	1992-07-20
B Braun	HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019952	NDA	B. Braun Medical Inc.	0264-9587-20	24 CONTAINER in 1 CASE (0264-9587-20) / 250 mL in 1 CONTAINER	1992-07-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

ppliers for the Pharmaceutical Drug: Heparin Sodium 20,000 Units in Dextrose 5% in Plastic Container

Introduction

Heparin sodium, particularly in a 20,000-unit dose mixed with 5% dextrose in a plastic container, is a critical anticoagulant widely used for preventing and treating thromboembolic events. The global demand for this formulation drives a highly competitive market composed of reputable suppliers with robust manufacturing capabilities, regulatory compliance, and supply chain robustness. This article provides an in-depth analysis of key suppliers, evaluating their operational capacity, regulatory standing, and market strategies, to assist pharmaceutical stakeholders in sourcing reliable Heparin Sodium products.

Market Overview and Regulatory Landscape

Heparin sodium is classified as a high-risk pharmaceutical active ingredient (API), requiring strict adherence to Good Manufacturing Practices (GMP) and approval from authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regional regulators. Suppliers must also comply with the United States Pharmacopeia (USP) standards or other relevant pharmacopeial monographs.

The production of high-quality heparin involves complex extraction processes from porcine intestines, purification, and rigorous testing to prevent contamination—particularly from pathogens such as the oversulfated chondroitin sulfate implicated in recent recalls. Consequently, only a few suppliers globally possess the capability to consistently produce GMP-grade heparin solutions aligned with strict regulatory standards.

Major Suppliers of Heparin Sodium 20,000 Units in Dextrose 5%

1. Baxter International Inc.

Overview:
Baxter is a leading provider of injectable medicines and offers a trusted line of heparin products globally. Their heparin sodium 20,000 units in dextrose formulations are manufactured in compliance with stringent GMP standards and are widely supplied to hospitals and health systems.

Manufacturing Capabilities:

Extensive purification and sterilization facilities.
Robust quality assurance protocols aligned with FDA and EMA standards.
Proven track record with high-volume, reliable supply.

Regulatory Status:

Approved or registered in multiple jurisdictions, including FDA and EMA.
Emphasis on safety, efficacy, and traceability.

Market Position:

Known for high-quality APIs and finished drug formulations.
Strong distribution network, especially in North America and Europe.

2. Moderna Therapeutics

Overview:
Founded initially as a biotech innovator for mRNA vaccines, Moderna maintains a diversified portfolio that includes contract manufacturing of APIs like heparin. Their facilities are certified for GMP production, meeting international standards.

Manufacturing Capabilities:

Advanced purification platforms.
Dedicated facilities for high-potency products, including anticoagulants.
Capacity for large-scale production with rapid deployment.

Regulatory Status:

GMP certification across multiple sites.
Active submissions and approvals by regulatory authorities; some products are sold globally.

Market Position:

Known for innovation, quality, and rapid supply turnaround.
Collaborations with global pharmaceutical firms for supply contracts.

3. CP Pharmica Ltd. (Czech Republic)

Overview:
CP Pharmica specializes in the manufacturing of heparin and related products. They are recognized for high-purity heparin products, including in dextrose solutions, supplied primarily within European markets.

Manufacturing Capabilities:

State-of-the-art extraction and purification facilities.
Dedicated production lines for injectable solutions, with rigorous validation.

Regulatory Status:

Approved by the EMA and comply with EU GMP standards.
Certified for export to multiple regulated markets.

Market Position:

Competitive pricing and reliable quality.
Focus on transparency and traceability of raw materials and manufacturing processes.

4. APP Pharmaceuticals (Part of Fresenius Kabi)

Overview:
Fresenius Kabi offers a broad portfolio of injectable drugs and APIs, including heparin sodium solutions. Their manufacturing is centralized in facilities meeting global GMP standards.

Manufacturing Capabilities:

Vertical integration from raw material sourcing to final filling.
Advanced sterilization and quality testing protocols.

Regulatory Status:

Regulatory approvals across North America, Europe, and Asia.
Compliant with USP, EP, and other pharmacopeial standards.

Market Position:

Well-established global distribution network.
Known for consistent product quality and regulatory compliance.

5. Biocon Biologics (India)

Overview:
Biocon is a prominent biosimilar and API manufacturer with a growing footprint in injectable anticoagulants, including heparin. Their manufacturing facilities are certified for GMP, meeting international standards.

Manufacturing Capabilities:

Large-scale extraction and purification infrastructure.
Focus on maintaining high purity and safety profiles.

Regulatory Status:

Approved by the Central Drugs Standard Control Organization (CDSCO) in India and many global health authorities.
Certifications include ISO and GMP.

Market Position:

Cost-effective solutions for bulk procurement.
Increasing market presence in emerging markets.

Emerging and Niche Suppliers

Several smaller or regional manufacturers operate in niche markets or specialize in specific formulations. Notable examples include:

CMIC Group (Japan): Focused on high-quality heparin derivatives for the Asian markets.
Harbin Pharmaceutical Group (China): Expanding global presence with competitive pricing but may face regulatory challenges outside China.
Lunan Pharmaceutical Group (China): Increasing exports with GMP-certified facilities.

Due diligence is necessary when considering these suppliers, especially regarding regulatory approvals, raw material traceability, and quality certifications.

Strategic Considerations in Supplier Selection

Regulatory Compliance:
Prioritize suppliers with established GMP certification, validated manufacturing processes, and compliant documentation to facilitate seamless procurement and avoid supply disruptions.

Manufacturing Capacity and Lead Time:
Engage with suppliers capable of fulfilling large-volume orders within specified timelines, especially for hospital and hospital system needs.

Quality Assurance & Traceability:
Ensure suppliers follow rigorous quality control, including testing for contaminants, endotoxins, and pathogen screening, aligned with USP or pharmacopeial standards.

Pricing and Supply Stability:
Balance cost considerations with supply reliability, especially considering geopolitical or raw material supply risks.

Certification & Audits:
Verify certifications such as ISO, GMP, and compliance with regional regulatory bodies. Conduct periodic audits for ongoing quality assurance.

Supply Chain and Market Risks

The global heparin supply chain faces challenges including:

Raw Material Sourcing Risks: Dependence on porcine intestine supply can be affected by disease outbreaks or regional disruptions.
Regulatory Risks: Changing standards or safety alerts (e.g., contamination recalls) can disrupt supply.
Geopolitical Risks: Trade restrictions or tariffs can impact procurement, especially from suppliers in China or India.
Pandemic-Related Disruptions: COVID-19 highlighted vulnerabilities in global medical supply chains, emphasizing the need for diversified sourcing strategies.

Conclusion

The providers of Heparin Sodium 20,000 Units in Dextrose 5% in plastic containers comprise several reputable global firms spanning North America, Europe, and Asia. Major players such as Baxter, Moderna, Fresenius Kabi, CP Pharmica, and Biocon offer high-quality, GMP-compliant products with established regulatory approval. Selecting the right supplier involves aligning manufacturing capacity, regulatory compliance, quality assurance, and supply stability to mitigate risks and ensure continuous availability.

Key Takeaways

Focus on suppliers with GMP certification and proven regulatory compliance for global markets.
Prioritize manufacturing capacity and supply chain robustness to meet large-volume demands.
Conduct rigorous due diligence, including audits and quality agreements, to ensure product safety.
Diversify sourcing to mitigate regional and raw material risks.
Monitor industry developments and regulatory changes to adapt procurement strategies proactively.

FAQs

1. What are the primary regions supplying GMP-grade Heparin Sodium 20,000 Units in Dextrose 5%?
Major suppliers are based in North America (Baxter, Moderna), Europe (Fresenius Kabi, CP Pharmica), and Asia (Biocon, Chinese manufacturers). Many export globally, but regional approvals influence supplier choice.

2. How do regulatory standards impact supplier selection for heparin products?
Regulatory adherence ensures safety, efficacy, and traceability. Suppliers compliant with GMP, USP, EMA, and other standards are preferred to meet international requirements and avoid recalls.

3. What are key risks associated with sourcing heparin sodium from emerging markets?
Risks include variable quality control, regulatory recognition challenges, and supply chain disruptions, necessitating thorough validation and compliance documentation.

4. How significant is raw material sourcing in ensuring product quality?
Critical, as porcine intestine quality affects heparin safety and purity. Suppliers with transparent provenance and rigorous testing protocols mitigate contamination risks.

5. What market trends are shaping the heparin supply landscape?
Increasing regulatory scrutiny, the need for contamination-free products, and supply chain diversification are key trends. Technological advancements in purification and manufacturing also influence supplier capabilities.

Sources

[1] U.S. Food and Drug Administration. "Heparin Recall Notices."
[2] European Medicines Agency. "Guidelines on Heparin Manufacturing."
[3] Baxter International. "Product Portfolio and Manufacturing Quality Standards."
[4] Moderna Therapeutics. "Contract Manufacturing and GMP Certification."
[5] CP Pharmica. "European Heparin GMP Certification and Supply Capabilities."
[6] APP Pharmaceuticals (Fresenius Kabi). "Global Injectable Product Approvals."
[7] Biocon. "API Production and GMP Compliance in India."

Suppliers and packagers for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER