Bulk Pharmaceutical API Sources for ISOSORBIDE DINITRATE

Bulk Pharmaceutical API Sources for ISOSORBIDE DINITRATE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		6883
ZINC		ZINC18089317
Hangzhou APIChem Technology		AC-12153

Bulk Active Pharmaceutical Ingredient (API) Sources for Isosorbide Dinitrate

Last updated: July 30, 2025

Introduction

Isosorbide dinitrate (ISDN) is a key vasodilator employed primarily for angina pectoris and other ischemic heart conditions. As a nitrate compound, its global manufacturing and supply chain are essential for ensuring consistent availability for pharmaceutical use. The procurement of high-quality bulk API sources is crucial for pharmaceutical companies, generic manufacturers, and contract manufacturing organizations (CMOs). This report offers an in-depth analysis of the leading suppliers, manufacturing geographies, supply chain trends, and regulatory considerations associated with bulk ISDN API sourcing.

Market Overview

The demand for isosorbide dinitrate remains stable, driven by the prevalence of cardiovascular diseases worldwide. The API landscape for ISDN is characterized by a limited pool of high-quality suppliers capable of meeting stringent pharmaceutical standards, including Good Manufacturing Practices (GMP). The key geopolitical regions involved include India, China, Europe, and North America, with India and China dominating global production owing to cost advantages and manufacturing capacity.

Leading API Suppliers for Isosorbide Dinitrate

1. Indian API Manufacturers

India remains the dominant supplier base for ISDN API, leveraging its well-established chemical manufacturing infrastructure and cost-effective production facilities.

• Glenmark Pharmaceuticals

  Glenmark is a prominent Indian pharmaceutical company with a diversified portfolio that includes APIs such as ISDN. The company emphasizes compliance with international GMP standards and FDA approvals, ensuring high-quality supply for export markets.

• Hetero Labs

  Hetero is a leading Indian manufacturer involved in the synthesis of nitrates and cardiovascular APIs. Their APIs frequently meet stringent pharmaceutical standards, and they export globally, especially to North America and Europe.

• Aurobindo Pharma

  Aurobindo supplies a broad range of cardiovascular APIs, including isosorbide dinitrate. Their manufacturing facilities are GMP-certified, with a focus on reliable supply and quality control.

2. Chinese API Manufacturers

China accounts for a substantial share of the global API market, including ISDN, owing to its vast chemical production capacity.

• Hengli Industrial

  Hengli Industrial specializes in nitrate synthesis and supplies ISDN API to various international markets. Their manufacturing facilities are GMP-compliant, and they have a focus on quality assurance.

• North China Pharmaceutical Group Corporation (NCPC)

  A state-owned enterprise, NCPC supplies nitrate-based APIs, including ISDN, with consistent quality and large-scale output capabilities.

• Qingdao QingLibao Pharmaceutical

  Qingdao-based firm offers competitive pricing and GMP-certified APIs, serving both domestic and export sectors.

3. European and North American Suppliers

While less prominent, certain GMP-compliant manufacturers serve specialized niches or provide customized synthesis.

• Dottikon Exclusive Synthesis (Switzerland)

  Dottikon is known for high-value specialty APIs. They offer custom synthesis services for nitrates and cardiovascular APIs, including batch sizes suitable for clinical trials or limited commercial use.

• Hoffmann-La Roche (Switzerland)

  As a longstanding pharmaceutical innovator, Roche produces certain nitrates for its formulations, though its API production for ISDN principally supports internal needs.

4. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies engage CMOs for API synthesis, often leveraging Indian and Chinese manufacturing facilities. These partnerships are driven by cost efficiencies and manufacturing scalability.

• SeWee Pharmaceutical (India)

  A CMO offering integrated API synthesis and packaging, with GMP compliance and validated processes for nitrates.

• BASF (Germany)

  While primarily a chemical supplier, BASF offers custom synthesis for specialty APIs and intermediates, catering to high-purity requirements.

Supply Chain Trends

• Regulatory Harmonization and Quality Standards:
  Suppliers globally have enhanced GMP adherence to meet EMA, FDA, and other international standards, reducing supply disruptions due to quality issues.

• Cost Dynamics:
  Chinese and Indian API producers dominate on cost, but geopolitical tensions and trade regulations influence sourcing decisions.

• Supply Chain Resilience:
  COVID-19 underscored vulnerabilities in global supply chains. Companies now prioritize multi-sourcing and local manufacturing to mitigate risks associated with single-source dependencies.

• Environmental and Sustainability Initiatives:
  Manufacturers are increasingly adopting greener processes, such as solvent reduction and waste management, aligning with global regulatory expectations.

Regulatory Considerations

API suppliers for ISDN must comply with applicable GMP standards, declaration of Good Import Practices (GIP) where relevant, and ensure traceability. Regulatory agencies scrutinize suppliers for consistency, purity, and absence of contaminants, which directly impact approval timelines and product efficacy.

Key Challenges in API Sourcing for ISDN

• Quality Consistency:
  Maintaining batch-to-batch consistency is critical, especially given ISDN’s sensitive pharmacological profile.

• Regulatory Compliance:
  Suppliers must regularly update documentation and undergo audits to sustain GMP certification.

• Price Volatility:
  Fluctuations in raw material costs and geopolitical factors influence API pricing stability.

• Supply Chain Disruptions:
  Geopolitical tensions, export restrictions, and pandemics can impact supply reliability.

Conclusion

Sourcing bulk isosorbide dinitrate API involves navigating a complex landscape predominantly characterized by suppliers from India and China, supported by specialized manufacturers in Europe and North America. Ensuring supply chain resilience, compliance with regulatory standards, and high-quality manufacturing are paramount. Strategic partnerships with diversified suppliers and adherence to quality standards facilitate uninterrupted supply, critical for maintaining pharmaceutical production and patient care.

Key Takeaways

• India and China are the primary, cost-effective sources of ISDN API, with GMP-certified facilities meeting international standards.
• Regulatory compliance and quality assurance are critical to avoid batch failures and delays in drug approval processes.
• Global supply chain resilience increasingly depends on multi-sourcing, local manufacturing, and sustainable practices.
• Contract manufacturing partnerships can optimize costs and ensure flexibility in API procurement.
• Continual regulatory and geopolitical developments impact sourcing strategies, necessitating proactive risk management.

FAQs

1. What are the primary factors to consider when sourcing ISDN API?
Quality compliance (GMP standards), supply reliability, cost, regulatory approval status, and the manufacturer's reputation are key considerations.

2. Which regions dominate the manufacturing of ISDN API?
India and China are the leading regions, with European companies specializing in high-value custom synthesis.

3. How does regulatory compliance impact API sourcing?
Regulatory standards ensure product quality and safety. Suppliers without compliant GMP certifications pose risks of supply rejection, delays, or recalls.

4. Are there alternative or emerging sources for ISDN API?
Yes, specialized manufacturers in Europe and North America offer custom synthesis services, though at higher costs. Emerging manufacturers are also adopting greener production processes.

5. What future trends may influence the API sourcing landscape for ISDN?
Increased emphasis on environmental sustainability, geopolitical stability, supply chain diversification, and digitalization of quality assurance processes will shape future sourcing strategies.

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References

[1] Pharmaceutical Global Market Data, IQVIA (2022).
[2] U.S. FDA API Registration Database, FDA (2023).
[3] World Health Organization (WHO), Global Drug Market Report (2022).
[4] Indian Pharmaceutical Industry Report, OPPI India (2022).
[5] Chinese Chemical Industry Update, China Chemical Industry Journal (2022).