Suppliers and packagers for generic pharmaceutical drug: ALBUTEROL SULFATE

ALBUTEROL SULFATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Armstrong Pharms	ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	212447	ANDA	Armstrong Pharmaceuticals, Inc.	17270-0740-0	1 INHALER in 1 CARTON (17270-0740-0) / 200 INHALANT in 1 INHALER	2024-08-06
Armstrong Pharms	ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	212447	ANDA	NuCare Pharmaceuticals,Inc.	68071-3902-2	1 INHALER in 1 CARTON (68071-3902-2) / 200 INHALANT in 1 INHALER	2024-08-06
Armstrong Pharms	ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	212447	ANDA	Preferred Pharmaceuticals, Inc.	68788-4041-2	1 INHALER in 1 CARTON (68788-4041-2) / 200 INHALANT in 1 INHALER	2025-10-13

Suppliers for the Pharmaceutical Drug: ALBUTEROL SULFATE

Last updated: July 28, 2025

Introduction
Albuterol sulfate, a bronchodilator primarily used to treat asthma and chronic obstructive pulmonary disease (COPD), is a widely manufactured pharmaceutical compound. Its importance in respiratory therapy has created a global demand driven by both branded and generic formulations. This article delves into the key suppliers of albuterol sulfate, examining the manufacturing landscape, regional distribution, and market dynamics, providing critical insights for stakeholders.

Manufacturers and Major Suppliers
The supply chain for albuterol sulfate encompasses both multinational pharmaceutical companies and regional manufacturers. These entities produce active pharmaceutical ingredients (APIs) and finished dosage forms, including inhalers and nebulizer solutions.

Top Global API Manufacturers
Several companies dominate the global production of albuterol sulfate API, chiefly due to their scale, compliance with Good Manufacturing Practices (GMP), and extensive distribution networks.

• Pfizer Inc.
  As a pioneer and leading manufacturer, Pfizer supplies albuterol sulfate API and inhalers, benefiting from its extensive R&D capabilities and global presence. The company’s long-standing reputation ensures high-quality standards and consistent supply.

• Mitsubishi Tanabe Pharma Corporation
  This Japanese pharmaceutical giant produces albuterol sulfate API mainly for the Asian markets. Known for sophisticated manufacturing processes, Mitsubishi Tanabe focuses on quality compliance and reliable supply.

• Cipla Limited
  An Indian-based pharmaceutical leader, Cipla manufactures both APIs and various inhalation products. Its low-cost manufacturing model and regional focus make it a significant supplier in developing markets.

• Sun Pharmaceutical Industries Ltd.
  This Indian pharmaceutical firm arises as a prominent supplier, with a considerable share in API production and finished formulations, particularly for emerging markets.

• Dr. Reddy’s Laboratories
  Another Indian pharmaceutical company, Dr. Reddy’s, produces albuterol sulfate API, focusing on quality and cost-efficiency, serving both domestic and export markets.

Regional Manufacturing Hubs
Besides global leaders, regional manufacturers play pivotal roles, especially in Asia, Latin America, and Eastern Europe. These suppliers often cater to local markets through generic formulations and biosimilar platforms.

• China's API market is expanding rapidly, with companies such as Zhejiang Huahai Pharmaceutical and Jiangsu Hengrui Medicine Co., Ltd., emerging as significant API producers for albuterol sulfate due to lower manufacturing costs.

• Brazil and Mexico host regional players like Eurofarma and Laboratórios Richter, which supply generic albuterol sulfate, aligning with local regulatory standards and catering to Latin American demand.

Supply Chain Dynamics and Quality Standards
The production and supply of albuterol sulfate are heavily regulated to ensure safety and efficacy. Regulatory bodies like the FDA (USA), EMA (Europe), and PMDA (Japan) impose stringent standards on manufacturing practices, impacting suppliers' operations.

• GMP Compliance
  Manufacturers must adhere to GMP regulations, which influence their ability to supply globally. Firms with robust quality systems can access diverse markets, creating barriers for less compliant producers.

• Patent Expirations and Generics
  The patent expiration of key formulations has spurred proliferation of generic API manufacturers, increasing supply options but also intensifying competition. This trend benefits large-scale producers capable of cost-effective large-volume manufacturing.

Market Trends and Challenges
The global demand for albuterol sulfate remains strong, driven by asthma prevalence and respiratory illnesses. However, supply chains face challenges such as:

• Regulatory Divergence
  Different regional standards complicate supply chain logistics, especially when exporting APIs across jurisdictions with diverse approval pathways.

• Raw Material Availability
  Dependencies on specialized chemical precursors can create supply disruptions. Sustainable sourcing and manufacturing process improvements are ongoing responses.

• Price Fluctuations
  Global market competition and raw material costs influence pricing, impacting both suppliers' profitability and affordability for end-users.

• COVID-19 Impact
  The pandemic disrupted supply chains temporarily, highlighting the need for diversified sourcing strategies and increased local manufacturing capabilities.

Emerging Opportunities
Innovations in API synthesis, such as greener manufacturing processes and bio-based production methods, are anticipated to improve supply stability and sustainability.

Additionally, regional governments and multinational corporations are increasingly investing in local API manufacturing facilities to reduce reliance on imports and meet growing regional demand.

Key Players Summary Table

Company	Region	Market Focus	Notable Attributes
Pfizer Inc.	Global	Large-scale, branded	Extensive R&D, global distribution
Mitsubishi Tanabe Pharma	Asia-Pacific	Asian markets	High-quality standards, regional focus
Cipla Limited	India	Developing markets	Cost-effective manufacturing, API & formulations
Sun Pharmaceutical Industries	India	Emerging markets	Extensive API portfolio
Dr. Reddy’s Laboratories	India	Global	Competitive pricing, quality assurance
Zhejiang Huahai Pharmaceutical	China	Asia, global	Large API capacity, cost efficiency

Regulatory Frameworks and Certification
Successful suppliers must comply with international standards such as:

• FDA for North America
• EMA standards for Europe
• ICH guidelines for quality consistency

Certification of their manufacturing facilities through licensing, GMP validation, and audits remains critical for maintaining market access.

Conclusion
The supply landscape for albuterol sulfate is characterized by a mix of global giants, regional manufacturers, and emerging players. While established companies like Pfizer maintain dominance through high scale and quality standards, regional players in Asia and Latin America respond to local demand with cost-effective, GMP-compliant production. The ongoing expansion of generics and biosimilars enhances supply availability but necessitates rigorous quality controls to meet regulatory requirements. Market stability hinges on diversified sourcing strategies, adherence to regulations, and ongoing technological innovation in API manufacturing.

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Key Takeaways

• Global market leaders such as Pfizer and Mitsubishi Tanabe dominate high-quality albuterol sulfate API supply, ensuring consistent worldwide distribution.
• Regional manufacturers, especially in Asia and Latin America, play critical roles in meeting local demand through cost-effective, GMP-compliant production.
• Regulatory compliance, including GMP adherence and certification, is paramount in maintaining supply chain integrity.
• Market dynamics influenced by patent expirations and generic proliferation increase supply options but intensify competition.
• Future opportunities lie in sustainable manufacturing practices and regional investment, reducing supply disruptions.

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FAQs

1. Who are the top global suppliers of albuterol sulfate API?
   Pfizer, Mitsubishi Tanabe Pharma, Cipla, Sun Pharma, and Dr. Reddy’s are the leading global API suppliers, known for their quality standards and extensive distribution networks.

2. What regions are emerging as key manufacturing hubs for albuterol sulfate?
   China, India, and Latin America are rapidly expanding their API manufacturing capabilities, driven by lower production costs and increasing regional demand.

3. How do regulatory standards impact albuterol sulfate suppliers?
   Compliance with GMP, FDA, EMA, and other regional regulations ensures market access, influences manufacturing practices, and impacts the supplier’s reputation and distribution capabilities.

4. What challenges do albuterol sulfate supply chains currently face?
   Disruptions from raw material shortages, regulatory divergence, pricing fluctuations, and pandemic-related interruptions pose ongoing risks.

5. What future trends could influence albuterol sulfate supply dynamics?
   Innovations in green manufacturing, local API production initiatives, and increased focus on biosimilar development are expected to shape the supply landscape.

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References
[1] U.S. Food and Drug Administration (FDA). “Guidance for Industry: Good Manufacturing Practices for Finished Pharmaceuticals.”
[2] European Medicines Agency (EMA). “Guidelines on Good Manufacturing Practice.”
[3] Market research reports on pharmaceutical active ingredients and inhalation therapies.