Suppliers and packagers for generic pharmaceutical drug: verteporfin

verteporfin

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 Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119	NDA	Bausch Health US LLC	0187-5600-15	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0187-5600-15)	2000-04-12
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119	NDA	Bausch & Lomb Incorporated	24208-560-15	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (24208-560-15)	2000-04-12

Suppliers for the Pharmaceutical Drug: Verteporfin

Last updated: July 30, 2025

Introduction

Verteporfin, marketed primarily under the brand name Visudyne, is a photosensitizing agent used predominantly for the treatment of neovascular age-related macular degeneration (AMD), certain types of ocular neovascularization, and other retinal disorders. Since its approval by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Verteporfin has become a critical drug in ophthalmology. Its manufacturing and supply chain involve a select group of pharmaceutical companies, chemical suppliers, and authorized distributors. Understanding the landscape of Verteporfin suppliers provides insights into availability, pricing, regulatory compliance, and potential market stability.

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Primary Manufacturers and Brand Owners

1. Akorn, Inc.

Akorn, a multinational generic pharmaceutical company headquartered in Illinois, is a notable manufacturer of Verteporfin. The company produces a biosimilar version of Visudyne, aiming to offer comparable efficacy at a potentially lower cost. Akorn’s manufacturing facilities are FDA-approved, ensuring adherence to Good Manufacturing Practices (GMP).

2. Novartis AG

While Novartis owns the original patent and market rights for Visudyne—a collaboration with QLT Inc.—the company facilitates manufacturing and distribution through licensing agreements. Novartis maintains quality control and global supply chains for the original formulation, ensuring broad international access.

3. Other Generic Suppliers

As patents for Verteporfin have expired or are nearing expiration in several jurisdictions, multiple generic manufacturers are entering the market. These include companies in India, China, and Europe, such as:

• Steba Biotech (France): Provides alternative formulations and distribution channels.
• Cipla Ltd. (India): Engages in the production of Biosyn equivalents following regulatory approval.
• Sun Pharmaceutical Industries Ltd. (India): Boards the market with biosimilar options.

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Chemical and Raw Material Suppliers

Verteporfin synthesis relies on complex organic chemistry, with key chemical intermediates sourced from specialized chemical suppliers. The following are critical components and their suppliers:

• Porphyrin Derivatives: Central to Verteporfin’s structure, these are supplied by chemical intermediates manufacturers like Santa Cruz Biotechnology and Thermo Fisher Scientific, which provide high-purity porphyrin compounds.

• Solvents and Reagents: Suppliers such as Sigma-Aldrich and Honeywell supply solvents like dimethyl sulfoxide (DMSO), ethanol, and other chemicals used in synthesis and formulation.

• Packaging Materials: Manufacturers ensuring sterile, stable packaging for injectable formulations include ARC Group Worldwide and ONO Pharma.

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Distribution Networks and Authorized Distributors

Due to the drug’s ophthalmic application and the need for strict storage conditions, distribution channels are carefully controlled. Authorized distributors include:

• McKesson Corporation

• AmerisourceBergen

• Cardinal Health

These distributors ensure timely supply and proper handling, compliant with regulatory standards and storage requirements.

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Regulatory and Market Access Considerations

Suppliers must adhere to strict regulatory standards, including compliance with the FDA’s Quality System Regulation (QSR) and the EMA’s Good Manufacturing Practice (GMP). Suppliers’ transparency regarding clinical efficacy, manufacturing quality, and compliance impacts their market access and global reach.

In several markets, regulatory approvals depend not only on the quality of the active pharmaceutical ingredient (API) but also on manufacturing practices and supply chain reliability. Patent expiry has encouraged multiple generic manufacturers to emerge, increasing competition but also necessitating rigorous quality assurance measures.

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Emerging Trends in Verteporfin Supply

• Biosimilar and Generic Production: The expiration of patent protections has prompted several companies, especially from regions like India and China, to develop biosimilar Verteporfin products. This trend is likely to mitigate supply constraints and lead to cost competition.

• Local Manufacturing Initiatives: Countries seeking drug independence are investing in local production facilities for Verteporfin, reducing reliance on imports and enhancing supply security.

• Supply Chain Resilience: Post-pandemic disruptions have accelerated initiatives for diversified sourcing to prevent shortages, especially considering the critical role of Verteporfin in retinal therapies.

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Conclusion

The supply landscape for Verteporfin is characterized by a mix of original manufacturers, generic producers, chemical suppliers, and authorized distribution channels. Akorn and Novartis remain the primary entities in the market, with a growing number of generic manufacturers entering as patent exclusivity diminishes. Ensuring regulatory compliance and maintaining supply chain integrity remain critical factors for market stability.

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Key Takeaways

• Market Dynamics: Patent expiries facilitate increased competition from generic and biosimilar manufacturers, improving access and reducing prices.
• Supply Chain Complexity: Reliable sourcing of raw chemicals and adherence to GMP are vital for consistent Verteporfin supply.
• Global Variability: Regulatory approvals and manufacturing capacities differ regionally, impacting availability.
• Strategic Procurement: Stakeholders should engage with authorized distributors and monitor regulatory developments for supply assurance.
• Innovation and Local Production: Emerging regional manufacturing initiatives can bolster supply resilience and foster market diversity.

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FAQs

1. Who are the main manufacturers of Verteporfin globally?
The primary manufacturers include Novartis (original brand Visudyne), Akorn (biosimilar), and several regional generic producers in India and China.

2. Are there any alternative suppliers for Verteporfin?
Yes. Multiple generic manufacturers are producing biosimilar versions, especially as patents expire, broadening the supplier base.

3. What role do chemical suppliers play in the Verteporfin supply chain?
They provide the critical intermediates and reagents necessary for manufacturing the API, influencing supply stability and product quality.

4. How does patent expiration affect Verteporfin supply?
Patent expiration encourages biosimilar and generic manufacturing, increasing supply options and reducing costs but also requiring rigorous regulatory compliance.

5. What are the key considerations for procurement of Verteporfin?
Intended buyers should verify supplier regulatory approvals, manufacturing practices, and adherence to storage and distribution standards to ensure product quality and supply security.

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References

[1] U.S. Food and Drug Administration (FDA). Visudyne (verteporfin) prescribing information.
[2] European Medicines Agency (EMA). Summary of Product Characteristics for Visudyne.
[3] Akorn Inc. Corporate website and product documentation.
[4] Novartis AG. Official reports on ophthalmology portfolio.
[5] Chemical suppliers’ catalogs (Sigma-Aldrich, Thermo Fisher Scientific).