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Suppliers and packagers for EFUDEX
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EFUDEX
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Extrovis | EFUDEX | fluorouracil | CREAM;TOPICAL | 016831 | NDA | Bausch Health US, LLC | 0187-3204-47 | 1 TUBE in 1 CARTON (0187-3204-47) / 40 g in 1 TUBE | 1970-07-29 |
| Extrovis | EFUDEX | fluorouracil | CREAM;TOPICAL | 016831 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-4791-06 | 1 TUBE in 1 CARTON (0378-4791-06) / 40 g in 1 TUBE | 2013-09-19 |
| Extrovis | EFUDEX | fluorouracil | SOLUTION;TOPICAL | 016831 | NDA | Bausch Health US, LLC | 0187-3204-47 | 1 TUBE in 1 CARTON (0187-3204-47) / 40 g in 1 TUBE | 1970-07-29 |
| Extrovis | EFUDEX | fluorouracil | SOLUTION;TOPICAL | 016831 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-4791-06 | 1 TUBE in 1 CARTON (0378-4791-06) / 40 g in 1 TUBE | 2013-09-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: EFUDEX (Fusidic Acid)
Introduction
EFUDEX, the brand name for fusidic acid, is an antibiotic primarily used in dermatology and ophthalmology to treat bacterial skin infections, eye infections, and certain systemic infections. As a niche yet vital antimicrobial agent, its supply chain involves a relatively limited pool of pharmaceutical manufacturers, raw material suppliers, and distribution channels. This comprehensive analysis explores the key suppliers involved in EFUDEX’s manufacturing, the regulatory landscape impacting supply, and market trends influencing its availability.
Overview of EFUDEX and Its Manufacturing
Fusidic acid is a steroid-based antibiotic discovered in the 1960s. Its clinical utility hinges on its ability to inhibit bacterial protein synthesis, making it effective against Gram-positive bacteria, notably Staphylococcus aureus. Given its market niche, production involves a complex pharmaceutical synthesis process, with suppliers sourcing raw materials, active pharmaceutical ingredients (APIs), and excipients globally.
The manufacturing of fusidic acid is concentrated among a handful of companies, predominantly in Europe, Asia, and North America. Notably, certain companies hold license agreements or patents facilitating the production of EFUDEX and related formulations.
Primary Suppliers of Fusidic Acid API
1. Flamma Group (Italy)
Flamma is a prominent Italian manufacturer specializing in producing APIs, intermediates, and finished dosage forms. The company is known for its high-quality fusidic acid API, supplying various pharmaceutical firms worldwide. Flamma’s API manufacturing facilities adhere to Good Manufacturing Practices (GMP), making them a trusted supplier for flagship products like EFUDEX.
2. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
Zhejiang Huahai is a leading Chinese pharmaceutical company engaged in the synthesis of APIs, including fusidic acid. Their manufacturing capabilities span complex organic syntheses, and they’re known for competitive pricing and scale, which makes them an essential API supplier for generics manufacturers.
3. Selleck Chemicals (USA)
While primarily a research chemicals supplier, Selleck offers fusidic acid for research purposes. Their role is more aligned with lab-scale supply but signals market interest and availability from multiple sources.
4. Bactolac Pharmaceutical Inc. (USA)
Bactolac supplies sterile and non-sterile APIs, including fusidic acid. Their facilities include GMP-compliant plants, facilitating bulk procurement for international companies.
Key Raw Material and Intermediates Suppliers
The synthesis of fusidic acid involves complex organic reactions requiring specialized intermediates:
- Chiral building blocks sourced chiefly from Chinese and Indian suppliers.
- Specialized solvents and catalysts supplied by global chemical giants like BASF, Sigma-Aldrich, or local chemical producers.
Securing these raw materials is critical for supply chain stability, often requiring longer procurement lead times.
Formulation and Packaging Suppliers
The final formulation of EFUDEX—ointments, creams, or ophthalmic solutions—entails partnerships with excipient manufacturers:
- BASF and Dow Chemical supply excipients like glycerin, mineral oil, and emulsifiers.
- Packaging specialists such as Schott AG (glazing and vials) and Amcor (blister packs) contribute to the finished drug’s integrity and stability.
Distribution and Logistics
Global distribution of EFUDEX depends on regional licensing agreements. Key regional distributors include:
- Germany's Merck KGaA for European markets.
- Mundipharma and Sandoz in North America.
- Zhejiang Taikang Pharmaceutical and Aurobindo Pharma for Asian and emerging markets.
Supply chain stability hinges on logistical efficiency, regulatory compliance, and inventory management amidst geopolitical and pandemic-related disruptions.
Regulatory Influences on Supply
The production and availability of EFUDEX are heavily influenced by regulatory frameworks:
- EMA (European Medicines Agency) and FDA (Food and Drug Administration) set stringent standards, influencing manufacturing practices and approvals.
- Patent expirations have prompted increased generic manufacturing, enlarging the supplier base.
- Regulatory delays or bans (e.g., importing restrictions, GMP compliance issues) can cause significant supply shocks.
Market Trends and Future Outlook
The global antimicrobial market faces mounting pressure to combat antibiotic resistance. For fusidic acid, this means:
- Increased R&D to develop new formulations or derivatives.
- Consolidation among key suppliers due to high R&D costs.
- Supply chain diversification to mitigate risks associated with geopolitical tensions, trade disputes, or manufacturing disruptions.
The rising adoption of generic fusidic acid formulations, including EFUDEX, also accelerates supply chain expansion but introduces variability in quality and regulatory compliance.
Conclusion
The landscape of EFUDEX suppliers showcases a mix of established European API manufacturers like Flamma, emerging Asian producers such as Zhejiang Huahai, and specialized regional distributors. Market stability depends on maintaining high-quality API supplies, adhering to evolving regulatory standards, and diversifying sourcing strategies to counteract disruptions.
Key Takeaways
- Limited but Global Supply Pool: Key API suppliers for EFUDEX include Flamma (Italy) and Zhejiang Huahai (China), with additional inputs from North American suppliers.
- Regulatory Dynamics: Regulatory compliance and patent expirations are pivotal in shaping market competition and supplier entry.
- Supply Chain Risks: Geopolitical tensions, pandemics, and trade restrictions can disrupt raw material and API availability.
- Market Expansion: Growing demand for generic formulations necessitates diversified sourcing strategies and robust quality assurance.
- Strategic Sourcing: Business success relies on establishing long-term relationships with GMP-compliant suppliers and integrating supply chain resilience measures.
FAQs
1. Who are the leading API manufacturers supplying fusidic acid for EFUDEX?
The leading API manufacturers include Flamma (Italy), Zhejiang Huahai Pharmaceutical (China), and Bactolac (USA). These companies meet GMP standards and supply global markets.
2. What regulatory factors influence the availability of EFUDEX?
Regulatory approvals from agencies like EMA and FDA impact manufacturing licenses, batch releases, and import/export permissions, affecting overall supply.
3. How does patent expiration affect the supply chain for EFUDEX?
Patent expirations open opportunities for generic manufacturers, expanding the supplier base and potentially reducing costs but also raising concerns over quality and consistency.
4. Are there regional differences in EFUDEX supply?
Yes. Europe and North America typically rely on domestic or licensed API manufacturers, while Asian markets primarily source from Chinese and Indian producers.
5. What future trends could impact EFUDEX supply?
Increased emphasis on combating antibiotic resistance, new formulations, and supply chain diversification efforts are likely to influence future supply stability and supplier competition.
Sources
- European Medicines Agency (EMA) - EFUDEX product data.
- Zhejiang Huahai Pharmaceutical official website.
- Flamma Group API product catalog.
- Industry market reports on antimicrobial API manufacturing.
- U.S. Food and Drug Administration (FDA) approval databases.
Disclaimer: This analysis is for informational purposes and reflects current market conditions as of 2023. Business decisions should incorporate comprehensive due diligence and consultation with regulatory and industry experts.
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