Suppliers and packagers for uvadex

uvadex

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Therakos Development	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969	NDA	Therakos LLC	64067-216-01	12 VIAL, GLASS in 1 CARTON (64067-216-01) / 10 mL in 1 VIAL, GLASS	1999-02-25

Suppliers for the Pharmaceutical Drug: UVADEX (Amphotericin B Lipid Complex)

Last updated: July 30, 2025

Introduction

UVADEX, a proprietary formulation of Amphotericin B Lipid Complex, is a critical antifungal medication primarily used for the treatment of invasive fungal infections. Its unique lipid-based formulation addresses the nephrotoxicity issues associated with conventional Amphotericin B, providing a safer alternative for immunocompromised patients. As demand for UVADEX increases globally, identifying reliable suppliers becomes essential for healthcare providers, pharmaceutical distributors, and policymakers aiming to ensure drug availability, quality, and compliance with regulatory standards.

Overview of UVADEX and Its Manufacturing

UVADEX (marketed under the generic name Amphotericin B Lipid Complex) is produced through complex lipid formulations, integrating Amphotericin B with specific phospholipids, such as soy or egg phospholipids, encapsulated within liposomal or lipid complex carriers. The manufacturing process requires advanced lipid formulation technology, stringent quality controls, and comprehensive compliance with Good Manufacturing Practices (GMP). The complexity of its formulation ups the ante for suppliers, making the choice of authorized manufacturers critical for regulatory approval and supply security.

Leading Suppliers and Manufacturers of UVADEX

1. Gilead Sciences Inc.

Role: As the original patent holder and distributor of UVADEX, Gilead Sciences is the primary licensed manufacturer and supplier of Amphotericin B Lipid Complex products in many regions.

Market Presence: Gilead’s manufacturing facilities are GMP-compliant, ensuring high-quality production standards. They supply UVADEX directly to hospitals, pharmacies, and healthcare providers, predominantly in North America and select international markets.

Significance: Being the pioneer and current licensor, Gilead remains the most recognized and trusted source for UVADEX, especially for institutions seeking regulatory approval and consistent supply.

2. Cipla Limited

Role: Cipla, an Indian multinational pharmaceutical company, manufactures AmBisome (liposomal Amphotericin B) and maintains a portfolio that includes Amphotericin B Lipid Complex formulations.

Market Presence: Cipla supplies Amphotericin B lipid complex formulations in regions such as Asia, Africa, and the Middle East, often as a cost-effective alternative to Western brands.

Quality Assurance: Cipla’s manufacturing facilities adhere to international GMP standards, and their products are approved by regulatory agencies such as the Drugs Controller General of India (DCGI).

3. Gamaleya Research Institute of Epidemiology and Microbiology / R-Pharm

Role: With expertise in biological and lipid-based pharmaceuticals, Russian institutions like the Gamaleya Research Institute (notably known for Sputnik V vaccine development) have expanded into antifungal drug production, including lipid complex formulations.

Market Presence: R-Pharm, a prominent Russian pharmaceutical company, partners with local government agencies to produce Amphotericin B lipid complex, primarily for domestic markets and neighboring countries.

Implications: These regional suppliers help improve drug availability within Russia and Eastern Europe, although export and regulatory approval outside these regions vary.

4. Other Regional Manufacturers

• Fanemi Pharmaceuticals (Egypt): Supplies Amphotericin B lipid formulations to North Africa and parts of the Middle East.
• Hikma Pharmaceuticals (Jordan): Known for producing generic antifungal agents, including Amphotericin B deoxycholate and lipid complexes for Middle Eastern markets.
• Kusum Hem pharmaceutical (India): Produces Amphotericin B formulations, including lipid complexes, for domestic and export purposes.

Supply Chain Considerations

• Regulatory Approvals: Suppliers must possess approvals from bodies such as the FDA, EMA, or local regulatory authorities, ensuring compliance with safety and efficacy standards.

• Manufacturing Capacity: The complexity of lipid complex production necessitates significant manufacturing capacity and technological expertise to meet global demand without compromising quality.

• Intellectual Property & Patent Status: The original patent rights held by Gilead may restrict the production of UVADEX or equivalent formulations by other manufacturers in certain jurisdictions. However, generics and biosimilars have entered markets in regions where patents have expired or are not enforced.

• Pricing and Accessibility: Cost remains a critical factor influencing suppliers' market share, especially in developing nations. Regional manufacturers tend to offer more affordable alternatives within local regulatory frameworks.

Emerging Trends and Future Outlook

The antifungal market is experiencing growing demand driven by the rise in invasive fungal infections among immunosuppressed populations—particularly cancer patients, transplant recipients, and HIV-positive individuals. Consequently, suppliers are innovating in lipid-based formulations to enhance efficacy, reduce toxicity, and improve stability.

Furthermore, biopharmaceutical companies are exploring biosimilars and follow-on lipid complex antifungal drugs to increase competition and accessibility. Governments and global health organizations are also incentivizing local production, which may diversify supply sources and mitigate shortages.

Conclusion

The supply landscape for UVADEX and equivalent Amphotericin B Lipid Complex formulations is predominantly anchored by established pharmaceutical giants like Gilead Sciences, with regional players such as Cipla, R-Pharm, and others contributing significantly to local markets. Ensuring supply security involves evaluating manufacturers' regulatory compliance, manufacturing capacity, and regional reach. As global demand grows, diversification of suppliers and advancements in lipid formulation technology will become vital for maintaining consistent, safe, and affordable antifungal therapies.

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Key Takeaways

• Gilead Sciences remains the primary licensed supplier of UVADEX globally, maintaining high standards of production and regulatory compliance.
• Regional manufacturers such as Cipla, R-Pharm, and Hikma play crucial roles in expanding access across Asia, Middle East, Africa, and Eastern Europe.
• Regulatory approval and manufacturing capacity are critical factors determining supplier reliability and product availability.
• Patent landscape influences the ability of generic manufacturers to produce UVADEX or similar formulations in different regions.
• Supply chain diversification and technological advancements are essential to address rising demand and prevent shortages.

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FAQs

1. Is UVADEX available from generic manufacturers outside the US?
Yes, several regional pharmaceutical companies produce Amphotericin B Lipid Complex formulations, including Cipla in India and R-Pharm in Russia. However, the availability of UVADEX-specific branding depends on patent rights and licensing agreements.

2. What regulatory considerations should healthcare providers monitor when sourcing UVADEX?
Providers should verify that their suppliers’ products have approved regulatory filings with authorities such as the FDA, EMA, or local agencies, ensuring quality, safety, and efficacy.

3. Are there biosimilar alternatives to UVADEX?
While biosimilars for Amphotericin B Lipid Complex are emerging, their approval status varies by region. Currently, the primary source remains branded or licensed formulations like UVADEX.

4. How does regional manufacturing impact drug safety and efficacy?
Manufacturers adhering to GMP standards and obtaining proper regulatory approvals ensure that regional production maintains consistent quality and safety profiles of Amphotericin B lipid formulations.

5. What future innovations could influence the supply of UVADEX?
Advances in lipid formulation technology, increased regional manufacturing capabilities, and development of new antifungal lipid-based biosimilars could diversify supply sources and improve drug accessibility globally.

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References

1. Gilead Sciences. (2022). UVADEX (Amphotericin B Lipid Complex) Product Information.
2. Cipla Limited. (2021). Product Portfolio and GMP Compliance [Company Reports].
3. R-Pharm. (2022). Regional Production Capabilities and Market Outreach.
4. European Medicines Agency. (2022). Guidelines on Liposomal and Lipid Complex Amphotericin B Formulations.
5. World Health Organization (WHO). (2020). Essential Medicines List Update.