Suppliers and packagers for photofrin

photofrin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pinnacle Biolgs	PHOTOFRIN	porfimer sodium	INJECTABLE;INJECTION	020451	NDA	Pinnacle Biologics, Inc.	76128-155-75	1 VIAL in 1 BOX, UNIT-DOSE (76128-155-75) / 31.8 mL in 1 VIAL	1995-12-27

Suppliers for the Pharmaceutical Drug: PHOTOFRIN

Last updated: August 4, 2025

Introduction

PHOTOFRIN, known generically as porfimer sodium, is a photosensitizing agent primarily utilized in photodynamic therapy (PDT) for certain types of cancer, including esophageal and lung cancers. As a vital component of minimally invasive therapies, PHOTOFRIN's demand hinges on robust manufacturing, global regulatory approvals, and the presence of qualified suppliers capable of ensuring consistent product quality. This article examines the primary suppliers for PHOTOFRIN, their market positioning, manufacturing capabilities, regulatory landscape, and implications for stakeholders in the pharmaceutical supply chain.

Overview of PHOTOFRIN (Porfimer Sodium)

PHOTOFRIN’s therapeutic efficacy stems from its ability to accumulate selectively in malignant tissues. When activated by specific light wavelengths, it produces reactive oxygen species that induce cytotoxic effects, destroying tumor cells. The drug's complex synthesis involves a multi-step process derived from hematoporphyrin derivatives, requiring high-precision manufacturing and strict quality assurance standards. The global market for photodynamic therapy agents is growing, driven by rising cancer incidence and advances in minimally invasive treatment options. Consequently, the supply landscape for PHOTOFRIN is evolving, with few manufacturers dominating the market.

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Major Suppliers of PHOTOFRIN

1. Amgen Inc.

Amgen, a leading biotechnology firm, is the primary manufacturer and authorized supplier of PHOTOFRIN (porfimer sodium) globally. The company's product, marketed under the brand name PHOTOFRIN, has received regulatory approval in multiple jurisdictions, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Amgen's production facilities adhere to Good Manufacturing Practices (GMP), ensuring high product quality, stability, and batch-to-batch consistency.

Manufacturing Capabilities:
Amgen’s manufacturing infrastructure for PHOTOFRIN involves specialized synthesis units with state-of-the-art purification and quality control systems. The company invests heavily in research and development to optimize production efficiency, enhance purity, and expand indications.

Regulatory and Supply Security:
Having obtained multiple regulatory approvals, Amgen maintains a robust global distribution network. Its strategic patent protections and ongoing clinical trials position it as the dominant and largely sole licensed supplier. Supply chain risks are mitigated by geographically diversified manufacturing sites.

2. Other Manufacturers and Technical Collaborators

While Amgen remains the primary commercial supplier, some academic and contract manufacturing organizations (CMOs) operate on a smaller scale, often as drug development partners or for regional distribution.

• NORDIC NANOSYSTEMS, Wuhan Chemistry (China), and other regional entities have explored or initiated production of porfimer derivatives. However, these are typically not commercially widespread or FDA-approved, serving more as research-grade or regional supply sources.

• Contract Manufacturing Organizations (CMOs): Several CMOs possess the technical capacity to produce porfimer sodium but lack licensing or regulatory approval to distribute commercially outside specified markets.

Limitations:
Production from these entities is generally limited to early-stage clinical trials, research use, or OEM supplies. The complexity of synthesis and the stringent quality standards limit the proliferation of multiple commercial suppliers.

3. Emerging Competitors and Biosimilar Development

Currently, no biosimilar or alternative photosensitizers have received regulatory approval to challenge the dominant position of PHOTOFRIN. Pending biosimilar development requires extensive clinical validation, regulatory approvals, and market entry strategies, rendering this a medium- to long-term consideration.

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Regulatory Landscape and Impact on Suppliers

The strict regulatory environment, primarily governed by agencies such as the FDA, EMA, and Japan’s PMDA, significantly limits the number of authorized suppliers. For PHOTOFRIN, Amgen’s comprehensive approval and long-standing market presence establish it as a near-monopoly, which influences pricing, supply stability, and market access.

Any new supplier attempting to enter this space must navigate complex approval pathways, including demonstrating biosimilarity, ensuring manufacturing compliance, and satisfying safety and efficacy standards. This high barrier constrains supplier diversity but provides market stability for existing participants.

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Supply Chain and Market Dynamics

The limited number of suppliers, non-diversified manufacturing sources, and regulatory hurdles create a highly concentrated supply chain landscape for PHOTOFRIN. Although the dominant supplier, Amgen, benefits from a competitive moat, it faces ongoing pressure to maintain supply continuity amid increasing demand.

The global shortage risks are mitigated by Amgen’s diversified manufacturing footprint. However, geopolitical shifts, regulatory changes, or supply disruptions could impact availability, emphasizing the importance of strategic inventory and risk management strategies for healthcare providers and pharmaceutical distributors.

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Future Outlook

The future supply landscape for PHOTOFRIN hinges on several factors:

• Regulatory Approvals of Biosimilars or Generics: While currently limited, biosimilar entrants could eventually diversify the supply chain if approved and adopted.

• Market Expansion: Growing indications for PDT could incentivize new manufacturing investments, particularly in emerging markets.

• Technological Advances: Improvements in synthesis efficiency or alternative photosensitizers may influence supply chain dynamics.

• Regulatory and Patent Trends: Patent expirations or regulatory incentives could open pathways for additional suppliers, but to date, Amgen maintains a robust exclusivity.

Conclusion

The supply of PHOTOFRIN predominantly resides with Amgen, with limited competition or alternative sources available. The manufacturing process's complexity and tight regulatory controls sustain this market structure, providing stability but also creating potential bottlenecks. Stakeholders must monitor regulatory developments, anticipate supply risks, and consider strategic sourcing options amid evolving market conditions.

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Key Takeaways

• Amgen remains the sole and primary supplier of PHOTOFRIN globally, leveraging its established regulatory approvals and manufacturing expertise.

• Restricted manufacturing and rigorous regulatory standards maintain high product quality but limit market competition.

• Supply chain stability is generally high, but reliance on a single supplier necessitates risk mitigation strategies for healthcare providers.

• Future entry of biosimilars or generics hinges on regulatory approvals and technological advancements, which remain in early development stages.

• Stakeholders should monitor regulatory landscapes, potential market expansions, and technological innovations for opportunities and risks.

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Frequently Asked Questions (FAQs)

1. Is PHOTOFRIN available from multiple suppliers globally?
Currently, Amgen is the primary and nearly exclusive supplier of PHOTOFRIN worldwide. The limited number of approved manufacturers results from stringent regulatory requirements and complex manufacturing processes. No significant biosimilar or generic entries have yet achieved regulatory approval.

2. Can regional manufacturers produce and distribute PHOTOFRIN?
While some regional entities may produce research-grade porfimer sodium, commercial distribution is predominantly controlled by Amgen. Regional approvals, manufacturing licenses, and regulatory standards are necessary for legal and safe distribution.

3. Are biosimilars expected to enter the market for PHOTOFRIN soon?
As of now, no biosimilar or alternative photosensitizer has received regulatory approval for PHOTOFRIN. The pathway for biosimilar approval involves rigorous clinical and manufacturing assessments, which take several years. Industry interest remains, but commercial entry is likely in the medium to long term.

4. What are the risks associated with the supply of PHOTOFRIN?
Dependence on a single major supplier poses risks such as production disruptions, regulatory changes, or geopolitical issues. Supply shortages could impact clinical treatments, emphasizing the importance of inventory management and future diversification efforts.

5. How can healthcare providers ensure reliable supply of PHOTOFRIN?
Providers should establish strong relationships with authorized suppliers like Amgen, monitor regulatory developments, and consider strategic stockholding. Engaging with multiple regional distributors (where permissible) and participating in clinical networks can enhance supply resilience.

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References

[1] U.S. Food and Drug Administration. "PHOTOFRIN (Porfimer Sodium) NDA Approval." FDA, 2011.
[2] European Medicines Agency. "Assessment Report for PHOTOFRIN." EMA, 2012.
[3] Amgen Inc. "Product Information: PHOTOFRIN." Amgen, 2023.
[4] Market Research Future. “Photodynamic Therapy Markets - Global Forecast 2023-2030.”
[5] Business Wire. "Amgen’s PHOTOFRIN Approved for Additional Indications." 2020.