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Suppliers and packagers for PANRETIN
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PANRETIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Advanz Pharma | PANRETIN | alitretinoin | GEL;TOPICAL | 020886 | NDA | Advanz Pharma (US) Corp. | 59212-601-22 | 60 g in 1 TUBE (59212-601-22) | 2019-09-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Panretin
Introduction
Panretin, a trademarked formulation of bexarotene, is an oral capsule prescribed primarily for treating cutaneous T-cell lymphoma (CTCL) in patients who have not responded adequately to other therapies. As a niche oncology treatment, Panretin's supply chain is critical for ensuring uninterrupted patient access. This article examines the key suppliers involved in the manufacturing, distribution, and supply chain of Panretin, along with considerations impacting its availability.
Manufacturers of Panretin (Bexarotene)
Pharmaceutical Originator
The primary producer of Panretin is Ligand Pharmaceuticals Inc., which holds the rights to produce and distribute Bexarotene via licensing agreements with Eisai Co., Ltd.. Eisai originally developed and marketed the drug after approval by the U.S. Food and Drug Administration (FDA) in 2000.
Contract Manufacturing Organizations (CMOs)
In addition to the originator, several CMOs globally may be involved in the synthesis of active pharmaceutical ingredients (APIs) and formulation of Panretin capsules. These organizations often operate under strict Good Manufacturing Practices (GMP) to ensure quality and regulatory compliance. Key contract manufacturers include:
- Catalent Pharma Solutions
- Boehringer Ingelheim
- Samsung Biologics
While publicly available data does not explicitly detail their involvement in Panretin's manufacturing, these CMOs are known for handling similar oncology drugs, and some may have manufacturing agreements with Ligand or Eisai.
Raw Material Suppliers
The API, bexarotene, is synthesized through complex organic chemistry processes involving multiple precursor chemicals. Suppliers of precursor chemicals are typically based in China, India, and Europe, given their large-scale chemical manufacturing industries. Notable suppliers include:
- Sigma-Aldrich (Merck Group)
- Alfa Aesar (Thermo Fisher Scientific)
- Taj Pharmaceuticals (India)
The procurement process for APIs involves rigorous quality checks, as APIs are critical to drug efficacy and safety.
Distribution Channels and Wholesalers
Pharmaceutical Distributors
Post-manufacture, Panretin is distributed through a network of wholesalers who supply hospitals, clinics, and specialty pharmacies. Major pharmaceutical distributors include:
- McKesson Corporation
- AmerisourceBergen Corporation
- Cardinal Health
These distributors are responsible for maintaining supply chain integrity, managing inventory, and ensuring compliance with regulatory standards.
Specialty Pharmacies
Due to Panretin's niche application, it is primarily dispensed through specialty pharmacies equipped to handle complex oncology medications. These entities often work directly with manufacturers or distributors to procure the drug and provide patient-specific support.
Supply Chain Challenges and Considerations
Regulatory Compliance
The manufacturing and distribution of Panretin are heavily regulated by agencies such as the FDA, EMA, and equivalent global authorities. These bodies impose stringent quality controls to prevent contamination, ensure stability, and verify bioequivalence, which affects sourcing and manufacturing logistics.
Supply Risks
Dependence on a limited number of manufacturing facilities and API suppliers increases vulnerability. Factors contributing to supply disruption include regulatory delays, raw material shortages, geopolitical tensions, and manufacturing capacity constraints.
Market Demand Dynamics
As a treatment targeting a rare disease—CTCL—Panretin’s demand remains relatively stable but limited. This niche market influences supply chain decisions, often prioritizing quality over volume, and results in potential bottlenecks if manufacturing scales are not maintained.
Emerging Trends and Future Outlook
Orphan Drug Designation and Manufacturing Incentives
Under orphan drug status, Panretin benefits from regulatory incentives like market exclusivity and tax credits, which may influence manufacturing investment and supplier stability. Such policies encourage existing suppliers to maintain or expand production capacity, ensuring supply security.
Generic and Biosimilar Development
Currently, no approved generic versions of Panretin are on the market. The absence of biosimilars reflects the complexity of API manufacturing and patent protections, which restrict competition and influence supplier options.
Potential for Supply Diversification
To mitigate supply risks, stakeholders are exploring alternate sourcing of APIs and partnering with regional manufacturers to diversify supply chains, enhancing resilience.
Key Takeaways
- Primary manufacturers of Panretin are licensed to Ligand Pharmaceuticals and Eisai, with API synthesis potentially handled by global chemical suppliers.
- Distribution is managed through major wholesalers (McKesson, AmerisourceBergen, Cardinal Health) and specialty pharmacies.
- API suppliers are predominantly based in Asia and Europe, selected for their quality and capacity, but sourcing risks remain.
- Supply chain vulnerabilities stem from regulatory, geopolitical, and capacity constraints, necessitating diversification and strategic inventory management.
- Future prospects include potential expansion of manufacturing capacity, continued reliance on licensed producers, and exploration of biosimilars or generics, though regulatory development remains a barrier.
FAQs
1. Who are the main manufacturers of Panretin?
The primary manufacturer is Ligand Pharmaceuticals, which licenses manufacturing rights to Eisai Co., Ltd. Additionally, contract manufacturing organizations worldwide may produce the API and formulation components under strict regulatory standards.
2. Are there alternative suppliers for Bexarotene’s active ingredient?
While API procurement is concentrated among select chemical suppliers, multiple manufacturers in Asia and Europe supply precursor chemicals. However, the synthesis of bexarotene is complex, and high-quality sources are limited, maintaining a concentrated supplier base.
3. How is Panretin distributed globally?
Distribution involves pharmaceutical wholesalers such as McKesson, AmerisourceBergen, and Cardinal Health, with specialty pharmacies providing the final dispense point, especially within developed markets like the U.S. and Europe.
4. What factors could disrupt Panretin’s supply chain?
Regulatory delays, raw material shortages, geopolitical issues, and manufacturing capacity challenges can disrupt supply. The niche market size also limits buffering capacity against such disruptions.
5. Are biosimilars or generics expected for Panretin?
Currently, no biosimilar or generic versions are approved or marketed, primarily due to patent protections and the complexity of API manufacturing. Future regulatory or patent landscape changes could influence this.
References
- U.S. Food and Drug Administration (FDA). Bexarotene Capsules – Prescribing Information. 2000.
- Ligand Pharmaceuticals. Licensing and Manufacturing Agreements. [Online] Available at: [Ligand Official Website]
- McKesson Corporation. Product Distribution Network. [Online] Available at: [McKesson Official Website]
- Sigma-Aldrich. API and Chemical Precursors. [Online] Available at: [Sigma-Aldrich Website]
- European Medicines Agency (EMA). Guidelines on Pharmaceutical Supply Chain Security.
In conclusion, maintaining a robust and diverse supply chain for Panretin hinges on strategic collaborations among licensed manufacturers, reliable API sources, and efficient distribution networks. Continued investment in supply security, coupled with regulatory compliance, will be crucial in ensuring uninterrupted access to this vital oncology therapy.
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