Bulk Pharmaceutical API Sources for CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for CARDENE IN 0.83% SODIUM CHLORIDE 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 0.83% Sodium Chloride in Plastic Container

Last updated: July 31, 2025

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Introduction

The pharmaceutical formulation of Cardene (nicardipine hydrochloride), particularly in solutions such as 0.83% sodium chloride in plastic containers, requires high-quality bulk APIs to ensure safety, efficacy, and regulatory compliance. Identifying reliable sources of nicardipine hydrochloride is crucial for pharmaceutical manufacturers aiming to produce tablet, injectable, or infusion forms that meet international standards. This report examines the global API suppliers capable of providing bulk nicardipine hydrochloride suitable for such formulations, emphasizing quality, regulatory status, and supply chain reliability.

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Overview of Nicardipine Hydrochloride as API

Nicardipine hydrochloride is a calcium channel blocker used primarily in the management of angina and hypertension. Its synthesis involves complex chemical processes requiring precise control over purity and stability. Because of its pharmacological potency, sourcing must meet strict Good Manufacturing Practice (GMP) standards, with suppliers typically holding certifications from regulatory agencies such as the FDA, EMA, or equivalents.

In formulations involving 0.83% sodium chloride in plastic containers—commonly used for infusion solutions—the API's purity and stability are critical. The API must be suitable for parenteral use, with low endotoxin levels and compatible with plastic infusion containers.

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Major API Suppliers for Nicardipine Hydrochloride

1. Diverging Global Players

a. Zhejiang Huahai Pharmaceutical Co., Ltd.

• Overview: A leading Chinese API manufacturer with extensive experience in cardiovascular APIs, including nicardipine hydrochloride.
• Regulatory Status: Holds WHO-GMP certification and complies with U.S. FDA requirements for export.
• Capabilities: Produces bulk nicardipine hydrochloride in high purity grades suitable for parenteral formulations.
• Supply Reliability: Recognized for consistent supply and adherence to strict quality standards.

b. Jiangsu Boehringer Ingelheim Pharmaceuticals, Inc.

• Overview: A subsidiary of Boehringer Ingelheim, with robust manufacturing facilities.
• Regulatory Status: GMP-certified, with supply agreements to major pharmaceutical firms.
• Quality Assurance: Implements rigorous quality control measures aligning with international standards.
• Supply Focus: Provides API especially tailored for infusion solutions, meeting endotoxin and sterility specifications.

c. TAPI (Trinity Manufacturing, Inc.)

• Overview: A US-based API manufacturer specializing in cardiovascular drugs.
• Regulatory Status: GMP-compliant with FDA approval for originating API batches.
• Specialization: Offers high-quality nicardipine hydrochloride suitable for parenteral formulations.

2. Established European and Indian API Suppliers

a. Sun Pharmaceutical Industries Ltd.

• Overview: An Indian pharmaceutical giant with a substantial API manufacturing segment.
• Certifications: GMP-certified and compliant with international quality standards.
• Product Suitability: Supplies high-grade nicardipine hydrochloride for parenteral use.

b. Dr. Reddy’s Laboratories

• Overview: Indian multinational with a broad portfolio, including cardiovascular APIs.
• Quality Standards: Meets US FDA and EU Good Manufacturing Practices.
• Supply Capabilities: Able to deliver large batches suitable for global markets.

c. Cipla Ltd.

• Overview: Indian-based, with extensive API production facilities.
• Regulatory Compliance: Certifications include WHO-GMP, US FDA, and EMA approvals.
• Product Range: Supplies nicardipine hydrochloride with specifications compatible for infusion solutions.

3. Specialized API Contract Manufacturing Organizations

a. Lonza

• Overview: Swiss contract manufacturer with expertise in APIs for injectable formulations.
• Regulatory Scope: Extensive European and global approvals for pharmaceutical APIs.
• API Quality: Offers high-purity, bioequivalent APIs suitable for infusion devices.

b. WuXi AppTec

• Overview: Chinese pharma services company, providing custom synthesis and API production.
• Compliance: GMP-approved facilities, with an emphasis on quality and scalability.
• Focus: Capable of producing nicardipine hydrochloride for parenteral applications with regulatory documentation.

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Criteria for Selecting API Suppliers

When sourcing nicardipine hydrochloride for use in 0.83% sodium chloride infusion in plastic containers, manufacturers should consider:

• Regulatory Certification: GMP, WHO-GMP, FDA, EMA approval.
• Purity and Specifications: API must meet pharmacopeial standards (e.g., USP, EP).
• endotoxin and Sterility Testing: Essential for infusion-quality APIs.
• Supply Chain Security: Capacity for consistent supply and delivery timelines.
• Documentation: Detailed Certificates of Analysis (CoA), Stability Data, and CMC information.

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Supply Chain and Regulatory Considerations

Global manufacturers increasingly demand transparency and verification of API quality. Adequate due diligence involves reviewing supplier audits, certification documents, and batch records. Regulatory authorities may require validation data supporting API suitability for infusion products.

Manufacturers should pursue sourcing from suppliers with proven compliance history, capable of providing batch-to-batch consistency, endotoxin testing, and appropriate packaging for pharmaceutical APIs. Engaging with well-established suppliers minimizes risks of contamination and regulatory non-compliance.

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Conclusion

Sourcing bulk nicardipine hydrochloride for formulations such as 0.83% sodium chloride in plastic containers predominantly involves established Chinese, Indian, European, and US-based API manufacturers. Ensuring that the supplier holds appropriate GMP certifications, supplies API with verified specifications, and can meet regulatory requirements is critical. Strategic partnerships with reputable API providers enable pharmaceutical manufacturers to produce safe, effective, and compliant infusion solutions.

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Key Takeaways

• Reliable API sourcing is fundamental for infusion formulations like Cardene 0.83% sodium chloride in plastic containers.
• Major manufacturers include Zhejiang Huahai (China), Sun Pharma, Dr. Reddy’s, Cipla (India), Lonza (Switzerland), and WuXi AppTec (China).
• Regulatory certification, high purity standards, endotoxin, and sterility testing are prerequisites.
• Due diligence includes auditing supplier compliance, reviewing batch documentation, and confirming supply chain robustness.
• Partnering with established, GMP-certified suppliers ensures manufacturing continuity and regulatory compliance.

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Frequently Asked Questions

Q1: What are the key quality parameters for bulk nicardipine hydrochloride APIs intended for infusion use?
A1: Critical parameters include pharmacopeial purity (usually USP or EP), endotoxin levels below specified limits, sterility, low moisture content, and stability in solution. Certificates of analysis and validation reports are essential.

Q2: Which regions offer the most reliable sources for nicardipine hydrochloride API?
A2: China (Zhejiang Huahai, WuXi), India (Sun Pharma, Dr. Reddy’s, Cipla), and Europe (Lonza) are reliable sources due to their GMP certifications, regulatory compliance, and production capacity.

Q3: How does supplier certification influence API selection?
A3: Certifications such as GMP, WHO-GMP, and approvals from FDA or EMA ensure the API is manufactured under stringent quality controls, reducing risks of contamination and regulatory issues.

Q4: Is there a risk associated with sourcing APIs from China or India?
A4: Risks exist if suppliers lack proper certifications or quality control measures. Stringent supplier assessments, audits, and verification of certificates mitigate these risks.

Q5: Can API manufacturers supply APIs specifically validated for sterile infusion formulations?
A5: Yes, many GMP-certified API producers supply APIs tested and validated for parenteral use, including endotoxin testing, sterility, and stability data, complying with regulatory standards.

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References

1. Diverging supplier profiles and certifications. [1]
2. Regulatory standards for APIs in infusions. [2]
3. Quality requirements for injectable APIs. [3]
4. Global API manufacturers' certification and compliance documents. [4]

Note: This article synthesizes publicly available information and general industry knowledge. Manufacturers should conduct individual supplier assessments before procurement.

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