Bulk Pharmaceutical API Sources for FLOVENT DISKUS 250

Bulk Pharmaceutical API Sources for FLOVENT DISKUS 250

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-847-468
Hangzhou APIChem Technology		AC-457
Amadis Chemical		A839922
AKos Consulting & Solutions		AKOS015895220
Finetech Industry Limited		FT-0626494

Bulk Active Pharmaceutical Ingredient (API) Sources for: FLOVENT DISKUS 250

Last updated: August 19, 2025

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Introduction

FLOVENT DISKUS 250 is a commercially marketed inhalation corticosteroid used in asthma and COPD management. The active pharmaceutical ingredient (API) in FLOVENT DISKUS 250 is fluticasone propionate, a potent glucocorticoid with anti-inflammatory properties. The efficient, safe, and compliant sourcing of fluticasone propionate is critical for pharmaceutical manufacturers to ensure product quality, regulatory adherence, and cost-effectiveness.

This report provides an in-depth evaluation of bulk API suppliers for fluticasone propionate tailored for the manufacturing of FLOVENT DISKUS 250, highlighting global sources, quality considerations, regulatory status, and market trends.

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Overview of Fluticasone Propionate API

Chemical Profile:
Fluticasone propionate (C₂₂H₃₁F₃O₅S) is a synthetic trifluorinated corticosteroid characterized by its high potency and low systemic absorption when administered via inhalation. Its chemical stability, bioavailability, and performance hinge on the purity and quality of the API supplied.

Manufacturing Challenges:
The synthesis involves complex multi-step processes, typically including chlorination, fluorination, and esterification, demanding stringent control measures to ensure high purity and batch-to-batch consistency.

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Key API Sources for FLOVENT DISKUS 250

1. International Major API Manufacturers

a. Teva Pharmaceutical Industries Ltd.
Teva’s manufacturing facilities in Israel and India are capable of producing high-quality fluticasone propionate, adhering to cGMP standards. They are pre-approved suppliers for many global markets and hold multiple regulatory authorizations, including US FDA and EMA approvals.

b. Mylan (now part of Viatris)
Mylan’s robust API manufacturing infrastructure in India and Europe supplies various inhalation APIs, including fluticasone propionate. Their facilities comply with rigorous quality standards, and they maintain extensive regulatory dossiers.

c. Sandoz (Novartis AG)
Sandoz operates manufacturing units in Europe and Asia capable of producing inhalation steroids at scale. Their API quality management aligns with international regulatory frameworks, ensuring supply chain security.

d. Cipla Ltd.
As a leading Indian generic pharmaceutical manufacturer, Cipla produces fluticasone propionate API under strict cGMP conditions, serving both domestic and international markets. Their R&D enables custom synthesis tailored to inhaler formulations.

e. 503B and 503A Compounders (US-based)
Several US-based compounding companies, under FDA oversight, source APIs from approved international suppliers for sterile and non-sterile inhalation products. While generally not primary API suppliers for commercial inhalers, their reliance on high-quality API sources is critical for compounded formulations.

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2. Regional and Specialty API Suppliers

a. Dr. Reddy’s Laboratories
Operating manufacturing facilities in India and North America, Dr. Reddy's supplies high-purity fluticasone APIs compliant with international standards, emphasizing sustainable production processes.

b. Glenmark Pharmaceuticals
Glenmark’s API manufacturing at their facilities in India is capable of producing fluticasone propionate with a focus on high purity and batch consistency.

c. Famar Pharmaceuticals
A European API manufacturer providing advanced synthesis capabilities for inhalation APIs, including fluticasone derivatives, often used by innovative inhaler developers.

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Quality and Regulatory Considerations

The choice of API supplier for FLOVENT DISKUS 250 hinges upon several critical factors:

• Regulatory Approvals: Only suppliers with validated manufacturing processes and approvals (FDA, EMA, PMDA, etc.) should be considered to meet the stringent quality standards.

• Batch Consistency and Purity: API purity levels typically exceed 99.9%, with low levels of residual solvents, impurities, and residual catalysts. Certificates of Analysis (CoA) must confirm batch-specific quality.

• Supply Chain Security: Verified suppliers with proven track records mitigate risks related to shortages or regulatory non-compliance, particularly as regulatory agencies increase scrutiny of API manufacturing.

• Audit and Compliance: Routine on-site audits and quality audits are essential for maintaining supplier accreditation.

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Market Trends and Future Outlook

• Growing Demand: The global inhaled corticosteroid market continues to expand, driven by rising asthma and COPD prevalence. Ensuring a reliable API supply chain is increasingly critical.

• Shift Towards Asian Suppliers: Indian API manufacturers like Cipla, Glenmark, and Dr. Reddy's are expanding their global footprint due to cost advantages and robust manufacturing capabilities.

• Regulatory Stringency: Suppliers investing in quality management systems (QMS) aligned with ICH guidelines are preferred. The trend toward tighter regulatory oversight emphasizes the importance of validated APIs.

• Potential for Biosynthetically Derived APIs: Advances in synthetic routes and bioengineering could diversify API sources and improve supply stability.

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Conclusion

Securing high-quality fluticasone propionate API for FLOVENT DISKUS 250 involves identifying suppliers that offer regulatory compliance, consistent quality, and supply security. Leading international manufacturers such as Teva, Mylan, Sandoz, Cipla, and Dr. Reddy’s are primary sources, each with proven capacity and regulatory approvals. Ongoing market growth and regulatory evolution underscore the importance of strategic sourcing, supplier audits, and monitoring of global API manufacturing trends.

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Key Takeaways

• Selecting a reputable API supplier is paramount for compliance, safety, and product efficacy.
• Indian manufacturers are significant and expanding sources of high-quality fluticasone propionate.
• Regulatory approvals (FDA, EMA) and rigorous quality controls are essential for supplier qualification.
• Supply chain robustness should be prioritized given market demands and potential disruptions.
• Continuous market and regulatory intelligence are necessary for maintaining a reliable API sourcing strategy.

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FAQs

Q1: Are there any authorized generic API manufacturers for fluticasone propionate in the US?
Yes. Suppliers like Cipla and Dr. Reddy’s are FDA-registered and have been approved to produce high-purity APIs used in inhalers like FLOVENT DISKUS 250.

Q2: What is the typical purity level required for API in inhaled corticosteroids?
The purity generally exceeds 99.9%, with stringent limits on residual solvents, related impurities, and contaminants, according to pharmacopeial standards such as USP and EP.

Q3: How does supply chain security impact API sourcing for inhaler products?
Secure, qualified, and diverse API sources minimize risks of shortages, regulatory non-compliance, and production delays, safeguarding consistent product supply.

Q4: Are there any renewable or biosynthetic alternatives to traditional chemical synthesis for fluticasone?
Current mainstream production relies on chemical synthesis. However, ongoing research into biotechnological approaches may in future provide alternative production methods.

Q5: What role do regulatory audits play in API supplier qualification?
Regulatory audits validate compliance with cGMP standards, ensuring the supplier’s manufacturing processes, facilities, and quality systems meet international requirements.

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References:

[1] U.S. Food and Drug Administration (FDA). Inhalation API manufacturing standards.
[2] European Medicines Agency (EMA). Guideline on quality of inhalation products.
[3] GlobalData. API Market Insights for Inhaled Corticosteroids, 2022.
[4] ICH Q7 Guidelines. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
[5] Company disclosures and regulatory submissions from Cipla, Dr. Reddy’s, Teva, and other suppliers.

Note: This document synthesizes publicly available information and industry knowledge. Stakeholders should conduct due diligence and consult directly with suppliers to verify current manufacturing status and regulatory compliance.