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Suppliers and packagers for generic pharmaceutical drug: ISOSORBIDE DINITRATE
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ISOSORBIDE DINITRATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch | ISORDIL | isosorbide dinitrate | TABLET;ORAL | 012093 | NDA | Bausch Health US LLC | 0187-0152-01 | 100 TABLET in 1 BOTTLE (0187-0152-01) | 2013-04-01 |
| Bausch | ISORDIL | isosorbide dinitrate | TABLET;ORAL | 012093 | NDA | Bausch Health US LLC | 0187-0192-01 | 100 TABLET in 1 BOTTLE (0187-0192-01) | 2013-04-01 |
| Bausch | ISORDIL | isosorbide dinitrate | TABLET;ORAL | 012093 | NDA | Oceanside Pharmaceuticals | 68682-192-01 | 100 TABLET in 1 BOTTLE (68682-192-01) | 2020-03-02 |
| Bausch | ISORDIL | isosorbide dinitrate | TABLET;ORAL | 012093 | NDA | Oceanside Pharmaceuticals | 68682-193-01 | 100 TABLET in 1 BOTTLE (68682-193-01) | 2020-03-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Isosorbide Dinitrate
Introduction
Isosorbide dinitrate (ISDN) is a potent nitrate vasodilator widely used in the treatment of angina pectoris and chronic heart failure. As a proven therapy to improve myocardial oxygen supply, ISDN's global demand hinges on its reliable supply chain, which involves key pharmaceutical ingredients (API) manufacturers, formulators, and distributors. Understanding the landscape of suppliers is crucial for pharmaceutical companies, healthcare providers, and investors seeking steady procurement or market entry.
This article explores the leading suppliers of isosorbide dinitrate, analyzing their manufacturing capacities, geographical reach, regulatory standing, and market share. It emphasizes the importance of sourcing integrity amid rising regulatory scrutiny and generics proliferation, providing actionable insights into the supplier landscape.
Manufacturers of Isosorbide Dinitrate API
Major Global API Suppliers
1. Synthesis International Inc.
Based in India, Synthesis International is among the leading manufacturers of isosorbide dinitrate API. The company's facilities operate under current Good Manufacturing Practices (cGMP), with export licenses covering North America, Europe, and Asia. Their annual capacity exceeds 300 metric tons, tailored to meet high-volume demands of generic pharmaceutical companies.
2. Torrent Pharmaceuticals Limited
Torrent Pharmaceuticals, an Indian multinational, manufactures both formulations and APIs, including isosorbide dinitrate. The company's API manufacturing unit adheres to strict regulatory standards, providing high-quality supplies to global markets. Their API facilities are certified by the Drug Controller General of India (DCGI) and hold approvals from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
3. Beijing Wanhua Pharmaceutical Co., Ltd.
Wanhua, a Chinese API manufacturer, supplies isosorbide dinitrate chiefly to Asian markets but is expanding its export footprint. Their API production complies with China Food and Drug Administration (CFDA) standards and holds certifications recognized internationally. The company emphasizes cost-effective production, leveraging China’s manufacturing scale.
4. Teva Pharmaceuticals
Teva, based in Israel, is both a manufacturer and a licensor of multiple generic APIs. Teva's API division produces ISDN for its own formulations and for other licensees, emphasizing regulatory compliance and high purity standards. The company's global distribution ensures steady supply for North American and European markets.
5. Granules India
An Indian contract manufacturing organization, Granules India has established a comprehensive portfolio of producing small-molecule APIs, including isosorbide dinitrate. Their GMP-certified facilities serve as a key source for generic pharmaceutical companies seeking reliable API procurement.
Regional and Emerging API Suppliers
Emerging API producers in Eastern Europe, Southeast Asia, and Latin America are increasingly gaining recognition. Companies such as Hetero Labs (India), Aurobindo Pharma (India), and Lek Pharmaceuticals (Slovenia) are expanding capacities and investing in quality certifications to access global markets.
Pharmaceutical Formulations and Final Drug Suppliers
While API manufacturers form the backbone of supply, finished drug manufacturers and distributors also influence availability.
Leading Formulation Manufacturers
- Pfizer and Novartis utilize APIs from multiple sources, including Indian and Chinese manufacturers, for their angina formulations.
- Sun Pharmaceutical Industries and Dr. Reddy’s Laboratories produce generic formulations containing ISDN, sourcing APIs globally.
Distribution Channels
Global distributors like Mundipharma, McKesson, and Cardinal Health maintain inventories, enabling timely supply chains for hospitals and clinics. These organizations often consolidate raw material sourcing from multiple API suppliers to ensure price competitiveness and supply security.
Regulatory and Quality Assurance Considerations
Suppliers' regulatory compliance significantly impacts their market access. The U.S. FDA, EMA, and Japan’s PMDA rigorously evaluate manufacturing practices, raw material sourcing, and process validation. Suppliers with strong regulatory approvals tend to have higher credibility and market reach, especially in highly regulated regions.
Quality certifications, such as ISO 9001, cGMP compliance, and data integrity audits, are prerequisites for engaging with top-tier suppliers. Some emerging suppliers may lack comprehensive certification, posing risks to pharmaceutical companies relying on them.
Market Trends and Supplier Dynamics
The generic API market for isosorbide dinitrate is highly competitive. Price pressures, patent expiries, and regulatory hurdles shape the supplier landscape. Indian manufacturers dominate due to cost advantages, but regulatory challenges require consistent quality improvements and transparency.
Supply chain resilience gains importance amid geopolitical tensions, trade restrictions, and global disruptions like COVID-19. Companies now prioritize diversified sourcing strategies, engaging multiple suppliers across territories to mitigate risks.
Conclusion
The supply landscape for isosorbide dinitrate encompasses a spectrum of established global manufacturers and emerging regional players. Indian and Chinese API producers lead in capacity and cost efficiency, while European and Middle Eastern firms bolster supply security and regulatory credibility.
Ensuring an uninterrupted supply of ISDN demands rigorous supplier qualification, considering regulatory compliance, manufacturing capacity, and supply chain stability. Strategic sourcing, coupled with ongoing supplier audits and engagement, sustains procurement integrity amid evolving market dynamics.
Key Takeaways
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Market Leadership: Indian companies like Torrent Pharmaceuticals and Granules India dominate API manufacturing, offering high capacity and cost advantages.
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Regulatory Compliance: Suppliers with approvals from FDA, EMA, and other agencies prefer for market certainty, especially in regulated regions.
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Supply Chain Resilience: Diversifying sourcing across geographies minimizes risks associated with geopolitical, regulatory, or logistical disruptions.
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Quality Assurance: Certifications such as cGMP, ISO 9001, and data integrity protocols are critical differentiators among API suppliers.
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Emerging Markets: Southeast Asian and Eastern European firms are expanding, driven by lower costs and growing demand, warranting close supplier monitoring.
FAQs
1. What are the primary regions producing isosorbide dinitrate API?
India and China are the dominant producers, owing to their extensive manufacturing capacities and cost advantages. European firms also supply high-quality APIs, particularly for regulated markets.
2. How do I assess the quality of an API supplier for isosorbide dinitrate?
Verify regulatory certifications (FDA, EMA, PMDA), cGMP compliance, quality audit reports, and track record of consistent supply and regulatory adherence.
3. Are there any bioequivalence or patent considerations with ISDN?
Since ISDN is largely off-patent, generic manufacturing is widespread, emphasizing the importance of quality and regulatory approval for market acceptance.
4. What factors influence the pricing of isosorbide dinitrate APIs?
Manufacturing costs, certification standards, supply chain stability, and regional economic factors primarily dictate API pricing.
5. How can companies mitigate supply chain risks associated with ISDN?
Engage multiple diversified suppliers, maintain strategic inventory buffers, and conduct regular supplier audits to ensure compliance and capacity alignment.
References
[1] "Global API Market Report," PharmaVision, 2022.
[2] "Indian API Industry Overview," Department of Pharmaceuticals, Government of India, 2021.
[3] "Regulatory Standards for API Manufacturing," U.S. FDA, 2022.
[4] "Chinese Pharmaceutical Industry Development," China Food and Drug Administration (CFDA), 2020.
[5] "Pharmaceutical Supply Chain Resilience," Deloitte Insights, 2022.
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