Bulk Pharmaceutical API Sources for PROAIR RESPICLICK

Bulk Pharmaceutical API Sources for PROAIR RESPICLICK

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		S5013_SIGMA
TCI (Tokyo Chemical Industry)		S0531
Molport		MolPort-003-933-916
Amadis Chemical		A828402
AKos Consulting & Solutions		AKOS015994719

Bulk Active Pharmaceutical Ingredient (API) Sources for ProAir RespiClick

Last updated: August 5, 2025

Introduction

ProAir RespiClick is a respiratory inhaler prescribed for the management of asthma and chronic obstructive pulmonary disease (COPD). Its active pharmaceutical ingredient (API), albuterol sulfate, acts as a short-acting beta-2 adrenergic receptor agonist, providing bronchodilation. Accurate sourcing of the API is critical for the production of ProAir RespiClick, affecting quality control, cost management, and supply chain resolve. This article examines key API suppliers, regulatory considerations, and market dynamics surrounding albuterol sulfate used specifically for ProAir RespiClick.

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Overview of API Requirements for ProAir RespiClick

ProAir RespiClick requires a high-quality, pharmaceutical-grade albuterol sulfate API compliant with stringent regulatory standards such as the U.S. Pharmacopeia (USP) and International Conference on Harmonisation (ICH) guidelines. The API supplier must guarantee purity (>99%), stability, and consistency, given the inhaler's sensitive delivery mechanism. Additionally, the source must have robust manufacturing processes, proven traceability, and compliance with Good Manufacturing Practices (GMP).

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Major API Suppliers for Albuterol Sulfate

The primary sources of albuterol sulfate API cater to global pharmaceutical manufacturers, with some specializing in respiratory pharmaceuticals, including inhalers like ProAir RespiClick. Supply can be categorized into large-scale API producers, contract manufacturing organizations (CMOs), and specialty chemical manufacturers.

1. Cipla Limited

Cipla, one of India's leading pharmaceutical companies, is a prominent supplier of albuterol sulfate API. Recognized for its robust manufacturing infrastructure and adherence to international quality norms, Cipla supplies pharmaceutical-grade API globally. Their facilities are GMP-certified, and they serve major respiratory pharmaceutical brands, including inhalers similar to ProAir.

2. Jiangsu Hengrui Medicine Co., Ltd.

As an established Chinese API manufacturer, Jiangsu Hengrui emphasizes respiratory APIs, including albuterol sulfate. They possess strong R&D and GMP-compliant manufacturing capabilities, making them a reliable source for inhaler API needs. Their global reach includes supplying to multinational pharmaceutical companies.

3. Famar Pharmaceutical Services

Famar offers contract manufacturing and API supply services for respiratory drugs. They have extensive experience in producing inhaled APIs, with facilities adhering to strict quality standards. Their global logistics network supports rapid deployment to meet demand fluctuations.

4. Teva Pharmaceutical Industries Ltd.

Teva, a major global generics manufacturer, produces albuterol sulfate API at multiple sites. Their manufacturing practices ensure high purity and batch-to-batch consistency, supplying APIs to various companies that produce inhalation medications, including ProAir RespiClick.

5. Sino Biopharmaceutical Limited

This Chinese pharmaceutical firm supplies a range of respiratory APIs, with albuterol sulfate prominent on their portfolio. They have GMP-compliant plants and export to North America and Europe, complying with regional standards.

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Emerging and Contract Manufacturing Options

Increasingly, pharmaceutical companies rely on Contract Manufacturing Organizations (CMOs) to source APIs, including albuterol sulfate. These CMOs often provide tailored manufacturing capacities, quality assurance measures, and regulatory support, essential for timely supply of APIs for inhalers like ProAir RespiClick.

Examples include:

• Famar Pharmaceutical Services: Offers API manufacturing with an emphasis on respiratory compounds.
• Hubei Puli Yuan Pharmaceutical Co., Ltd.: Specializes in high-quality respiratory APIs, including customized formulations for inhaler applications.
• Piramal Pharma Solutions: Provides GMP-compliant API manufacturing with global logistics and regulatory expertise.

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Regulatory and Quality Considerations

API sources for ProAir RespiClick must align with stringent regulatory standards; in particular:

• GMP Compliance: Ensures the API's consistent quality, purity, and potency.
• Regulatory Certification: Certifications such as FDA approval or European Medicines Agency (EMA) approval verify compliance with regional standards.
• Supply Chain Integrity: Traceability and manufacturing transparency are vital for regulatory audits and product recalls.
• Batch Consistency: Critical for inhalers, as dose uniformity impacts therapeutic effectiveness.

Manufacturers must also demonstrate stability data, environmental controls, and quality control testing aligned with pharmacopeial standards like USP or Ph. Eur.

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Market Dynamics and Supply Chain Challenges

The sourcing landscape of albuterol sulfate API faces several challenges:

• Global Supply Disruptions: The COVID-19 pandemic exposed vulnerabilities in supply chains, affecting API availability.
• Patent Expirations and Generics: With patent expiries, more players enter the market, increasing competition but also necessitating rigorous quality verification.
• Pricing Pressures: Cost reductions driven by competition influence sourcing decisions, often favoring Asia-based suppliers.
• Regulatory Variability: Different regional standards require exporters to adapt manufacturing and documentation processes.

Despite these challenges, the API supply for ProAir RespiClick remains stable owing to diversified sourcing strategies and robust quality assurance protocols.

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Future Outlook

The API sourcing landscape for ProAir RespiClick is poised for growth, driven by increased prevalence of respiratory diseases and expanding inhaler formulations. Technological advancements in API manufacturing, such as continuous production and process intensification, may improve supply chain resilience and cost efficiency. Moreover, regional regulatory harmonization efforts will streamline API approvals and sourcing processes.

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Key Takeaways

• Reliable API sourcing for ProAir RespiClick hinges on high-quality, GMP-compliant manufacturers such as Cipla, Jiangsu Hengrui, and Teva.
• Asian API producers dominate the market, offering cost-effective and scalable options, but must meet rigorous quality standards for inhaler applications.
• Contract manufacturing organizations are increasingly vital in providing flexible, compliant API supply solutions amid global supply chain volatility.
• Regulatory compliance, traceability, and batch consistency are non-negotiable criteria for API suppliers in respiratory formulations.
• Emerging technological innovations and international regulatory harmonization will shape future API sourcing strategies for inhaler manufacturers.

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FAQs

1. What are the key quality standards for albuterol sulfate API used in ProAir RespiClick?
The API must conform to pharmacopeial standards such as USP or Ph. Eur., emphasizing purity (>99%), stability, and low levels of impurities. GMP compliance and comprehensive quality control are mandatory.

2. Are there regional differences in sourcing APIs for ProAir RespiClick?
Yes. While North American and European manufacturers often prefer locally approved APIs, many companies source from Asia, especially China and India, due to cost advantages and manufacturing capacity, provided the suppliers meet regional regulatory standards.

3. How does supply chain disruptions impact API sourcing for respiratory drugs?
Disruptions, as seen during the COVID-19 pandemic, challenge the availability and price stability of APIs, prompting companies to diversify sources and implement better supply chain resilience measures.

4. Can emerging API manufacturers meet the quality requirements for inhaler production?
Yes. Several emerging manufacturers are investing in compliance with international standards, GMP certification, and rigorous testing protocols to supply APIs suitable for inhalers like ProAir RespiClick.

5. What are the future trends in API sourcing for respiratory inhalers?
Trends include increased reliance on contract manufacturing, technological innovations in API synthesis, regional regulatory harmonization, and sustainability considerations impacting supply chain decisions.

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References

1. U.S. Pharmacopeia, USP Monograph on Albuterol Sulfate.
2. ICH Guidelines on Good Manufacturing Practices (GMP).
3. Market reports on respiratory API manufacturing.
4. Industry whitepapers on supply chain resilience during health crises.
5. Company disclosures and certifications from Cipla, Jiangsu Hengrui, and Teva.

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This comprehensive overview equips pharmaceutical professionals and supply chain managers with critical insights into the sourcing landscape of albuterol sulfate API for ProAir RespiClick, fostering informed procurement and quality assurance strategies.