NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Inforlife	NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	203978	ANDA	WG Critical Care, LLC	44567-850-12	12 BAG in 1 CARTON (44567-850-12) / 200 mL in 1 BAG (44567-850-01)	2025-07-10
Inforlife	NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	203978	ANDA	WG Critical Care, LLC	44567-851-12	12 BAG in 1 CARTON (44567-851-12) / 200 mL in 1 BAG (44567-851-01)	2025-07-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 9, 2025

Introduction

The pharmaceutical landscape demands high-quality suppliers for critical medications like nicardipine hydrochloride in 0.86% sodium chloride, primarily used in hypertensive emergencies and perioperative hypertension management. Ensuring a reliable supply chain, adherence to regulatory standards, and product consistency are vital for healthcare providers and pharmaceutical companies. This report delineates key suppliers, their capabilities, regulatory compliance, and the current market landscape.

Overview of Nicardipine Hydrochloride in 0.86% Sodium Chloride

Nicardipine hydrochloride is a calcium channel blocker utilized for intravenous infusion to control blood pressure. It is typically supplied as a sterile solution in compatible infusion bags or bottles with a sodium chloride diluent, often at concentrations around 0.86%. Given its critical role, sourcing from reputable suppliers with robust manufacturing capabilities and quality assurance processes is imperative.

Major Global Suppliers

1. Fresenius Kabi

Fresenius Kabi is a leading manufacturer of intravenous drugs and infusion solutions. Their portfolio includes nicardipine hydrochloride in various formulations, including sodium chloride diluents. The company's manufacturing facilities comply with Good Manufacturing Practices (GMP), and their products are widely accepted in North America, Europe, and Asia.

Product Features: GMP-compliant, high purity, consistent formulation, comprehensive regulatory documentation.
Certifications: FDA-approved, EMA compliance, ISO 13485.

2. Pfizer

Pfizer supplies nicardipine hydrochloride as part of its hospital-focused portfolio. The medication is available in centralized infusion solutions, with the company's broad regulatory approvals and established supply chains ensuring product reliability.

Product Features: High standards of manufacturing, extensive regulatory submissions, and global distribution.
Certifications: FDA, EMA, and WHO GMP standards.

3. Hospira (Now part of Pfizer)

Hospira has historically been a major supplier of injectable drugs, including nicardipine hydrochloride formulations. Their manufacturing sites adhere to stringent quality controls, and their products are commonly used in hospitals worldwide.

Product Features: Extensive portfolio of IV medications, GMP compliance, and robust distribution network.
Certifications: FDA-approved manufacturing facilities.

4. Sagent Pharmaceuticals

Sagent offers a range of injectable medications, including nicardipine hydrochloride in sodium chloride solutions, focusing on North American markets with quality and supply reliability.

Product Features: Focus on hospital institutions, high-quality sterile manufacturing, rapid response to supply needs.
Certifications: FDA-approved processes, cGMP compliance.

5. local and regional pharmaceutical manufacturers

Various regional manufacturers in India, China, and Eastern Europe produce nicardipine hydrochloride solutions for local and export markets. Companies such as Sun Pharmaceutical Industries, Cadila Healthcare, and Hetero Drugs may supply nicardipine formulations, including sodium chloride diluents, often at lower costs but with varying regulatory accreditations.

Product Features: Cost-effective, accessible, but variable in quality assurance.
Certifications: Often WHO GMP, with some obtaining US FDA or EMA approval.

Distributor and Broker Networks

In addition to direct suppliers, pharmaceutical distributors such as McKesson, Becton Dickinson, and Henry Schein provide access to nicardipine hydrochloride solutions. These channels facilitate procurement for hospitals and clinics, especially in regions with limited manufacturing direct access.

Regulatory and Quality Considerations

High-quality suppliers will possess comprehensive regulatory documentation, including:

Certificates of Analysis (CoA)
Compliance with pharmacopeial standards (USP, EP, JP)
Proper validation and sterility assurance
Good Distribution Practice (GDP) certifications

Choosing suppliers with WHO-GMP or equivalent accreditation ensures product safety and regulatory compliance across markets.

Market Trends and Supplier Challenges

The global market for intravenous antihypertensives faces challenges including:

Supply chain disruptions owing to raw material shortages or geopolitical issues.
Regulatory harmonization requiring suppliers to meet diverse regional standards.
Price fluctuations driven by manufacturing costs and demand-supply dynamics.

To mitigate risks, buyers should diversify their supplier base, verify quality standards, and establish robust qualification processes.

Conclusion

The leading global suppliers for nicardipine hydrochloride in 0.86% sodium chloride include Fresenius Kabi, Pfizer, Hospira, and Sagent Pharmaceuticals. Regional manufacturers supplement this landscape, offering cost-effective alternatives. Ensuring procurement from GMP-certified sources with rigorous quality controls remains non-negotiable for healthcare safety and regulatory compliance.

Key Takeaways

Major suppliers like Fresenius Kabi and Pfizer dominate the global market, known for quality and regulatory compliance.
Regional manufacturers, primarily in Asia and Eastern Europe, offer cost-effective options but require rigorous quality verification.
Supplier diversification is critical to mitigate manufacturing or geopolitical risks.
Regulatory documentation and GMP standards are vital in supplier qualification.
Continuous market monitoring is essential to manage price fluctuations and supply stability.

FAQs

1. How can healthcare providers verify the quality of nicardipine hydrochloride suppliers?
They should request and review certifications such as GMP compliance, Certificates of Analysis (CoA), and regulatory approvals (FDA, EMA). Auditing manufacturing facilities, where feasible, further ensures quality.

2. Are there regional differences in supplier offerings for nicardipine hydrochloride?
Yes. Global suppliers typically meet stringent standards, while regional manufacturers may vary in regulatory compliance. It's essential to verify approvals pertinent to the target market.

3. What factors should influence supplier selection for critical medications like nicardipine hydrochloride?
Regulatory compliance, product quality, manufacturing capacity, supply reliability, delivery timelines, and cost are primary considerations.

4. How have recent supply chain disruptions impacted the availability of nicardipine hydrochloride?
Disruptions due to raw material shortages, geopolitical tensions, or manufacturing delays have led to intermittent shortages, underscoring the need for diversified sourcing strategies.

5. Is there a trend toward sourcing biosimilar or generic versions of nicardipine hydrochloride?
While biosimilars are more common for biologics, high-quality generics for small-molecule drugs like nicardipine are widely available, often at lower costs, impacting supplier choices and procurement strategies.

References

[1] U.S. Pharmacopeia. (2022). NICARDIPINE monograph.
[2] European Pharmacopoeia. (2022). NICARDIPINE HYDROCHLORIDE specifications.
[3] Company websites and regulatory filings for Fresenius Kabi, Pfizer, and Hospira.
[4] WHO-GMP certified manufacturers list.

Disclaimer: This article provides an overview of current suppliers and industry practices; procurement decisions should involve direct consultation with manufacturers and regulatory authorities.

Suppliers and packagers for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE