Share This Page
Suppliers and packagers for ecoza
✉ Email this page to a colleague
ecoza
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Resilia Pharms | ECOZA | econazole nitrate | AEROSOL, FOAM;TOPICAL | 205175 | NDA AUTHORIZED GENERIC | Trifluent Pharma, LLC | 73352-100-70 | 1 CANISTER in 1 CARTON (73352-100-70) / 70 g in 1 CANISTER | 2025-09-13 |
| Resilia Pharms | ECOZA | econazole nitrate | AEROSOL, FOAM;TOPICAL | 205175 | NDA | Resilia Pharmaceuticals, Inc. | 81811-100-70 | 1 CANISTER in 1 CARTON (81811-100-70) / 70 g in 1 CANISTER | 2023-12-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ECOZA
Introduction
ECOZA (generic name: econazole nitrate) is an antifungal medication primarily used in topical formulations to treat dermatophyte infections, candidiasis, and other fungal skin conditions. As a critical pharmaceutical product, the supply chain for ECOZA’s active pharmaceutical ingredients (APIs) and finished dosage forms involves a network of global suppliers, manufacturing entities, and distributors. Understanding the landscape of ECOZA suppliers is vital for stakeholders involved in procurement, regulatory compliance, and market strategy.
Manufacturers and API Suppliers for ECOZA
The core of ECOZA's supply chain hinges on the procurement of high-quality API, econazole nitrate. Multiple pharmaceutical companies worldwide produce econazole API, often with overlapping markets and manufacturing capacities. Major API manufacturers include:
1. Orchid Pharmatech (India)
One of the prominent producers of econazole nitrate API, Orchid Pharmatech boasts a robust manufacturing infrastructure adhering to WHO-GMP standards. The company supplies APIs to both domestic and international markets, including formulations for OTC and prescription antifungal products. Their focus on quality and compliance with regulatory standards makes them a key supplier for generic drug manufacturers.
2. Zhejiang South Pharmaceutical Co., Ltd. (China)
This Chinese API manufacturer specializes in antifungal and antimicrobial agents. Zhejiang South Pharmaceutical offers econazole nitrate API aligned with international pharmacopoeial standards. They serve both domestic Chinese clients and export markets, emphasizing cost-effective manufacturing processes.
3. Huzhou Ouye Pharm Co., Ltd. (China)
Huzhou Ouye Pharm produces econazole nitrate API, with certification from European and Chinese regulatory authorities. Their capacity for large-scale manufacturing supports steady supply, making them a significant player in the Asian API market.
4. Cipla Ltd. (India)
Cipla, while primarily known as a finished drug manufacturer, also supplies API through strategic partnerships. Their integrated supply chain ensures reliable access to econazole nitrate for their topical formulations distributed globally.
5. Other Regional and Contract Manufacturers
Other smaller and contract manufacturing organizations (CMOs) in India, South Korea, and Europe produce econazole nitrate API, often for specific markets or under private label agreements.
Finished Dosage Form Suppliers
ECOZA is marketed mainly by pharmaceutical companies as topical creams and solutions. Leading formulators and distributors include:
1. Novartis
Novartis markets ECOZA in various countries, with production largely conducted through internal facilities and authorized contract manufacturers that ensure compliance with international standards such as FDA and EMA regulations.
2. Sandoz (Novartis Division)
Sandoz supplies generic formulations of econazole-based creams and solutions, leveraging a global distribution network. Their manufacturing involves both internal plants and trusted third-party suppliers.
3. Teva Pharmaceuticals
Teva produces and distributes econazole antifungal formulations worldwide, maintaining a robust supply chain derived from both proprietary facilities and approved third-party manufacturers.
4. Mylan (Now part of Viatris)
Viatris (formerly Mylan) supplies econazole topical formulations, often sourced from a combination of internal manufacturing and external contract manufacturers with validated quality systems.
5. Regional Generic Companies
Various regional players across Eastern Europe, Latin America, and Asia produce econazole nitrate creams and solutions, often under licensing agreements or private labels for local markets.
Regulatory and Quality Considerations
The suppliers of econazole nitrate API and finished products operate within strict regulatory frameworks. Most reputable manufacturers hold certifications such as WHO-GMP, ISO 9001, and comply with the requirements of agencies including the U.S. FDA, the European Medicines Agency (EMA), and regional regulators. Ensuring supplier compliance is critical for product safety, efficacy, and market access.
Market Dynamics and Supply Chain Challenges
The global supply chain for ECOZA faces several challenges:
- Supply Chain Disruptions: Pandemic-related manufacturing interruptions and geopolitical tensions impact the availability of API and finished products.
- Regulatory Barriers: Variations in regulatory standards across markets impose hurdles in supplier qualification and product registration.
- Pricing Pressures: Competitive markets, especially in India and China, drive down API costs, influencing the pricing of final formulations.
- Quality Assurance: Ensuring consistent quality across multiple sourcing origins remains vital, given the topical and dermatological application.
Future Outlook and Strategic Implications
The demand for antifungal medications like ECOZA is expected to grow, driven by rising incidences of fungal skin infections. Consequently, supply chains might witness increased consolidation, with key API manufacturers expanding capacity or entering strategic alliances. Stakeholders should prioritize supplier audits, quality assurance, and diversifying sources to mitigate risks.
Key Takeaways
- The primary API suppliers for econazole nitrate include Orchid Pharmatech (India), Zhejiang South Pharmaceutical, and Huzhou Ouye Pharm (China).
- Major finished product suppliers encompass Novartis, Sandoz, Teva, and Viatris, leveraging internal manufacturing and external CMOs.
- Regulatory compliance (WHO-GMP, ISO, FDA, EMA) remains critical in maintaining supply chain integrity.
- Market volatility, geopolitical factors, and regulatory variability pose ongoing risks to supply stability.
- Contracting with diversified, validated suppliers ensures continuity of supply and quality assurance.
FAQs
1. Who are the leading API manufacturers for econazole nitrate?
Top producers include Orchid Pharmatech (India), Zhejiang South Pharmaceutical (China), and Huzhou Ouye Pharm (China), all adhering to international quality standards.
2. Are there alternative suppliers for ECOZA products in different regions?
Yes, regional manufacturers across India, China, and Europe supply econazole nitrate API and finished formulations, providing alternatives to major suppliers.
3. How does regulatory compliance influence supplier selection?
Suppliers with WHO-GMP, FDA, or EMA certifications are preferred, as they meet the stringent requirements necessary for global market access and product safety assurance.
4. What are the main challenges in sourcing ECOZA?
Disruptions from global supply chain issues, regulatory differences, and maintaining consistent quality standards pose significant sourcing challenges.
5. How can companies mitigate supply chain risks for ECOZA?
Diversifying suppliers, establishing long-term contracts with validated manufacturers, and maintaining robust quality control systems are essential strategies.
References
- [1] Market reports on antifungal pharmaceutical manufacturing, Global Data, 2022.
- [2] WHO Global Benchmarking Tool for API manufacturing, WHO, 2021.
- [3] Pharmaceutical APIs market overview, IQVIA, 2022.
- [4] Regulatory standards and certifications for APIs, U.S. FDA, EMA, 2023.
- [5] Company filings and press releases from Orchid Pharmatech, Zhejiang South Pharmaceutical, and others.
This comprehensive overview equips stakeholders with essential insights into the supply landscape for ECOZA, guiding procurement strategies, risk management, and market positioning.
More… ↓
