Last updated: August 2, 2025
Introduction
The medication CARDENE (generic: nicardipine hydrochloride) in a 5.0% Dextrose in Plastic Container is a vital intravenous antihypertensive used in critical care settings to manage severe hypertension and vasospasm. This formulation involves the delivery of nicardipine, a calcium channel blocker, dissolved in a 5% dextrose solution, housed within a sterile plastic container designed for IV administration. The procurement of this specific formulation hinges on identifying reliable, compliant suppliers capable of meeting regulatory standards, ensuring consistent quality, and providing global or regional supply.
This report examines the current landscape of suppliers for CARDENE in 5.0% Dextrose in Plastic Container, emphasizing their manufacturing capabilities, regulatory compliance, certification status, and market presence to assist healthcare providers, procurement officers, and pharmaceutical partners in making well-informed sourcing decisions.
Manufacturers of Nicardipine in Dextrose IV Formulation
1. Novartis Pharmaceuticals
Market Leadership & Manufacturing Scope:
Novartis is the primary manufacturer of branded CARDENE (nicardipine hydrochloride) in various formulations globally, including the 5.0% Dextrose IV formulation. With authorized manufacturing facilities compliant with Good Manufacturing Practices (GMP) and certifications from regulatory authorities (FDA, EMA, and WHO), Novartis offers a reliable supply chain.
Regulatory Compliance & Certifications:
Novartis maintains extensive GMP certification, ensuring quality and safety. Its products are approved by relevant health authorities across multiple regions, facilitating broad distribution.
Global Reach & Distribution:
Novartis supplies through a robust international distribution network, catering to hospitals, pharmacies, and government procurement systems.
Key Consideration:
While primarily branded, Novartis’s formulations are often available via authorized generics or through authorized distributors, especially in regions where patent barriers limit immediate access.
2. Sandoz (A Novartis Division)
Role & Capabilities:
Sandoz specializes in generic pharmaceuticals, including injectable formulations like nicardipine in dextrose solutions. As a division of Novartis, it leverages the parent company's manufacturing expertise but focuses specifically on generics.
Quality & Certification:
Sandoz manufacturing facilities are GMP-compliant with certifications recognized internationally (FDA, EMA, WHO). Their generic options often facilitate cost-effective procurement for healthcare systems.
Availability & Distribution:
Widely distributed across North America, Europe, and emerging markets, Sandoz’s products are integrated into public health procurement programs.
3. Cipla Limited
Regional prominence:
Cipla is a leading Indian pharmaceutical producer with a significant presence in the injectable segment, including nicardipine in dextrose solutions. Cipla adheres to international quality standards and GMP regulations.
Regulatory Status & Certifications:
Cipla’s manufacturing facilities are certified by the US FDA, WHO-GMP, and other regulatory authorities, enabling export to multiple markets.
Product Availability:
Cipla primarily supplies to South Asia, Africa, and parts of Southeast Asia, often acting as a cost-effective alternative to branded formulations.
4. Mylan (Now part of Viatris)
Company Profile:
Viatris, formerly Mylan, produces a range of injectable drugs, including calcium channel blockers like nicardipine in dextrose solutions.
Regulatory & Quality Standards:
Viatris maintains compliance with GMP and has approvals from FDA, EMA, and other agencies. The company emphasizes high-quality manufacturing suitable for hospital formulary needs.
Distribution Network:
Viatris supplies globally, including in North America, Europe, and emerging markets.
5. Local and Regional Manufacturers
In addition to multinational corporations, regional manufacturers in Asia, Latin America, and Eastern Europe also produce nicardipine 5.0% dextrose IV formulations to address local market demand.
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China: Several local GMP-certified companies manufacture injectable formulations, often supplied to the domestic market and exported under licensing agreements.
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Brazil and Mexico: Local pharmaceutical firms are authorized to produce for regional distribution, often compliant with ANVISA (Brazil) or COFEPRIS (Mexico).
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South Africa and Southeast Asia: Local producers comply with WHO-GMP standards and serve markets where imported products are limited due to logistical or regulatory constraints.
Regulatory and Quality Considerations
Procurement of CARDENE in 5.0% Dextrose requires strict adherence to quality standards. Suppliers must have:
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GMP Certification: Ensuring sterile production and consistent drug quality.
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Regulatory Approvals: Validations from agencies such as the FDA (U.S.), EMA (Europe), or respective regional authorities for each market.
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Stability and Packaging Certifications: For plastic container integrity, compatibility, and stability under specified storage conditions.
Alternative Sourcing Strategies
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Authorized Generic Distributors: If branded CARDENE is unavailable, authorized generic equivalents from companies like Sandoz or regional suppliers can provide cost-effective alternatives while maintaining quality.
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Regional Suppliers: Engage local manufacturers who meet international standards, considering regulatory equivalency and import licenses.
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Contract Manufacturing: Pharmacovigilance, Quality Assurance, and regulatory audits should precede engagement with contract manufacturers to mitigate risks of substandard products.
Market Trends and Supply Chain Challenges
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Global Supply Chain Disruptions: The COVID-19 pandemic highlighted vulnerabilities affecting production and distribution of injectable drugs, necessitating diversified supplier sourcing.
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Regulatory Harmonization: Increasing standardization efforts have eased cross-border procurement, though regional variances persist.
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Cost Considerations: While brand-name suppliers like Novartis offer assured quality, budget-conscious markets frequently rely on regional generics, emphasizing the importance of verifying certifications.
Key Takeaways
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Primary Supplier: Novartis remains the dominant manufacturer of CARDENE in 5.0% Dextrose in Plastic Container, with global reach and comprehensive regulatory approval.
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Generic Alternatives: Sandoz (a Novartis division), Cipla, Mylan (Viatris), and regional manufacturers are significant sources, especially in markets with cost constraints.
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Regulatory Due Diligence: Validation of GMP certification and regulatory approval status is critical to ensure product safety, efficacy, and legal compliance.
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Supply Security: Diversify suppliers within approved regulatory frameworks to mitigate risks posed by disruptions and shortages.
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Regional Manufacturing: In emerging markets, regional manufacturers can provide accessible alternatives, provided they adhere to international standards.
FAQs
1. Who are the leading global suppliers of NICARDIPINE in dextrose IV formulations?
Novartis and Sandoz are primary global suppliers, offering branded and generic options. They operate GMP-certified manufacturing facilities and have broad regulatory approvals.
2. Can regional pharmaceutical companies supply qualified NICARDIPINE in 5.0% Dextrose?
Yes, regional producers in Asia, Latin America, and Africa manufacture approved formulations, typically adhering to WHO-GMP standards. Procurement should involve verification of certification and regulatory compliance.
3. What regulatory considerations should be prioritized when sourcing NICARDIPINE in dextrose solution?
Affirm GMP certification, regional approval status, and documentation of stability, sterility, and packaging quality are essential to ensure compliance and patient safety.
4. Are there reputable distributors that can supply NICARDIPINE in plastic containers globally?
Yes, authorized distributors of Novartis, Sandoz, Cipla, and Viatris provide reliable supply channels, often linked through hospital procurement networks and government tenders.
5. How do I evaluate the quality of generic NICARDIPINE options?
Verify GMP certification, seek product approval documentation from local regulatory bodies, conduct supplier audits if possible, and review stability and sterility testing data.
References
[1] Novartis Pharmaceuticals. Product information: CARDENE.
[2] Sandoz. Product catalog and certification details.
[3] Cipla Limited. Quality certifications and product approvals.
[4] Viatris (formerly Mylan). Injectable product compliance data.
[5] World Health Organization. WHO-GMP guidelines and regional manufacturing standards.
