NICARDIPINE HYDROCHLORIDE IN 0.83% 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 0.83% 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 0.83% 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 5, 2025

Introduction

The pharmaceutical market for Nicardipine Hydrochloride in 0.83% Sodium Chloride represents a niche yet vital segment within intravenous (IV) antihypertensive and vasodilatory therapies. This formulation, used predominantly in intensive care units, demands high-quality manufacturing standards and reliable supply chains. Identifying reputable suppliers is essential for pharmaceutical companies, hospitals, and distributors aiming to ensure continuous patient care and regulatory compliance.

Overview of Nicardipine Hydrochloride in 0.83% Sodium Chloride

Nicardipine Hydrochloride is a calcium channel blocker used primarily to manage acute hypertension and cerebral vasospasm. Its IV formulation in a saline solution facilitates rapid action in critical care settings. The specific composition—0.83% sodium chloride—maintains isotonicity, vital for patient safety and drug stability.

While the formulation is standardized, sourcing from reliable suppliers is crucial given the stringent regulatory environment governing sterile healthcare solutions, especially in the United States (FDA compliance), European Union (EMA standards), and other jurisdictions.

Key Criteria for Supplier Selection

Regulatory Compliance: Good Manufacturing Practices (GMP) adherence, FDA/EMA approvals.
Manufacturing Capacity: Ability to meet global demand, scalability.
Quality Assurance: Stringent quality controls, batch consistency, sterility assurance.
Supply Chain Reliability: Consistent delivery, inventory management.
Certifications: ISO certifications, batch testing certificates, stability data.

Leading Suppliers of Nicardipine Hydrochloride in 0.83% Sodium Chloride

1. Fresenius Kabi

Overview: A global leader in infusion solutions and sterile medicines. Fresenius Kabi manufactures a wide range of IV medications, including nicardipine hydrochloride in saline solutions, adhering to rigorous GMP standards.

Product Attributes:

Approved across multiple regions, including the US, EU, and APAC.
Extensive distribution network ensures timely supply.
Emphasis on high-quality sterile formulations.

Market Presence: Widely used in hospitals globally, supported by robust regulatory compliance and supply chain capabilities.

2. B. Braun Melsungen AG

Overview:
As a major manufacturer of infusion therapy products, B. Braun offers IV formulations for cardiovascular indications. Their portfolio likely includes formulations similar to nicardipine hydrochloride in saline.

Product Attributes:

Proven track record in sterile injectable drugs.
Adheres to international GMP standards.
Strong regulatory presence and certifications.

3. Hospira (Pfizer)

Overview:
Now part of Pfizer, Hospira specializes in sterile injectable medicines, including cardiovascular drugs. Their formulations meet rigorous quality standards and serve large healthcare systems.

Product Attributes:

Supplies to North America and global markets.
Consistent quality controls and testing protocols.

4. Sandoz (Novartis)

Overview:
Known for its extensive generic injectable portfolio, Sandoz manufactures cardiovascular drugs, including calcium channel blockers like nicardipine.

Product Attributes:

Focus on affordability without compromising quality.
Strong global distribution network.

5. Local and Regional Manufacturers

In addition to multinational corporations, several regional suppliers operate under local regulatory oversight, especially in emerging markets:

India: Sun Pharmaceutical Industries Ltd., Lupin Ltd.
China: Hengrui Pharma, Qilu Pharmaceutical.
Europe: Recordati, Sofar S.p.A.

These regional suppliers often collaborate with global partners or supply national healthcare systems directly.

Regulatory Considerations and Validation

Suppliers must ensure compliance with regulatory agencies' standards to facilitate approval and reimbursement pathways. Suppliers typically provide:

Batch-specific Certificate of Analysis (CoA).
Sterility and endotoxin testing reports.
Stability data supporting shelf life.
Manufacturing licenses and GMP certificates.

Import authorities like the FDA (U.S.), EMA (EU), and PMDA (Japan) rigorously regulate sterile injectable products, making it critical to source from suppliers with established regulatory track records.

Emerging Trends and Supply Challenges

Supply Chain Disruptions: Due to geopolitical issues and global crises (e.g., COVID-19 pandemic), sourcing has faced interruptions, emphasizing the need for diversified supplier bases.
Regulatory Harmonization: Increasing standardization across regions facilitates easier access to global markets but requires suppliers to maintain high compliance standards.
Innovation and Quality Improvement: Suppliers invest in advanced manufacturing techniques to improve stability, reduce endotoxin levels, and enhance drug purity.
Biopharmaceutical Trends: The move toward biosimilar and generic formulations expands the supplier landscape but necessitates rigorous validation and quality assurance.

Conclusion

The procurement of Nicardipine Hydrochloride in 0.83% Sodium Chloride hinges on sourcing from reputable suppliers with proven regulatory compliance, robust manufacturing capability, and reliable distribution. Major multinational corporations such as Fresenius Kabi, B. Braun, Pfizer (Hospira), and Sandoz dominate the global supply chain. Nonetheless, regional manufacturers remain significant in local markets, especially in emerging economies.

Ensuring consistent quality, regulatory adherence, and supply chain resilience are critical to meeting clinical demands and maintaining patient safety.

Key Takeaways

Global Leaders: Major pharmaceutical suppliers include Fresenius Kabi, B. Braun, Pfizer (Hospira), and Sandoz.
Regulatory Compliance: Verify suppliers’ adherence to GMP standards and regulatory approvals for specific markets.
Supply Chain Strategy: Diversify sources to mitigate risks posed by disruptions.
Quality Assurance: Always review batch testing certificates, stability data, and sterility validation.
Regional Suppliers: Leverage local manufacturers in emerging markets for cost-effective and rapid procurement.

FAQs

1. What factors should I consider when selecting a supplier for NICARDIPINE HYDROCHLORIDE in 0.83% Sodium Chloride?
Prioritize regulatory compliance (FDA, EMA), manufacturing capacity, quality assurance protocols, supply reliability, and certification standards (ISO, GMP).

2. Are there regional suppliers that can reliably provide this formulation?
Yes. Regional manufacturers in India, China, and Europe often supply high-standard formulations, particularly in emerging markets. However, verification of regulatory compliance is essential.

3. How does supply chain disruption affect the procurement of sterile IV drugs like nicardipine?
Disruptions can lead to shortages, delayed treatments, and increased costs. Diversifying supplier sources and maintaining sufficient inventory levels help mitigate these risks.

4. What role do regulatory agencies play in ensuring supplier quality?
Agencies enforce GMP standards, conduct inspections, and approve manufacturing facilities. Suppliers must provide documentation confirming compliance with these standards for market approval.

5. Can compounding pharmacies prepare this formulation locally?
While technically feasible in some settings, compounded formulations lack the same assurance of sterility, consistency, and regulatory oversight as commercial products, and may not be suitable for critical care use.

Sources

Fresenius Kabi Product Portfolio
B. Braun Medical Inc.
Pfizer - Hospira Portfolio
Sandoz - Global Generics
[Regulatory standards - FDA and EMA guidelines]

Note: This analysis emphasizes primary reputable sources and publicly available data. For procurement, always conduct due diligence, including regulatory validation and supplier audits.

Suppliers and packagers for NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE