Bulk Pharmaceutical API Sources for CARDENE

Bulk Pharmaceutical API Sources for CARDENE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		N7510_SIGMA
TCI (Tokyo Chemical Industry)		N0635
Molport		MolPort-002-484-049
Molport		MolPort-003-666-362
Hangzhou APIChem Technology		AC-19947

Bulk Active Pharmaceutical Ingredient (API) Sources for Cardene

Last updated: July 28, 2025

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Introduction

Cardene, whose generic name is nicardipine hydrochloride, is a calcium channel blocker used primarily in the management of hypertension and angina. The manufacturing and sourcing of high-quality bulk API are critical for pharmaceutical companies to ensure product efficacy, safety, and regulatory compliance. As a vital component in cardiovascular therapy, the stability and purity of nicardipine hydrochloride are paramount, necessitating a thorough understanding of global API suppliers.

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Global API Supply Chain for Nicardipine Hydrochloride

1. Market Overview

The API supply chain for nicardipine hydrochloride is concentrated among leading pharmaceutical ingredient manufacturers globally. These companies operate across North America, Europe, and Asia, especially India and China, regions recognized for producing cost-effective and high-quality APIs at scale. The competitive landscape is driven by stringent quality standards, regulatory requirements, and the ability to meet large-volume demands.

2. Leading API Manufacturers

a. Zhejiang Hisun Pharmaceutical Co., Ltd.
Based in China, Hisun Pharmaceuticals has expanded its portfolio to include various cardiovascular APIs, including nicardipine hydrochloride. Their manufacturing facilities abide by cGMP standards, and the company is known for consistent quality and competitive pricing (source: company disclosures, industry databases).

b. Jiangsu Hengrui Medicine Co., Ltd.
Another Chinese leader, Hengrui, specializes in small molecule APIs and intermediates. Their facilities are certified by international regulatory agencies, such as the Chinese CFDA and the US FDA, enabling them to supply globally compliant nicardipine hydrochloride API (source: Hengrui annual reports, industry analysis).

c. Accord Healthcare (India)
Part of the Intas Pharmaceuticals Group, Accord is known for producing high-quality APIs for the generics sector. Their facilities in India are compliant with WHO, US FDA, and EU GMP standards, making them a strong supplier of nicardipine hydrochloride API for export markets (source: Accord Healthcare certifications).

d. Hikal Ltd.
An Indian manufacturer with a diversified spectrum of APIs, Hikal has received multiple global regulatory approvals. They focus on high-quality, reliable supply, including cardiovascular APIs like nicardipine hydrochloride (source: Hikal disclosures).

e. Teva Pharmaceuticals
Although primarily a finished dosage manufacturer, Teva also sources APIs externally. The company's global procurement strategy includes high-standard API suppliers, often from verified Chinese and Indian manufacturers.

3. Key Sourcing Criteria

• Regulatory Compliance: Suppliers must hold current GMP certification, with approvals from agencies like the FDA, EMA, or WHO.
• Quality Assurance: Strict quality control measures, including HPLC testing, residual solvents analysis, and endotoxin testing, are non-negotiable.
• Capacity & Lead Time: Suppliers should have the capacity for large-scale production and reliable lead times.
• Price Competitiveness: Market dynamics favor China and India for cost-effective APIs while maintaining compliance standards.

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Regulatory and Quality Considerations

Healthcare authorities around the world, such as the FDA (United States) and EMA (European Union), require rigorous documentation to approve APIs for pharmaceutical manufacturing. Suppliers must demonstrate batch-to-batch consistency, high purity (>99%), and detailed analytical data. Many Chinese and Indian API manufacturers proactively seek regulatory inspections to achieve international compliance, making them suitable for global pharmaceutical supply chains.

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Recent Trends and Challenges

• Regulatory Scrutiny: Increased FDA and EMA inspections of API manufacturing sites focus on compliance with cGMP standards, impacting supply continuity.
• Supply Chain Disruptions: The COVID-19 pandemic exposed vulnerabilities in the global API supply chain, emphasizing the importance of diversified sourcing.
• Cost and Quality Balance: While Indian and Chinese manufacturers dominate due to affordability, larger pharmaceutical companies are increasingly demanding verified high-quality suppliers to mitigate quality-related risks.
• Sustainability & Green Chemistry: Suppliers adopting environmentally sustainable manufacturing processes are gaining favor, aligning with global environmental regulations.

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Conclusion

The sourcing of nicardipine hydrochloride API involves multiple regional suppliers primarily based in China and India, with a handful of established firms holding rigorous quality and regulatory standards. Pharmaceutical companies prefer suppliers with proven compliance, capacity for large-scale production, and consistent quality. As regulatory oversight intensifies and supply chain resilience becomes paramount, diversified sourcing strategies involving multiple validated suppliers are increasingly vital for the continuous, reliable production of Cardene.

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Key Takeaways

• Leading suppliers in China and India dominate the nicardipine hydrochloride API market, with several manufacturing facilities complying with global GMP standards.
• Regulatory compliance and quality assurance are critical determinants in choosing API sources, especially for global markets.
• Supply chain resilience has become a priority, prompting companies to diversify suppliers and validate additional sources.
• Cost competitiveness does not compromise quality, as Chinese and Indian manufacturers escalate their international regulatory approvals.
• Emerging trends include sustainability initiatives and advanced analytical testing, ensuring APIs meet evolving safety standards.

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FAQs

1. What are the primary regions producing nicardipine hydrochloride API?
Mainly China and India, with several companies in these regions supplying global markets due to their established manufacturing infrastructure and cost advantages.

2. How do companies validate the quality of nicardipine hydrochloride API suppliers?
Through audits, review of regulatory certifications (FDA, EMA, WHO), batch testing reports, and ongoing supplier qualification programs.

3. Are there any US-based or European manufacturers of nicardipine hydrochloride API?
Few US or European companies produce this API domestically; most supply comes from Chinese and Indian manufacturers that meet international standards.

4. What regulatory hurdles do API suppliers face for global distribution?
Suppliers must maintain current GMP certifications, pass audits by regulatory agencies, and provide comprehensive analytical data to demonstrate purity, stability, and consistent quality.

5. How has recent geopolitical and trade tensions impacted API sourcing for Cardene?
Tensions have prompted pharmaceutical companies to reassess supplier dependencies, diversify supply chains, and prioritize suppliers with strong regulatory compliance and proven stability.

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Sources

1. Zhejiang Hisun Pharmaceutical Co., Ltd. Annual Report, 2022.
2. Jiangsu Hengrui Medicine Co., Ltd. Regulatory filings and certifications.
3. Accord Healthcare Official Website. (2023).
4. Hikal Ltd. Regulatory and quality documentation.
5. Industry analysis on global API manufacturing, PharmaIQ, 2023.