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Suppliers and packagers for generic pharmaceutical drug: FLUTICASONE FUROATE
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FLUTICASONE FUROATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625 | NDA | GlaxoSmithKline LLC | 0173-0874-10 | 1 INHALER in 1 CARTON (0173-0874-10) / 30 POWDER in 1 INHALER | 2014-08-20 |
| Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625 | NDA | GlaxoSmithKline LLC | 0173-0874-14 | 1 INHALER in 1 CARTON (0173-0874-14) / 14 POWDER in 1 INHALER | 2014-08-20 |
| Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625 | NDA | GlaxoSmithKline LLC | 0173-0876-10 | 1 INHALER in 1 CARTON (0173-0876-10) / 30 POWDER in 1 INHALER | 2014-08-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Fluticasone Furoate
Introduction
Fluticasone furoate is a potent corticosteroid primarily used to treat allergic rhinitis, asthma, and other inflammatory respiratory conditions. Its efficacy, combined with its favorable pharmacokinetic profile, has led to widespread adoption across the pharmaceutical industry. As demand surges, identifying reliable suppliers for high-quality fluticasone furoate becomes imperative for pharmaceutical companies, healthcare providers, and regulatory bodies. This article provides a comprehensive analysis of primary suppliers, manufacturing players, and the broader supply chain landscape for fluticasone furoate.
Manufacturers and Suppliers in the Global Market
1. GlaxoSmithKline (GSK)
Overview:
GSK is the original developer of fluticasone furoate, holding significant patent rights and manufacturing capabilities. Their flagship products, such as Breo Ellipta (combination of fluticasone furoate and vilanterol), exemplify their leadership in this segment.
Supply Chain Role:
GSK supplies both APIs (Active Pharmaceutical Ingredients) and finished dosage forms. The company's expansive manufacturing infrastructure ensures consistent quality and supply continuity globally.
Market Impact:
As the patent holder and a key manufacturer, GSK remains a dominant force, especially in North America and Europe.
2. Teva Pharmaceutical Industries
Overview:
Teva is a global generic pharmaceutical giant with diversified portfolio offerings. The company has manufactured generic formulations containing fluticasone furoate.
Supply Chain Role:
Teva sources APIs from multiple manufacturers and produces generic inhalers and nasal sprays for various regions, often at lower costs, increasing access.
Market Impact:
Teva's widespread manufacturing capacity ensures an alternative supply channel, especially critical as patent protections evolve.
3. Cipla Limited
Overview:
Cipla, an Indian pharmaceutical leader, manufactures both APIs and finished formulations, including inhalers and nasal sprays containing fluticasone furoate.
Supply Chain Role:
Cipla's robust API manufacturing facilities in India contribute significantly to the supply chain, especially for developing markets.
Market Impact:
Cipla helps meet rising global demand with competitive pricing, ensuring broader access in emerging markets.
4. Sandoz (Novartis)
Overview:
Sandoz specializes in generics and biosimilars, including inhalation products with fluticasone furoate.
Supply Chain Role:
Their manufacturing facilities in Europe and emerging markets produce both APIs and finished goods, adhering to strict regulatory standards.
Market Impact:
Sandoz enhances the availability of fluticasone-based therapies through its extensive product range.
5. Other Notable Suppliers
- Ariadne Pharma (India): Emerging API manufacturer targeting domestic and international markets.
- Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Focused on corticosteroid APIs and formulations.
- Dottikon Exclusive Synthesis (Switzerland): Contract manufacturer specializing in complex APIs, including corticosteroids.
- STADA Arzneimittel AG (Germany): Produces generic inhalation products with fluticasone furoate.
API Manufacturing and Supply Dynamics
The core of the supply chain lies in the production of Active Pharmaceutical Ingredients. Fluticasone furoate synthesis involves intricate multi-step organic processes, demanding high precision and strict quality controls.
Key API manufacturing hubs include:
- India: Rapidly growing API sector, led by companies like Cipla and Dr. Reddy's Laboratories.
- China: Increasing capacity for corticosteroid API production, with increased regulatory scrutiny.
- Europe: Sandoz and other firms maintaining high-quality production aligned with stringent regulatory standards.
Manufacturers must adhere to Good Manufacturing Practices (GMP) set forth by agencies like the FDA, EMA, and equivalents to ensure API purity and consistency.
Supply Chain Challenges
- Regulatory Barriers: Different countries impose varied compliance standards, affecting API export/import.
- Raw Material Availability: Fluctuations in precursor chemicals can disrupt production schedules.
- Patent Expiry: Post-patent expiration, increased generic competition can influence supply dynamics.
- Geopolitical Factors: Trade tensions and import restrictions impact global supply.
Distribution and Logistics
Once manufactured, fluticasone furoate APIs and finished products traverse complex logistics, involving:
- Bulk API distribution centers acting as intermediaries.
- Regional manufacturing units converting APIs into inhalers or nasal sprays.
- Distribution partners ensuring timely delivery to pharmacies and healthcare systems globally.
This multi-tiered supply chain necessitates meticulous inventory management to prevent shortages, especially in high-demand markets like the US and Europe.
Regulatory and Quality Considerations
Suppliers must maintain GMP compliance and undergo rigorous audits to ensure product quality and safety. Regulatory agencies, including the FDA and EMA, routinely scrutinize manufacturing facilities, influencing supplier credibility.
Moreover, suppliers with transparent quality records and robust pharmacovigilance systems are preferred, especially given the critical nature of respiratory therapies.
Emerging Trends and Future Outlook
- Contract Manufacturing Organizations (CMOs): Increasing reliance on CMOs for cost-effective and scalable production.
- Sustainability Initiatives: Suppliers adopting greener manufacturing practices to meet environmental standards.
- Regional Focus: Expansion in Asia and emerging markets to meet local demand and reduce reliance on Western manufacturing hubs.
- Innovation in API Synthesis: Advances in synthetic pathways aiming for higher yields and fewer impurities.
Key Takeaways
- GSK remains the primary innovator and supplier for fluticasone furoate, holding patents and manufacturing pivotal for branded products.
- Diversification of suppliers, including generics manufacturers like Teva and Cipla, ensures supply stability and broad access.
- Asia-Pacific region dominates API manufacturing, with India and China leading capacity growth.
- Maintaining strict regulatory compliance and quality standards** is critical for all suppliers.
- Future supply chain resilience hinges on geopolitical stability, technological innovations, and strategic diversification.
FAQs
1. Who are the leading global manufacturers of fluticasone furoate API?
Leading API manufacturers include Cipla (India), Zhejiang Hisun Pharmaceutical (China), and Sandoz (Europe). GSK primarily controls the formulation development and branding.
2. Are there alternatives to GSK in supplying fluticasone furoate?
Yes, several generic and contract manufacturers supply fluticasone furoate, especially post-patent expiry, providing alternative sources.
3. What are the primary challenges in sourcing fluticasone furoate?
Challenges include regulatory compliance, raw material availability, geopolitical issues, and maintaining consistent quality across manufacturing sites.
4. How does the supply chain impact drug pricing and availability?
A robust, diversified supply chain ensures stable pricing and minimizes shortages, while disruptions can lead to higher costs and limited access.
5. What future trends will influence suppliers of fluticasone furoate?
Emerging trends include increased focus on contract manufacturing, sustainability practices, manufacturing in emerging markets, and technological advancements in synthesis processes.
References
[1] Pharmaceutical Technology. "The Role of API Suppliers in the Global Respiratory Market." 2022.
[2] GSK Official Website. "Respiratory Portfolio." 2023.
[3] Teva Pharmaceuticals. "Global API Supply Chain." 2022.
[4] Cipla Limited. "API Manufacturing Capabilities." 2023.
[5] Sandoz Annual Report. "Innovations in Corticosteroid Production." 2022.
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