Bulk Pharmaceutical API Sources for ISOSORBIDE

Bulk Pharmaceutical API Sources for ISOSORBIDE

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ChemExper Chemical Directory		HetB@@[iRfUgJXZjjjJKHfh@
Sigma-Aldrich		329207_ALDRICH
Hangzhou Trylead Chemical Technology		TL8004635
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Bulk Active Pharmaceutical Ingredient (API) Sources for Isosorbide

Last updated: July 27, 2025

Introduction

Isosorbide, a prominent component in cardiovascular therapy, particularly for angina pectoris, is gaining increasing attention within the pharmaceutical supply chain due to its widespread therapeutic application. As a chemically synthesized vasodilator, isosorbide serves as both a direct active ingredient and an intermediate in the manufacturing of various pharmaceutical formulations. Given the critical role of raw material sourcing in ensuring drug quality, manufacturing consistency, and regulatory compliance, an understanding of prominent API suppliers for isosorbide is essential for pharmaceutical companies, distributors, and formulators.

Overview of Isosorbide as an API

Isosorbide is a bicyclic nitrate derivative derived primarily from sorbitol, itself produced via the hydrogenation of glucose or sorbitol manufacturing processes. It is characterized by its stability, oral bioavailability, and low toxicity, making it suitable for chronic therapy in cardiovascular diseases. Its chemical name is 1,4:3,6-dianhydro-D-glucitol, with CAS Number 118-26-7. The regulatory landscape demands rigorous purity standards, typically exceeding 98% purity with minimal residual solvents or impurities.

Global API Suppliers for Isosorbide

The API supply landscape for isosorbide is dominated by select countries and manufacturing hubs known for their robust chemical and pharmaceutical industries. Major suppliers fall into several regions, notably India, China, and Europe, each with their own licensing, quality certification standards, and production capacities.

India: A Leading Exporter in Isosorbide API

India's pharmaceutical industry has established a significant presence in the supply of isosorbide API, driven by cost competitiveness and expanding manufacturing capabilities.

• Suizhou Weike Biological & Chemical Co., Ltd.
  A notable player specializing in the production of sugar alcohol derivatives, including high-grade isosorbide API, with certifications aligned with USFDA, EDQM, and ISO standards. Their facilities emphasize quality control, ensuring compliance with clinical and commercial pharmaceutical needs.

• Kesar Life Sciences
  Based in Mumbai, Kesar Life Sciences provides pharmaceutical-grade isosorbide API with purity levels exceeding 99%, suitable for both generic formulations and innovative drug development. They maintain ISO 9001 and GMP certifications, facilitating exports across Asia, Africa, and Latin America.

• Mistry Industries
  A manufacturer with a focus on chemicals derived from sorbitol and related compounds, offering customized production capacities for isosorbide API tailored to client specifications. Quality assurance processes follow pharmacopeial standards, including USP and EP.

China: Growing Presence with Cost-Effective Production

Chinese companies have proliferated in the API domain for isosorbide, benefitting from large-scale chemical manufacturing infrastructure and government support for chemical industry development.

• Shandong Laigang Group
  Operating a dedicated segment for carbohydrate-derived APIs, including isosorbide, boasting capacity expansions and adherence to GMP protocols. Their APIs meet stringent pharmacopeial and quality benchmarks suitable for global regulatory approvals.

• Qingdao Hengsheng Chemical Co., Ltd.
  Specializes in sugar alcohol derivatives and provides high-purity isosorbide APIs, with a focus on export markets, particularly Southeast Asia and Africa. The company demonstrates ISO 9001 and ISO 14001 certifications, emphasizing environmental compliance.

• Hubei Huaguang Pharmaceutical Co., Ltd.
  Offers bulk batches of pharmaceutical-grade isosorbide API with consistent quality metrics and competitive pricing, catering to both generic and branded drug manufacturers.

Europe: Established Quality and Regulatory Compliance

European suppliers tend to focus on high-quality APIs and are often preferred by pharmaceutical firms targeting stringent markets such as the US and EU.

• BASF SE
  A global chemical leader with a dedicated division for active pharmaceutical ingredients including isosorbide, offering pharmaceutical-grade APIs compliant with all major pharmacopeial standards. Their API manufacturing adheres to cGMP, with a focus on sustainability and traceability.

• Evonik Industries
  Provides high-purity isosorbide APIs as part of their specialty chemicals portfolio, emphasizing formulations for cardiovascular and other therapeutic areas. Their APIs meet regulatory requirements such as EMA, FDA, and ICH guidelines.

• Siegfried AG
  Specializes in custom manufacturing of APIs and intermediates, including isosorbide, with a strong reputation for quality assurance, supply reliability, and regulatory support.

Emerging and Niche Suppliers

Smaller-scale and regional suppliers are increasingly entering the market, often offering customized solutions or niche product grades for specialized formulations.

• VIVA Biotech
  A biotechnology-focused manufacturer with capabilities to produce pharmaceutical intermediates, including isotopic variants of isosorbide, primarily serving innovative drug development.

• Synthelabo
  A private Chinese manufacturer providing cost-effective isosorbide APIs for generic formulations, with rapidly scalable production lines.

Considerations in Choosing API Suppliers

Pharmaceutical companies should evaluate multiple factors, including:

• Regulatory Compliance: GMP certifications, documentation, and adherence to pharmacopeial standards (USP, EP, JP).

• Quality Assurance: Consistency of purity (>99%), residual solvent levels, and impurity profiles.

• Manufacturing Capacity and Lead Times: Ability to meet supply demands and ensure timely delivery.

• Pricing and Term Negotiability: Competitive costs balanced with quality considerations.

• Traceability and Supply Chain Transparency: Ensuring full traceability throughout manufacturing and supply.

Challenges in API Sourcing for Isosorbide

• Quality Variability: Non-standardized impurities can impact formulation stability and regulatory approval.

• Regulatory Hurdles: Increasing requirements for documentation, audits, and compliance can impede supplier qualification.

• Geopolitical Risks: Trade restrictions and geopolitical tensions may affect supply continuity, especially from China or India.

• Environmental and Sustainability Standards: Growing emphasis on environmentally sustainable manufacturing practices may influence supplier selection.

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Key Takeaways

• The global API market for isosorbide is primarily driven by Indian, Chinese, and European manufacturers, each offering distinct advantages in cost, quality, and compliance.

• Stringent quality control, regulatory certifications, and supply reliability are non-negotiable factors for pharmaceutical companies sourcing isosorbide API.

• Indian suppliers provide cost-effective options with extensive capacity; Chinese manufacturers offer scalable solutions; European companies focus on high-end quality and regulatory adherence.

• Regional and emerging suppliers can serve niche markets but require thorough qualification and validation.

• Strategic sourcing should balance cost, quality, regulatory compliance, and supply chain resilience to optimize pharmaceutical development and manufacturing.

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FAQs

1. What should I consider when sourcing isosorbide API for my pharmaceutical product?
Prioritize suppliers with GMP certification, high purity standards (>99%), proven regulatory compliance, reliable supply chain, and transparent quality documentation to ensure consistent product quality and regulatory approval.

2. Are there regional differences in the quality standards of isosorbide API?
Yes. European and North American suppliers typically adhere to stricter quality and environmental standards (e.g., EMA, FDA, ICH guidelines), whereas Indian and Chinese manufacturers may vary but can meet regulatory requirements with proper qualification and documentation.

3. How does the cost of isosorbide API influence supplier choice?
While cost is a key factor, it should not compromise quality or regulatory compliance. A strategic balance is essential; sourcing low-cost API may risk quality issues or regulatory hurdles, potentially increasing total production costs.

4. What are the regulatory challenges associated with importing isosorbide API from China or India?
Challenges include ensuring documentation authenticity, verifying GMP compliance, and managing customs and import regulations. Proper validation, supplier audits, and certification verification mitigate these issues.

5. Is there a growing trend toward sustainable manufacturing of isosorbide API?
Yes. Increasing environmental concerns are prompting suppliers worldwide to adopt greener processes, reduce waste, and obtain environmental certifications, impacting supplier selection for environmentally responsible pharmaceutical companies.

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References

[1] CAS Registry Number 118-26-7, PubChem.
[2] Global Chemical Industry Reports, "API Manufacturing Trends," 2022.
[3] WHO Guidelines on Good Manufacturing Practices (GMP), 2021.
[4] European Pharmacopoeia (EP), Monographs for Isosorbide, 2022.
[5] U.S. FDA Guidance for Industry, "API Quality Standards," 2021.