NITROGLYCERIN IN DEXTROSE 5%: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	NITROGLYCERIN IN DEXTROSE 5%	nitroglycerin	INJECTABLE;INJECTION	019970	NDA	Baxter Healthcare Company	0338-1047-02	12 BOTTLE, GLASS in 1 BOX (0338-1047-02) / 250 mL in 1 BOTTLE, GLASS	1989-12-29
Baxter Hlthcare	NITROGLYCERIN IN DEXTROSE 5%	nitroglycerin	INJECTABLE;INJECTION	019970	NDA	Baxter Healthcare Company	0338-1049-02	12 BOTTLE, GLASS in 1 BOX (0338-1049-02) / 250 mL in 1 BOTTLE, GLASS	1989-12-29
Baxter Hlthcare	NITROGLYCERIN IN DEXTROSE 5%	nitroglycerin	INJECTABLE;INJECTION	019970	NDA	Baxter Healthcare Company	0338-1051-02	12 BOTTLE, GLASS in 1 BOX (0338-1051-02) / 250 mL in 1 BOTTLE, GLASS	1989-12-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Nitroglycerin in dextrose 5% is a critical formulation primarily used in hospitals and emergency care settings for vasodilatory therapy to manage angina pectoris and acute coronary syndromes. Its pharmaceutical formulation involves a complex manufacturing process aimed at ensuring stability, bioavailability, and regulatory compliance. Identifying reliable suppliers for this medication is essential for healthcare providers, pharmaceutical distributors, and procurement agencies seeking consistent quality and supply security.

Manufacturers and Global Suppliers

1. Leading Pharmaceutical Manufacturers

Major pharmaceutical companies with a focus on cardiovascular therapeutics often serve as primary suppliers for nitroglycerin in various formulations, including dextrose 5%. These manufacturers typically offer a broad portfolio that encompasses injectable and infusion solutions.

Pfizer Inc.

Pfizer is a prominent player in cardiovascular therapeutics, supplying nitroglycerin solutions globally. Although specific formulations like nitroglycerin in dextrose 5% are produced in compliance with regional regulatory standards, Pfizer's manufacturing facilities located across North America, Europe, and Asia maintain stringent quality controls.
Baxter International Inc.

Baxter produces a range of infusion solutions, including nitroglycerin infusions for clinical use. Their global manufacturing network ensures wide distribution, often including specialized formulations such as nitroglycerin in dextrose 5%. Baxter emphasizes compliance with Good Manufacturing Practices (GMP) and holds multiple regulatory approvals.
Fresenius Kabi

A key player in sterile injectables, Fresenius Kabi manufactures nitroglycerin infusion solutions, including custom formulations tailored to regional manufacturing needs. Their focus on hospital-use infusions makes them a dependable supplier for critical care medications.
B. Braun Melsungen AG

B. Braun offers specialized infusion products, including nitroglycerin solutions. Their extensive European manufacturing facilities adhere to strict quality standards, and they often supply formulations compatible with multiple infusion protocols.

2. Regional and Emerging Suppliers

In addition to global giants, several regional and emerging pharmaceutical companies manufacture and supply nitroglycerin in dextrose 5%. These suppliers are often critical in markets with limited access to international brands.

Sun Pharmaceutical Industries Ltd.

As one of India's largest pharmaceutical firms, Sun Pharma produces various cardiovascular infusion medications, including nitroglycerin. Their manufacturing plants follow WHO-GMP standards, and they export to multiple countries.
Zhejiang Jiuzhou Pharmaceutical Co., Ltd.

Based in China, this company manufactures sterile injectable solutions, including nitroglycerin infusions, serving both domestic and export markets. Their facilities are certified under local authorities and often meet international standards.
Teva Pharmaceutical Industries Ltd.

An Israeli global pharmaceutical group, Teva produces a range of injectable solutions. While their focus includes nitroglycerin, regional formulations may vary, and their supply chain spans multiple continents.

Regulatory and Quality Considerations

Since nitroglycerin in dextrose 5% is a critical care medication, regulatory compliance is vital. Suppliers must adhere to rigorous standards:

GMP Certification: Ensures manufacturing quality and safety.
ISO Certification: Demonstrates adherence to international quality standards.
Regional Regulatory Approvals: CE marking (Europe), FDA approval (USA), and other country-specific authorizations.

Healthcare providers should prioritize suppliers with validated compliance, transparent quality control measures, and consistent supply histories.

Supply Chain Dynamics

The procurement of nitroglycerin in dextrose 5% involves navigating complex supply chains affected by geopolitical factors, raw material availability, and regulatory changes. Recent trends indicate a move toward regional manufacturing to mitigate disruptions, emphasizing local partnerships, especially in regions with high demand.

Emerging Trends and Suppliers

1. Custom Formulation Manufacturers

As demand for specialized intravenous solutions rises, contract manufacturers and compounding pharmacies increasingly offer customized formulations, including nitroglycerin in dextrose 5%. These entities typically have flexible manufacturing capabilities but require rigorous validation for compliance.

2. Biosimilar and Generic Druggists

Global generic drug manufacturers are entering the market, offering cost-efficient alternatives. This increases competition and may improve supply security but necessitates thorough vetting for quality assurance.

Key Challenges in Sourcing

Regulatory Barriers

Variations in approvals between countries can delay procurement. Navigating the regulatory landscape requires detailed understanding of regional requirements.
Supply Chain Disruptions

Global events such as pandemics or geopolitical tensions can impact the availability of raw materials and finished products, leading to potential shortages.
Quality Assurance

Ensuring suppliers maintain consistent quality standards is paramount, particularly for injectable drugs utilized in critical care.

Conclusion

Reliable suppliers for nitroglycerin in dextrose 5% include globally recognized pharmaceutical firms such as Pfizer, Baxter, Fresenius Kabi, and B. Braun, alongside regional manufacturers like Sun Pharma, Zhejiang Jiuzhou, and Teva. The choice of supplier depends on regional availability, regulatory compliance, and quality standards. As the demand for high-quality, consistent supply continues, healthcare entities must develop partnerships with established suppliers while remaining vigilant to emerging suppliers that can offer cost-effective solutions without compromising safety.

Key Takeaways

Major global pharmaceutical companies dominate the supply of nitroglycerin in dextrose 5%, ensuring regulatory compliance and manufacturing quality.
Regional manufacturers play a vital role in providing accessible solutions, especially in emerging markets and regions with logistical constraints.
Ensuring GMP or equivalent certification is essential when selecting suppliers, given the critical nature of the medication.
Supply chain resilience relies on diversified sourcing and understanding regional regulatory landscapes.
Contract manufacturing and compounding pharmacies are emerging sources for customized formulations, highlighting market flexibility.

FAQs

Q1: What should healthcare providers consider when selecting a supplier for nitroglycerin in dextrose 5%?
A: Providers should prioritize suppliers with validated GMP certifications, regional regulatory approvals, consistent supply history, and quality assurance records.

Q2: Are there regional differences in formulations of nitroglycerin in dextrose 5%?
A: Yes. Formulations may vary based on regional regulatory requirements, packaging standards, and manufacturing practices, necessitating verification before procurement.

Q3: How can supply chain disruptions be mitigated for critical medications like nitroglycerin?
A: Diversifying supplier base, maintaining safety stock levels, and engaging in long-term contracts can mitigate risks associated with disruptions.

Q4: Are biosimilar or generic versions of nitroglycerin in dextrose 5% available?
A: Yes, several generic manufacturers produce nitroglycerin formulations. They often offer cost advantages but require careful assessment of quality standards.

Q5: What regulatory hurdles exist in importing nitroglycerin solutions across borders?
A: Variability in drug approvals, import/export restrictions, and compliance with local pharmacopoeia standards can pose hurdles, requiring thorough regulatory clearance processes.

Sources

[1] U.S. Food and Drug Administration (FDA). “Approved Drugs."
[2] European Medicines Agency (EMA). “Medicines."
[3] Baxter International. “Product Portfolio.”
[4] Fresenius Kabi. “Infusion Solutions.”
[5] Sun Pharmaceutical Industries Ltd. Annual Reports.

Suppliers and packagers for NITROGLYCERIN IN DEXTROSE 5%