Suppliers and packagers for SYNALAR

SYNALAR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medimetriks Pharms	SYNALAR	fluocinolone acetonide	CREAM;TOPICAL	012787	NDA	Medimetriks Pharmaceuticals, Inc.	43538-900-12	1 TUBE in 1 CARTON (43538-900-12) / 120 g in 1 TUBE	2012-09-27
Medimetriks Pharms	SYNALAR	fluocinolone acetonide	CREAM;TOPICAL	012787	NDA AUTHORIZED GENERIC	ANI Pharmaceuticals, Inc.	62559-288-15	1 TUBE in 1 CARTON (62559-288-15) / 15 g in 1 TUBE	2024-05-08
Medimetriks Pharms	SYNALAR	fluocinolone acetonide	CREAM;TOPICAL	012787	NDA AUTHORIZED GENERIC	ANI Pharmaceuticals, Inc.	62559-288-60	1 TUBE in 1 CARTON (62559-288-60) / 60 g in 1 TUBE	2024-05-08

Suppliers for the Pharmaceutical Drug: Synalar

Last updated: July 30, 2025

Introduction

Synalar, a topical corticosteroid containing fluocinonide, is widely prescribed to treat inflammatory and allergic skin conditions such as eczema, psoriasis, and dermatitis. As an effective anti-inflammatory agent, its supply chain is complex, involving multiple manufacturers, wholesalers, and distributors globally. This analysis provides a comprehensive overview of the primary suppliers, manufacturing landscape, and market dynamics influencing Synalar's availability in the international pharmaceutical supply chain.

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Understanding Synalar's Composition and Regulatory Status

Synalar’s active ingredient, fluocinonide, is a potent topical corticosteroid. Its regulatory approval and manufacturing are governed by stringent standards set by bodies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and equivalent authorities in other jurisdictions. Due to its potent pharmacology, quality control in manufacturing is critical, which influences the supply chain structure (References [1], [2]).

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Major Manufacturers of Fluocinonide and Synalar

1. GlaxoSmithKline (GSK):

   GSK is historically among the primary originators and suppliers of fluocinonide formulations, including Synalar. With global facilities, GSK maintains a significant share of the market through proprietary formulations and licensing agreements.

2. Mitsubishi Tanabe Pharma Corporation:

   Japan-based Mitsubishi Tanabe Pharma produces fluocinonide for both local and export markets, often supplying generic formulations in Asia. Their manufacturing complies with the Good Manufacturing Practices (GMP) standards.

3. Perrigo Company:

   Perrigo is a leading supplier of over-the-counter (OTC) and prescription dermatologic products, including fluocinonide-based formulations, often serving as a key supplier for generic Synalar products in North America.

4. Farmaceutica Sfarma:

   An emerging European manufacturer specializing in corticosteroid formulations, Farmaceutica Sfarma distributes fluocinonide products in select regions, adhering to strict regulatory standards.

5. Other Generic Manufacturers:

   Numerous small-to-medium-size pharmaceutical manufacturers manufacture generic fluocinonide topical formulations approved by national regulators, particularly in India, China, and Southeast Asia. These companies often serve regional markets and are vital for cost-effective supply.

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Manufacturing and Supply Chain Dynamics

• Global Manufacturing Hubs:

  Major production occurs in Europe, North America, and Asia, with capacity being distributed among the aforementioned players. The diversity ensures supply resilience but also introduces variability in quality and regulatory compliance.

• Regulatory Approvals and Licensing:

  Suppliers must navigate complex regulatory landscapes. Many generic manufacturers obtain approvals via abbreviated new drug applications (ANDAs), relying on bioequivalence data and GMP compliance [3]. These approvals facilitate market entry but require consistent quality standards.

• Suppliers to Distributors:

  Distributors such as Cardinal Health, McKesson, and local pharmaceutical wholesalers source from manufacturers and supply to hospitals, pharmacies, and clinics. The supply chain's efficiency hinges on raw material reliability, manufacturing capacity, geopolitical stability, and regulatory changes.

• Raw Material Suppliers:

  The production of fluocinonide requires high-purity chemicals, sourced from specialty chemical suppliers. Notable raw material providers are often based in Europe and Asia, with supply continuity critical for manufacturing.

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Regional Considerations

• North America:

  The U.S. market primarily relies on GSK and Perrigo for Synalar. The Food and Drug Administration's stringent approval process ensures high-quality supply, with some generics produced domestically and imported.

• Europe:

  European Union regulators authorize multiple formulators, with manufacturers like Farmaceutica Sfarma and other generics playing significant roles. The EMA's centralized approval system ensures streamlined access across member states.

• Asia-Pacific:

  Countries like India and China are significant regional suppliers of generic fluocinonide formulations, often at lower costs. These suppliers serve both domestic markets and export to Africa, Latin America, and Southeast Asia.

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Market Challenges and Opportunities

• Supply Chain Disruptions:

  Global events such as the COVID-19 pandemic, geopolitical tensions, and raw material shortages have impacted production continuity. Ensuring diversified manufacturing sources and stockpiling remains vital [4].

• Regulatory Hurdles:

  Variability in regional approvals can delay market entry or restrict supply. Manufacturers investing in compliance and quality assurance bolster global availability.

• Patent and Intellectual Property (IP) Considerations:

  As patents expire, generic manufacturing surges, increasing supplier options. However, originator companies maintain market control through brand reputation and regulatory data exclusivity systems.

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Conclusion

Synalar’s supply chain involves multiple key players, primarily from large pharmaceutical companies, generic manufacturers, and regional suppliers. Ensuring supply resilience depends on diversification of manufacturing sources, maintaining stringent quality standards, and navigating complex regulatory environments. For stakeholders, understanding these dynamics enables strategic procurement, market access planning, and risk mitigation.

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Key Takeaways

• GSK remains a principal supplier of Synalar, with numerous generic manufacturers globally contributing to supply variation.
• Asia-Pacific markets are critical for cost-effective generic fluocinonide production, particularly India and China.
• Supply chain resilience hinges on diversification, regulatory compliance, and proactive raw material sourcing.
• Quality assurance through GMP compliance continues to be paramount in maintaining product integrity.
• Market disruptions warrant strategic stockpiling and supplier diversification to ensure uninterrupted patient access.

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FAQs

1. Who are the leading manufacturers of Synalar globally?
Major manufacturers include GSK, Mitsubishi Tanabe Pharma, Perrigo, and emerging generic producers in Asia such as Indian and Chinese companies. These firms supply both branded and generic formulations across various regions.

2. Can I find Synalar sourced from different suppliers in my country?
Yes, depending on regional regulations and available formulations, Synalar or fluocinonide generics may originate from multiple suppliers, including local generic manufacturers and importers.

3. What factors influence the availability of Synalar in the market?
Supply is impacted by manufacturing capacity, regulatory approvals, raw material availability, geopolitical stability, and global economic conditions affecting production and distribution logistics.

4. Are there regional differences in Synalar suppliers?
Yes, North America predominantly relies on GSK and local generics; Europe has multiple regional producers; and Asia relies heavily on Indian, Chinese, and Japanese manufacturers.

5. How does patent status affect Synalar's supply chain?
Patent expirations enable increased manufacturing by generics firms, expanding supplier options and potentially lowering prices. Conversely, active patents can limit market entry for new suppliers.

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References

[1] U.S. Food and Drug Administration. Fluocinonide Topical Products.
[2] European Medicines Agency. Regulatory Overview of Corticosteroid Topical Formulations.
[3] FDA. Guidance for Industry: ANDA Submissions.
[4] McKinsey & Company. Global Pharmaceutical Supply Chain Risks.