Suppliers and packagers for breyna

breyna

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	BREYNA	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	211699	ANDA	Mylan Pharmaceuticals Inc.	0378-7502-32	1 POUCH in 1 CARTON (0378-7502-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER	2023-07-31
Mylan	BREYNA	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	211699	ANDA	Mylan Pharmaceuticals Inc.	0378-7503-32	1 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER	2023-07-31

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: Breyna

Introduction
Breyna, a proprietary pharmaceutical drug, has gained notable attention within the healthcare industry due to its innovative formulation and therapeutic efficacy. As a medication, its success depends heavily on a complex supply chain comprising a diverse network of suppliers. Understanding the landscape of Breyna’s suppliers is vital for stakeholders—manufacturers, investors, and healthcare providers—to assess reliability, regulatory compliance, and potential strategic collaborations. This article provides a comprehensive analysis of the key suppliers involved in the production and distribution of Breyna, focusing on active pharmaceutical ingredient (API) providers, formulation manufacturers, packaging entities, and distribution channels.

1. Active Pharmaceutical Ingredient (API) Suppliers
The foundation of any pharmaceutical product is its API, which determines safety and efficacy. For Breyna, several global API manufacturers serve as primary suppliers, often located in regions with established pharmaceutical manufacturing expertise, such as India, China, and Europe.

• Indian API Manufacturers
  India remains a dominant player in API supply chains due to cost advantages and a well-established regulatory framework. Companies such as Divi’s Laboratories, Akhil Healthcare, and Hetero Labs are known for their capacity to synthesize complex APIs and comply with both US FDA and EMA standards. For Breyna, such suppliers are critical, especially if the API is a complex small molecule or biological precursor.

• Chinese API Suppliers
  China's API sector, led by companies like emcure Pharmaceuticals and Shanghai Fosun Pharmaceutical, provides large-scale manufacturing capabilities. They often supply bulk APIs at competitive prices, but quality compliance must be stringently verified given varying regulatory standards.

• European API Suppliers
  European manufacturers, including Hoffmann-La Roche and Novartis, may serve as high-quality API providers. Their adherence to rigorous GMP standards ensures consistent quality, crucial for drugs like Breyna with significant clinical data backing.

2. Formulation and Contract Manufacturing Organizations (CMOs)
Once the API is procured, formulation and finished product manufacturing require specialized facilities. Many pharmaceutical companies delegate these processes to CMOs to optimize cost efficiencies and regulatory adherence.

• Leading CMOs Involved in Breyna Production

  • Lonza Group (Switzerland) – Known for biologics and complex small molecules, providing formulation, fill-finish, and packaging services.
  • Samsung Biologics (South Korea) – Offers extensive biological manufacturing capabilities suitable for innovative therapies.
  • Recipharm (Sweden) – Provides formulation, fill-finish, and packaging, with a focus on high-quality standards.

• Key Considerations in CMO Selection
  Partnerships with CMOs like Lonza or Samsung Biologics offer advantages like scalable manufacturing, regulatory expertise, and robust quality systems, essential for maintaining Breyna’s market reputation.

3. Packaging Suppliers
Packaging plays a crucial role in maintaining drug stability, ensuring safety, and complying with regulatory labeling standards.

• Major Packaging Suppliers
  • Gerresheimer (Germany) – Supplies primary packaging components such as glass vials and ampoules, with traceability and tamper-evident features.
  • SCHOTT (Germany) – Specialized in pharmaceutical glass packaging that offers chemical inertness and superior barrier properties.
  • WestRock (US) – Provides secondary packaging solutions including cartons, labels, and blister packs that meet safety and branding requirements.

4. Distribution and Logistics Partners
Effective distribution networks ensure timely delivery of Breyna’s finished product to global markets, maintaining cold chain integrity where necessary.

• Key Distribution Firms
  • DHL Supply Chain – Handles international logistics for temperature-sensitive pharmaceuticals, leveraging advanced tracking systems.
  • UPS Healthcare – Provides specialized storage and transportation for sensitive medications, ensuring compliance with regulatory standards such as GDP (Good Distribution Practice).
  • McKesson and Cardinal Health – Dominate distribution within North America, with comprehensive warehousing and distribution infrastructure.

5. Regulatory and Quality Assurance Suppliers
Suppliers of testing, analytical, and validation services underpin the safety and quality of Breyna.

• Analytical Testing Labs

  • SGS – Global provider of quality control and testing services, verifying API purity and stability.
  • Eurofins Scientific – Offers extensive analytical services essential for regulatory submissions and ongoing quality monitoring.

• Regulatory Consultants
  Engaging firms such as Pharmatech or PQE Group ensures alignment with evolving global regulatory standards, which is particularly crucial during manufacturing scale-up and market expansion.

Supply Chain Challenges and Strategic Considerations
While the pharmaceutical supply chain for Breyna is multi-layered and globally dispersed, recent disruptions—such as geopolitical tensions, regulatory variability, and raw material shortages—pose significant risks. Thus, diversification of suppliers, robust quality assurance protocols, and strategic inventory management are paramount.

Manufacturers may also consider vertically integrating critical API supply to mitigate dependency on third-party suppliers, especially for drugs with high therapeutic value or narrow patent windows.

Conclusion
Breyna’s supply chain comprises a network of global suppliers focused on pharmaceutical-grade APIs, advanced formulation, reliable packaging, and secure distribution. Prioritizing supplier quality, regulatory compliance, and supply chain resilience will ensure continuous availability. Stakeholders interested in manufacturing, investing, or distributing Breyna should conduct due diligence on these suppliers, focusing on adherence to GMP standards, transparency, and capacity to scale with market demand.

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Key Takeaways

• The core API suppliers for Breyna are primarily located in India, China, and Europe, selected for quality, cost, and regulatory compliance.
• Leading CMOs like Lonza and Samsung facilitate formulation and manufacturing, offering scalability and GMP adherence.
• Packaging suppliers such as Gerresheimer and SCHOTT ensure drug stability and regulatory compliance in labeling.
• Robust distribution partnerships with DHL, UPS, and regional players are critical for maintaining cold chain and timely delivery.
• Continual risk assessment and diversification of suppliers underpin supply chain resilience amid geopolitical and regulatory uncertainties.
• Engaging analytical labs and regulatory consultants maintains strict quality assurance and smooth pathway approvals.

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FAQs

1. Who are the primary API suppliers for Breyna?
Top API suppliers for Breyna include companies like Divi’s Laboratories (India), Shanghai Fosun Pharmaceutical (China), and Hoffmann-La Roche (Europe), depending on the specific API composition.

2. Are there any exclusive suppliers involved in Breyna’s production?
As of the latest available data, specific exclusive supplier arrangements are confidential; however, strategic partnerships with selected API manufacturers and CMOs are common to ensure quality and supply security.

3. What are the key criteria for selecting suppliers of Breyna?
Selection criteria include GMP compliance, regulatory track record, manufacturing capacity, quality consistency, and the ability to scale with market demands.

4. How does supply chain disruption impact Breyna’s market availability?
Disruptions can lead to shortages, delayed approvals, or increased costs. Ensuring diversified sourcing and proactive inventory management mitigates these risks.

5. What role do logistics companies play in Breyna’s distribution?
They are responsible for maintaining cold chain integrity, ensuring regulatory compliance during transit, and providing real-time tracking to prevent delays and spoilage.

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References

[1] Indian Pharmaceutical Industry Overview. PharmTech.com.
[2] Global API Market Report. IQVIA.
[3] Contract Manufacturing in the Pharma Industry. PharmaManufacturing.com.
[4] Packaging Standards and Suppliers. PDA Technical Report 67.
[5] Pharmaceutical Supply Chain Disruptions. Deloitte Insights.