Bulk Pharmaceutical API Sources for ADVAIR DISKUS 500/50

Bulk Pharmaceutical API Sources for ADVAIR DISKUS 500/50

Vendor	Vendor Homepage	Vendor Sku	API Url
Smolecule		S543013
DC Chemicals		DC34223
TargetMol		TP2406
BenchChem		B610793
CymitQuimica		CQ_136112-01-1
Starshine Chemical		2023-03-14B4338

Bulk Active Pharmaceutical Ingredient (API) Sources for: ADVAIR DISKUS 500/50

Last updated: August 16, 2025

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Introduction

The pharmaceutical industry relies heavily on the quality and consistency of Active Pharmaceutical Ingredients (APIs). For asthma and COPD management, Advair Diskus 500/50 contains a combination of fluticasone propionate (500 mcg) and salmeterol xinafoate (50 mcg) per inhalation. Securing reliable API sources is crucial for manufacturers, ensuring regulatory compliance, product efficacy, and market supply stability. This article explores the primary API sources for Advair Diskus 500/50, emphasizing supplier landscape, quality considerations, and strategic sourcing implications.

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Composition Overview of Advair Diskus 500/50

Advair Diskus combines:

• Fluticasone Propionate: a synthetic corticosteroid with anti-inflammatory properties.
• Salmeterol Xinafoate: a long-acting beta2-adrenergic agonist (LABA).

Each delivers 500 mcg fluticasone and 50 mcg salmeterol per inhalation. The APIs’ sourcing influences formulation integrity, inhalation device compatibility, and therapeutic efficacy.

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Global API Supply Landscape

The major API suppliers for fluticasone propionate and salmeterol xinafoate are concentrated in specific regions, with stringent regulatory adherence:

1. Fluticasone Propionate API Sources

a. GSK and Core API Manufacturers

GlaxoSmithKline (GSK), the original developer of Flovent and Advair, internally produces fluticasone for in-house use and collaborates with external API manufacturers. Some key API manufacturing entities include:

• Dr. Reddy’s Laboratories (India): A major supplier for generic APIs, including fluticasone. They possess robust API manufacturing facilities compliant with global standards (ICH Q7, cGMP) and supply to multiple generic drug producers.
• Mitsubishi Chemical Corporation (Japan): Known for synthesizing corticosteroids, including fluticasone. Their production facilities maintain high regulatory standards suitable for APIs used in inhalation products.
• TEVA Pharmaceuticals (Israel): Produces both generics and active pharmaceutical ingredients, including corticosteroid APIs, with proven safety and quality systems.

b. Contract Manufacturing Organizations (CMOs)

Several CMOs in India, China, and Europe provide fluticasone APIs, including:

• Hikal Ltd. (India) – Complies with WHO and USFDA standards, supplying bulk APIs to multinational companies.
• Solara Active Pharmas Ltd. (India) – Operates cGMP-compliant facilities, with a range of respiratory-related APIs.

c. Geographic Focus

India dominates fluticasone propionate API production, leveraging established bulk manufacturing capabilities at cost-effective scales. European and Japanese firms primarily serve markets requiring originator APIs or high regulatory stringency.

2. Salmeterol Xinafoate API Sources

a. GSK and Other Major Suppliers

GSK also produces salmeterol for internal use and external licensing agreements. However, several other firms manufacture and distribute salmeterol APIs:

• Dr. Reddy’s Laboratories: Supplies salmeterol xinafoate API globally, especially for generic inhaler products.
• Synthesis Pharmaceuticals (India): Produces salmeterol adhering to global cGMP standards.
• Sun Pharmaceutical Industries Ltd.: Acts as a significant supplier of salmeterol in various markets.

b. Contract and Custom Synthesis

Third-party CROs and CMOs in India, China, and Europe with expertise in beta-adrenergic compounds provide salmeterol xinafoate APIs for both branded and generic applications.

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Quality and Regulatory Considerations

API sources for Advair Diskus 500/50 must meet strict cGMP standards, with documentation supporting:

• Batch consistency
• Potency specifications
• Absence of unacceptable contaminants
• Stability compatibility with device formulation

Originator APIs used in branded products like Advair originated from approved suppliers meeting FDA, EMA, or other international standards. Generic manufacturers sourcing APIs from established suppliers are required to validate API quality and compliance.

Regulatory filings often specify approved API suppliers to ensure traceability and quality assurance. Transitioning between suppliers or sourcing from lesser-known entities increases the need for stringent quality verification, including audits, stability testing, and analytical validation.

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Strategic Implications for Manufacturers

• Supply Security: Potential risks include geopolitical tensions, manufacturing disruptions, or regulatory exclusions impacting API availability.
• Cost Optimization: India and China remain cost-effective sources, but quality and regulatory tracking are paramount.
• Regulatory Strategy: Maintaining relationships with approved API suppliers aligns with regulatory expectations and product approvals.
• Technology Transfer: When switching API sources, comprehensive transfer protocols preserve product quality and device compatibility.

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Emerging Trends in API Sourcing for Respiratory APIs

• Supply Chain Resilience: Diversification of API sources, including dual-sourcing strategies, mitigates risk.
• Local Manufacturing Initiatives: Some regions incentivize local production to reduce dependency on global imports.
• Regulatory Stringency: Increased auditing and requirements for API qualification, particularly with evolving standards like ICH Q11.

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Conclusion

The bulk API sourcing landscape for Advair Diskus 500/50 primarily revolves around manufacturers in India, supplemented by European and Japanese firms meeting high-quality standards. Strategic sourcing necessitates rigorous validation, regulatory compliance, and supply chain risk management to uphold the product’s therapeutic integrity and market availability.

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Key Takeaways

• India and China dominate the API supply chain for fluticasone propionate and salmeterol xinafoate, offering cost-effective and compliant options.
• Ensuring API batch consistency and regulatory approval is paramount for maintaining Advair Diskus quality.
• Close supplier management and diversifying API sources minimize supply disruptions.
• Originator APIs for Advair are sourced from highly regulated manufacturers, setting a benchmark for quality.
• Ongoing industry trends favor resilient supply chains and increased regulatory oversight for respiratory APIs.

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FAQs

1. Who are the primary API suppliers for fluticasone propionate used in Advair Diskus?
Major suppliers include Dr. Reddy’s Laboratories (India), Mitsubishi Chemical Corporation (Japan), and CMOs in India and Europe adhering to cGMP standards.

2. What regulatory standards do API manufacturers for Advair need to meet?
Manufacturers must comply with ICH Q7, cGMP, and specific regulatory agency requirements like the USFDA and EMA to ensure API safety, potency, and purity.

3. Can alternative API sources be used for manufacturing generic versions of Advair?
Yes, provided these sources meet regulatory approval, quality standards, and have approved documentation supporting their safety and efficacy.

4. What are the risks associated with sourcing APIs from emerging markets?
Potential risks include regulatory non-compliance, supply interruptions, and quality variability. Thorough qualification, audits, and quality audits mitigate these concerns.

5. How is supply chain resilience maintained for APIs used in respiratory medications?
By diversifying suppliers, maintaining strategic inventories, implementing robust supplier qualification processes, and fostering regional manufacturing capabilities.

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References

[1] U.S. FDA. (2022). Guidance for Industry: Good Manufacturing Practice Regulations for Finished Pharmaceuticals.
[2] International Council for Harmonisation (ICH). (2009). ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
[3] GSK Annual Reports and API supplier disclosures.
[4] Indian Pharmaceutical Association (IPA). Indian API manufacturing landscape overview.
[5] Pharmaceutical Technology. API sourcing strategies in respiratory pharmaceuticals.