Last updated: July 30, 2025
Introduction
The pharmaceutical landscape requires a comprehensive understanding of suppliers responsible for manufacturing and distributing specific drug formulations. Cardene IN 0.83% Sodium Chloride in a plastic container is a specialized intravenous (IV) medication used to treat hypertension and angina. Its pharmaceutical formulation comprises nicardipine hydrochloride, a calcium channel blocker, diluted in a sodium chloride solution for IV administration. Identifying reliable suppliers through regulatory and industry channels is crucial for healthcare providers, procurement entities, and investors.
Overview of Cardene IN 0.83% Sodium Chloride in Plastic Container
Cardene IN is a proprietary formulation of nicardipine hydrochloride, provided as an IV infusion in a plastic container. The drug’s stability, efficacy, and safety depend heavily on the manufacturing standards of its suppliers. The packaging involves a plastic container, designed for compatibility with IV systems and maintaining drug stability over its shelf life. The formulation’s concentration—0.83% sodium chloride—provides isotonic conditions conducive to intravenous infusion.
Major Manufacturers and Suppliers
1. Boehringer Ingelheim
Boehringer Ingelheim is the primary licensed manufacturer of Cardene IN in the United States and globally. The company produces the drug under its proprietary manufacturing facilities adhering to Good Manufacturing Practices (GMP). Their facility in Germany and the United States are certified by regulatory bodies such as the FDA and EMA, ensuring strict compliance with quality standards.
- Market Availability: Exclusively supplied through Boehringer Ingelheim’s distribution channels, including hospitals, clinics, and pharmacy networks.
- Regulatory Status: Approved by the FDA under New Drug Application (NDA) process, with manufacturing facilities conducting regular audits for compliance.
- Supply Chain: Boehringer Ingelheim’s extensive distribution network globally supports several hundreds of hospitals and healthcare providers.
2. Contract Manufacturing Organizations (CMOs)
While Boehringer Ingelheim is the primary source, other regional or generic manufacturers may produce similar formulations as authorized generics or biosimilar counterparts. These organizations often operate under licensing agreements or subcontract manufacturing arrangements but may not produce the branded Cardene IN directly.
3. Distributors and Wholesale Suppliers
Major pharmaceutical distributors such as McKesson, AmerisourceBergen, and Cardinal Health serve as middlemen for Cardene IN, sourcing from Boehringer Ingelheim or regional manufacturers. They ensure a wide reach to hospitals and clinics, maintaining inventory according to demand cycles.
4. Regulatory and Third-party Listing
Suppliers must be listed in authorities such as:
- FDA’s Drug Listing Act Database (USA)
- EMA’s Qualified Person (QP) Listings (Europe)
- WHO Prequalification Program, for international procurement standards
These listings confirm the legitimacy and compliance of suppliers involved in production and distribution.
Supply Chain Dynamics and Regulatory Considerations
The production of Cardene IN is characterized by stringent regulatory oversight. The manufacturer must validate its process, minimize contamination risks, and ensure batch-to-batch consistency. Supply chains are often impacted by:
- Global manufacturing constraints: Disruptions at manufacturing sites can delay supply.
- Regulatory approvals: Variability in license approvals across regions influences supplier availability.
- Market demand: Emergency needs, such as during pandemic scenarios, can shift supply dynamics.
Healthcare providers should verify supplier credentials, inspect regulatory approvals, and ensure sourcing from authorized entities to mitigate counterfeit risks.
Alternative Suppliers and Generics
Current market trends include the introduction of generic versions or biosimilars of nicardipine hydrochloride IV solutions. Such alternatives often originate from:
- Indian pharmaceutical companies like Sun Pharma, Zydus Cadila, or Dr. Reddy’s Laboratories, which manufacture similar calcium channel blocker formulations in line with local regulatory standards.
- Chinese pharmaceutical firms that supply injectable drugs compliant with WHO-GMP standards, often utilized in emerging markets.
- European generics manufacturers that offer biosimilar options, pending approval by European medicines agencies.
However, these alternatives are typically not identical in packaging or formulation concentration and may have different stability profiles.
Regulatory Challenges & Future Outlook
The supply of Cardene IN depends heavily on regulatory consistency, manufacturing quality, and demand. Increasing emphasis on quality standards and traceability is pushing suppliers to adopt advanced serialization and tracking measures. Moreover, with the rising prominence of personalized medicine and IV therapy, suppliers are investing in scalable manufacturing infrastructure.
Emerging biosimilar entrants could provide competition, potentially lowering costs and increasing access. However, regulatory pathways remain rigorous, emphasizing manufacturing integrity and clinical equivalence.
Key Considerations for Procurement and Business Intelligence
- Confirm supplier licensing and approval status with pertinent regulatory agencies.
- Evaluate quality assurance measures, including batch testing and stability data.
- Establish supply agreements with primary manufacturers such as Boehringer Ingelheim.
- Source through authorized distributors to prevent counterfeit exposure.
- Monitor geopolitical and logistical factors that influence supply stability.
Key Takeaways
- Primary Supplier: Boehringer Ingelheim is the exclusive manufacturer of Cardene IN 0.83% Sodium Chloride in a plastic container, with global distribution channels supporting its availability.
- Alternative Sources: Generic manufacturers and regional distributors supply similar formulations, but due diligence regarding regulatory approval and quality standards is essential.
- Regulatory Oversight: Strict regulation by agencies like the FDA and EMA ensures the safety, efficacy, and quality of supplied products.
- Supply Chain Risks: Manufacturing disruptions, geopolitical issues, and regulatory delays influence availability; proactive sourcing from authorized suppliers is critical.
- Emerging Competition: Biosimilar and generic entrants may diversify supply options, potentially impacting market pricing and access.
FAQs
1. Is Boehringer Ingelheim the only manufacturer of Cardene IN 0.83% Sodium Chloride?
Yes, Boehringer Ingelheim is the exclusive approved manufacturer of the branded Cardene IN formulation. Alternative options on the market are generally generic equivalents licensed by regional regulatory authorities.
2. Can I procure Cardene IN from international suppliers?
Procurement from international suppliers is possible but subject to rigorous approval, licensing, and compliance with local regulatory standards. Always verify suppliers' credentials with regulatory agencies.
3. Are generic versions of Cardene IN available, and are they considered equivalent?
Generic formulations of nicardipine IV solutions are available in some markets. Their clinical equivalence depends on regulatory approval, manufacturing process, and bioavailability data.
4. What are the risks associated with sourcing from non-verified suppliers?
Risks include counterfeit products, substandard quality, contamination, and regulatory non-compliance, which can jeopardize patient safety and lead to legal consequences.
5. How can healthcare providers ensure a reliable supply of Cardene IN?
By establishing procurement agreements with authorized distributors, verifying regulatory approval status, maintaining inventory buffers, and monitoring supply chain disruptions.
References
- [1] Food and Drug Administration (FDA). Drug Listings. Available at: FDA website.
- [2] European Medicines Agency (EMA). Authorized Medicinal Product Database. Available at: EMA website.
- [3] World Health Organization (WHO). Prequalification of Medicines Programme. Available at: WHO website.
- [4] Boehringer Ingelheim. Product Information and Registry. Available at: Boehringer Ingelheim official site.
- [5] Global pharmaceutical supply chain analysis. Pharma Intelligence Reports. 2022.
Disclaimer: This article is for informational purposes only. Always verify the current regulatory approval and licensing status of pharmaceuticals before procurement or clinical use.
