Suppliers and packagers for monoket

monoket

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Omnivium Pharms	MONOKET	isosorbide mononitrate	TABLET;ORAL	020215	NDA AUTHORIZED GENERIC	Lannett Company, Inc.	62175-106-01	100 TABLET in 1 BOTTLE (62175-106-01)	1993-06-30
Omnivium Pharms	MONOKET	isosorbide mononitrate	TABLET;ORAL	020215	NDA AUTHORIZED GENERIC	Lannett Company, Inc.	62175-107-01	100 TABLET in 1 BOTTLE (62175-107-01)	1993-06-30
Omnivium Pharms	MONOKET	isosorbide mononitrate	TABLET;ORAL	020215	NDA AUTHORIZED GENERIC	Proficient Rx LP	63187-900-30	30 TABLET in 1 BOTTLE (63187-900-30)	1993-06-30

Suppliers for the Pharmaceutical Drug: Monoket

Last updated: August 5, 2025

Introduction

Monoket, known generically as isosorbide mononitrate, is a nitrates class drug primarily prescribed for the prevention of angina pectoris caused by coronary artery disease. As with many vital cardiovascular medications, securing reliable and reputable suppliers is essential for pharmaceutical companies, healthcare providers, and distributors. This analysis delineates the key suppliers of Monoket globally, evaluates their market presence, manufacturing capabilities, and compliance standards, providing critical insights for procurement decision-making.

Overview of Monoket (Isosorbide Mononitrate)

Isosorbide mononitrate is a vasodilator that relaxes blood vessels, improving blood flow and reducing heart workload. It is produced either as immediate-release or sustained-release formulations, with the latter offering prolonged therapeutic effects. The manufacturing and distribution of Monoket involve stringent regulatory adherence, ensuring quality, efficacy, and safety.

Major Suppliers by Market Presence

1. Sun Pharmaceutical Industries Ltd.

   • Global Reach: Sun Pharma is among the leading producers of cardiovascular medications, including isosorbide mononitrate. The company's extensive manufacturing network spans India, the United States, and Europe.

   • Product Portfolio & Compliance: Sun Pharma offers a variety of formulations of Monoket, adhering to cGMP (current Good Manufacturing Practices) standards and obtaining approvals from regulatory agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) [1].

   • Market Share & Distribution: As one of the top suppliers in emerging markets, Sun Pharma’s distribution channels facilitate access worldwide, especially in Asia, Africa, and Latin America.

2. Macleods Pharmaceuticals

   • Manufacturing Capabilities: Based in India, Macleods is a significant producer of cardiovascular generics, including isosorbide mononitrate. Their facilities comply with stringent standards, with manufacturing licenses from multiple regulators.

   • Product Quality & Approvals: Their Monoket equivalents meet international quality standards, with approvals from the WHO-predicted prequalification programs and certifications such as ISO 9001.

   • Supply Channels: They serve both domestic Indian markets and international export markets, including Africa and Southeast Asia [2].

3. Glenmark Pharmaceuticals

   • Product Range & Quality Assurance: Glenmark manufactures various cardiovascular medications, including formulations of isosorbide mononitrate. Their production facilities are compliant with cGMP, and the company emphasizes quality control.

   • Global Distribution: The company markets Monoket and equivalent products in Latin America, Asia, and parts of Europe, with exports supported by strong regulatory compliance.

   • Innovative Formulations: Glenmark continues to develop sustained-release formulations, increasing their competitiveness.

4. Aurobindo Pharma

   • Manufacturers & Quality Standards: Aurobindo offers generic equivalents of Monoket, manufactured in compliance with U.S. and European standards. Their facilities are certified by the FDA, EMA, and other agencies.

   • Market Penetration: Supplies mainly to North America, Europe, and Asia, with a strategic focus on expanding access in developing markets.

5. Cipla Limited

   • Specialization & Certifications: Cipla's extensive cardiovascular product line includes isosorbide mononitrate. Their manufacturing compliance with WHO-GMP and ISO standards enables their products' acceptance worldwide.

   • Distribution Network: Cipla exports to over 155 countries, leveraging a broad distribution network and strategic partnerships.

Emerging and Regional Suppliers

While the above-listed companies dominate the global supply, numerous regional manufacturers in countries like Egypt, Sri Lanka, Russia, and Argentina produce Monoket or its equivalents, often focusing on local markets due to cost advantages and regulatory familiarity.

Regulatory Considerations

Suppliers must comply with stringent regulatory standards to ensure drug safety and efficacy. Certifications such as FDA approval or EMA authorization are proxies for quality assurance. Suppliers lacking these certifications may produce lower-cost versions but pose risks related to quality and regulatory acceptance, especially in stringent markets like the U.S. and Europe.

Market Dynamics & Procurement Factors

• Quality & Compliance: Selecting suppliers with verified cGMP compliance and international certifications minimizes regulatory risk.
• Pricing & Cost-efficiency: Generic manufacturers in India and Asia often offer more competitive pricing, but quality assurance remains paramount.
• Supply Chain Reliability: Diversifying suppliers across regions reduces risks of disruptions due to geopolitical, logistical, or regulatory issues.
• Intellectual Property & Patent Status: Monoket’s patent status has generally expired, facilitating a broad supply base, but vigilance remains necessary regarding regional patent laws and exclusivity rights.

Conclusion

The landscape of Monoket suppliers encompasses several established pharmaceuticals primarily based in India, with notable regional producers and multinational corporations expanding supply capabilities globally. Ensuring compliance with international regulatory standards, verifying quality certifications, and analyzing supply chain robustness are critical in selecting appropriate vendors.

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Key Takeaways

• The leading global suppliers of Monoket include Sun Pharma, Macleods, Glenmark, Aurobindo, and Cipla, all with robust manufacturing facilities and certifications.
• Indian pharmaceutical companies dominate the generic supply segment due to cost advantages and manufacturing capabilities aligned with international standards.
• Regulatory compliance, including FDA and EMA approvals, remains a critical factor in supplier selection to mitigate legal and safety risks.
• Diversification of supplier sources enhances supply chain resilience amid geopolitical or logistical disruptions.
• Continuous monitoring of patent status and regional market regulations is vital for strategic procurement.

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FAQs

1. Are there major differences in quality between mononitrate suppliers?
High-quality suppliers adhere strictly to cGMP standards and possess certifications like FDA and EMA approvals. Cross-region variations often relate to manufacturing practices; hence, selecting suppliers with verified regulatory compliance is essential for consistent quality.

2. Can I source Monoket from regional or lesser-known manufacturers?
Yes, regional manufacturers can offer cost advantages, but it's vital to verify their regulatory compliance, quality certifications, and manufacturing standards to ensure drug safety and efficacy.

3. How do patent laws influence Monoket supplier options?
Since the primary patent for Monoket has expired in many jurisdictions, multiple manufacturers produce generic versions, broadening supplier options. However, legal restrictions may persist in certain regions or for specific formulations, affecting supplier availability.

4. What role do regulatory agencies play in supplier vetting?
Regulatory agencies like the FDA and EMA set manufacturing and quality standards. Suppliers with approved facilities and certified products are considered more reliable, reducing compliance and safety risks for end-users.

5. Are there emerging suppliers or markets likely to impact Monoket availability?
Emerging markets in Southeast Asia, South America, and Africa are increasing their manufacturing capabilities, potentially expanding supply options. However, verifying regulatory standards remains critical before procurement.

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References

[1] Sun Pharmaceutical Industries Ltd. Corporate and Product Approvals.
[2] Macleods Pharmaceuticals: Product Portfolio and Certifications.