DILATRATE-SR bulk active fine chemical vendors

Subscribe to access the full database, or Get Started Free
Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology	⤷ Get Started Free	AC-12153	⤷ Get Started Free
AKos Consulting & Solutions	⤷ Get Started Free	AKOS015895227	⤷ Get Started Free
AKos Consulting & Solutions	⤷ Get Started Free	AKOS015960761	⤷ Get Started Free
>Vendor	>Vendor Homepage	>Vendor Sku	>API Url

Last updated: July 30, 2025

Introduction

Dilatrate-SR, a sustained-release formulation of isosorbide dinitrate, plays a critical role in managing angina pectoris by vasodilatory mechanisms. As a vital cardiovascular therapeutic, its efficacy hinges on the quality and consistency of its active pharmaceutical ingredient (API), isosorbide dinitrate. Ensuring a reliable supply chain for high-grade API is essential for pharmaceutical manufacturers to meet regulatory standards and maintain product integrity. This article provides a comprehensive analysis of potential bulk API sources for Dilatrate-SR, emphasizing supplier options, quality considerations, and sourcing strategies.

Understanding Isosorbide Dinitrate as API

Isosorbide dinitrate is a nitrate vasodilator with a molecular formula of C_6H_9N_3O_6. It is widely manufactured globally, with production processes involving nitration of sorbitol derivatives. The API must comply with pharmacopeial standards such as the USP, EP, or BP, which specify tests for purity, potency, and residual solvents.

Global API Manufacturers and Suppliers

The supply landscape for isosorbide dinitrate API is extensive, featuring manufacturers across North America, Europe, Asia, and other regions. These suppliers vary in scale from large, integrated chemical producers to specialized API manufacturers.

1. Large-Scale API Producers

Hetero Labs (India): A prominent player with a significant share in cardiovascular APIs, including isosorbide derivatives. Hetero’s API manufacturing facilities adhere to stringent GMP standards under international accreditation bodies.
Zhejiang Hisoar Pharmaceutical (China): Recognized for large-scale production of nitrate APIs, leveraging advanced nitration processes aligned with quality regulations.
Mitsubishi Chemical (Japan): Part of a broader chemical conglomerate, Mitsubishi maintains high-quality standards and supply commitments for cardiovascular APIs.
Hanlim Pharmaceutical (South Korea): An established producer focusing on nitrate and other cardiovascular APIs, with a reputation for consistency and regulatory compliance.

2. Contract Manufacturing Organizations (CMOs) and Custom API Producers

Aenova (Germany): Offers custom synthesis and sourcing options for APIs, aligning with client specifications and regulatory needs.
Lonza (Switzerland): Provides comprehensive API development and manufacturing services, especially for branded and generic formulations.
Capsugel (United States): While primarily known for dosage forms, they collaborate with API suppliers for integrated solutions.

3. Regional Suppliers and Emerging Markets

Vasudha Pharma (India): Supplies cost-effective API batches with adherence to international standards, suitable for generics and biosimilar markets.
Shandong Eastchem (China): Emerging producer with a focus on nitrate APIs, offering competitive pricing and flexible production schedules.
Synthesis & Supply (South Africa): Smaller but reliable suppliers catering to local and regional needs.

Quality and Regulatory Considerations in API Sourcing

Quality assurance remains paramount. Suppliers should provide certifications such as:

GMP compliance documentation
Certificates of Analysis (CoA)
Batch Release Data
Stability and purity profiles in accordance with USP/EP/BP standards

Regulatory authorities like the FDA, EMA, and China’s NMPA scrutinize API quality rigorously. Establishing API suppliers with validated quality systems eases registration processes and reduces market delays.

Factors Influencing API Supplier Selection

Regulatory Track Record: Preference for suppliers with a history of compliance and successful audits.
Supply Capacity and Lead Time: Capacity to meet production demands and flexible delivery schedules.
Cost Competitiveness: Price stability, considering bulk purchase discounts.
Quality Certification: ISO certifications, third-party audits, and documented validation processes.
Intellectual Property Security: Agreements that ensure proprietary process confidentiality.

Emerging Trends in API Sourcing for Dilatrate-SR

Vertical Integration: Some pharmaceutical companies are investing in their supply chains to secure API sources, reducing dependency risks.
Sustainability and Green Chemistry: Suppliers adopting environmentally friendly nitration and synthesis processes are gaining favor.
Digitalization and Transparency: Blockchain and digital platforms facilitate real-time supply chain visibility, ensuring authenticity and quality compliance.

Supply Chain Risks and Mitigation Strategies

Regulatory Changes: Monitor evolving global standards that could impact API approval or manufacturing practices.
Political and Economic Instability: Diversify supplier base across regions to mitigate geopolitical risks.
Raw Material Shortages: Engage in long-term contracts and inventory buffering for critical raw materials.
Quality Variability: Regular audits and second-source validation to ensure consistent API quality.

Conclusion

Securing a reliable, high-quality bulk API source for Dilatrate-SR's active ingredient, isosorbide dinitrate, demands meticulous supplier qualification and ongoing quality assurance. Leading global manufacturers such as Hetero, Zhejiang Hisoar, Mitsubishi, and Hanlim form the backbone of API supply, supplemented by specialized CMOs and regional producers. Strategic sourcing aligned with regulatory compliance and supply chain resilience underpins consistent manufacturing operations, ultimately safeguarding patient outcomes.

Key Takeaways

The global market offers diverse API sources, with prominent suppliers in India, China, Japan, and South Korea for isosorbide dinitrate.
Rigorous supplier qualification, including quality certifications and regulatory compliance, is essential for API procurement.
Supply chain diversification mitigates risks associated with geopolitical, regulatory, and raw material disruptions.
Advances in sustainability and digital transparency enhance supply chain robustness and product integrity.
Proactive risk management strategies ensure continuous supply, supporting long-term commercial success for Dilatrate-SR formulations.

FAQs

1. What are the critical quality parameters for isosorbide dinitrate API?
Key parameters include purity (>98%), residual solvent levels within limits, consistent particle size, low moisture content, and compliance with pharmacopeial specifications.

2. How does geographic diversification impact API sourcing for Dilatrate-SR?
It reduces dependency on a single supplier or region, minimizes risks from geopolitical issues, supply disruptions, or regulatory changes, and enhances supply chain resilience.

3. Are there any proprietary or exclusive API supplier arrangements for Dilatrate-SR?
While some manufacturers establish exclusive agreements to secure supply, many rely on multi-source strategies to ensure continuous availability and cost competitiveness.

4. How do quality standards influence API selection?
Compliance with international GMP standards and third-party audits ensures consistent product quality, regulatory approval ease, and customer confidence.

5. What future trends could impact the API supply landscape for Dilatrate-SR?
Emerging trends include digital supply chain management, green chemistry practices, vertical integration, and increased demand for sustainable manufacturing.

References

[1] U.S. Pharmacopeia, "Isosorbide Dinitrate Monograph," USP, 2022.
[2] European Pharmacopoeia, "Isosorbide Dinitrate," EP, 2022.
[3] Global API Market Analysis, IQVIA Institute, 2021.
[4] Regulatory Guidelines on API Manufacturing, EMA, 2022.
[5] Industry Reports on API Suppliers, Pharmatech, 2022.

Bulk Pharmaceutical API Sources for DILATRATE-SR