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

YUPELRI: Key Suppliers and Manufacturing Landscape

Last updated: February 19, 2026

YUPELRI (revefenacin) is a long-acting muscarinic antagonist (LAMA) indicated for the maintenance treatment of adults with moderate to very severe chronic obstructive pulmonary disease (COPD). Its supply chain involves specialized contract manufacturing organizations (CMOs) and raw material providers. The active pharmaceutical ingredient (API) and the finished drug product manufacturing are critical components of its availability.

Who Manufactures YUPELRI API?

The primary manufacturer of YUPELRI's active pharmaceutical ingredient (API), revefenacin, is Catalent Pharma Solutions at its facility located in Vittel, France. Catalent is a leading global provider of drug manufacturing and development services.

• Facility: Catalent Biologics, Vittel, France
• API: Revefenacin

Catalent’s involvement suggests a reliance on their expertise in complex API synthesis and adherence to stringent regulatory requirements for pharmaceutical manufacturing.

Who Manufactures YUPELRI Finished Drug Product?

The finished drug product, specifically the inhalation solution for nebulization, is also manufactured by Catalent Pharma Solutions. This indicates a vertically integrated supply chain for YUPELRI, with a single CMO responsible for both API production and the final formulation and filling of the product.

• Manufacturer: Catalent Pharma Solutions
• Dosage Form: Inhalation solution for nebulization
• Packaging: Vials

This consolidation of manufacturing processes with one provider can offer advantages in terms of quality control, efficiency, and supply chain management.

What are the Key Excipients and Their Suppliers?

The formulation of YUPELRI includes several excipients that are essential for its stability, solubility, and delivery. While specific proprietary excipient suppliers are not publicly disclosed, typical excipients found in inhalation solutions for nebulization include:

• Solvents: Water for injection is the primary solvent.
• Buffering Agents: To maintain pH stability. Examples include citrate buffers or phosphate buffers.
• Tonicity Agents: To ensure isotonicity with physiological fluids. Sodium chloride is a common agent.
• Preservatives: For multi-dose formulations to prevent microbial growth, though YUPELRI is supplied in single-dose vials, negating the need for preservatives.

The suppliers of these pharmaceutical-grade excipients are typically large chemical manufacturers with specialized pharmaceutical divisions that meet Good Manufacturing Practices (GMP) standards. Companies like BASF, Merck KGaA, and Sigma-Aldrich (a subsidiary of Merck KGaA) are major global suppliers of pharmaceutical excipients. The specific selection and qualification of these suppliers are critical for product quality and regulatory compliance.

What is the Regulatory Landscape for YUPELRI Manufacturing?

The manufacturing of YUPELRI is subject to rigorous oversight by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Key regulatory considerations include:

• Good Manufacturing Practices (GMP): All manufacturing facilities, including those for API and finished drug product, must comply with cGMP regulations. These regulations ensure product quality, safety, and efficacy.
• Drug Master Files (DMFs): Manufacturers of APIs typically file DMFs with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and quality control of the API.
• Site Inspections: Regulatory agencies conduct periodic inspections of manufacturing sites to ensure ongoing compliance with GMP.
• Process Validation: The manufacturing process for both API and the finished drug product must be validated to demonstrate its consistency and reliability in producing a product meeting predefined specifications.
• Quality Control Testing: Comprehensive testing is performed at various stages of manufacturing, including raw material testing, in-process testing, and final product release testing.

The FDA approved YUPELRI on October 23, 2018, based on the manufacturing and quality data submitted by the applicant. [1]

What are the Potential Supply Chain Risks for YUPELRI?

As with any pharmaceutical product, YUPELRI's supply chain is susceptible to various risks:

• Single-Source Manufacturing: The reliance on Catalent Pharma Solutions for both API and finished product manufacturing, while offering integration benefits, also presents a single point of failure risk. Disruptions at Catalent's Vittel facility due to natural disasters, labor issues, or regulatory actions could halt production.
• Raw Material Sourcing: Dependence on specific suppliers for key raw materials and excipients can introduce risks if those suppliers face production issues or have their own supply chain vulnerabilities.
• Geopolitical Instability: Manufacturing operations in specific geographic regions can be affected by political events, trade disputes, or changes in international regulations.
• Quality Deviations and Recalls: Any significant quality issue or recall could lead to product shortages and impact patient access.
• Transportation and Logistics: Global shipping disruptions, increased freight costs, or delays in customs clearance can affect the timely delivery of raw materials and finished products.

Mitigation strategies may include dual sourcing for critical raw materials, establishing buffer stocks, and conducting regular supply chain risk assessments.

What is the Historical Manufacturing Information for YUPELRI?

YUPELRI was developed by Mylan N.V. (now Viatris Inc.) and Theravance Biopharma Corp. Mylan was responsible for the commercialization of YUPELRI in the U.S. market. The manufacturing agreements and site selections were established during the development and commercialization phases.

• Development Partner: Theravance Biopharma Corp.
• Commercial Partner (U.S.): Mylan N.V. (now Viatris Inc.)

The selection of Catalent as the sole manufacturer for both API and the finished drug product indicates a strategic decision made by the development and commercial partners to streamline production and maintain a high level of quality control.

How Does YUPELRI Manufacturing Compare to Other LAMAs?

The manufacturing landscape for other long-acting muscarinic antagonists (LAMAs) varies. Some LAMAs may have their API manufactured by one CMO and their finished product by another, or by an integrated internal manufacturing operation of the marketing pharmaceutical company.

• Multi-Sourcing: Competitors might utilize multiple suppliers for API and finished product to enhance supply chain resilience and potentially reduce costs through competitive bidding.
• In-House Manufacturing: Larger pharmaceutical companies may have internal manufacturing capabilities for their blockbuster drugs, providing greater control over production.
• Specialized Delivery Systems: The complexity of the delivery device (e.g., metered-dose inhalers vs. nebulizers) significantly influences manufacturing requirements and the types of specialized CMOs involved. YUPELRI's nebulizer solution requires sterile manufacturing processes.

The single-source manufacturing for YUPELRI is a notable characteristic that differentiates it from some multi-sourced or internally manufactured comparator drugs.

Key Takeaways

• YUPELRI's active pharmaceutical ingredient (API), revefenacin, is manufactured by Catalent Pharma Solutions at its Vittel, France facility.
• The finished drug product, an inhalation solution for nebulization, is also manufactured by Catalent Pharma Solutions.
• This single-source manufacturing arrangement for both API and finished product consolidates production with one CMO.
• The supply chain relies on the qualification of pharmaceutical-grade excipients from major global chemical manufacturers, with water for injection, buffering agents, and tonicity agents being standard components.
• Manufacturing is subject to stringent regulatory oversight, including cGMP compliance, FDA and EMA inspections, and process validation.
• Potential supply chain risks include reliance on a single manufacturer, raw material sourcing vulnerabilities, and global logistics challenges.

Frequently Asked Questions

1. Who owns the manufacturing facility for YUPELRI API? The manufacturing facility is owned and operated by Catalent Pharma Solutions.

2. Are there any alternative suppliers for YUPELRI API or finished product? Publicly available information indicates Catalent Pharma Solutions is the sole designated manufacturer for both YUPELRI's API and its finished drug product.

3. What quality standards must YUPELRI manufacturing facilities adhere to? Manufacturing facilities must adhere to current Good Manufacturing Practices (cGMP) as mandated by regulatory bodies like the FDA and EMA.

4. How is the sterility of YUPELRI ensured during manufacturing? The manufacturing process for YUPELRI's inhalation solution involves aseptic processing and stringent environmental controls to maintain sterility throughout the formulation and filling stages.

5. What is the typical lead time for producing a batch of YUPELRI? Typical pharmaceutical manufacturing lead times are complex and dependent on batch size, production schedules, and raw material availability, but generally range from several weeks to months for complex sterile products. Specific lead times for YUPELRI are proprietary.

Citations

[1] U.S. Food and Drug Administration. (2018, October 23). FDA approves YUPELRI™ (revefenacin) inhalation solution for the maintenance treatment of COPD. [Press release]. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-yupelritm-revefenacin-inhalation-solution-maintenance-treatment-copd