Suppliers and packagers for brovana

brovana

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912	NDA	Lupin Pharmaceuticals, Inc.	27437-060-30	30 POUCH in 1 CARTON (27437-060-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE	2024-04-15
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912	NDA	Lupin Pharmaceuticals, Inc.	27437-060-60	60 POUCH in 1 CARTON (27437-060-60) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE	2024-04-15

Last updated: August 2, 2025

ppliers for the Pharmaceutical Drug: BROVANA

Introduction
BROVANA (arformoterol tartrate) is a long-acting beta-2 agonist (LABA) used primarily as a bronchodilator for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). As a critical medication in respiratory therapy, understanding its supply chain dynamics, including key suppliers, is vital for stakeholders across pharmaceutical manufacturing, healthcare procurement, and policy domains. This article provides a comprehensive overview of the current suppliers of BROVANA, analyzing manufacturing origins, market presence, and implications for pharmaceutical stakeholders.

Overview of BROVANA and Its Manufacturing Ecosystem
BROVANA (arformoterol tartrate) was developed by Sunovion Pharmaceuticals, a subsidiary of Sumitomo Dainippon Pharma. The drug's API (active pharmaceutical ingredient) production and formulation are integral to its successful supply chain. While Sunovion predominantly manufactures the drug for North American markets, international supply chains involve multiple stakeholders, including active pharmaceutical ingredient (API) producers, formulation manufacturers, and distributors.

Primary API Suppliers for BROVANA

1. Sunovion Pharmaceuticals (USA)
   Sunovion is both the innovator and primary manufacturer of BROVANA. The company's manufacturing facilities are located in the United States, primarily in Marlborough, Massachusetts, where the drug's formulation and packaging are centralized. The API sourcing, however, is often complemented by external suppliers to ensure supply stability.

2. External API Suppliers
   While Sunovion maintains stringent control over its core API manufacturing processes, it sources arformoterol tartrate intermediates from specialized chemical producers globally. These suppliers operate in regions such as Asia and Europe, providing raw materials that meet Good Manufacturing Practice (GMP) standards. The key API suppliers include:

• APIs Manufacturers in China and India

  • Several Chinese and Indian chemical companies are known to produce arformoterol intermediates or analogues that meet international regulatory standards. Companies such as Shandong Yulong Chemical Co., Ltd. and Jinan Meinuo Pharmaceutical Co., Ltd. have been reported as suppliers specializing in beta-agonist APIs for export.

• European API Producers

  • Regulated European API manufacturers like Evonik Industries and Syndial may supply intermediates or completed APIs for global distribution, including for BROVANA's formulation.

Formulation and Distribution

1. Formulation Manufacturers
   Sunovion undertakes in-house formulation to ensure product quality, control, and compliance, but in some markets, third-party contract manufacturing organizations (CMOs) may produce BROVANA under licensing agreements. These CMOs are often located in regions with robust pharmaceutical manufacturing infrastructure, including Europe and Asia.

2. Distribution Channels
   Post-production, BROVANA is distributed through both Sunovion’s proprietary channels and licensed distributors worldwide. The distribution network depends heavily on the regulatory landscapes of each country, with partnerships established to ensure reliable supply chains, especially in regions like Europe, Asia, and Latin America.

Third-Party Suppliers and Licensing Agreements

Some markets rely on licensed manufacturing and distribution agreements. For example, in the European Union, the drug may be supplied by Sunovion directly or through partners licensed under the European Medicines Agency (EMA). These licensing arrangements often involve third-party manufacturers holding the rights to produce the drug locally.

Supply Challenges and Market Implications

The global supply chain for BROVANA is subject to challenges such as raw material shortages, regulatory delays, and geopolitical tensions affecting API sourcing, especially from countries like China and India. Sunovion's vertical integration and diversified sourcing strategy aim to mitigate such risks. Moreover, the advent of biosimilar and generic versions could influence the supply chain, prompting shifts in sourcing strategies.

Emerging Trends in BROVANA Suppliers

• Diversification of Supply Sources
  To reduce risks, pharmaceutical companies are increasingly diversifying their API suppliers, including establishing sourcing agreements with suppliers in Southeast Asia and Eastern Europe.

• Local Manufacturing Initiatives
  Some markets are encouraging local API production to improve supply resilience, especially in Europe following regulatory pressures and supply chain disruptions during the COVID-19 pandemic.

• Technology Adoption
  Investments in pharmaceutical-grade chemical synthesis and process improvements facilitate reliable supply, reduce costs, and ensure compliance with international standards.

Regulatory and Quality Considerations

Suppliers must meet stringent GMP standards, including the World Health Organization (WHO) and U.S. Food and Drug Administration (FDA) certifications. Non-compliance risks product recalls, regulatory sanctions, and supply interruptions, emphasizing the importance of supplier due diligence.

Conclusion
Understanding the supplier landscape for BROVANA reveals a complex web involving primary manufacturers, external API suppliers, formulation facilities, and distribution channels. While Sunovion retains control over core production, the global nature of API sourcing—dominated by Chinese, Indian, and European producers—enhances supply resilience but introduces risks associated with geopolitical tensions and regulatory compliance. Stakeholders must monitor developments in API sourcing, licensing agreements, and manufacturing strategies to ensure consistent availability of this vital respiratory medication.

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Key Takeaways

• BROVANA’s API is primarily sourced from Chinese, Indian, and European suppliers, alongside Sunovion’s in-house manufacturing.
• Diversification strategies by pharmaceutical companies mitigate supply chain risks.
• Regulatory compliance, GMP standards, and quality assurance are critical for all suppliers involved in BROVANA's production.
• Geopolitical and global supply chain disruptions pose ongoing challenges to BROVANA availability.
• Monitoring licensing and manufacturing agreements is essential for assessing market supply stability and pricing dynamics.

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FAQs

1. Who are the main API suppliers for BROVANA?
The primary API suppliers include Sunovion’s in-house manufacturing in the U.S. and external chemical producers in China, India, and Europe that manufacture arformoterol tartrate intermediates and APIs.

2. How does Sunovion ensure the quality of its BROVANA supply chain?
Sunovion maintains strict GMP compliance, quality audits, and regulatory certifications for its manufacturing processes and API sourcing, ensuring high standards across its supply chain.

3. Are there alternative sources for BROVANA in case of supply disruptions?
Yes. Pharmaceutical companies often diversify API sources and establish licensing agreements with local manufacturers to mitigate supply risks. However, any alternatives must meet rigorous regulatory standards.

4. How might geopolitical tensions affect BROVANA's supply chain?
Trade restrictions, export controls, and geopolitical tensions, especially involving China and India, can disrupt API sourcing, impacting overall supply and pricing. Stakeholders need active risk management strategies.

5. Are biosimilars or generics affecting BROVANA’s market supply?
While biosimilars are more common in biologics, the generic market for arformoterol-based drugs may influence supply dynamics, prompting original manufacturers to secure diversified, stable supply chains.

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Sources
[1] Sunovion Pharmaceuticals Official Website.
[2] Global API manufacturers’ directories and industry reports.
[3] U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory standards.
[4] Industry market analysis reports on API sourcing and pharmaceutical supply chains.