Bulk Pharmaceutical API Sources for ISORDIL

Bulk Pharmaceutical API Sources for ISORDIL

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-12153
AKos Consulting & Solutions		AKOS015895227
AKos Consulting & Solutions		AKOS015960761
AKos Consulting & Solutions		AKOS015994784
BOC Sciences		87-33-2
Glentham Life Sciences Ltd.		GC6329
TargetMol		T1479

Bulk Active Pharmaceutical Ingredient (API) Sources for ISORDIL

Last updated: August 3, 2025

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Introduction

Isordil, a pharmaceutical compound with the active ingredient isosorbide dinitrate, is predominantly prescribed for the management of angina pectoris. Ensuring a reliable and high-quality source of the API—isosorbide dinitrate—is critical for pharmaceutical manufacturers, distributors, and regulatory bodies. The integrity of the supply chain, compliance with regulatory standards, and cost efficiency hinge on sourcing from reputable suppliers. This article provides an in-depth review of bulk API sources for isosorbide dinitrate, emphasizing key suppliers, geographic origins, quality considerations, and regulatory compliance.

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Understanding Isosorbide Dinitrate API

Isosorbide dinitrate (CAS Number: 660-31-1) is a nitrate ester utilized for its vasodilatory effects, reducing myocardial oxygen demand. The API quality influences drug efficacy, safety, and compliance with pharmacopeial standards such as USP, EP, and JP. Consequently, sourcing high-purity, pharmaceutically certified isosorbide dinitrate is paramount.

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Global API Production Landscape

The global API production landscape for isosorbide dinitrate is characterized by manufacturing facilities in North America, Europe, and Asia. Key manufacturers must adhere to good manufacturing practices (GMP) and hold certifications from regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or respective national bodies.

Major API manufacturing regions include:

• India
• China
• Europe
• United States

These regions host prominent pharmaceutical ingredient manufacturers, offering diverse API options with varying sourcing and compliance postures.

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Leading Suppliers of Isosorbide Dinitrate API

1. Indian API Manufacturers

India remains a dominant hub for affordable, high-quality APIs, including isosorbide dinitrate. Several Indian pharmaceutical producers specialize in nitrate APIs, with a strong emphasis on compliance with international standards.

• Sun Pharmaceutical Industries Ltd.
  An integrated pharmaceutical giant offering GMP-certified isosorbide dinitrate API. Their supply chain is well-established, with exports to North America and Europe.

• Hetero Labs Ltd.
  Known for their diversified portfolio, Hetero provides pharmaceutically compliant API with rigorous quality control and global certification.

• Granules India Ltd.
  Focused on high-quality manufacturing, Granules supplies APIs that meet USP and other pharmacopeial standards.

Advantages of sourcing from India: cost competitiveness, extensive manufacturing capacity, adherence to global quality standards.

2. Chinese API Manufacturers

China’s API industry has grown substantially, with numerous facilities producing isosorbide dinitrate for export.

• Zhejiang Huazheng Medicine Co., Ltd.
  Offers a range of nitrate APIs, adhering to GMP standards, with export licenses to numerous countries.

• Taizhou Huangyan Pharmaceutical Co., Ltd.
  Supplies pharmaceutical-grade nitrate APIs with quality certifications conforming to international standards.

• Weifang Herun Pharmaceutical Co., Ltd.
  Emphasizes product quality and regulatory compliance, serving global markets.

Key considerations: Due diligence on quality certifications is essential; Chinese suppliers are increasingly compliant with international standards, but verification remains critical.

3. European and US API Manufacturers

Premium API sourcing often involves European or North American manufacturers known for stringent regulations and high-quality standards.

• BASF (Germany)
  A leading global chemical and pharmaceutical supplier, offering high-purity APIs, including isosorbide dinitrate, with comprehensive regulatory documentation.

• Fresenius Kabi (Germany)
  Provides pharmaceutical-grade APIs, emphasizing quality, safety, and regulatory compliance.

• West-Ward Pharmaceuticals (USA)
  Specializes in API manufacturing for generic drugs, including nitrate compounds compliant with US pharmacopeia.

Advantages: assured quality, robust documentation, regulatory alignment with global standards.

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Quality & Regulatory Compliance

Selecting a bulk API supplier involves rigorous reliability assessment. Key criteria include:

• GMP Certification: Essential for manufacturing APIs used in pharmaceuticals.
• Pharmacopeial Compliance: US Pharmacopeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP).
• Regulatory Approvals: FDA registration, EMA certification, and equivalent standards in the supplier's country.
• Batch Consistency & Purity: Critical for ensuring drug safety and efficacy.

Manufacturers with proven quality track records and transparent quality assurance processes are preferred.

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Supply Chain & Logistics Considerations

• Lead Times: Dependence on supplier production capacity and logistical constraints.
• Regulatory Documentation: COA (Certificate of Analysis), COA, and Batch Release Certificates.
• Pricing: Balancing quality with cost, considering shipping, tariffs, and import duties.
• Geopolitical Factors: Political stability and trade relations can impact supply stability.

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Emerging Trends and Future Outlook

The API sourcing landscape is witnessing increased integration of Quality by Design (QbD), digital transparency, and global audits. Manufacturers are investing in advanced quality controls, and many suppliers are expanding capacity to meet rising demand for nitrate APIs.

Additionally, the push toward more sustainable and environmentally friendly manufacturing processes influences supplier selection. Regulatory bodies are continuously updating standards, prompting suppliers to strengthen compliance.

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Conclusion

Reliable sourcing of isosorbide dinitrate API requires a thorough understanding of the global manufacturing landscape. Leading suppliers from India, China, Europe, and North America provide diverse options, balancing cost, quality, and regulatory compliance. Due diligence, including verification of GMP certification, pharmacopeial adherence, and regulatory approvals, is vital for pharmaceutical companies. Establishing strong supplier relationships and leveraging transparent supply chains will mitigate risks and ensure consistent production of high-quality Isordil formulations.

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Key Takeaways

• The primary global sources for isosorbide dinitrate API include India, China, Europe, and North America, with each region offering distinct advantages.
• Indian and Chinese manufacturers provide cost-effective options, but rigorous quality verification remains essential.
• European and US suppliers lead in regulatory assurance, ideal for companies emphasizing strict compliance.
• Ensuring supplier GMP certification, pharmacopeial compliance, and licensing is critical for maintaining API quality.
• Supply chain resilience depends on strategic supplier selection, transparent documentation, and proactive logistics management.

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FAQs

1. What are the key quality standards for sourcing isosorbide dinitrate API?
Pharmacopeial standards such as USP, EP, or JP are essential benchmarks. Suppliers must hold GMP certification and provide comprehensive documentation, including COAs and stability data.

2. How does geographic origin influence API quality and cost?
Indian and Chinese APIs tend to be more cost-effective but may require extra diligence regarding regulatory compliance. European and US APIs typically offer higher assurance of quality, though at a higher cost.

3. What are the primary risks associated with API sourcing from emerging markets?
Risks include variability in quality control, regulatory discrepancies, supply chain disruptions, and intellectual property concerns. Due diligence and supplier audits mitigate these risks.

4. How can manufacturers verify API supplier compliance?
Through third-party audits, verification of GMP certificates, batch certification, site inspections, and review of regulatory registration statuses.

5. Is there a trend toward sourcing more sustainable API manufacturing processes?
Yes. Increasing emphasis on environmentally friendly processes, green chemistry, and reduced waste drives suppliers to adopt sustainable manufacturing practices aligned with global standards.

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References

1. U.S. Pharmacopeia (USP). Isosorbide Dinitrate Monograph.
2. European Pharmacopoeia (EP). Isosorbide Dinitrate Monograph.
3. Pharmaceutical API Market Reports, IQVIA, 2022.
4. Global API manufacturing profiles, PharmaSources, 2023.
5. FDA Guidance on API quality and GMP compliance.