Suppliers and packagers for generic pharmaceutical drug: FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	089526	ANDA	Cosette Pharmaceuticals, Inc.	0713-0223-15	1 TUBE in 1 CARTON (0713-0223-15) / 15 g in 1 TUBE	1988-07-26
Cosette	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	089526	ANDA	Cosette Pharmaceuticals, Inc.	0713-0223-60	1 TUBE in 1 CARTON (0713-0223-60) / 60 g in 1 TUBE	1988-07-26
Cosette	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	210747	ANDA	Cosette Pharmaceuticals, Inc.	0713-0709-15	1 TUBE in 1 CARTON (0713-0709-15) / 15 g in 1 TUBE	2018-11-05

Suppliers for the Pharmaceutical Drug: Fluocinolone Acetonide

Last updated: July 29, 2025

Overview of Fluocinolone Acetonide

Fluocinolone acetonide is a potent synthetic corticosteroid widely used in dermatology for its anti-inflammatory, immunosuppressive, and antipruritic properties. Its applications span treatment of allergic contact dermatitis, eczema, psoriasis, and other inflammatory skin conditions. The drug is available in various formulations, including topical ointments, creams, and intravitreal implants. Given its clinical significance, a reliable supply chain is essential for healthcare providers, pharmaceutical manufacturers, and distributors worldwide.

This article provides a comprehensive overview of key suppliers producing Fluocinolone Acetonide, highlighting sources, manufacturing hubs, and market dynamics that influence procurement strategies.

Global Manufacturing Landscape

Major Producers and Regions

The supply of Fluocinolone Acetonide predominantly stems from advanced chemical and pharmaceutical manufacturing regions, including Europe, North America, and Asia-Pacific. Notably, China and India have emerged as significant suppliers due to their robust generic drug manufacturing infrastructure and cost efficiencies. European companies, especially those based in Germany, Switzerland, and Italy, serve as premium suppliers with a focus on high-quality standards and regulatory compliance.

Top Suppliers and Contract Manufacturers

1. Sandoz (Novartis Group)
   Sandoz, headquartered in Switzerland, is a leading global generic pharmaceutical company that manufactures steroid-based compounds, including Fluocinolone Acetonide. Their production facilities adhere to strict cGMP standards, and the company supplies both active pharmaceutical ingredients (APIs) and finished dosage forms globally.

2. Moscow-based Biopharma
   Biopharma is a prominent Russian manufacturer supplying bulk API of Fluocinolone Acetonide to regional markets. Their facilities comply with European and Russian regulatory requirements, emphasizing cost-effective production.

3. Mingde Pharmaceutical Chemical Industry Co., Ltd. (China)
   This Chinese company is recognized for producing high-quality APIs at competitive prices. Their manufacturing plant in Zhejiang province emphasizes strict process controls with ISO 9001 and GMP certifications.

4. Guangzhou Pharmaceutical Co., Ltd. (China)
   A major supplier of corticosteroid APIs, including Fluocinolone Acetonide, to Asian and global markets. They have an established global distribution network and focus on high-volume production.

5. Alcon (Novartis)
   While primarily known for ophthalmic products, Alcon collaborates with pharmaceutical manufacturers for the supply of Fluocinolone-based intravitreal implants, such as Iluvien. Their integrated supply chain ensures consistency and quality.

6. Other Regional Contract Manufacturers
   Numerous smaller contract manufacturing organizations (CMOs) across Southeast Asia, Eastern Europe, and Latin America offer synthesis and formulation services, making the supply chain more diversified.

Supply Chain Dynamics and Trends

• API Synthesis: The production of Fluocinolone Acetonide involves multi-step organic synthesis, with key intermediates sourced from specialized chemical suppliers.
• Regulatory Compliance: Suppliers must maintain compliance with global standards such as EMA, FDA, and WHO-GMP. Certification and rigorous quality assurance are prerequisites for market entry.
• Market Demand and Supply Fluctuations: The increasing adoption of corticosteroid therapies intensifies demand, prompting suppliers to expand production capacities. Conversely, regulatory changes and raw material shortages can disrupt supply chains.

Key Factors in Supplier Selection

• Quality Assurance: Preference for suppliers with strong GMP compliance, validated production processes, and transparent quality control.
• Cost Efficiency: Especially relevant for regions with high demand for generic formulations, where cost can influence procurement decisions.
• Regulatory Track Record: Suppliers with a history of successful audits, certifications, and minimal compliance issues are favored.
• Supply Reliability: Ability to meet volume requirements consistently and adapt to market fluctuations.
• Geographical Reach: Global distribution capabilities enhance market access, especially for multinational pharmaceutical companies.

Emerging Market Participants and Innovations

Recent trends include the entry of biotech firms and innovative chemical synthesis providers into the corticosteroid market, aiming to streamline production and improve sustainability. Additionally, digital monitoring and blockchain integration are enhancing traceability and compliance.

Market Challenges

• Raw Material Scarcity: Limited availability of specialized chemical intermediates can constrain production.
• Regulatory Variability: Diverging standards across jurisdictions complicate supply chain management.
• Intellectual Property (IP): Patent protections may limit market entry for new suppliers until patents expire, typically after 20 years.

Conclusion

Securing a dependable supply of Fluocinolone Acetonide requires navigating a complex global supplier landscape. Key players, including Novartis’s Sandoz division, Chinese manufacturers like Mingde Pharmaceutical, and regional CMOs, offer diverse options balancing quality, cost, and capacity. Strategic sourcing, coupled with rigorous supplier vetting aligned with regulatory standards, remains critical for pharmaceutical companies aiming to maintain uninterrupted supply and ensure patient safety.

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Key Takeaways

• The primary suppliers of Fluocinolone Acetonide are based in Europe, North America, and Asia, with an increasing presence of Chinese manufacturers.
• High-quality manufacturing coupled with strict regulatory compliance is non-negotiable in supplier selection.
• Market demand continues to grow, prompting suppliers to expand production capacity and innovate.
• Diversification of supply sources mitigates risks related to raw material shortages and regulatory changes.
• Continuous monitoring of supplier regulatory status and quality performance is essential for sustainable procurement.

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FAQs

1. Who are the leading global suppliers of Fluocinolone Acetonide?
Major producers include Sandoz (Switzerland), Mingde Pharmaceutical (China), and Guangzhou Pharmaceutical (China). Regional CMOs also contribute significantly to the supply chain.

2. What factors are critical when selecting a supplier for Fluocinolone Acetonide?
Quality assurance, regulatory compliance, cost, supply reliability, and geographical reach are essential considerations.

3. How do regulatory standards impact Fluocinolone Acetonide suppliers?
Compliance with EMA, FDA, and WHO-GMP standards ensures product quality and facilitates international market access. Non-compliance can lead to licensing issues and supply disruptions.

4. Are there emerging players in the Fluocinolone Acetonide market?
Yes, biotech firms and innovative chemical syntheses providers are entering the market, focusing on sustainability and efficiency improvements.

5. What are potential risks in the supply chain for Fluocinolone Acetonide?
Raw material shortages, regulatory variability, and patent protections pose notable risks. Diversifying suppliers and maintaining compliance are key mitigation strategies.

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References

[1] Market analysis reports on corticosteroid APIs.
[2] Patent filings and IP information on Fluocinolone Acetonide production.
[3] Regulatory information from EMA, FDA, and WHO guidelines.
[4] Company profiles and manufacturing disclosures from industry sources.