Last updated: July 31, 2025
Introduction
Cardene, the brand name for nicardipine hydrochloride, is a calcium channel blocker primarily used to manage hypertension and angina. Formulated as an injectable, it often comes in a plastic container with a 4.8% dextrose solution (dextrose 4.8%) for intravenous administration. Securing reliable suppliers for this specific formulation is crucial for hospitals, pharmacies, and contract manufacturing organizations (CMOs) aiming to ensure uninterrupted access to this medication, especially amid fluctuating global supply chains. This analysis explores the key suppliers manufacturing Cardene in 4.8% dextrose solutions in plastic containers, focusing on their manufacturing capabilities, regulatory backgrounds, and market presence.
Market Overview and Regulatory Context
The global supply of nicardipine hydrochloride in dextrose solution is governed by strict regulatory frameworks, notably the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regional agencies. These regulators ensure quality, safety, and efficacy, often requiring that pharmaceutical companies adhere to Good Manufacturing Practices (GMP). Suppliers must also meet specific packaging standards, especially for IV drugs in plastic containers, which demand compatibility, stability, and sterilization protocols.
Major Suppliers of Cardene in 4.8% Dextrose in Plastic Containers
1. Moderna Therapeutics (McGaw Medical and Contract Manufacturers)
While Moderna is best known for mRNA vaccines, the manufacturing of Cardene is typically handled by licensed pharmaceutical companies, not Moderna directly. In the case of Cardene, the primary manufacturer historically has been:
2. Pfizer (Ferndale Laboratories)
Pfizer, through its subsidiary Ferndale Laboratories, has been a key player in producing nicardipine formulations, including in dextrose solutions. Pfizer’s manufacturing plant in the United States adheres to stringent GMP regulations, producing both branded and generic formulations of nicardipine hydrochloride [1].
- Capabilities: Facilities equipped for sterile, large-volume IV solutions.
- Availability: Pfizer supplies Cardene to hospitals and pharmaceutical distributors globally.
- Regulatory Status: Approved by FDA, with ongoing compliance and manufacturing audits ensuring the distribution of high-quality injectable solutions.
3. Hikma Pharmaceuticals
Hikma is recognized for its portfolio of injectable cardiovascular drugs, including proprietary formulations of nicardipine in dextrose solutions.
- Manufacturing Facilities: Located in Jordan and the UK, these facilities are GMP-certified and supply to North America, Europe, and emerging markets.
- Market Role: Hikma’s injectable cardiovascular portfolio includes a 4.8% dextrose in plastic container formulation of Cardene.
- Compliance: Certificated by the relevant health authorities, Hikma is a significant alternative supplier, especially for generic formulations.
4. Hikma’s Contract Manufacturers
Some formulations are produced under contract manufacturing agreements with other pharmaceutical firms, expanding supply options for Cardene. These partnerships often leverage reputable facilities with specialized capabilities in aseptic manufacturing and container sterilization [2].
5. Local and Regional Manufacturers
In addition to major global suppliers, several regional manufacturers in Asia, Europe, and South America produce licensed or hospital-compounded versions of nicardipine in dextrose solutions. Their offerings, while often unbranded or generic, serve local markets and occasionally supply large healthcare systems with bulk drugs.
- Examples include Eczacıbaşı Pharmaceuticals (Turkey) and Sun Pharmaceutical Industries (India), which produce similar formulations approved for regional markets [3].
Key Attributes of Suppliers
| Attribute |
Details |
| Regulatory Compliance |
Must meet GMP standards from regional agencies (FDA, EMA, etc.) |
| Packaging Compatibility |
Use of PVC or compatible plastic containers to reduce leaching and ensure stability |
| Sterility & Stability |
Must guarantee sterility over shelf life and stability within plastic containers |
| Manufacturing Capacity |
Capable of high-volume production to meet global or regional demand |
Challenges in Sourcing Cardene in 4.8% Dextrose Solutions
- Supply Chain Disruptions: COVID-19 emphasized vulnerabilities in global pharmaceutical manufacturing, impacting availability.
- Regulatory Variances: Differing regional approvals can complicate procurement.
- Formulation Complexity: Maintaining drug stability and sterility in plastic containers demands advanced manufacturing technology.
- Intellectual Property & Patents: Some formulations may be under patent restrictions, affecting the emergence of new suppliers.
Emerging Trends and Future Outlook
- Generic Expansion: Increased approval and manufacturing of generic nicardipine formulations expand supplier bases worldwide.
- Manufacturing Innovations: Advanced aseptic plastic container technology enhances stability, safety, and shelf life.
- Supply Chain Diversification: Companies seek to mitigate risks through multi-sourcing strategies, including regional manufacturers.
- Regulatory Harmonization: Efforts by health authorities to streamline approvals may facilitate quicker access to new suppliers.
Key Takeaways
- The primary established suppliers for Cardene in 4.8% dextrose in plastic containers include Pfizer (Ferndale Laboratories) and Hikma Pharmaceuticals.
- Regional and generic manufacturers supplement supply chains, especially in emerging markets.
- Ensuring supplier compliance with GMP and proper packaging standards is crucial for maintaining medication integrity.
- Supply disruptions during global crises underscore the importance of diversified sourcing strategies.
- Regulatory status and manufacturing capacity should be verified before procurement to ensure consistent supply.
FAQs
1. Who are the leading global suppliers of Cardene in dextrose solutions?
Pfizer (through Ferndale Laboratories) and Hikma Pharmaceuticals are the predominant global suppliers, with additional regional manufacturers supplying various markets.
2. What regulatory approvals are required for suppliers of Cardene?
Suppliers must hold GMP certification from relevant authorities such as the FDA (U.S.), EMA (Europe), or local health agencies, confirming compliance with manufacturing, sterility, and stability standards.
3. Are generic formulations of Cardene in 4.8% dextrose available?
Yes, several generic manufacturers, particularly Hikma and regional producers, supply bioequivalent formulations that meet regional regulatory approvals.
4. What factors influence the choice of a supplier for Cardene in IV solutions?
Manufacturing capacity, regulatory compliance, product stability, packaging compatibility, and supply reliability are key criteria.
5. How is supply chain risk managed for critical IV drugs like Cardene?
Strategies include multi-sourcing, maintaining safety stock, engaging contract manufacturing organizations, and collaborating with regional suppliers to diversify procurement sources.
References
[1] U.S. Food and Drug Administration. Drug Approvals and Compliance. FDA website.
[2] Hikma Pharmaceuticals. Product Portfolio & Manufacturing Capabilities. Hikma Annual Reports 2022.
[3] European Medicines Agency. Market Authorization of Nicardipine formulations. EMA Database.
