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Suppliers and packagers for generic pharmaceutical drug: PORFIMER SODIUM
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PORFIMER SODIUM
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: PORFIMER SODIUM
Introduction
Porfimer sodium, marketed globally as Photofrin, is a photosensitizing agent used primarily in photodynamic therapy (PDT) for cancer treatment, especially non-small cell lung cancer, esophageal cancer, and Barrett's esophagus with high-grade dysplasia. Its unique mechanism involves accumulation within cancerous tissues, where activation by specific light wavelengths induces localized cell destruction. The precise procurement and supplier landscape of porfimer sodium are critical for healthcare providers, pharmaceutical companies, and researchers aiming to ensure drug availability, regulatory compliance, and cost-efficiency.
Manufacturers and Key Suppliers of Porfimer Sodium
1. Pinnacle Biomed Ltd.
Based in India, Pinnacle Biomed is among the prominent manufacturers of porfimer sodium. The company produces the drug under strict regulatory standards and supplies its product to various markets, including Southeast Asia and parts of Europe. Pinnacle Biomed emphasizes quality assurance and adheres to Good Manufacturing Practices (GMP), ensuring compliance with international standards. Their production facilities are certified by multiple regulatory agencies, including the Drug Control Administration in India.
2. Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a U.S.-based biopharmaceutical company historically involved in the development and commercialization of various cancer therapies, including porfimer sodium. While Spectrum previously marketed Photofrin (the brand name), its focus has shifted due to market dynamics and regulatory navigations. Spectrum’s involvement in the supply chain has historically included licensing agreements with other manufacturers.
3. DUSA Pharmaceuticals (a division of Sun Pharmaceutical Industries)
DUSA Pharmaceuticals, a U.S. pharmaceutical company, historically held the rights to Photofrin and supplied porfimer sodium for clinical and commercial use. In recent years, DUSA was acquired by Sun Pharmaceutical Industries, one of India’s largest pharma companies, which now potentially supports ongoing production and distribution.
4. International Contract Manufacturers and Distributors
Given the complex supply chain, various international contract manufacturing organizations (CMOs) may produce porfimer sodium under licensing agreements. These include facilities in India, Europe, and Asia that adhere to GMP standards. Some of these organizations supply unbranded versions, primarily for research purposes, with branded versions supplied to specific markets.
Regulatory and Market Dynamics Influencing Supply
United States:
The FDA-approved Photofrin (porfimer sodium) is supplied primarily through DUSA Pharmaceuticals/Sun Pharmaceutical. The drug’s approval status guides supply continuity and market stability. Post-approval, supply disruptions are usually linked to manufacturing issues or regulatory hurdles.
European Union:
In Europe, porfimer sodium is approved under different regulatory regimes, with several authorized suppliers, including Sun Pharmaceutical. The European Medicines Agency (EMA) ensures that manufacturing standards meet the European specifications, influencing supplier diversity.
Emerging and Developing Markets:
India, China, and Southeast Asian countries have expanded local production capabilities of porfimer sodium. Pinnacle Biomed and other regional manufacturers cater to local markets, lowering dependency on Western suppliers and reducing overall procurement costs.
Market Challenges and Supply Reliability
The limited number of approved manufacturers can lead to supply constraints, especially during global disruptions like the COVID-19 pandemic. Additionally, intellectual property rights, licensing agreements, and patent exclusivities dictate market entry and supply options, often restricting rapid market expansion or diversification.
Key Players and Their Market Share
While detailed market share data is proprietary, estimates suggest that DUSA Pharmaceuticals/Sun Pharma maintains the majority of the commercial supply within North America and parts of Europe due to their longstanding regulatory approvals. Indian manufacturers like Pinnacle Biomed, supported by GMP certifications and competitive pricing, serve expanding markets in Asia and other emerging regions. The landscape is further shaped by licensing agreements, regional regulatory approvals, and manufacturing capacities.
Supply Channels and Distribution Networks
Hospitals and Specialty Clinics:
Porfimer sodium is predominantly supplied directly or through specialized medical suppliers to hospitals and clinical centers. These institutions often work closely with authorized distributors who ensure cold chain maintenance during storage and delivery.
Pharmaceutical Distributors:
Authorized distributors for Photofrin or equivalent formulations supply pharmacies, outpatient clinics, and surgical centers. Regulatory compliance and traceability are central to their operations.
Research and Diagnostic Use:
Unbranded or generic versions, often produced by contract manufacturers, are used in research settings. These suppliers might not be FDA or EMA approved but serve internal or trial purposes.
Future Trends and Supplier Outlook
Regulatory Approvals and Patent Expirations:
Pending or recent patent expirations could facilitate entry of generic suppliers, increasing competition and availability. Regulatory approvals in developing regions could broaden the global supplier base, improving supply resilience.
Manufacturing Innovations
Technological advancements in synthesis pathways may lower production costs and enable new players to enter the market. Enhanced sterilization, stability, and shelf life protocols can further broaden supplier options.
Market Expansion
Increased adoption of photodynamic therapy globally, particularly for early-stage cancers, is expected to drive demand. Suppliers investing in scalable manufacturing and reliable distribution channels will be favored in these growth markets.
Conclusion
The supplier landscape for porfimer sodium is characterized by a small group of established manufacturers, primarily DUSA Pharmaceuticals/Sun Pharmaceutical, and regional producers such as Pinnacle Biomed. Market dynamics, regulatory frameworks, and patent protections influence supply diversity and stability. As demand grows and patent protections evolve, new entrants and generic manufacturers are poised to diversify the supplier base, ultimately securing more reliable, cost-effective supply chains.
Key Takeaways
- DUSA Pharmaceuticals/Sun Pharmaceutical remains the primary supplier of porfimer sodium in North America and Europe.
- Indian manufacturers like Pinnacle Biomed are vital for supplying regional markets, especially in Asia and emerging economies.
- Regulatory approvals significantly influence supplier reach and market accessibility.
- Supply stability can be challenged by regulatory changes, patent expirations, and global disruptions.
- Market expansion and technological innovation are likely to increase the number of suppliers, improving affordability and availability.
FAQs
1. Who are the main global manufacturers of porfimer sodium?
The primary manufacturers include DUSA Pharmaceuticals (now part of Sun Pharmaceutical Industries), Pinnacle Biomed in India, and various contract manufacturing organizations globally. Each operates under strict regulatory standards to ensure product quality.
2. Are there generic versions of porfimer sodium available?
While no widespread generic versions are currently marketed in major regions like the U.S. and Europe due to patent protections, regional and unbranded versions produced by contract manufacturers exist mainly for research, and potential patent expirations may facilitate future generics.
3. How does regulation affect the supply of porfimer sodium?
Regulatory approvals by agencies such as the FDA and EMA confirm manufacturing quality and safety, restricting supply to approved manufacturers. Changes in regulations or approval statuses can disrupt or expand supply channels.
4. Can regional manufacturers meet global demand?
Regional manufacturers like Pinnacle Biomed primarily serve local markets, but their capacity can contribute to global supply, especially in developing countries. Large-scale, global manufacturing capacity remains limited to key players.
5. What are the prospects for increased supply diversification?
Upcoming patent expirations, advances in synthesis technology, and greater regional regulatory approvals are expected to facilitate increased diversification, improving supply resilience and lowering costs.
Sources
[1] U.S. Food and Drug Administration (FDA). Photofrin (porfimer sodium) product label.
[2] European Medicines Agency (EMA). Summary of Product Characteristics—Photofrin.
[3] Sun Pharmaceutical Industries Ltd. Corporate disclosures.
[4] Pinnacle Biomed Ltd. Manufacturer information.
[5] Market analysis reports on photodynamic therapy agents.
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