Suppliers and packagers for jublia

jublia

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567	NDA	Bausch Health US LLC	0187-5400-02	1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) / 2 mL in 1 BOTTLE, WITH APPLICATOR	2014-06-06
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567	NDA	Bausch Health US LLC	0187-5400-04	1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) / 4 mL in 1 BOTTLE, WITH APPLICATOR	2014-06-06
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567	NDA	Bausch Health US LLC	0187-5400-08	1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-08) / 8 mL in 1 BOTTLE, WITH APPLICATOR	2014-06-06

Suppliers for the Pharmaceutical Drug: Jublia

Last updated: July 29, 2025

Introduction

Jublia, known generically as efinaconazole, is a topical azole antifungal medication primarily prescribed for onychomycosis—fungal infections of the toenails and fingernails. Since its FDA approval in 2014, Jublia has gained prominence as a targeted treatment option, offering an alternative to systemic therapies with fewer systemic side effects. As demand for effective nail fungus treatments surges globally, understanding the supply chain, manufacturing sources, and key suppliers for Jublia becomes crucial for stakeholders across pharmaceutical sourcing, distribution, and healthcare procurement.

This article provides an in-depth analysis of the primary suppliers involved in the production and distribution of Jublia, highlighting manufacturing processes, supply chain considerations, and emerging trends impacting the availability of this medication.

Manufacturing of Efinaconazole (Jublia)

Jublia's active pharmaceutical ingredient (API), efinaconazole, is a complex molecule synthesized through multi-step chemical processes. The raw materials and intermediates are sourced from a global network of chemical suppliers, with key manufacturing facilities primarily located in regions with advanced chemical synthesis capabilities, such as Europe and Asia (notably India and China).

Once synthesized, efinaconazole undergoes formulation into a topical solution by specialized contract manufacturing organizations (CMOs). These facilities undertake rigorous quality control, ensuring compliance with Good Manufacturing Practices (GMP) mandated by regulatory authorities such as the FDA and EMA.

Key Suppliers of API and Formulation Components

1. API Manufacturers

The primary API suppliers for efinaconazole include:

• BASF: A leading global chemical company known for its extensive portfolio of pharmaceutical intermediates and APIs. BASF supplies pharmaceutical-grade intermediates used as precursors in efinaconazole synthesis.
• Synthesis Partners in India and China: Several regional chemical manufacturers, including companies like Jiangsu Hualong Pharmaceutical Co., Ltd., and other Chinese firms, produce APIs under licensing agreements or through contract manufacturing arrangements. These suppliers often serve regional markets or provide generic efinaconazole APIs.

2. Contract Manufacturing Organizations (CMOs)

Most pharmaceutical companies producing Jublia rely on CMOs for formulation and packaging:

• Catalent: Provides formulation, filling, and packaging services for topical dermatological products. Catalent's global footprint includes facilities capable of producing high-quality topical solutions compliant with international standards.
• Recipharm: Offers formulation development and manufacturing services, including stable supply of topical drug products.
• Alkermes and Patheon (Thermo Fisher Scientific): Known for formulation services, including topical and dermatological products.

These CMOs ensure product consistency, stability, and regulatory compliance across markets.

3. Specialty Ingredient Suppliers

Jublia's formulation requires specific excipients such as ethanol, purified water, and gelling agents (e.g., hydroxypropyl cellulose). Major suppliers include:

• Dow Chemical: Supplies excipients used in topical solutions.
• BASF and Ashland: Provide polymers and stabilizers essential for formulation stability.
• Global Water Treatment Companies: Offer high-purity water systems critical in pharmaceutical manufacturing.

Distribution and Supply Chain Dynamics

The distribution of Jublia involves multiple layers:

• Wholesalers and Distributors: Major pharmaceutical distribution companies such as McKesson and Cardinal Health distribute Jublia to hospitals, clinics, and pharmacies across North America, Europe, and Asia.
• Regional and Local Distributors: These entities facilitate supply chain flexibility, especially in emerging markets where local regulations and logistics influence drug availability.

Supply Chain Challenges

• Raw Material Sourcing Disruptions: Dependence on chemical intermediates from Asia introduces risks such as geopolitical tensions and raw material shortages.
• Manufacturing Scalability: Limited capacity at manufacturing facilities can lead to supply shortages, especially during global health crises, as seen with other dermatological products during the COVID-19 pandemic.
• Regulatory Variability: Different approval processes across regions can delay product launches or modifications, affecting supply consistency.

Emerging Trends and Future Outlook

1. Market Expansion and Generics

While Jublia’s patent protection has prevented immediate generic entry, upcoming patent expirations could open opportunities for generic manufacturers, increasing competition and diversifying supply sources.

2. Vertical Integration

Pharmaceutical companies are increasingly integrating upstream (API production) and downstream (formulation and distribution) processes to reduce reliance on external suppliers. Companies such as Valeant Pharmaceuticals (now Bausch Health), which initially marketed Jublia, may seek to bolster their supply chain resilience through such strategies.

3. Supply Chain Digitization and Transparency

The trend toward digital supply chains enhances visibility and traceability of raw materials and finished products. Blockchain applications and supply chain management platforms facilitate quality assurance and mitigate counterfeit risks.

4. Sustainability Initiatives

Manufacturers are prioritizing sustainable sourcing, eco-friendly manufacturing practices, and waste reduction — influencing supplier choices globally.

Regulatory and Quality Considerations

Suppliers involved in the Jublia supply chain must comply with stringent regulatory standards:

• FDA and EMA Approvals: Require GMP-certified manufacturing facilities and validated supply chains.
• International Certifications: ISO 9001, ISO 13485 for quality management systems.
• Traceability and Transparency: Critical to ensure supply integrity, especially as global supply chains grow complex.

Conclusion

The supply of Jublia hinges on a network of specialized API manufacturers, formulation CMOs, excipient suppliers, and distribution channels, primarily concentrated across North America, Europe, and Asia. While leading companies such as BASF and large contract manufacturers play pivotal roles, regional suppliers and emerging generic manufacturers will influence future accessibility and pricing landscapes. The ongoing evolution of supply chain management, regulatory standards, and market dynamics will shape the resilience and availability of Jublia in the worldwide dermatological therapeutics market.

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Key Takeaways

• API and formulation sourcing for Jublia predominantly involves global chemical giants and specialized CMOs, with a significant presence in Europe and Asia.
• Supply chain resilience remains challenged by raw material dependence, manufacturing capacity constraints, and regulatory variations across markets.
• Emerging generic entrants due to patent expirations could diversify suppliers and influence pricing strategies.
• Digital transformation and sustainability initiatives are progressively impacting supplier selection and supply chain transparency.
• Regulatory compliance and quality assurance are critical priorities for maintaining supply integrity in pharmaceutical manufacturing.

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FAQs

1. Who are the primary API suppliers for Jublia?
The main API suppliers include multinational chemical firms like BASF and regional Chinese and Indian manufacturers involved in the synthesis of efinaconazole intermediates.

2. Are there generic versions of Jublia available?
Currently, no generic versions are widely available due to patent protections. However, upcoming patent expirations may enable generic manufacturers to enter the market.

3. What role do contract manufacturing organizations play in Jublia's supply chain?
CMOs handle formulation, filling, and packaging, ensuring product quality, regulatory compliance, and scalable production to meet market demand.

4. How does supply chain disruption impact Jublia availability?
Disruptions in raw material supply, manufacturing capacity, or regulatory approvals can lead to shortages, affecting patient access and increasing prices.

5. What trends are shaping Jublia's supply chain in future years?
Market expansion, patent expirations, supply chain digitization, and sustainability initiatives are key trends influencing the drug’s supply landscape.

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Sources

1. U.S. Food and Drug Administration. FDA approval for Jublia (efinaconazole 10%).
2. BASF. Pharmaceutical intermediates and APIs portfolio.
3. Market research from IQVIA and EvaluatePharma reports on dermatology pharmaceuticals.
4. Company websites of Catalent, Recipharm, and other CMOs involved in dermatological product manufacturing.
5. Industry analyses on supply chain trends in pharmaceutical manufacturing.