Suppliers and packagers for DUOBRII

DUOBRII

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354	NDA	Bausch Health US, LLC	0187-0653-01	1 TUBE in 1 CARTON (0187-0653-01) / 100 g in 1 TUBE	2019-04-25
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354	NDA	Bausch Health US, LLC	0187-0653-03	6 TUBE in 1 CARTON (0187-0653-03) / 3 g in 1 TUBE	2019-04-25

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Duobrii

Introduction

Duobrii, a topical pharmaceutical agent used primarily for dermatological conditions, exemplifies a complex product with specific sourcing requirements. As a combination of two active ingredients—halobetasol propionate, a potent topical corticosteroid, and Tildrakizumab, an interleukin-23 (IL-23) inhibitor—this drug's supply chain involves multiple specialized suppliers. Ensuring drug consistency, regulatory compliance, and timely distribution depends heavily on a well-coordinated supplier network. This report provides a comprehensive overview of the key suppliers involved in manufacturing and distributing Duobrii, highlighting their roles, regional footprints, and strategic importance within the supply chain.

Active Pharmaceutical Ingredient (API) Suppliers

1. Halobetasol Propionate
As a corticosteroid, halobetasol propionate's sourcing involves multiple API manufacturers globally, owing to its high demand and patent status limitations. Several companies supply pharmaceutical-grade halobetasol, with notable players including:

• Mundipharma International GmbH & Co. KG
• GKhan Pharma Pvt Ltd
• Sun Pharmaceutical Industries Ltd
• Schiavon Pharma
• LGM Pharma

Quality assurance protocols, including Good Manufacturing Practices (GMP), are critical for API suppliers to ensure safety and efficacy, especially for potent corticosteroids like halobetasol.

2. Tildrakizumab
The IL-23 inhibitor Tildrakizumab, marketed as Ilumya in the U.S. and different trade names globally, is developed by Sun Pharmaceutical Industries. The primary manufacturer of Tildrakizumab is AbbVie, which originally developed the drug but collaborates with Sun Pharmaceutical for production and distribution under licensing agreements.

• AbbVie Inc.: As the originator, AbbVie maintains control over the initial API manufacturing, leveraging its global supply network.
• CMOs (Contract Manufacturing Organizations): Several CMOs capable of producing monoclonal antibodies (mAbs) globally serve as secondary suppliers, primarily in North America and Europe.

Formulation and Filling Suppliers

Once APIs are procured, formulation involves specialized facilities capable of creating topical creams or gels. Key issues include stability, preservative inclusion, and packaging.

• Contract Manufacturing Organizations (CMOs)

  • Multiple CMOs in North America and Europe handle formulation, with expertise in sterile filling, primarily due to the monoclonal antibody component.
  • Large-scale CMO providers like Lonza, Samsung BioLogics, and Catalent play roles in producing biologics and topical creams for pharmaceutical companies.

• Packaging Suppliers

  • Suppliers like Gerresheimer and West Pharmaceutical Services supply the specialized vials, tubes, and applicators necessary for single-dose and multi-dose formulations of Duobrii.

Distribution and Logistics Providers

Supply chain resilience hinges on efficient logistics:

• Global and Regional Distributors
  • Companies such as McKesson and Cardinal Health serve as primary distributors in North America.
  • In Europe, Medipal Holdings and Alliance Healthcare provide distribution channels.
• Cold Chain Logistics (critical for monoclonal antibodies like Tildrakizumab)
  • Specialized logistics providers such as DHL Supply Chain and FedEx are engaged for temperature-sensitive components to maintain stability and efficacy.

Regulatory and Quality Assurance Suppliers

• Analytical and Certification Laboratories
  • SGS and Eurofins offer testing services to validate API purity, stability, and contaminant levels.
  • Regulatory compliance relies on certifications such as ISO 9001, GMP certifications, and adherence to FDA, EMA, or other regional agencies’ standards.

Strategic Considerations

Regional Sourcing & Supply Chain Risks

• Dependency on specific regions (e.g., India and China for APIs) presents geopolitical, logistical, and regulatory risks. Diversifying suppliers or establishing regional manufacturing hubs can mitigate potential disruptions.

Intellectual Property & Licensing

• Coordination with patent holders and licensors like AbbVie is essential for legal and regulatory compliance, influencing supplier selection and contracts.

Manufacturing Scale & Capacity

• Biologics like Tildrakizumab require high-capacity facilities capable of GMP-compliant large-volume production, often limiting sourcing options to well-established CMOs.

Emerging Trends & Future Outlook

• Vertical Integration: Pharmaceutical companies are increasingly investing in in-house manufacturing capabilities for key APIs to reduce dependency and improve control.
• Supply Chain Digitization: Technology platforms enable real-time tracking of raw materials, enhancing transparency and responsiveness.
• Sustainability Initiatives: Suppliers are adapting sustainable practices to comply with environmental regulations and corporate social responsibility expectations.

Conclusion

The supply chain for Duobrii integrates a sophisticated network of API suppliers, formulation facilities, packaging firms, and logistics providers. Key for maintaining quality, compliance, and reliable delivery, this network involves global companies with specialized capabilities, especially in biologics manufacturing. Strategic management of these supplier relationships, alongside diversification and technological enhancements, will be critical for ensuring consistent supply amid evolving geopolitical and regulatory landscapes.

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Key Takeaways

• Diverse API sourcing: Major suppliers for halobetasol include Mundipharma and Sun Pharmaceutical, while Tildrakizumab production is primarily managed by AbbVie and licensed CMOs.
• Specialized formulation and packaging: Partnered with CMOs capable of sterile compounding and advanced packaging solutions.
• Robust distribution networks: Leveraging regional distributors and cold chain logistics to ensure product integrity.
• Supply chain risks: Dependency on regional API producers necessitates diversification strategies.
• Future trends: Vertical integration, digital tracking, and sustainability are shaping the supply landscape.

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FAQs

1. Who are the primary API suppliers for halobetasol propionate used in Duobrii?
Major API suppliers include Mundipharma, Sun Pharmaceutical Industries, and GKhans Pharma, all complying with GMP standards to ensure pharmaceutical-grade quality.

2. What companies manufacture Tildrakizumab for Duobrii?
Initially developed by AbbVie, Tildrakizumab is produced by AbbVie and licensed to Sun Pharmaceutical for commercial distribution, with additional CMOs supporting biologic manufacturing.

3. How does the supply chain ensure the quality and safety of Duobrii?
Through rigorous GMP compliance, certification by independent testing laboratories such as SGS, and adherence to international regulatory standards set by FDA and EMA.

4. Are there regional differences in suppliers for Duobrii?
Yes, regional factors influence sourcing, with Asia-Pacific (notably India and China) serving as major API manufacturing hubs, necessitating diversified strategies to address geopolitical and logistical risks.

5. What are the future supply chain trends impacting Duobrii?
Increased vertical integration, adoption of digital supply chain management, and sustainability initiatives are expected to enhance reliability and compliance.

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Sources
[1] Bloomberg Intelligence. "Global Pharmaceutical Supply Chains." 2022.
[2] Abbvie Official Website. "Tildrakizumab (Ilumya) Overview." 2023.
[3] Sun Pharmaceutical Industries Ltd. Annual Reports. 2022.
[4] GMP Certification and Standards Overview. WHO, 2021.
[5] Logistics in Pharma. DHL Supply Chain. Insights, 2022.