Suppliers and packagers for VISUDYNE

VISUDYNE

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: VISUDYNE

Last updated: July 29, 2025

Introduction

Visudyne (verteporfin) is an essential ophthalmic drug primarily used in the treatment of neovascular age-related macular degeneration (AMD), pathological myopia, and certain other retinal disorders. Approved by regulatory authorities such as the FDA and EMA, Visudyne stands out as a cornerstone in photodynamic therapy (PDT) due to its specificity and efficacy. The supply chain for Visudyne involves key pharmaceutical manufacturers, authorized distributors, and regulatory agencies that ensure consistent availability across global markets. This comprehensive review examines the primary suppliers, manufacturing landscape, distribution channels, market dynamics, and future trends shaping the supply of Visudyne.

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Manufacturers of Visudyne

The origin of Visudyne traces back to the collaboration between QLT Inc. (a Canadian biotechnology firm) and Novartis (a global pharmaceutical giant), which held exclusive rights for its manufacturing and distribution prior to the drug’s market approval.

1. Novartis AG

Novartis is the primary authorized supplier globally for Visudyne, holding significant intellectual property rights, manufacturing facilities, and distribution networks. As of current market data, Novartis remains the sole licensure holder responsible for the production and supply of Visudyne [1]. Their extensive global network facilitates the manufacturing of the drug at their facilities, ensuring adherence to Good Manufacturing Practices (GMP), quality control, and regulatory compliance.

2. Contract Manufacturing Organizations (CMOs)

While Novartis maintains in-house production capabilities, they also partner with specialized CMOs to meet global demand, facilitate capacity scaling, or ensure supply chain resilience. Major CMOs involved in pharmaceutical production, such as Lonza and Catalent, may handle bulk manufacturing or formulation development in specific regions under contractual agreements, although Novartis typically retains sole responsibility for commercial supply [2].

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Distribution and Authorized Suppliers

Securing Visudyne hinges on a network of authorized distributors and regional suppliers that operate within the regulatory frameworks of various jurisdictions. These entities ensure timely delivery to hospitals, clinics, and specialty pharmacies.

1. Regulatory Authorization and Supply Licenses

The distribution of Visudyne is governed by strict licensing protocols. Novartis holds the central license, which extends to regional distributors authorized under licensing agreements. Distribution partners operate under Good Distribution Practices (GDP), ensuring the drug’s stability and traceability throughout the supply chain.

2. Regional Distributors

In North America, major authorized distributors include:

• McKesson Corporation
• Cardinal Health

In Europe, authorized suppliers typically include:

• ImmunoGen (for specific markets)
• Regional authorized importers operating in countries such as Germany, France, and the UK.

In Asia-Pacific, distributors are often localized entities licensed by Novartis, ensuring regional regulatory compliance [3].

3. Specialty Pharmacy Providers

Some ophthalmic clinics and specialty pharmacies source Visudyne directly through licensed wholesale suppliers or via hospital procurement contracts. These channels are tightly controlled to prevent unauthorized distribution and ensure pharmaceutical integrity.

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Market Dynamics Impacting Supply

The supply of Visudyne is influenced by multiple facets, including patent status, manufacturing capacity, regulatory approvals, and market demand.

1. Patent and Exclusivity Period

Initially patent-protected, Novartis’s exclusivity allowed for controlled production and distribution. Although patent expiration may open avenues for biosimilar development, as of now, no major biosimilar versions of verteporfin have entered the market. Consequently, Novartis remains the dominant supplier globally.

2. Manufacturing Capacity Constraints

Global capacity to produce verteporfin at scale is limited, partly because of the complex synthesis process and stringent quality standards. Potential disruptions—such as supply chain interruptions or quality control issues—can impact availability.

3. Regulatory and Market Approvals

While Visudyne has received widespread approval, some countries face delays or restrictions due to local regulatory processes. Variations in approvals influence regional distribution and availability.

4. Demand Fluctuations

The global burden of AMD and other retinal diseases drives predictable demand, but supply shortages have occasionally occurred, especially during the COVID-19 pandemic, which disrupted manufacturing and logistics networks.

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Future Outlook and Trends

The future of Visudyne’s supply chain is poised for evolution driven by biosimilar developments, innovative delivery mechanisms, and regional manufacturing initiatives.

1. Biosimilar Development

Although no biosimilars for verteporfin have yet gained approval, the expiration of patents could catalyze competition, potentially offering alternative suppliers. Such entrants might diversify the supply landscape, potentially reducing costs and expanding access.

2. Regional Manufacturing Initiatives

To mitigate supply risks, Novartis and other stakeholders are exploring regional manufacturing hubs, particularly in emerging markets, to meet local demand and navigate import restrictions.

3. Supply Chain Digitalization

Enhanced integration and transparency through digital supply chain tools could improve inventory management, track expiry, and prevent shortages.

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Conclusion

The supply chain for Visudyne is predominantly controlled by Novartis, leveraging a network of manufacturing facilities, contractual CMOs, and authorized distribution partners across major regions. This controlled ecosystem ensures high-quality standards and regulatory compliance but also leaves it vulnerable to capacity limitations and geopolitical factors. The potential entry of biosimilars and regional manufacturing initiatives pose opportunities and challenges ahead, necessitating vigilant monitoring by healthcare providers and stakeholders.

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Key Takeaways

• Novartis is the principal manufacturer and licensor of Visudyne globally, supported by oversight of supply and distribution.

• Authorized distributors operate under strict licensing and regulatory frameworks, ensuring drug integrity throughout the supply chain.

• Manufacturing capacity and regulatory factors are primary influences on supply stability, with potential disruptions affecting availability.

• The biosimilar landscape may reshape supply dynamics in the future, potentially increasing market competition and reducing costs.

• Embracing digital supply chain solutions can enhance transparency, prevent shortages, and optimize inventory management.

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FAQs

1. Who are the main suppliers of Visudyne currently?
Novartis is the exclusive global supplier of Visudyne, with distribution partners authorized to handle regional logistics and compliance.

2. Are biosimilars of verteporfin available in the market?
As of now, no biosimilar versions of verteporfin have been approved or marketed, but patent expiration may lead to future development.

3. How does supply disruption in one region affect global availability?
Global supply is typically resilient due to Novartis's centralized manufacturing; however, regional shortages can occur due to logistical issues, regulatory delays, or capacity constraints.

4. What role do contract manufacturing organizations play in Visudyne production?
CMOs support Novartis in manufacturing capacity and scalability, especially during demand surges or capacity expansion efforts.

5. How might future trends influence the supply chain of Visudyne?
Emerging biosimilars, regional manufacturing hubs, and digital supply chain innovations are likely to diversify and stabilize supply, enhance access, and reduce costs.

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References

[1] Novartis. (2022). Product Information: Visudyne.
[2] Pharmaceutical Technology. (2019). CMO Partnerships in Ophthalmic Drug Manufacturing.
[3] European Medicines Agency. (2021). Registration and Distribution of Ophthalmic Drugs.