Bulk Pharmaceutical API Sources for CARDENE SR

Bulk Pharmaceutical API Sources for CARDENE SR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		N7510_SIGMA
NovoSeek		41114
NovoSeek		4474
MP Biomedicals		190244
TCI (Tokyo Chemical Industry)		N0635

Bulk Active Pharmaceutical Ingredient (API) Sources for: CARDENE SR

Last updated: August 6, 2025

Introduction

Cardene SR (sublingual/extended-release nicardipine hydrochloride) is a calcium channel blocker primarily used for managing hypertension and angina pectoris. Its efficacy depends on the consistent supply of high-quality active pharmaceutical ingredients (API). The availability and sourcing of API are critical factors influencing drug stability, efficacy, regulatory compliance, and manufacturing costs. This report evaluates the primary global API suppliers for nicardipine hydrochloride, focusing on their manufacturing footprint, quality standards, and regulatory status.

---

Overview of Nicardipine Hydrochloride as API

Nicardipine hydrochloride belongs to the dihydropyridine class of calcium channel blockers. It inhibits calcium influx in vascular smooth muscle and cardiac cells, resulting in vasodilation and decreased cardiac workload. The API's synthesis involves complex chemical processes, necessitating a reliable supply chain for pharmaceutical manufacturing.

The global demand for nicardipine API has shown consistent growth, driven by increasing hypertension prevalence and advances in formulating controlled-release products like CARDENE SR. Manufacturers seek suppliers that align with stringent quality standards like cGMP compliance, Good Laboratory Practices (GLP), and environmental sustainability.

---

Major API Suppliers for Nicardipine Hydrochloride

1. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Overview:
Zhejiang Hisun is a leading Chinese pharmaceutical manufacturer with a significant portfolio in cardiovascular APIs. The company boasts extensive cGMP-certified facilities and a strong export footprint.

API Quality & Manufacturing:
Hisun’s nicardipine hydrochloride API meets international standards such as the US FDA's current Good Manufacturing Practices (cGMP), EMA guidelines, and China Food and Drug Administration (CFDA) requirements. Their quality systems include rigorous analytical testing, stability studies, and batch consistency.

Supply Capacity & Reliability:
With large-scale production capacity, Hisun supplies large-volume orders, maintaining consistent quality, which ensures stable supply to global markets. Their technological expertise in complex API synthesis offers competitive pricing.

Regulatory Status:
Hisun’s APIs often hold regulatory approvals or clearances in multiple jurisdictions, including the US ANDA (Abbreviated New Drug Application) filings and European certifications.

[1]

---

2. Xinhua Pharmaceutical (China)

Overview:
Xinhua Pharmaceutical specializes in cardiovascular and central nervous system APIs, including nicardipine hydrochloride. Their manufacturing facilities are certified under cGMP, with a focus on export markets.

API Quality & Compliance:
Their nicardipine API adheres to pharmacopeial standards (USP/EP), with strong analytical validation. The company's commitment to quality management ensures consistency across production batches.

Supply Reliability & Capacity:
Xinhua’s API manufacturing capacity is geared toward fulfilling both large and custom orders, with an emphasis on supply chain stability for key clients.

Regulatory & Market Access:
Xinhua actively pursues regulatory acceptance in the US, EU, and emerging markets, positioning them as a reliable API source.

[2]

---

3. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

Overview:
Huahai is a major global supplier known for its comprehensive portfolio in cardiovascular APIs. Their manufacturing facilities are accredited with auditable histories of compliance and quality.

API Quality & Standards:
Their nicardipine hydrochloride API complies with international pharmacopoeias and has undergone rigorous regulatory audits, including those by the FDA and EMA.

Production Capacity & Supply Chain:
Huahai's extensive manufacturing infrastructure allows high-volume API production, ensuring supply resilience amid global demand.

Regulatory Acceptance:
The company’s APIs are used in numerous marketed drugs globally, and their facilities are regularly inspected, demonstrating ongoing compliance.

[3]

---

4. Jiangsu Hengrui Medicine Co., Ltd. (China)

Overview:
Hengrui is a prominent Chinese pharmaceutical innovator and API supplier, with a focus on cardiovascular and anti-cancer APIs. Their cGMP-compliant facilities support large-scale production.

Quality & Regulatory Assurance:
Hengrui’s nicardipine API complies with USP/EP standards, with a strong emphasis on analytical validation and process controls. Their APIs are approved for use in multiple markets.

Supply & Capacity:
The company's strategic investments in manufacturing enable flexible supply, catering to both small and large-scale manufacturing needs.

[4]

---

5. International API Suppliers (India and Europe)

• Sun Pharmaceutical Industries Ltd. (India):
  Sun Pharma produces a range of cardiovascular APIs, including nicardipine hydrochloride, with cGMP certification and supply to global clients. Their manufacturing meets US/FDA and European standards.

• Tapi Geographic & Other European Suppliers:
  Several European-based API manufacturers, such as Tablets S.p.A. and Teva Pharmaceuticals, also supply high-quality nicardipine API, often catering to regulatory markets requiring E.U. GMP compliance.

---

Key Considerations in API Sourcing

Regulatory Compliance:
Manufacturers should prioritize suppliers with current cGMP certification, validated analytical methods, and proven audit histories (FDA, EMA, CFDA, etc.). Regulatory credibility ensures minimal supply disruptions and consistent product quality.

Quality Assurance:
Rigorous testing, batch-to-batch consistency, stability profile, and purity levels are essential. Suppliers with comprehensive quality documentation promote regulatory confidence.

Supply Capacity and Reliability:
Given global supply chain challenges, suppliers with scalable manufacturing capacity and proven delivery schedules reduce risk for pharmaceutical companies.

Pricing and Lead Times:
Cost competitiveness is crucial, but should not compromise quality. Long-term partnership potentials depend on flexible lead times and reliable inventory management.

---

Emerging Trends and Future Outlook

• Diversification of Sources:
  To mitigate geopolitical and supply chain risks, companies increasingly diversify API procurement across multiple trusted suppliers, especially from India, China, and Europe.

• Regulatory Harmonization:
  Increasing harmonization of quality standards across jurisdictions simplifies approval processes and facilitates smoother API import/export pathways.

• Quality Innovations:
  Suppliers investing in green chemistry and sustainable manufacturing techniques enhance regulatory acceptance and corporate responsibility profiles.

---

Conclusion

The sourcing landscape for nicardipine hydrochloride API is predominantly dominated by Chinese manufacturers, including Zhejiang Hisun Pharmaceutical, Xinhua Pharmaceutical, Zhejiang Huahai, and Jiangsu Hengrui. These suppliers demonstrate high-quality standards and manufacturing capacities aligning with global regulatory requirements. Supplementing these with reputable Indian and European API providers offers diversification and supply stability. Ultimately, pharmaceutical companies must evaluate suppliers based on regulatory compliance, quality assurance, capacity, and cost to ensure continuous supply of high-quality API necessary for CARDENE SR production.

---

Key Takeaways

• Leading suppliers of nicardipine hydrochloride API are headquartered in China, including Zhejiang Hisun, Xinhua Pharmaceutical, Huahai, and Hengrui.
• Regulatory compliance (FDA, EMA, USP/EP standards) remains critical when selecting API sources.
• Supply chain resilience depends on diversifying API suppliers and maintaining strong contractual agreements.
• High-quality API suppliers invest in advanced manufacturing processes, quality assurance, and environmental sustainability.
• Ongoing regulatory monitoring and supplier audits are essential to mitigate manufacturing risks.

---

FAQs

1. What factors should I consider when choosing an API supplier for CARDENE SR?
Prioritize regulatory compliance, manufacturing capacity, quality assurance processes, price competitiveness, and supplier reliability.

2. Are Chinese API suppliers compliant with international regulations?
Many Chinese manufacturers, including Zhejiang Hisun and Huahai, operate under cGMP standards and have received inspections and approvals from global regulatory bodies such as the FDA and EMA.

3. How does API quality impact the efficacy of CARDENE SR?
API purity, consistency, and stability directly influence drug efficacy, safety, and regulatory approval of finished products.

4. What are the risks of relying on a single API source?
Single sourcing increases risks related to supply disruptions, regulatory non-compliance, or quality issues, highlighting the importance of diversification.

5. How is the future of API sourcing evolving for cardiovascular drugs?
Growing focus on sustainable manufacturing practices, regulatory harmonization, and risk mitigation strategies are shaping the future, with an emphasis on quality, reliability, and diversification.

---

References

[1] Zhejiang Hisun Pharmaceutical Co., Ltd. Corporate Website.
[2] Xinhua Pharmaceutical Annual Reports.
[3] Zhejiang Huahai Pharmaceutical External Filings.
[4] Jiangsu Hengrui Medicine Official Disclosures.