Suppliers and packagers for yupelri

yupelri

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598	NDA	Viatris Specialty LLC	49502-806-87	7 POUCH in 1 CARTON (49502-806-87) / 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-33) / 3 mL in 1 VIAL, SINGLE-DOSE	2018-12-03
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598	NDA	Viatris Specialty LLC	49502-806-93	30 POUCH in 1 CARTON (49502-806-93) / 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-32) / 3 mL in 1 VIAL, SINGLE-DOSE	2018-12-03

Suppliers for the Pharmaceutical Drug: YUPELRI

Last updated: July 27, 2025

Introduction

YUPELRI ( reveoipran) is an inhaled bronchodilator specifically indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Approved by the U.S. Food and Drug Administration (FDA) in June 2018, YUPELRI offers a once-daily, nebulized bronchodilator solution for patients requiring long-term management of COPD symptoms. Given its recent market entry, the supply chain landscape for YUPELRI involves specialized pharmaceutical manufacturers, global distributors, and authorized suppliers. This article provides a comprehensive analysis of YUPELRI’s suppliers, their roles, and the strategic implications within the pharmaceutical supply ecosystem.

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Manufacturers of YUPELRI

The primary manufacturer of YUPELRI is Mylan N.V., a leading global pharmaceutical company. Mylan developed and markets the drug through its respiratory portfolio, leveraging established manufacturing facilities and distribution channels. Mylan’s expertise in inhalation therapies and its robust supply chain infrastructure position it as the central supplier for YUPELRI.

In 2020, Mylan announced a strategic merger with Pfizer’s Upjohn unit, forming Viatris Inc., an entity focused on diversified pharmaceutical products and biosimilars. Post-merger, Viatris continued to support the production and distribution of YUPELRI, ensuring continuity in supply and expanding global reach.

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Authorized Distributors and Supply Partners

While Mylan (and subsequently Viatris) maintains control over manufacturing, the distribution of YUPELRI involves a network of authorized pharmaceutical distributors. These entities operate under strict regulatory and licensing agreements with the manufacturer to ensure compliance with safety, efficacy, and quality standards.

Key authorized distributors include:

• McKesson Corporation – A major distributor of pharmaceutical products, supplying YUPELRI to hospitals, clinics, and specialty pharmacies.
• Cardinal Health – Provides supply chain solutions for inhalation therapies, ensuring timely delivery to healthcare providers.
• AmerisourceBergen – Powers distribution in both retail and institutional markets for YUPELRI.

Emerging regional and specialty pharmacies also partner with these major distributors to retail YUPELRI directly to patients, particularly in the outpatient setting.

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Supply Chain Dynamics and Regional Variations

Global Supply
Originally launched in the United States, the availability of YUPELRI extends to several international markets through partnerships with local distributors and regulatory approvals. For example, in Europe, the medication is marketed under local branding and supplied by regional pharmaceutical companies, subject to EMA regulations.

Manufacturing Capacity and Scalability
To meet increasing demand, Viatris has expanded manufacturing capacity at facilities compliant with Good Manufacturing Practices (GMP). This includes investments in sterile inhalation product lines and quality assurance measures, critical for respiratory drug products.

Supply Challenges and Mitigation
Global supply chains for inhaled medications are susceptible to manufacturing disruptions, supply chain bottlenecks, and regulatory delays. Viatris and partners mitigate risks through strategic stockpiling, diversified sourcing, and strong relationships with logistics providers.

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Regulatory and Quality Assurance

Manufacturers and suppliers of YUPELRI operate under rigorous FDA oversight, adhering to current Good Manufacturing Practices (cGMP). Distribution partners must also comply with federal and state regulations governing pharmaceutical handling, cold chain logistics, and storage conditions.

Any disruption or compliance lapses can impact supply and lead to shortages or distribution delays, emphasizing the importance of robust quality systems across the supply chain.

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Market Competition and Alternative Suppliers

Although Mylan/Viatris is the sole producer of YUPELRI, alternative bronchodilator therapies are available, such as nebulized formulations of tiotropium or combination inhalers. These alternatives influence demand and supply dynamics for YUPELRI, compelling manufacturers and distributors to maintain high supply standards to sustain market presence.

Potential entrants or biosimilar developers exploring nebulized COPD therapies could reshape the supplier landscape, impacting the current exclusive supply chain configuration.

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Strategic Considerations for Stakeholders

• Healthcare Providers: Need to verify supplier authorization and ensure procurement from reputable distributors to guarantee drug integrity.
• Manufacturers: Must prioritize scalable manufacturing processes and adaptive logistics to meet growing demand.
• Distributors: Should maintain compliance with regulatory standards and engage in proactive inventory management to prevent shortages.
• Regulators: Continue oversight to ensure manufacturing quality, supply chain integrity, and equitable access.

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Key Takeaways

• Primary Manufacturer: Mylan (now Viatris) is the sole producer of YUPELRI, focusing on maintaining high-quality manufacturing standards.
• Distribution Network: Major pharmaceutical distributors such as McKesson, Cardinal Health, and AmerisourceBergen manage YUPELRI's supply, ensuring delivery to healthcare facilities and pharmacies.
• Supply Chain Resilience: Capacity expansion, diversified sourcing, and regulatory compliance are critical to mitigating disruptions.
• Global Distribution: International markets have separate localized suppliers, with regulatory approvals influencing availability.
• Market Outlook: Continued demand for COPD management and potential market entrants could influence supplier strategies and supply chain dynamics.

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FAQs

1. Who are the main suppliers of YUPELRI in the United States?
The primary supplier is Viatris Inc., formerly Mylan. It manufactures YUPELRI and partners with major pharmaceutical distributors like McKesson, Cardinal Health, and AmerisourceBergen for distribution.

2. Are there alternative manufacturers of nebulized tiotropium medications?
Currently, YUPELRI is exclusively supplied by Viatris. While other bronchodilator therapies exist, no direct biosimilar competitors for YUPELRI are on the market as of early 2023.

3. How does the supply chain ensure the quality of YUPELRI?
Manufacturing adheres to cGMP standards enforced by the FDA, with quality controls conducted at every production stage. Distribution companies comply with strict handling requirements to preserve drug integrity.

4. What risks could disrupt the supply of YUPELRI?
Potential risks include manufacturing plant disruptions, raw material shortages, logistics challenges, and regulatory issues. Strategic inventory management and multiple sourcing options are employed to mitigate these risks.

5. Are YUPELRI supplies available globally?
Availability varies by country. In Europe and other regions, local licensing and distribution agreements determine supply chains, which may involve different regional manufacturers or authorized distributors.

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Conclusion

The supply ecosystem for YUPELRI hinges on Viatris as the sole manufacturer, supported by a network of authorized distributors committed to maintaining product quality and availability. As the COPD treatment landscape evolves, strategic supply chain management and regulatory compliance remain vital for ensuring patient access and sustaining market competitiveness. Stakeholders should monitor capacity expansions, regulatory developments, and potential competition to navigate the dynamic pharmaceutical supply environment effectively.

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Sources
[1] U.S. Food and Drug Administration (FDA). YUPELRI (reveoipran) approval details. 2018.
[2] Viatris Inc. Corporate website and press releases.
[3] Industry reports on pharmaceutical distribution and supply chain management.