Bulk Pharmaceutical API Sources for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		N7510_SIGMA
NovoSeek		41114
MP Biomedicals		190244
TCI (Tokyo Chemical Industry)		N0635
MolPort		MolPort-003-666-362
NIH Clinical Collection		SAM002564254

Bulk Active Pharmaceutical Ingredient (API) Sources for Cardene in 4.8% Dextrose in Plastic Container

Last updated: August 6, 2025

Introduction

Cardene, the brand name for nicardipine hydrochloride, is a calcium channel blocker primarily used intravenously to manage hypertension and angina. The formulation involving 4.8% dextrose in a plastic container indicates its use as an IV infusion, requiring high-purity NICARDIPINE API sourced from reputable manufacturers. The API sourcing process is pivotal in ensuring the drug’s safety, efficacy, and regulatory compliance, especially given the strict standards governing injectable products.

This article explores the landscape of Bulk NICARDIPINE API suppliers capable of providing pharmaceutical-grade product suitable for Cardene formulations, emphasizing quality, regulatory adherence, and supply chain stability.

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Overview of NICARDIPINE API

NICARDIPINE hydrochloride is a dihydropyridine calcium channel blocker with vasodilatory effects, administered primarily via IV infusion in critical care settings. The API must meet stringent purity standards (typically exceeding 99.5%), be free from residual solvents, heavy metals, and impurities, and conform to monographs like USP, EP, or JP.

The synthesis of NICARDIPINE involves multi-step chemical processes, demanding high control over manufacturing conditions to ensure batch consistency, stability, and compliance with Good Manufacturing Practices (GMP). The API's quality directly impacts the safety and quality of the final infused product.

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Key Criteria for API Suppliers

When identifying suppliers for NICARDIPINE API suitable for Cardene, the following criteria are essential:

• GMP Certification: Ensures manufacturing practices align with global regulatory standards, including FDA, EMA, and other authorities.
• Quality Certifications: Certifications such as ISO 9001, ISO 13485 (for medical devices if applicable) reinforce quality management systems.
• Supply Capacity & Reliability: Ability to fulfill large-volume orders consistently.
• Regulatory Documentation: Availability of Drug Master Files (DMFs), Certificates of Suitability (CEPs), and comprehensive API data.
• Pricing & Lead Times: Competitive costs with dependable lead times.
• Traceability & Transparency: Clear audit trails for raw materials and manufacturing processes.

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Major API Manufacturers for NICARDIPINE

1. Xinyi Pharmaceutical (Sino-American Pharmaceutical)

• Profile: Based in China, Xinyi Pharmaceutical is a recognized producer of cardiovascular APIs, including NICARDIPINE.
• Strengths: Large-scale GMP manufacturing, extensive regulatory dossiers, and proven supply reliability.
• Certifications: GMP, ISO 9001, and presence of DMFs with regulatory agencies.
• Market Position: A prominent supplier capable of meeting global demand.

2. Zydus Cadila

• Profile: Indian pharmaceutical giant with a broad portfolio of active ingredients, including NICARDIPINE.
• Strengths: Established manufacturing infrastructure, compliance with international standards, and active participation in global markets.
• Certifications: GMP, ISO, and relevant regulatory approvals.
• Regulatory Support: May hold CEPs or equivalent for NICARDIPINE API.

3. PhibroChem

• Profile: A US-based or global API manufacturer specialized in cardiovascular and calcium channel blocker APIs.
• Strengths: Emphasis on quality assurance stemming from rigorous GMP compliance.
• Certifications: US FDA approval (for US-based plants), ISO certifications.
• Competitive Edge: Proven track record with US and European regulators.

4. Zhejiang Hisun Pharmaceutical Co., Ltd.

• Profile: Chinese manufacturer with a significant portfolio of cardiovascular APIs.
• Strengths: Cost-effective manufacturing, robust quality systems.
• Certifications: GMP and DMF filings, aligned with international standards.

5. Aurobindo Pharma

• Profile: Indian pharmaceutical leader with a diverse product pipeline, including NICARDIPINE.
• Strengths: Large-scale manufacturing, global regulatory approvals.
• Certifications: GMP, CEPs, DMFs, and FDA approval.

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Emerging & Niche Suppliers

In addition to established players, niche suppliers and contract manufacturing organizations (CMOs) serve as flexible alternatives:

• Sandoz (Novartis)
• Teva Pharmaceuticals
• Hikma Pharmaceuticals

These companies possess extensive API manufacturing capabilities and typically can customize bulk sourcing per client specifications while maintaining regulatory compliance.

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Supply Chain and Regulatory Considerations

For manufacturers and pharmaceutical companies sourcing NICARDIPINE API, it is crucial to verify:

• Regulatory Acceptance: Confirm API suppliers have valid DMFs and Certificates of Suitability (CEPs).
• Traceability: Ensure raw material documentation, process validation data, and batch records are transparent.
• Quality Standards: API must adhere to pharmacopeial monographs, with strict impurity profiling.
• Stability & Storage: Suppliers should provide stability data supporting storage conditions compatible with the final formulation.
• Logistics & Lead Times: Adequate planning minimizes disruptions in the production of Cardene infusions.

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Conclusion

The selection of high-quality NICARDIPINE API suppliers is vital for the consistent production of Cardene 4.8% dextrose IV formulations. Reputable manufacturers such as Xinyi Pharmaceutical, Zydus Cadila, Aurobindo Pharma, Zhejiang Hisun, and established CMOs stand out as reliable sources capable of meeting stringent quality and regulatory requirements. Engaging with suppliers possessing comprehensive regulatory dossiers, GMP compliance, and transparent supply chains ensures the delivery of safe, effective intravenous medications to critical care settings.

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Key Takeaways

• Supplier Selection: Prioritize GMP-certified manufacturers with proven regulatory compliance, including DMFs and CEPs.
• Quality Assurance: Ensure APIs meet pharmacopeial standards (USP, EP, JP) with low impurity levels.
• Supply Chain Reliability: Consider suppliers with scalable capacity and dependable logistics for consistent API availability.
• Regulatory Alignment: Confirm API specifications and registration documents align with target market requirements.
• Strategic Partnerships: Establish collaborations with reputable API manufacturers to secure long-term supply stability for Cardene formulations.

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FAQs

1. What quality standards must NICARDIPINE API meet for injectable formulations?
The API must conform to pharmacopeial specifications (USP, EP, JP), with purity above 99.5%, low residual solvents, and acceptable levels of impurities, ensuring safety and efficacy for intravenous use.

2. Are Chinese API manufacturers suitable sources for NICARDIPINE?
Yes, several Chinese manufacturers, such as Xinyi Pharmaceutical, possess GMP certifications and regulatory dossiers, making them suitable global supply partners when compliance and documentation are verified.

3. How does regulatory compliance influence API sourcing decisions?
Regulatory compliance, including GMP certification and possession of DMFs or CEPs, guarantees the API is manufactured under internationally recognized quality systems, facilitating approval processes across markets.

4. What logistical considerations are critical when sourcing NICARDIPINE API?
Ensuring reliable lead times, temperature-controlled transportation, batch traceability, and import/export compliance are crucial for maintaining uninterrupted supply chains.

5. Can biosimilar or contract manufacturing organizations (CMOs) produce NICARDIPINE API?
While most NICARDIPINE API is produced by integrated pharmaceutical companies, reputable CMOs with proven GMP compliance can serve as alternative sources, especially for large-volume or tailored needs.

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Sources

[1] United States Pharmacopeia. (2022). USP Monograph for NICARDIPINE HYDROCHLORIDE.
[2] European Pharmacopoeia. (2022). NICARDIPINE Hydrochloride monograph.
[3] Drug Master Files (DMFs) and Certificates of Suitability (CEPs) from major manufacturers.
[4] Industry reports on pharmaceutical API manufacturing and global supply chains.
[5] Company websites and quality documentation of Xinyi Pharmaceutical, Zydus Cadila, Aurobindo Pharma, Zhejiang Hisun.