Suppliers and packagers for NITRO-DUR

NITRO-DUR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145	NDA AUTHORIZED GENERIC	Dr. Reddy's Laboratories, Inc.	43598-893-30	30 POUCH in 1 BOX, UNIT-DOSE (43598-893-30) / 1 PATCH in 1 POUCH	2020-03-01
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145	NDA AUTHORIZED GENERIC	Dr. Reddy's Laboratories, Inc.	43598-894-30	30 POUCH in 1 BOX, UNIT-DOSE (43598-894-30) / 1 PATCH in 1 POUCH	2020-03-01
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145	NDA AUTHORIZED GENERIC	Dr. Reddy's Laboratories, Inc.	43598-895-30	30 POUCH in 1 BOX, UNIT-DOSE (43598-895-30) / 1 PATCH in 1 POUCH	2020-03-01

Suppliers for the Pharmaceutical Drug: NITRO-DUR

Last updated: July 29, 2025

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Introduction

NITRO-DUR is a transdermal nitroglycerin patch primarily used to prevent angina pectoris, a symptom of coronary artery disease. As a critical medication in cardiology, NITRO-DUR’s supply chain involves multiple suppliers across the pharmaceutical manufacturing ecosystem, including active pharmaceutical ingredient (API) producers, formulation manufacturers, and packaging entities. Ensuring a resilient, compliant, and high-quality supply chain is vital, especially given the critical nature of this medication.

This analysis explores the key suppliers of NITRO-DUR, focusing on API providers, formulation facility operators, and packaging firms, to guide stakeholders in procurement, risk mitigation, and strategic planning.

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Manufacturers and Suppliers of NITRO-DUR

Active Pharmaceutical Ingredient (API) Suppliers

At the core of NITRO-DUR are the nitroglycerin API, a highly potent and sensitive compound requiring specialized manufacturing processes. Leading API suppliers include:

• BASF SE: A major global chemical producer, BASF supplies bulk nitroglycerin for pharmaceutical purposes, adhering to stringent pharmacopeial standards. Their extensive R&D capabilities allow for custom synthesis tailored to pharmaceutical specifications.

• Hawkins, Inc.: Specializes in fine chemicals, including pharmaceutical-grade nitroglycerin, sourced predominantly for regulated markets in North America. Their vertically integrated process ensures supply continuity and compliance.

• Nippon Chemical Industrial Co., Ltd.: A Japanese manufacturer supplying high-quality nitroglycerin API to Asian markets and exporting globally, with a focus on safety and consistent purity levels.

• AbbVie and Teva Pharmaceutical Industries Ltd.: Some generic producers hold their own API manufacturing facilities or source API from third-party suppliers; Teva, in particular, has vertically integrated API production capabilities in compliance with cGMP (current Good Manufacturing Practice) standards.

Formulation and Manufacturing of NITRO-DUR Patches

The formulation of transdermal patches involves advanced technology to ensure controlled drug release and skin permeability. Key contract manufacturers and formulators include:

• Mylan (a subsidiary of Viatris): Known for producing various transdermal patches, including nitroglycerin formulations, often through strategic alliances with specialized formulation firms.

• Novartis: Engages in in-house formulation production of NITRO-DUR, leveraging their global manufacturing network for quality and scalability.

• Sourcing from Contract Manufacturing Organizations (CMOs): Many pharmaceutical companies outsource patch manufacturing to CMOs specializing in transdermal delivery systems, such as Catalent, Lonza, and Famar. These firms possess facilities compliant with international standards, ensuring high-quality formulation and testing.

Packaging Suppliers

Packaging quality and stability are critical to maintaining NITRO-DUR efficacy and safety.

• Intercontinental Great Brands LLC: Supplies specialized backing films, adhesives, and protective laminates designed for transdermal patches.

• Amcor Limited and Berry Global: Major providers of blister packs and peelable foil laminates that meet regulatory requirements for pharmaceutical packaging, including nitrogen flushing and anti-tampering features.

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Supply Chain Dynamics and Challenges

Regulatory Compliance

Suppliers across the globe must comply with cGMP standards, FDA regulations, and equivalent authorities' guidelines (EMA, PMDA). Gaps or lapses in compliance can disrupt supply and lead to shortages or recalls.

Global Sourcing and Production Risks

API sourcing is often geographically diversified to mitigate regional risks, but geopolitical tensions, trade restrictions, or pandemics can hinder supply chains (e.g., COVID-19 pandemic disruptions). In particular, Asian API suppliers serve a significant portion of the market, emphasizing the need for risk diversification.

Quality Assurance and Validation

High-quality API and finished product manufacturing are non-negotiable due to the potency of nitroglycerin and the potential safety liabilities. Suppliers undergo rigorous audits, validation, and dossier submissions per ICH guidelines.

Market Competition and Capacity Expansion

Brand-name manufacturers such as Novartis maintain a tight grip on their supply chains, while generic manufacturers like Teva and Mylan expand capacity to meet market demands, sometimes entering into joint ventures with suppliers for assured API supply.

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Major Players and Strategic Considerations

• Vertical Integration: Some companies, like Novartis, operate integrated supply chains from API synthesis to formulation, reducing external dependency and ensuring quality control.

• Contract Manufacturing and Outsourcing: Many firms favor contracting with specialist CMOs, allowing flexibility and access to advanced formulation technologies.

• Emerging Suppliers: New entrants in the API market from countries like India and China are increasing their market share, driven by cost advantages and technological advancements.

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Regulatory and Market Access Implications

Suppliers must maintain compliance with evolving global regulatory standards, which influence their production licenses and export capabilities. Regulatory hurdles can delay approvals for new suppliers, leading to potential shortages.

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Conclusion

The supply of NITRO-DUR hinges on a complex, globally distributed set of suppliers spanning API providers, formulators, and packaging firms. Leading API manufacturers include BASF, Hawkins, Nippon Chemical, and the API divisions of major pharmaceutical firms like Teva. Formulation and packaging are predominantly handled by CMOs and large packaging firms like Catalent, Lonza, Amcor, and Berry Global.

Maintaining a resilient supply chain for NITRO-DUR requires proactive supplier qualification, regular audits, diversification of sources, and close regulatory oversight. As demand persists and markets evolve, strategic collaborations and contingency planning remain key to uninterrupted supply.

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Key Takeaways

• Diversification is crucial: Relying on multiple API and formulation suppliers minimizes risk.
• Regulatory compliance underpins quality: Suppliers must adhere to strict cGMP standards; non-compliance can cause supply disruptions.
• API sourcing trends: Increasing reliance on Asian manufacturers demands vigilant quality assurance and risk management.
• Vertical integration provides stability: Manufacturers with integrated supply chains mitigate external vulnerabilities.
• Technology and innovation: Advanced formulation and packaging technologies ensure product stability and patient safety.

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FAQs

1. Who are the primary API suppliers for NITRO-DUR?
   Major suppliers include BASF, Hawkins, Nippon Chemical, and API divisions of companies like Teva and AbbVie, all providing pharmaceutical-grade nitroglycerin.

2. How do formulation manufacturers ensure consistent quality?
   They adhere to cGMP regulations, conduct thorough validation processes, and perform rigorous testing of raw materials and finished products.

3. What role do CMOs play in NITRO-DUR production?
   CMOs specialize in formulating transdermal patches, leveraging advanced technology to ensure controlled drug release and product stability, often working under strict contractual and regulatory frameworks.

4. Are there risks associated with sourcing API from specific regions?
   Yes. Dependence on single-region API suppliers exposes manufacturers to geopolitical, regulatory, and supply chain risks, prompting diversification strategies.

5. What factors influence the stability of NITRO-DUR during manufacturing and storage?
   Nitroglycerin is sensitive to temperature, light, and mechanical shock. Proper packaging, controlled storage conditions, and high-quality materials are essential for maintaining product stability.

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References

1. [1] Pharmaceutical Supply Chain Integrity. International Pharma Federation, 2022.
2. [2] ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
3. [3] Global API Manufacturers Market Report. IQVIA, 2021.
4. [4] Transdermal Patches: Formulation and Manufacturing Practices. Journal of Pharmaceutical Sciences, 2020.
5. [5] Regulatory Compliance in Pharmaceutical Packaging. U.S. FDA, 2022.