Suppliers and packagers for qbrelis

qbrelis

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401	NDA	Azurity Pharmaceuticals, Inc.	52652-3001-1	150 mL in 1 BOTTLE (52652-3001-1)	2016-08-29

Suppliers for the Pharmaceutical Drug: QBRELIS

Last updated: July 30, 2025

Introduction

QBRELIS (buprenorphine transdermal system) is a prescription medication indicated for the management of pain severe enough to require opioid analgesia and for which alternative treatments are inadequate. As a controlled substance, supply chain integrity, legal compliance, and reliable sourcing are critical for healthcare providers and distributors. This article explores the primary suppliers of QBRELIS, their market presence, manufacturing capabilities, and strategic importance within the pharmaceutical supply network.

Overview of QBRELIS

QBRELIS offers a unique transdermal delivery system for buprenorphine, facilitating consistent plasma drug levels with once-daily application. Developed by Mylan (a subsidiary of Viatris), the drug combines patent-protected technology with a robust manufacturing infrastructure. Due to its opioid nature, the supply chain is tightly regulated, with a limited number of approved manufacturers authorized to produce the medication in compliance with U.S. Food and Drug Administration (FDA) standards.

Manufacturers of QBRELIS

Viatris (formerly Mylan)

Viatris is the primary and most recognized supplier of QBRELIS in the global pharmaceutical market. The company acquired Mylan in 2020, consolidating its portfolio and manufacturing capabilities. Viatris’ manufacturing facilities adhere to Good Manufacturing Practices (GMP) and are inspected regularly by regulatory authorities, including the FDA. Their facilities produce the transdermal patches and oversee the supply chain logistics ensuring continuity and compliance.

Contract Manufacturing and Outsourcing Providers

While Viatris maintains direct control over the core manufacturing processes, they also collaborate with several contract manufacturing organizations (CMOs) to scale production and meet global demand. These partnerships are subject to stringent compliance standards and are periodically audited to maintain quality certifications such as ISO 9001, ISO 13485, and GMP.

Supply Chain Considerations

Given the potency and regulatory classification of buprenorphine, supply chain security is paramount. Manufacturers of QBRELIS are required to implement robust anti-diversion measures, such as serialized packaging and tamper-evident features. Distribution channels are restricted to authorized wholesalers and pharmacies, with strict tracking systems to prevent diversion or misuse.

Market Dynamics and Supplier Reliability

Global Market Availability

Viatris remains the dominant supplier of QBRELIS in North America, Europe, and select Asian markets. Their expansive manufacturing footprint and extensive distribution network help maintain a stable supply chain, especially vital amid the ongoing challenges posed by global disruptions such as the COVID-19 pandemic.

Regulatory Challenges and Market Access

The supply landscape can be affected by regulatory approvals, patent protections, and market authorization statuses. For instance, attempts to introduce generic versions of buprenorphine transdermal systems face patent litigations, limiting competition and reinforcing the position of established manufacturers like Viatris.

Potential for Diversified Suppliers

Currently, no other pharmaceutical companies have received approval to produce QBRELIS specifically. However, in the biosimilar and generic drug markets, other companies are developing comparable transdermal buprenorphine formulations, which, if approved, could diversify supply sources. This potential shift could influence pricing strategies and supply stability in the future.

Quality and Compliance Standards

Manufacturers producing QBRELIS must meet rigorous regulatory standards. These include:

• GMP compliance: Ensures consistent product quality and safety.
• FDA/EMA approval: Necessary for market authorization in the U.S. and Europe.
• Supply chain security measures: Serialization, tracking, and anti-diversion protocols.
• Post-market surveillance: Monitoring for adverse events, recalls, and manufacturing irregularities.

Viatris’ ongoing compliance efforts and transparent reporting underpin its reputation and supply reliability.

Strategic Implications for Healthcare Providers

Knowing the primary supplier is essential for procurement planning, especially amid supply chain uncertainties. Healthcare providers and pharmacy networks should maintain communication channels with authorized distributors approved by Viatris to ensure a steady supply of QBRELIS. Additionally, understanding the regulatory environment helps anticipate potential shortages or price fluctuations driven by patent litigation or manufacturing disruptions.

Future Outlook

The landscape for QBRELIS suppliers is currently stable, with Viatris controlling the market. However, upcoming patent expirations and increased interest in alternative formulations present possible shifts. The emergence of generics or biosimilars could enhance supply diversity but also lead to intensified regulatory scrutiny and quality assurance requirements.

Key Takeaways

• Viatris (formerly Mylan) remains the sole major supplier of QBRELIS, with comprehensive manufacturing and distribution infrastructure.
• Current supply chain security measures, including serialization and strict regulation adherence, help ensure a reliable supply.
• The market exclusivity is reinforced by patent protections; future diversification depends on regulatory approvals of generics or biosimilars.
• Healthcare providers should maintain close relationships with authorized distributors to mitigate potential disruptions.
• Monitoring patent and regulatory developments is critical for strategic planning and market competitiveness.

Conclusion

For stakeholders involved in the procurement and distribution of QBRELIS, understanding its supplier landscape is crucial. Viatris’s dominance, adherence to quality standards, and strategic focus on supply chain security position it as the primary, reliable source. Nonetheless, vigilance regarding regulatory shifts and market entry of competitors remains essential for sustained market stability.

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FAQs

1. Who is the primary manufacturer of QBRELIS?
   Viatris, through its acquisition of Mylan, is the primary and exclusive manufacturer of QBRELIS, ensuring consistent product quality and supply.

2. Are there any other approved suppliers of QBRELIS globally?
   Currently, no other companies have received approval to produce QBRELIS in major markets like the U.S. or Europe.

3. What measures are in place to prevent diversion of QBRELIS?
   Manufacturer and distributor protocols include serialization, tamper-evident packaging, and strict supply chain tracking to prevent diversion and misuse.

4. How might patent expirations affect QBRELIS supply?
   Patent expiration could pave the way for generic biosimilar competitors, potentially diversifying supply sources and affecting pricing dynamics.

5. What should healthcare providers consider regarding the supply of QBRELIS?
   Providers should partner with authorized distributors, monitor regulatory updates, and plan inventories to mitigate potential shortages or disruptions.

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References

1. [1] FDA Approved Drug Products - QBRELIS (buprenorphine transdermal system).
2. [2] Viatris Corporate Website – Manufacturing and Quality Standards.
3. [3] Market Analysis Reports – Opioid Pharmacotherapies and Transdermal Delivery Systems.
4. [4] Patent and regulatory pathways for generic buprenorphine transdermal systems.
5. [5] Supply Chain Security in Opioid Pharmaceuticals.