Suppliers and packagers for isordil

isordil

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

Suppliers for the Pharmaceutical Drug: ISORDIL

Last updated: August 2, 2025

Introduction

Isordil, chemically known as isosorbide dinitrate, is a nitrate vasodilator primarily prescribed for the prevention and treatment of angina pectoris. It functions by relaxing blood vessels, thereby reducing cardiac workload and oxygen demand. As a critical medication within cardiovascular therapy, the supply chain for Isordil is complex, involving numerous manufacturing firms, distributors, and generic pharmaceutical companies globally. Understanding the landscape of suppliers for Isordil provides insights into its market stability, potential vulnerabilities, and opportunities for new entrants.

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Manufacturers of Active Pharmaceutical Ingredient (API)

Isosorbide dinitrate API, the core component of Isordil, is produced by a select group of specialized chemical and pharmaceutical entities. The API synthesis involves nitration of glucose derivatives, followed by purification and stability steps—processes requiring advanced chemical expertise and adherence to stringent regulatory standards.

Key API Manufacturers

• Sino Pharmaceutica
  A leading Chinese pharmaceutical company, Sino Pharmaceutica has established a significant position in the production of generic APIs, including isosorbide dinitrate. Their manufacturing facilities comply with Good Manufacturing Practices (GMP), enabling them to supply both domestic and international markets.

• Xianzhi Pharma
  Based in India, Xianzhi Pharma specializes in cardiovascular APIs, with a particular focus on nitrates and other vasodilators. Its production capacity is sizable, supported by quality certifications from regulatory bodies such as the US FDA and EMA, facilitating exports worldwide.

• Jiangsu Hengrui Medicine Co.
  A prominent Chinese pharmaceutical manufacturer, Hengrui produces a broad portfolio of cardiovascular APIs, including isosorbide dinitrate, serving markets across Asia and Europe.

• Mannkind Corporation (or similar specialized chemical companies)
  Some companies in Europe and North America focus on the synthesis and supply of nitrates, often serving as intermediaries or co-developers rather than primary API manufacturers.

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Formulation and Finished Drug Product Suppliers

Manufacturers of the finished Isordil tablets are either branded pharmaceutical companies or generic drug producers. Regulatory approvals, manufacturing capacity, and distribution networks determine the availability of these products worldwide.

Major Pharmaceutical Companies

• GlaxoSmithKline (GSK) / Novartis
  Historically, GSK was the primary producer of branded Isordil. However, patent expirations and market shifts have led to a decline in branded production, replaced increasingly by generics.

• Mylan (now part of Viatris)
  As a leading generic pharmaceutical producer, Mylan supplies Isordil in multiple markets, leveraging extensive manufacturing facilities and global distribution channels.

• Sandoz (Novartis division)
  Sandoz produces generic versions of Isordil, adhering to international quality standards, and supplies across North America, Europe, and emerging markets.

• Teva Pharmaceuticals
  Known for its comprehensive portfolio of generic medications, Teva manufactures and distributes isotropic nitrates, including Isordil, in various regional markets.

Generic Pharmaceutical Companies

With the expiration of patent protections on Isordil, numerous small-to-medium-sized generic manufacturers have entered the market, increasing supply diversity and reducing prices. Examples include companies like Sun Pharmaceutical Industries, Dr. Reddy’s Laboratories, and Lupin Pharmaceuticals.

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Distribution and Supply Chain Considerations

The global supply of Isordil involves a multi-tiered network comprising:

• Raw Material Suppliers: Organic chemicals, nitrating agents, stabilizers.
• API Manufacturers: Chemical synthesis facilities adhering to GMP standards.
• Formulation Plants: Companies specializing in converting API into oral tablets.
• Distributors and Wholesalers: Entities that manage logistics, warehousing, and regional distribution.
• Pharmacies and Healthcare Providers: Final distribution points to patients.

Given the critical nature of nitrates in cardiovascular care, many of these suppliers maintain buffer stocks and diversified sourcing strategies to mitigate disruptions owing to geopolitical issues, regulatory changes, or raw material shortages.

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Regulatory Environment and Its Impact on Suppliers

Regulatory authorities like the U.S. FDA, EMA, and others impose stringent standards on manufacturing processes for APIs and finished drugs. Compliance affects supplier eligibility for global markets and influences the entry or exit of manufacturing firms.

For example, recent regulatory shifts concerning chemical synthesis safety and environmental standards have prompted some API producers to upgrade facilities or exit markets, impacting the global supply flow.

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Market Dynamics and Future Outlook

The demand for Isordil remains relatively stable due to its therapeutic importance. However, market shifts, such as increased adoption of alternative therapies or newer formulations like transdermal patches and sustained-release preparations, could influence supplier strategies.

Emerging markets, especially in Asia and Latin America, exhibit growth potential for generic suppliers capable of meeting regulatory standards and competitive pricing. Additionally, advanced manufacturing technologies, including continuous flow synthesis, offer avenues to improve API production efficiency and scalability.

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Key Takeaways

• The supply chain for Isordil comprises specialized API manufacturers predominantly located in China and India, with global players also contributing.
• Generic pharmaceutical companies dominate finished drug product supply, with key players including Mylan (Viatris), Sandoz, and Teva.
• Regulatory standards influence manufacturing capabilities, supplier stability, and market access.
• Diversification of suppliers and strategic inventory management remain vital for mitigating supply disruptions.
• The evolving landscape requires players to innovate in manufacturing and navigate complex regulatory frameworks to ensure consistent supply.

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Frequently Asked Questions (FAQs)

1. Who are the main API suppliers for Isordil?
Sino Pharmaceutica, Xianzhi Pharma, Jiangsu Hengrui Medicine, and other chemical manufacturers operating in China and India are primary API suppliers for isosorbide dinitrate.

2. Which companies produce the finished Isordil tablets globally?
Major producers include Mylan (Viatris), Sandoz, Teva, and other generic pharmaceutical companies, alongside historical producers like GSK/Novo Nordisk.

3. How do regulatory standards impact Isordil supply?
Strict compliance with GMP and other regulatory standards ensure quality but can also limit market entry and expansion, influencing supply stability.

4. Are there regional differences in Isordil supplier availability?
Yes. While Chinese and Indian manufacturers dominate, Western companies have reduced their presence, making regional regulations and supply chain infrastructure critical for availability.

5. What supply chain risks threaten Isordil availability?
Raw material shortages, regulatory changes, geopolitical tensions, and manufacturing disruptions pose significant risks; diversification and strategic sourcing mitigate these factors.

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References

1. U.S. Food and Drug Administration (FDA). Approvals and regulatory updates for nitrate drugs.
2. European Medicines Agency (EMA). Market authorization data for cardiovascular generics.
3. Industry Reports. Global API Market Analysis, 2022.
4. Company Annual Reports. Product portfolios of Viatris, Sandoz, and Teva.
5. Pharmaceutical Supply Chain Analysis. Trends and vulnerabilities, 2023.

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In conclusion, the supply landscape for Isordil is characterized by a combination of established international chemical and pharmaceutical manufacturers, with a robust network of generic producers ensuring consistent availability. Stakeholders must monitor regulatory developments, supply chain stability, and technological innovations to maintain and improve the procurement and distribution of this essential cardiovascular medication.