Bulk Pharmaceutical API Sources for PROAIR DIGIHALER

Bulk Pharmaceutical API Sources for PROAIR DIGIHALER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		S5013_SIGMA
Hangzhou Trylead Chemical Technology		TL8003382
NovoSeek		39859
MP Biomedicals		156574
TCI (Tokyo Chemical Industry)		S0531
MolPort		MolPort-003-933-916
ABI Chem		AC1L22LX

Bulk Active Pharmaceutical Ingredient (API) Sources for: Proair Digihaler

Last updated: July 29, 2025

Introduction

The Proair Digihaler, a maintenance and rescue inhaler, primarily contains albuterol sulfate as its active pharmaceutical ingredient (API). This inhaler employs digital health technology to provide inhalation data, enhancing asthma and COPD management. As the downstream pharmaceutical supply chain is critical for device manufacturing, identifying reliable API sources is vital for ensuring product quality, regulatory compliance, and supply chain stability.

Understanding the API: Albuterol Sulfate

Albuterol sulfate, the API in Proair Digihaler, is a beta-2 adrenergic agonist that relaxes airway smooth muscle, providing bronchodilation. As a well-established pharmaceutical, albuterol sulfate is manufactured globally, with high regulatory standards maintained by leading API producers. These manufacturers supply bulk API in various grades—pharmaceutical, technical, and USP grade—depending on the application.

Global API Suppliers for Albuterol Sulfate

1. Major Domestic and International API Producers

Leading pharmaceutical API manufacturers supplying albuterol sulfate include:

• Hovione: A global, integrated drug development and manufacturing firm with facilities in Ireland, the US, China, and Portugal. Hovione produces high-quality APIs complying with cGMP standards, with a focus on inhalation APIs.

• Famar: A European contract manufacturer with capabilities in inhalation API production, ensuring purity and particle size specifications suitable for inhalers like Proair.

• G Profarma: A Brazilian API producer providing albuterol sulfate meeting international standards, with flexible scale manufacturing options.

• Chengdu Sincerity Pharmaceutical Co. Ltd.: Chinese manufacturer with Good Manufacturing Practice (GMP) certification, supplying albuterol sulfate APIs to international markets.

• Jubilant Pharma: An Indian pharmaceutical API producer known for consistent quality control and large-scale manufacturing of inhalation APIs, including albuterol sulfate.

2. Contract Manufacturing and API Bulk Suppliers

Many pharmaceutical companies rely on Contract Manufacturing Organizations (CMOs) for bulk API sourcing, including:

• Sun Pharmaceutical Industries: Offers bulk APIs of albuterol sulfate, with manufacturing plants compliant with global standards.

• Aurobindo Pharma: Supplies inhalation APIs, including albuterol sulfate, with proven global distribution networks.

• Dr. Reddy’s Laboratories: Provides high-quality APIs with extensive manufacturing expertise for inhalation products.

3. API Quality and Regulatory Considerations

When sourcing API for inhalers such as Proair Digihaler, quality is paramount. Suppliers must comply with US Pharmacopeia (USP) standards, be cGMP compliant, and have robust stability and purity profiles. Ensuring batch traceability, quality documentation, and validation records is vital for regulatory approval, especially when manufacturing products for the US market governed by the FDA.

Supply Chain Dynamics and Risk Management

The demand for inhaled APIs, especially for widespread products like Proair, is substantial and sensitive to market fluctuations. Disruptions can originate from geopolitical issues, manufacturing bottlenecks, or regulatory changes. Diversification of API sources, establishing long-term supply agreements, and rigorous supplier qualification processes mitigate these risks.

Emerging Trends and Innovations

Advancements in API manufacturing involve particle engineering for inhalation, ensuring optimal aerosolization profiles. Some manufacturers develop micronized or nano-sized albuterol sulfate to improve lung deposition, which may influence API sourcing decisions based on particle specifications.

Furthermore, quality assurance programs like continuous GMP audits and supply chain transparency initiatives are increasingly critical, especially for products integrated with digital health technology, like the Digihaler.

Regulatory Pathways and Compliance

API suppliers must meet the regulatory standards set by the FDA, EMA, and other global bodies. The supplier’s documentation, including analytical data, certificates of analysis, and compliance audits, underpin the continuous approval process. For inclusion in a sealed combination device like Proair Digihaler, APIs must also meet device-specific compatibility standards.

Conclusion

Reliable bulk API sourcing for albuterol sulfate essential to the Proair Digihaler involves engaging with globally recognized manufacturers capable of delivering high-purity, GMP-compliant products. Companies must evaluate suppliers based on quality infrastructure, regulatory compliance, production capacity, and supply chain robustness. As inhaled products evolve with technological integrations, maintaining API quality and consistency remains central to delivering safe and effective pulmonary therapies.

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Key Takeaways

• Leading API suppliers for albuterol sulfate include Hovione, Jubilant Pharma, Aurobindo Pharma, and others with strong regulatory compliance.
• Multiple sourcing strategies, including diversifying suppliers and establishing strategic partnerships, reduce supply chain risks.
• API quality standards, especially cGMP compliance and USP-grade certification, are non-negotiable for inhalation products.
• Technological advancements in API particle engineering influence sourcing decisions to meet inhalation delivery specifications.
• Continuous monitoring of regulatory compliance and supply chain transparency ensures consistent product quality for devices like Proair Digihaler.

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Frequently Asked Questions

1. What are the primary factors affecting API sourcing for inhaler products like Proair Digihaler?
Quality compliance, regulatory approval, manufacturing capacity, stability profiles, and supply chain reliability are paramount when sourcing APIs for inhalation devices.

2. How does API quality impact the safety and efficacy of inhaler medications?
High-quality APIs ensure consistent particle size, purity, and stability, directly influencing drug-delivery efficiency, safety, and regulatory approval outcomes.

3. Are there international differences in API manufacturing standards?
Yes. While most reputable manufacturers adhere to cGMP standards for APIs, variations in regulatory oversight across countries can influence supplier selection. Regulators require stringent documentation regardless of origin.

4. What strategic approaches can companies use to mitigate risks related to API supply interruptions?
Diversifying suppliers, developing long-term supply agreements, maintaining safety stock, and establishing secondary manufacturing sources can mitigate supply chain disruptions.

5. How does the digital component of the Proair Digihaler influence API sourcing considerations?
While the digital aspect primarily involves device electronics, ensuring API consistency and compatibility with the inhalation mechanism remains essential, especially for clinical performance validation and device integration.

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Sources

[1] Hovione. "API Manufacturing Capabilities." Hovione.com.
[2] Jubilant Pharma. "Pharmaceutical API Portfolio," Jubilant.com.
[3] US Pharmacopeia. "USP Standards for Albuterol Sulfate."USP.org.
[4] FDA Guidance for Industry: "Good Manufacturing Practices for Inhalation Drugs." FDA.gov.
[5] Inhalation API particle engineering advancements, Journal of Aerosol Medicine and Pulmonary Drug Delivery.