Suppliers and packagers for generic pharmaceutical drug: REVEFENACIN

REVEFENACIN

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: Revefenacin

Last updated: July 29, 2025

Introduction

Revefenacin, marketed under the brand name Yupelri, is a bronchodilator primarily prescribed for the maintenance treatment of chronic obstructive pulmonary disease (COPD). As a long-acting muscarinic antagonist (LAMA), revefenacin offers a once-daily inhalation therapy, providing sustained relief for COPD patients. The drug's manufacturing and supply are highly regulated, involving a network of specialized suppliers across different stages, including active pharmaceutical ingredient (API) production, formulation, packaging, and distribution. This article provides an in-depth overview of the key suppliers involved in the revefenacin supply chain, highlighting their roles, manufacturing capacities, and strategic significance.

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Active Pharmaceutical Ingredient (API) Suppliers for Revefenacin

The foundation of revefenacin’s supply chain hinges on its API, which is critical for efficacy, safety, and quality assurance. The API suppliers are typically biotech or chemical companies with expertise in complex synthesis processes, given revefenacin’s molecular structure and pharmacological specificity.

1. Septerna, Inc. (AstraZeneca Collaboration)

AstraZeneca, the original developer of revefenacin, collaborates with specialized API manufacturers to ensure supply continuity. Although specific suppliers are often kept confidential due to commercial agreements, reports indicate that AstraZeneca sources its revefenacin API from high-quality, cGMP-compliant manufacturers globally.

2. External Contract Manufacturing Organizations (CMOs)

Many large pharmaceutical companies, including AstraZeneca, rely on contract manufacturing organizations (CMOs) for API production to optimize capacity and reduce costs. These organizations often operate across continents, notably in North America, Europe, and Asia. Examples include:

• North American CMOs: Firms like Celanese or Patheon (a Thermo Fisher Scientific company) possess the technological capability for complex API synthesis and large-scale GMP manufacturing.
• Asian CMOs: Companies such as WuXi AppTec, Zhejiang Huahai Pharmaceutical, and Zhejiang Hisun Pharmaceutical frequently serve as API suppliers or contract manufacturers for European and North American clients due to their extensive manufacturing footprints and cost efficiencies.

3. Quality and Regulatory Standards

API suppliers for revefenacin must adhere to stringent regulatory standards, including cGMP compliance, rigorous quality control, and stability testing. Given AstraZeneca’s reputation for quality, its API suppliers, regardless of location, must meet international standards established by the FDA, EMA, and other regulatory bodies.

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Formulation and Inhalation Device Suppliers

Beyond API production, revefenacin’s formulation into inhaler devices involves partnerships with device manufacturers specializing in dry powder inhalers (DPIs) or nebulizer systems.

1. Cipla Ltd.

Cipla is a globally recognized pharmaceutical company that produces various inhalation products and may serve as a manufacturing partner for revefenacin formulations, especially in markets where AstraZeneca licenses or outsources manufacturing rights.

2. Vectura (now part of GSK)

Vectura has expertise in inhalation device development and manufacturing. Though primarily known for other products, partnerships with device technology firms facilitate device innovation, ensuring efficient drug delivery and patient adherence.

3. Contract Device Manufacturers

Specialized-device manufacturing firms, such as Tec Pharma or Nemera, provide customized DPI devices compatible with revefenacin, ensuring compliance with regulatory standards and patient usability.

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Packaging and Distribution Suppliers

The global distribution of revefenacin involves packaging components, such as inhaler cartridges, labels, and secondary packaging materials sourced from specialized suppliers.

1. Global Packaging Providers

Suppliers like WestRock and Amcor provide pharmaceutical-grade packaging materials that meet regulatory standards for stability, tamper evidence, and patient safety.

2. Logistic Partners

Leading logistics companies, including DHL and FedEx, facilitate cold-chain, secure distribution of revefenacin to pharmacies, hospitals, and distributors worldwide, ensuring product integrity during transit.

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Market Dynamics and Supplier Strategies

The supply chain for revefenacin is sensitive to regulatory changes, supply-demand fluctuations, and geopolitical factors. AstraZeneca’s strategic approach emphasizes diversified API sourcing, creating redundancy to avoid manufacturing disruptions. Additionally, recent trends show an increasing shift toward regional manufacturing hubs to reduce shipping times and ensure local regulatory compliance.

Supply Chain Challenges

• Regulatory Complexity: Strict quality standards necessitate rigorous oversight of API and formulation suppliers.
• Capacity Constraints: Limited API manufacturing capacity can threaten supply stability, prompting alliances with multiple CMOs.
• Intellectual Property (IP) Concerns: Suppliers involved in complex synthesis must have robust IP protections, influencing supplier selection.

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Conclusion

Revefenacin’s supply chain exemplifies the intricate network of high-quality API manufacturers, formulation specialists, device producers, and logistics providers. AstraZeneca, as the original developer and marketer, employs a combination of internal manufacturing and external partnerships to ensure a reliable and compliant supply chain. Companies seeking entry or expansion in this market should prioritize establishing partnerships with GMP-compliant API producers, device manufacturers with proven inhaler technology, and reliable logistics providers, all aligned with regulatory requirements and quality standards.

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Key Takeaways

• The core API supply for revefenacin typically involves global contract manufacturing organizations adhering to cGMP standards.
• Collaborations with specialized device manufacturers ensure optimal inhaler design and patient adherence.
• A diversified supply network mitigates risks related to capacity shortages and regulatory hurdles.
• Regulatory compliance, quality assurance, and robust logistics are pivotal for maintaining a reliable revefenacin supply chain.
• Companies aiming to participate in revefenacin’s market should focus on establishing strategic partnerships across the supply chain, emphasizing quality and regulatory alignment.

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FAQs

1. Who are the primary API suppliers for revefenacin?
While specific supplier details are proprietary, AstraZeneca generally collaborates with multiple GMP-certified CMOs worldwide, including firms in North America and Asia such as WuXi AppTec and Zhejiang Hisun Pharmaceuticals.

2. Can other pharmaceutical companies manufacture revefenacin?
Yes, companies with advanced chemical synthesis capabilities and GMP compliance can manufacture revefenacin if they secure necessary licensing agreements and meet quality standards.

3. What are the key factors influencing revefenacin's supply chain?
Regulatory compliance, manufacturing capacity, supplier quality, geopolitical stability, and logistical infrastructure are critical factors affecting the supply chain.

4. Are there regional differences in revefenacin suppliers?
Yes, manufacturing strategies often involve regional hubs to reduce shipping times and comply with local regulations, particularly for markets like North America, Europe, and Asia.

5. How does AstraZeneca ensure a reliable supply of revefenacin?
Through diversified API sourcing, strategic partnerships with multiple CMOs, strict quality controls, and maintaining inventory buffers to anticipate market fluctuations.

Sources

1. AstraZeneca official statements and pipeline disclosures.
2. Industry reports on inhaled drug manufacturing and supply chain strategies.
3. Contract manufacturing organization capacity reports (e.g., WuXi AppTec, Zhejiang Hisun).
4. Regulatory guidelines from the FDA and EMA concerning GMP standards.