Bulk Pharmaceutical API Sources for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		N7510_SIGMA
NovoSeek		41114
MP Biomedicals		190244

Bulk Active Pharmaceutical Ingredient (API) Sources for Cardene in 5.0% Dextrose in Plastic Container

Last updated: August 2, 2025

Introduction

The procurement of Active Pharmaceutical Ingredients (APIs) is a critical component in the manufacturing of sterile infusion products, such as Cardene (Nicardipine HCl) in 5.0% Dextrose solution. Ensuring a reliable supply chain for high-quality APIs is crucial for pharmaceutical companies aiming to meet regulatory standards, maintain product integrity, and secure competitive advantage. This report examines the primary sources for bulk Nicardipine HCl API, focusing on manufacturers capable of supplying pharmaceutical-grade material suitable for sterile infusion formulations in plastic containers.

Understanding Cardene (Nicardipine HCl) API Requirements

Pharmaceutical Grade Standards:
APIs intended for injectable solutions must comply with strict pharmacopeial standards, including USP, EP, or JP monographs. They must meet stringent specifications related to purity, potency, endotoxin levels, microbial limits, and residual solvents.

Manufacturing Considerations:
The API must be sourced from facilities equipped for high-potency APIs, supporting validation and sterilization processes aligned with aseptic manufacturing requirements for plastic container formulations. The supply chain reliability, traceability, and adherence to Good Manufacturing Practices (GMP) are fundamental.

Major Global API Suppliers for Nicardipine HCl

1. Local and Regional Suppliers

Several regional manufacturers dominate the supply chain for Nicardipine HCl API, primarily serving the Asia-Pacific, Europe, and North America markets:

• Hikma Pharmaceuticals
  Based in Jordan, Hikma produces a broad portfolio of sterile and non-sterile APIs, including Nicardipine HCl, adhering to international GMP standards. Their API manufacturing facilities are approved by regulatory authorities like the FDA and EMA, ensuring compliance with rigorous quality standards.

• Sun Pharmacy (India)
  A notable player in the Indian pharmaceutical industry, Sun Pharma offers Nicardipine HCl API that meets Indian Pharmacopoeia (IP), USP, and other pharmacopeial standards. Their API is widely used in generic formulations, with capacities suitable for large-scale infusion products.

• Cadila Pharmaceuticals (India)
  Zydus Cadila manufactures APIs including Nicardipine HCl. Their facilities are WHO-GMP certified, and they have a track record of producing APIs for sterile injectable formulations, with compliance verified through regulatory audits.

2. International and Global API Manufacturers

Global API suppliers with established reputations include:

• Hovione
  Headquartered in Portugal, Hovione specializes in the development and manufacturing of APIs for injectable drugs, including Nicardipine HCl. They operate compliant facilities with extensive experience in sterile API production and are frequently audited by regulatory agencies worldwide.

• Jubiliant Life Sciences
  Based in India, Jubiliant offers a range of APIs, including Nicardipine HCl, with robust regulatory approvals and production capabilities tailored for sterile injectables. Their API quality management aligns with international GMP standards.

• Fresenius Kabi
  While primarily known for their infusion solutions and finished dosage forms, Fresenius Kabi also supplies bulk APIs, including Nicardipine HCl, from certified manufacturing sites.

3. Contract Manufacturing and Custom Synthesis Providers

In addition to branded API producers, several CMOs offer custom synthesis tailored for pharmaceutical companies:

• Bachem
  Bachem provides high-quality, GMP-compliant APIs suitable for sterile infusion. Partnering with such providers allows for assured supply chain security and compliance.

• CordenPharma
  With extensive experience in sterile API production, CordenPharma offers bespoke manufacturing for Nicardipine HCl, including validation for use in plastic container formulations.

Key Selection Criteria for API Sourcing

When selecting an API supplier for Cardene in 5.0% Dextrose in plastic containers, the following criteria are paramount:

• GMP Certification:
  The supplier must have current GMP approvals from recognized authorities (FDA, EMA, PMDA, etc.).

• Regulatory Acceptance:
  The API should comply with relevant pharmacopeias (USP, EP, JP) and be accepted in the target markets.

• Quality Specifications:
  API must meet purity, residual solvents, endotoxin, microbial limits, and potency levels suitable for injectable formulations.

• Supply Capacity & Reliability:
  Long-term availability with contingency options to mitigate supply disruptions.

• Pricing & Lead Times:
  Cost-effectiveness without compromising quality; timely delivery is critical for production schedules.

Regulatory and Quality Certification

Suppliers should provide comprehensive documentation, including Batch Production Records, Certificates of Analysis (CoA), Drug Master File (DMF) submissions, and stability data. Regulatory audits and validation reports are essential for validation during the approval process.

Challenges in API Sourcing for Injectable Cardene

• Complex Sterile Manufacturing:
  Sourcing API from facilities capable of sterile manufacturing and handling high-potency chemicals remains complex.

• Regulatory Compliance:
  Variability in regional regulation enforcement necessitates rigorous supplier qualification processes.

• Supply Chain Risks:
  Global disruptions, geopolitical issues, or raw material shortages may impact API availability.

Emerging Trends in API Supply

• Local Manufacturing Initiatives:
  Increasingly, pharmaceutical companies aim to develop or partner with local API manufacturers to reduce reliance on imports and streamline validation.

• Supply Chain Digitalization:
  Integration of blockchain and digital traceability to enhance transparency.

• Sustainable Manufacturing:
  Emphasis on environmentally friendly processes, including solvent reduction and waste minimization.

Conclusion

Ensuring a reliable source of high-quality Nicardipine HCl API for Cardene in 5.0% Dextrose solutions involves engaging with established global manufacturers and reputable regional suppliers. Recognized players such as Hikma, Sun Pharma, Cadila, Hovione, and Jubiliant offer compliant, GMP-certified APIs capable of supporting sterile infusion formulations in plastic containers. Strategic supplier qualification, rigorous quality assessment, and transparency across the supply chain are vital to mitigate risks and guarantee product integrity.

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Key Takeaways

• Selecting API suppliers with GMP accreditation, regulatory compliance, and proven production capacity is essential for sterile infusion products like Cardene in dextrose solutions.

• Major suppliers include Hikma Pharmaceuticals, Sun Pharma, Cadila Pharmaceuticals, Hovione, and Jubiliant Life Sciences.

• Due diligence, including validation reports, certificates, and regulatory acceptance, underpins secure and compliant sourcing.

• Local manufacturing partnerships are growing in prominence to reduce supply chain vulnerabilities.

• Emphasizing sustainability, digital transparency, and contingency planning enhances supply resilience.

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Frequently Asked Questions (FAQs)

1. What are the primary considerations when sourcing Nicardipine HCl API for injectable formulations?
Quality standards, GMP certification, regulatory compliance, supply capacity, and ability to meet pharmaceutical specifications are critical considerations.

2. Are there regional differences in API quality for Nicardipine HCl?
While many suppliers meet international standards, compliance with regional pharmacopeial requirements and regulatory authority approvals varies, necessitating due diligence.

3. Can custom synthesis providers supply Nicardipine HCl API tailored for sterile infusion?
Yes, companies like CordenPharma and Bachem offer custom GMP synthesis of APIs designed explicitly for sterile injectable applications.

4. What challenges are associated with sourcing APIs for infusion products in plastic containers?
Sterile manufacturing requirements, endotoxin control, microbial limits, and maintaining API stability pose significant challenges.

5. How can pharmaceutical companies mitigate supply chain risks for API sourcing?
Diversifying suppliers, establishing long-term partnerships, maintaining inventory buffers, and validating local sourcing options help mitigate risks.

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References

[1] United States Pharmacopeia (USP) Monograph. Nicardipine Hydrochloride.
[2] European Pharmacopoeia (EP) Monograph. Nicardipine Hydrochloride.
[3] Regulatory filings and Certificate of Analysis from contributing API manufacturers.
[4] Industry reports on sterile API manufacturing and supply chain trends.