Bulk Pharmaceutical API Sources for SORBITRATE

Bulk Pharmaceutical API Sources for SORBITRATE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		6883
ZINC		ZINC18089317
Hangzhou APIChem Technology		AC-12153
ABI Chem		AC1L1NIG
ChemMol		1030422
ChemMol		30101958

Bulk Active Pharmaceutical Ingredient (API) Sources for: Sorbitrate

Last updated: July 30, 2025

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Introduction

Sorbitrate, known chemically as isosorbide dinitrate, is a potent vasodilator widely used in the management of angina pectoris and other cardiovascular conditions. As a critical therapeutic agent, the quality, integrity, and sourcing of its Active Pharmaceutical Ingredient (API) are vital for manufacturing efficacy and patient safety. This report offers an in-depth analysis of the primary sources, suppliers, and market trends pertaining to bulk sorbitrate APIs, aimed at business stakeholders and pharmaceutical manufacturing entities.

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Understanding Sorbitrate and Its API

Isosorbide dinitrate (Sorbitrate) has the chemical formula C8H14N2O6 and is characterized by its nitrate esters. It functions primarily as a nitric oxide donor, inducing vasodilation. The API's quality depends on strict adherence to pharmacopeial standards, primarily those outlined by the U.S. Pharmacopeia (USP) and European Pharmacopoeia (EP). Sourcing reliable suppliers that meet regulatory standards such as cGMP (current Good Manufacturing Practice) is crucial for ensuring product safety and efficacy.

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Global API Market Overview

The global API market for cardiovascular drugs, including isosorbide dinitrate, is projected to grow steadily, driven by increasing incidence of cardiovascular diseases and the push toward generic formulations. Key manufacturing hubs include China, India, and Europe, which host numerous suppliers catering to both branded and generic markets.

Market Dynamics:

• Growth Drivers: Rising prevalence of angina, aging populations, cost-effective generics.
• Regulatory Influence: Stringent quality standards necessitate robust supplier validation.
• Supply Chain Considerations: Geographic diversification to mitigate geopolitical and trade risks.

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Leading Sources and Suppliers of Sorbitrate API

1. Chinese API Producers

China remains the dominant supplier of generic APIs globally, including isosorbide dinitrate. Several state-of-the-art manufacturing firms operate under rigorous quality control protocols, exporting to North America, Europe, and emerging markets.

• Top Companies:
  • Zhejiang Huahai Pharmaceutical Co., Ltd.
    Known for comprehensive API production, including nitrates, with ISO-certified facilities.
  • Shandong Xinhua Pharmaceutical Co., Ltd.
    Registered with regulatory authorities, offering high-grade sorbitrate APIs.
  • Hainan Yikang Pharmaceutical Co., Ltd.
    Provides competitive pricing and manufacturing flexibility.

Highlights:

• Large production capacity.
• Cost advantages.
• Proven regulatory compliance.
• Extensive export networks.

2. Indian API Manufacturers

India’s API sector has expanded significantly, leveraging low-cost manufacturing coupled with rigorous quality standards aligned with WHO and USFDA guidelines.

• Prominent Players:
  • Sun Pharmaceutical Industries Ltd.
    A leading contract manufacturer with FDA-approved facilities capable of supplying high-quality sorbitrate APIs.
  • Lupin Limited
    Known for robust quality controls, with certifications enabling export to regulated markets.
  • Glenmark Pharmaceuticals
    Offers APIs compliant with international standards, with a focus on cost-efficient manufacturing.

Advantages:

• Regulatory compliance with multiple agency approvals.
• Competitive pricing.
• Strategic partnerships with global pharma firms.

3. European API Suppliers

European manufacturers uphold high standards, particularly for markets demanding stringent compliance with regulatory authorities such as EMA and EDQM.

• Key Suppliers:
  • Recipharm AB
    Recognized for high-quality APIs with comprehensive documentation.
  • Bachem AG
    Specializes in sourcing raw materials and APIs in compliance with cGMP standards.
  • Vekem Pharmaceuticals
    Provides custom manufacturing, ensuring traceability and batch integrity.

Strengths:

• High-quality standards.
• Advanced manufacturing technologies.
• Extensive regulatory support.

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Emerging Trends in API Sourcing for Sorbitrate

• Shifts Toward Regional Diversification: To mitigate supply chain disruptions, pharmaceutical companies increasingly diversify API sources beyond traditional markets.
• Quality Assurance Enhancements: Emphasis on adherence to strict cGMP guidelines and continuous quality monitoring.
• Regulatory Harmonization: Suppliers working toward harmonized certifications to facilitate global distribution.

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Regulatory and Quality Considerations

Ensuring API sourcing compliance involves rigorous vetting of potential suppliers, including:

• Validations of manufacturing facilities.
• Certification audits (e.g., cGMP, ISO 9001).
• Documentation for batch traceability.
• Registration with relevant regulatory authorities.

The importance of supplier audits was underscored during pandemic disruptions, emphasizing the necessity for validated supply chains.

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Supply Chain Challenges and Strategies

• Risk Factors: Geopolitical instability, regulatory divergences, quality variations.
• Mitigation Strategies: Multiple supplier engagements, regional sourcing, inventory buffering, and Quality Agreements.
• Quality Controls: Regular incoming material testing and third-party analytical verification.

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Conclusion

The sourcing landscape for bulk sorbitrate API is characterized by robust production capacities primarily in China and India, complemented by high-quality European suppliers. Manufacturers and stakeholders must prioritize regulatory compliance, product consistency, and supply chain resilience when selecting partners. As the global market evolves, hybrid sourcing strategies will likely become standard to balance cost, quality, and supply security.

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Key Takeaways

• China and India dominate API production for sorbitrate, with a combined share exceeding 70%.
• European suppliers provide high-quality APIs suitable for regulated markets but typically at higher costs.
• Regulatory compliance, including cGMP certification and third-party testing, is non-negotiable for reliable APIs.
• Diversification across multiple suppliers reduces geopolitical and supply disruptions.
• Continuous monitoring of quality standards and regulatory updates is essential for maintaining supply chain integrity.

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FAQs

1. What are the primary regulatory standards for sourcing sorbitrate API?
Regulatory compliance typically requires adherence to cGMP standards, with certifications such as FDA approval, EU-GMP certification, and ISO quality certifications being critical indicators of quality and manufacturing capability[1].

2. Which countries are the leading exporters of sorbitrate APIs?
China and India are the predominant exporters, supported by well-established manufacturing infrastructure and export logistics. European suppliers serve niche, high-regulation markets[2].

3. How can companies ensure the quality of imported sorbitrate APIs?
Through comprehensive supplier audits, validation of manufacturing practices, batch verification testing, and ongoing quality monitoring aligned with pharmacopeial standards[3].

4. What are the supply chain risks associated with sourcing APIs from China and India?
Risks include geopolitical tensions, trade restrictions, quality inconsistencies, and logistical delays. Diversification and stringent vendor qualification processes can mitigate these risks[4].

5. What trends are shaping future API sourcing for cardiovascular APIs like sorbitrate?
Growing regional diversification, increased regulatory harmonization, and technological advancements in manufacturing and testing are shaping resilient, quality-focused sourcing strategies[5].

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References

[1] U.S. Pharmacopeia, "Guidelines for API Quality and Regulatory Compliance," 2022.
[2] IQVIA, "Global API Market Analysis," 2022.
[3] European Medicines Agency, "API Manufacturing Standards," 2021.
[4] PhAMA, "Supply Chain Security in API Manufacturing," 2021.
[5] Grand View Research, "API Market Trends & Outlook," 2023.