SODIUM NITROPRUSSIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	209493	ANDA	Amneal Pharmaceuticals LLC	70121-1189-1	1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1189-1) / 2 mL in 1 VIAL, SINGLE-DOSE	2017-11-07
Be Pharms	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	214971	ANDA	BE Pharmaceuticals Inc.	71839-120-01	1 VIAL in 1 CARTON (71839-120-01) / 2 mL in 1 VIAL	2021-07-12
Caplin	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	211016	ANDA	Caplin Steriles Limited	65145-101-01	1 VIAL, SINGLE-DOSE in 1 CARTON (65145-101-01) / 2 mL in 1 VIAL, SINGLE-DOSE	2025-10-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Sodium nitroprusside is a potent vasodilator used primarily in hypertensive emergencies and controlled blood pressure reduction during surgical procedures. Its rapid onset and short duration make it a critical drug in acute settings. As demand for this medicament persists globally, identifying reliable sources and suppliers becomes essential for healthcare providers, pharmaceutical companies, and distributors.

This article provides an in-depth analysis of key suppliers for sodium nitroprusside, examining manufacturing jurisdictions, regulatory approvals, supply chain considerations, and market dynamics. Ensuring quality, compliance, and supply stability remains central to procurement decisions in the pharmaceutical supply ecosystem.

Manufacturers and Major Suppliers

1. Chinese Manufacturers

China dominates the global sodium nitroprusside supply chain. Several state-of-the-art chemical manufacturing firms produce high-purity sodium nitroprusside, exporting predominantly to North America, Europe, and Asia.

Hunan Yung Huei Chemical Co., Ltd.
Offers pharmaceutical-grade sodium nitroprusside conforming to GMP standards. Their products are widely distributed globally, with certifications from Chinese authorities and regulatory approvals from key markets.
Zhejiang Meiyu Pharmaceutical Co., Ltd.
Specializes in research, manufacturing, and distribution of cyanide and cyanide-related compounds, including sodium nitroprusside. Their quality assurance processes align with international standards.
Shandong Xinhua Pharmaceutical Co., Ltd.
Focuses on chemical intermediates and pharmaceutical raw materials, supplying sodium nitroprusside under strict quality controls, with regulatory approval in multiple regions.

2. Indian Suppliers

India has emerged as a significant supplier of raw materials and active pharmaceutical ingredients (APIs), including sodium nitroprusside.

Gujarat State Fertilizers & Chemicals Limited (GSFC)
Producing cyanide-based chemicals with applications including sodium nitroprusside. Their products meet international quality and safety standards.
Sun Pharmaceuticals Industries
While primarily known for APIs and formulations, they have developed facilities for cyanide derivatives utilized in pharmaceutical manufacturing.

3. European and North American Suppliers

Due to stringent regulatory environments, Europe and North America rely more on importation from established Chinese and Indian manufacturers. However, a few specialized suppliers have domestic production capabilities.

Merck KGaA (Germany)
Offers pharmaceutical-grade chemicals, including sodium nitroprusside, with comprehensive regulatory documentation meeting EMA standards.
Fresenius Kabi (Germany)
Provides hospital-use formulations of sodium nitroprusside, adhering to rigorous quality controls aligned with EU and US standards.
Sigma-Aldrich (Part of Merck Group)
Distributes sodium nitroprusside for research and laboratory purposes, with an established global supply chain.

Regulatory Status and Certifications

Manufacturers must adhere to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and meet certifications such as FDA approval (for US sales), EMA approval (Europe), and WHO prequalification. Many Chinese and Indian producers possess ISO certifications, with some pursuing or maintaining US FDA and European EMA approvals.

Supply chain reliability hinges on regulatory compliance; non-approved sources pose risks of inferior quality, regulatory rejection, or supply disruptions.

Supply Chain Considerations

The supply of sodium nitroprusside faces challenges including:

Raw Material Availability: Cyanide derivatives and nitrates are sourced from regulated chemical markets, subject to supply fluctuations.
Manufacturing Capacity: Limited facilities hold GMP approval for pharmaceutical-grade production, constraining supply volumes.
Regulatory Variability: Export restrictions or approval delays can hinder procurement, especially during geopolitical tensions or supply chain disruptions like the COVID-19 pandemic.
Price Volatility: Due to its hazardous raw materials and variable raw material costs, sodium nitroprusside pricing can fluctuate markedly.

Market Dynamics and Outlook

Global demand for sodium nitroprusside remains stable but concentrated. Major markets include the US, Europe, China, and India. The emergence of alternative vasodilators or formulations (e.g., nitroglycerin, clevidipine) could influence future procurement strategies.

The supply landscape is characterized by:

Consolidation: Larger firms acquiring smaller players to secure supply chains.
Innovation: Development of stabilized formulations to extend shelf life and reduce handling risks.
Regulatory harmonization: Increased emphasis on GMP compliance to meet international distribution standards.

Key Considerations for Buyers

Ensure regulatory compliance: Verify supplier approvals for your specific market (FDA, EMA, PMDA, etc.).
Assess manufacturing quality: Obtain certifications, batch testing reports, and stability data.
Evaluate supply stability: Confirm production capacity, lead times, and contingency plans.
Consider batch traceability: Source from suppliers with transparent origin tracking.
Negotiate contractual safeguards: Price stability clauses, supply continuity guarantees, and quality assurances.

Conclusion

Reliable sourcing of sodium nitroprusside involves navigating a complex landscape of regional manufacturers, regulatory rigor, and supply chain intricacies. Chinese and Indian producers currently dominate the market, supplemented by select European suppliers with high regulatory acceptance.

Ensuring product quality, regulatory compliance, and supply continuity are paramount. Strategic procurement, continuous supplier evaluation, and adherence to international standards will safeguard utility and patient safety.

Key Takeaways

Supplier diversity is essential; balance procurement between Chinese, Indian, and Western sources to mitigate risk.
Rigorous qualification processes must underpin supplier selection, emphasizing regulatory approvals and GMP compliance.
Supply chain resilience depends on supplier transparency, production capacity, and contingency planning.
Regulatory landscape influences supplier choice; staying updated on regional approvals and certifications is vital.
Market trends point toward consolidation and innovation, likely affecting future supply dynamics.

FAQs

1. Are sodium nitroprusside suppliers limited to specific regions?
While China and India dominate the supply of pharmaceutical-grade sodium nitroprusside, European and North American companies primarily import from these regions, with some specialized domestic manufacturers. Regulatory approvals and GMP compliance are critical considerations.

2. What regulatory approvals are essential for sodium nitroprusside suppliers?
Suppliers should possess GMP certification, FDA approval (for US distribution), EMA approval (for Europe), or equivalent regional certifications, ensuring product safety and quality.

3. How can healthcare providers ensure the quality of sodium nitroprusside sourced from overseas suppliers?
Verification includes reviewing batch release certificates, certification of analysis, supplier audits, and adherence to recognized quality standards such as ISO, GMP, and regional regulatory approvals.

4. What supply risks are associated with sodium nitroprusside procurement?
Risks include raw material shortages, geopolitical tensions affecting trade, manufacturing capacity limitations, regulatory delays, and price volatility.

5. Are there alternative drugs to sodium nitroprusside?
Yes. Alternatives include nitroglycerin, nicardipine, and clevidipine, which may be preferred in certain clinical scenarios depending on patient condition and logistical factors.

References

U.S. FDA Drug Database. (2022). Sodium nitroprusside drug summary.
European Medicines Agency (EMA). Approved medicinal products containing sodium nitroprusside.
Chinese GMP Certification Records. State Drug Administration of China.
Indian Pharmacopoeia Commission. Approved chemical manufacturing licenses.
Market analysis reports on pharmaceutical raw material supply chains, 2022.

Suppliers and packagers for generic pharmaceutical drug: SODIUM NITROPRUSSIDE