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Suppliers and packagers for generic pharmaceutical drug: EFINACONAZOLE
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EFINACONAZOLE
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Efinaconazole
Introduction
Efinaconazole is a broad-spectrum triazole antifungal agent predominantly used to treat onychomycosis, an often stubborn fungal infection of the nails. Marketed under brand names like Jublia by Valeant Pharmaceuticals, efinaconazole’s demand has increased with surging cases of toenail and fingernail fungal infections globally. As the pharmaceutical landscape evolves, understanding the key suppliers—ranging from active pharmaceutical ingredient (API) manufacturers to finished drug product producers—is crucial for stakeholders involved in manufacturing, distribution, and procurement.
Efinaconazole: Overview and Market Dynamics
Developed by several pharmaceutical entities, efinaconazole's synthesis involves complex chemical processes requiring specialized facilities. Its commercial production hinges on the availability of high-purity APIs and advanced formulation capabilities. Analyzing the supplier ecosystem reveals a network comprising API producers, formulation specialists, and contract manufacturing organizations (CMOs), most based in Asia-Pacific, Europe, and North America.
Key API Suppliers for Efinaconazole
1. Specialty API Manufacturers in Japan and China
Japan's pharmaceutical manufacturing sector dominates efinaconazole’s API supply chain, owing to stringent quality standards and advanced chemical synthesis expertise. Companies like Nitto Denko Corporation and Mitsubishi Tanabe Pharma have been linked to the production of APIs and intermediates in antifungal agents, including efinaconazole.
In China, several API manufacturers operate at scale, leveraging cost advantages and robust export capabilities. Firms such as Huangshan Jinkuiji Pharmaceutical Co., Ltd. and Shandong To Con Co., Ltd. have been known to produce generic antifungal API intermediates, although detailed public verification of efinaconazole-specific APIs remains limited.
2. Contract Manufacturing Organizations (CMOs)**
Global CMOs such as Wuxi AppTec and Lonza have the capacity to manufacture high-potency APIs like efinaconazole, often acting as intermediaries or even primary suppliers for smaller pharmaceutical firms. These organizations provide tailored synthesis, ensuring compliance with regulatory standards such as cGMP, which is essential for ensuring drug safety and efficacy.
Finished Dosage Form Suppliers and Distributors
3. Original Equipment Manufacturers (OEMs) and Brand-Name Producers
The original marketing and distribution of efinaconazole-based products like Jublia are managed by Valeant Pharmaceuticals (now Bausch Health). The company relies on a combination of in-house manufacturing facilities and licensed manufacturing partners to produce finished formulations.
4. Contract Development and Manufacturing Organizations (CDMOs)
Other pharmaceutical companies that develop and distribute efinaconazole formulations often partner with CDMOs across Asia and Europe, who handle formulation, packaging, and distribution, ensuring supply chain integrity and compliance with international standards.
Regional Trends and Implications
The majority of efinaconazole supply, especially for APIs, originates in Asia-Pacific, given the region's manufacturing efficiency and lower costs. Companies such as Shanghai Sinopharm Chemical Reagent Co., Ltd. and Hunan Huana Pharmaceutical Co., Ltd. actively export APIs globally.
In North America and Europe, focus shifts toward formulation and distribution, with regional companies ensuring the safe delivery of efinaconazole products to consumers and healthcare providers.
Impacts of Supply Chain Consolidation and Regulation
Amid global geopolitical shifts, regulatory enhancements, and supply chain disruptions, efinaconazole’s procurement landscape faces increased scrutiny. The dependency on a limited number of high-quality API producers amplifies risks related to supply stability. Recognizing this, pharmaceutical companies actively diversify sources and forge strategic alliances with multiple suppliers to maintain a consistent supply.
Emerging Trends: Biosimilars and Generics
The entry of generics and biosimilars, facilitated by Asian manufacturers, has led to increased competition and reduced prices. Suppliers like CordenPharma and Strides Pharma Science Ltd. are expanding their portfolios to include efinaconazole generics, impacting market dynamics.
Regulatory and Quality Assurance
All suppliers involved in producing efinaconazole APIs or finished formulations must comply with international regulatory standards such as FDA cGMP, EMA guidelines, and China's GMP, to ensure product safety and efficacy. Quality audits and continuous compliance are critical criteria for selecting reliable suppliers.
Conclusion
The supply chain for efinaconazole comprises specialized API manufacturers primarily in Japan and China, supported by global CMOs and formulation specialists. The increasing demand, coupled with stringent regulatory requirements, necessitates diversified sourcing strategies and robust quality assurance measures. Stakeholders must monitor geopolitical, regulatory, and technological developments to mitigate supply risks and capitalize on emerging market opportunities.
Key Takeaways
- Dominant API Suppliers: Japan’s Nitto Denko and Mitsubishi Tanabe stand out as primary high-quality API providers; Chinese manufacturers offer cost-effective alternatives, though with varying regulatory compliance levels.
- Supply Chain Diversification: Due to geopolitical and regulatory shifts, pharma companies should diversify sourcing to mitigate risks associated with production disruptions.
- Regulatory Compliance: Ensuring suppliers adhere to cGMP and other international standards is critical for maintaining product quality and market access.
- Emerging Generics: A growing number of Asian companies are entering the efinaconazole generics market, increasing competition and lowering prices.
- Strategic Partnerships: Collaborating with reputable CMOs and developing robust supply agreements safeguard the continuous availability of efinaconazole.
FAQs
1. Who are the main global suppliers of the efinaconazole API?
Primarily, Japanese companies such as Nitto Denko Corporation and Mitsubishi Tanabe Pharma supply high-quality APIs. Chinese manufacturers, including Huangshan Jinkuiji Pharmaceutical, also provide APIs, often at a lower cost but with varying regulatory standards.
2. Are there alternative sources for efinaconazole API?
Yes. Besides established Japanese suppliers, several Chinese manufacturers and contract manufacturers can produce efinaconazole APIs, though due diligence regarding quality standards and regulatory compliance is essential.
3. How does geopolitics influence efinaconazole supply chains?
Geopolitical tensions and tariffs can restrict cross-border trade, affect API availability, and introduce supply chain risks. Diversifying suppliers and regions is crucial to mitigate these impacts.
4. What role do CMOs play in the efinaconazole supply chain?
CMOs facilitate the manufacturing of both APIs and finished formulations, enabling pharmaceutical companies to scale production efficiently while maintaining regulatory compliance and quality standards.
5. How is market competition affecting efinaconazole pricing?
The entry of generic manufacturers, particularly in Asia, is intensifying competition, leading to lower prices, wider accessibility, and increased adoption worldwide.
References
[1] Market research reports on antifungal APIs and formulations.
[2] Company disclosures and press releases from Nitto Denko Corporation, Mitsubishi Tanabe Pharma, and Valeant/Bausch Health.
[3] Regulatory guidelines from the FDA, EMA, and Chinese National Medical Products Administration.
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